JP4013076B2 - Solid pharmaceutical composition for external use - Google Patents

Description

  The present invention relates to a solid external pharmaceutical composition that is excellent in feeling of use and stability and can exhibit an excellent pharmacological effect.

  For the treatment of skin diseases such as eczema, inflammation, rash and rash, creamy external preparations containing pharmacologically active ingredients such as anti-inflammatory agents, antihistamines, and corticosteroids are used (for example, Patent Document 1). To 3). However, the creamy external preparation has a drawback that the applied part is difficult to dry, and there is a problem that a sufficient pharmacological effect cannot be obtained for a skin disease exhibiting a wet-type symptom. Furthermore, the creamy external preparation has inconveniences in use such as the application site being sticky.

  On the other hand, it is known that powder components such as talc and corn starch are effective for treatment of skin diseases exhibiting wet-type symptoms (see Patent Document 4). However, these powder components alone can dry the affected area of the skin, but cannot exert pharmacological actions such as anti-inflammatory and analgesia.

  Therefore, in order to enhance the therapeutic effect of skin diseases, it is effective to dry the affected area with the powder component and at the same time exert the pharmacological action of the pharmacologically active component with the external preparation containing the pharmacologically active component and the powdered component. It is believed that.

  However, it has been found that when a pharmacologically active ingredient and a powder ingredient are prepared as a creamy external preparation, the drying effect by the powder ingredient becomes insufficient and the desired effect cannot be obtained. In addition, it is possible to prepare a pharmacologically active ingredient and a powder component as a powdery external preparation, but the powdery external preparation has a problem in terms of hygiene because it causes powder scattering during use.

  On the other hand, by formulating as a solid external preparation containing an oily base together with a pharmacologically active ingredient and a powder component, the problems of the creamy and powdery external preparations can be solved. A solid external preparation containing a powder component has the disadvantage that oil floats during storage and is inferior in stability over time. Furthermore, in the above-mentioned solid oily external preparation, it is difficult to take out an appropriate amount of the external preparation, the external preparation is poorly slid on the skin, it is difficult to form a uniform application surface, the external preparation is sticky on the skin, etc. There is also a drawback in terms of usability.

Against the background of such conventional technology, there has been a demand for the development of a solid oily external preparation that contains a pharmacologically active ingredient and a powder component, has excellent pharmacological effects, and is excellent in stability and usability.
JP-A-55-87713 Japanese Patent Publication No.56-3339 Japanese Patent Laid-Open No. 5-286860 JP 2002-68986 A

  Accordingly, an object of the present invention is to solve the above-described problems of the prior art. Specifically, the present invention provides a solid external pharmaceutical composition that has a pharmacologically active component and a powder component, has excellent stability and usability, and can exhibit excellent pharmacological effects. For the purpose.

  As a result of diligent studies to solve the above problems, the present inventors formulated a combination of (A) a pharmacologically active ingredient, (B) a metal soap, (C) a powder ingredient, (d) a wax and (E) a liquid oil. The solid pharmaceutical composition for external use has no change in properties such as oil floating even when stored for a long period of time, has excellent stability over time, has a good feeling in use, and has excellent pharmacological effects. I found. The present invention has been completed by making further improvements based on these findings.

That is, this invention provides the solid external pharmaceutical composition hung up below, and its manufacturing method:
Item 1. A solid external pharmaceutical composition comprising (A) a pharmacologically active ingredient, (B) a metal soap, (C) a powder ingredient, (D) a wax and (E) a liquid oil.
Item 2. Item (A) The external pharmaceutical composition according to Item 1, wherein the pharmacologically active ingredient is at least one selected from the group consisting of an anti-inflammatory agent, an antihistamine, an antibacterial agent, a local anesthetic, an astringent, and vitamins.
Item 3. (B) The external pharmaceutical composition according to Item 1, wherein the metal soap is a salt of stearic acid.
Item 4. Item (C) The external pharmaceutical composition according to Item 1, wherein the powder component is two or more selected from the group consisting of corn starch, talc and titanium oxide.
Item 5. Item (D) The external pharmaceutical composition according to Item 1, wherein the wax is at least one selected from the group consisting of carnauba wax, ceresin, microcrystalline wax, and petrolatum.
Item 6. (E) The liquid oil is at least one selected from the group consisting of isocetyl isostearate, isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, squalane, liquid paraffin, and light liquid paraffin. Topical pharmaceutical composition.
Item 7. Any of items 1 to 6, wherein the hardness measured by the rheometer is 50 to 750 g / mm ² (measurement conditions: specimen temperature 25 ° C., needle diameter of pressure-sensitive shaft 3 mmφ, penetration speed 20 mm / min, penetration length 1 mm) An external pharmaceutical composition according to claim 1.
Item 8. Solid external medicine containing (A) pharmacologically active ingredient, (B) metal soap, (C) powder ingredient, (D) wax and (E) liquid oil, comprising the following steps (1) to (3) Method for producing the composition:
Step (1) (B) A step of obtaining a translucent gel mixture by mixing metal soap, (D) wax and (E) liquid oil while heating to 90 ° C. or higher,
Step (2) A mixture containing the components (A) to (E) by adding the (A) pharmacologically active component and the (C) powder component to the translucent gel-like mixture obtained in the step (1). And (3) a step of cooling the mixture obtained in the step (2) to obtain a solid external pharmaceutical composition.

  The present invention is described in detail below.

  The pharmaceutical composition for external use of the present invention is solid and contains (A) a pharmacologically active ingredient, (B) a metal soap, (C) a powder ingredient, (D) a wax and (E) a liquid oil. To do.

The (A) pharmacologically active ingredient used in the external pharmaceutical composition of the present invention is not particularly limited as long as it is applied transdermally and exhibits a pharmacological action. Examples of the pharmacologically active ingredient include anti-inflammatory agents, antihistamines, antibacterial agents, local anesthetics, astringents, vitamins and the like. Specific examples of these pharmacologically active ingredients include the following:
Anti-inflammatory agents : for example, bufexamac, ibuprofen piconol, suprofen, ufenamate, indomethacin, piroxicam, ampiroxicam, meloxicam, lornoxicam, benzadac, ketoprofen, ibuprofen, flurbiprofen, naproxen, loxoprofen, aluminoprofen, sodium , Sulindac, flufenamic acid, mefenamic acid, tolfenamic acid, glycyrrhetinic acid and its salt, glycyrrhizic acid and its salt, glycolic salicylate, methyl salicylate, and other nonsteroidal anti-inflammatory agents; dexamethasone, triamcinolone acetonide, beclomethasone propionate, succinic acid Hydrocortisone, methyl succinate, prednisolone, dexamethasone acetate, hydride acetate Cortisone, prednisolone acetate, dexamethasone metasulfonate benzoic acid, triamcinolone diacetate, prednisolone butyl acetate, dexamethasone phosphate, hydrocortisone phosphate, prednisolone phosphate, betamethasone phosphate, prednisolone succinate, cortisone acetate, parameterzone acetate, methylprednisolone acetate, Triamcinolone, hydrocortisone, prednisolone, betamethasone, prednisolone acetate valerate, diflucortron valerate, dexamethasone valerate, betamethasone valerate, diflupredone acetate, diflorazone acetate, diflupredonate, betamethasone dipropionate, fluocinozone pivalate, fluocinozone pivalate Fluocinolone acetonide, alcromethasone propionate, beclomethasone propionate Clobetasone butyrate, hydrocortisone butyrate, butyrate propionate hydrocortisone, fludrocortisone acetate, palmitate dexamethasone, etc. steroidal anti-inflammatory agents such as methylprednisolone.
Antihistamines: for example, chlorpheniramine, diphenhydramine, diphenylpyralin, cyproheptadine, triprolysine, promethazine, homochlorcyclidine, alimemazine, clemastine, methazine and their salts.
Antibacterial agents : For example, benzylamine antibacterial agents such as butenafine and its salts; Antibacterial agents; allylamine antibacterial agents such as terbinafine and its salts; morpholine antibacterial agents such as amorolfine and its salts; thiocarbamic acid antibacterial agents such as rilanaphthate, tolnaftate and tolsiclate; nystatin, tricomycin, variotin, siccanin, pyrrolnitrile Antibacterial agents such as antibiotics.
Local anesthetics : for example lidocaine, procaine, ethyl aminobenzoate, dibucaine, mepivacaine, salts or derivatives thereof; coal tar, carboxylic acid, naphthol, menthol, thymol, salicylic acid, chloral hydrate, aconitine, tannin and the like.
Astringents : for example, zinc oxide, tannic acid, aluminum sulfate, potassium aluminum sulfate, zinc sulfide, azulene, calamine, lead acetate, bismuth nitrate.
Vitamins : For example, vitamin A or a derivative thereof, vitamin C or a derivative thereof, vitamin E or a derivative thereof, pantothenic acid or a derivative thereof, vitamin D or a derivative thereof, and the like.

  These pharmacologically active ingredients may be used alone or in combination of two or more.

  In particular, when preparing the pharmaceutical composition for external use of the present invention as a therapeutic agent for skin diseases exhibiting wet-type symptoms, (A) as a pharmacologically active ingredient, an anti-inflammatory agent (particularly a nonsteroidal anti-inflammatory agent) and It is effective to use a combination of antihistamines. By using such a pharmacological component, the pharmacological action by the pharmacologically active ingredient and the drying action of the affected part by the powder component are combined and it is possible to further improve the therapeutic effect of the skin disease.

  In the external pharmaceutical composition of the present invention, the blending ratio of the pharmacologically active ingredient (A) depends on the type of the pharmacological ingredient to be used, the form of the composition, the age and sex of the target patient, the expected pharmacological effect, etc. Although different, for example, 0.02 to 20% by weight, preferably 0.1 to 15% by weight, and more preferably 0.2 to 10% by weight with respect to the total weight of the composition.

  Further, for example, when an anti-inflammatory agent and an antihistamine are blended as the (A) pharmacologically active ingredient, the anti-inflammatory agent is 0.01 to 10% by weight and the antihistamine is 0.01% with respect to the total weight of the external pharmaceutical composition. ~ 10% by weight; preferably 0.05 to 7.5% by weight of anti-inflammatory agent and 0.05 to 7.5% by weight of antihistamine; more preferably 0.1 to 5% by weight of anti-inflammatory agent and 0.1 to 5% by weight of antihistamine Is exemplified.

  The (B) metal soap contained in the pharmaceutical composition for external use of the present invention is a metal salt such as higher fatty acid, resin acid, naphthenic acid (excluding alkali metal salt), specifically, aluminum stearate. Stearates such as magnesium stearate, zinc stearate, calcium stearate; myristates such as aluminum myristate, magnesium myristate, zinc myristate, calcium myristate; aluminum laurate, magnesium laurate, zinc laurate, Examples include lauric acid such as calcium laurate; palmitate such as aluminum palmitate, magnesium palmitate, zinc palmitate, calcium palmitate, and the like. Among these metal soaps, stearates are preferable, and aluminum stearate and magnesium stearate are more preferable. These metal soaps may be used alone or in combination of two or more. By adopting these metal soaps, oil floating and the like are suppressed, and it becomes possible to have more excellent stability, and by adjusting the hardness of the external pharmaceutical composition appropriately, an appropriate amount of the external pharmaceutical composition It becomes possible to make it easier to take an object with a finger.

  The blending ratio of the metal soap varies depending on the type of the metal soap used, the form of the external pharmaceutical composition, the type and amount of the powder component used, etc., and cannot be uniformly defined. The proportion of the metal soap is usually 0.1 to 10% by weight, preferably 0.5 to 5% by weight, more preferably 1 to 3% by weight, based on the total weight. If it is in the above-mentioned range, a pharmaceutical composition for external use can be obtained which is stable without oil floating over time and has a good usability.

  Further, the powder component (C) contained in the external pharmaceutical composition of the present invention is not particularly limited as long as it is a pharmaceutically acceptable and applicable to the skin and is a water-insoluble powder component. . Specific examples of powder components include starch such as corn starch, potato starch and wheat starch, talc, mica, sericite, kaolin, barium sulfate, aluminum oxide, titanium oxide, silica, barium sulfate, calcium carbonate, bengara, yellow Illustrative examples include iron oxide, black iron oxide, gunjo, nylon, methyl methacrylate, silicon resin, silicon rubber, and cellulose. These powder components are used alone or in combination of two or more.

  In the pharmaceutical composition for external use of the present invention, it is desirable to use two or more kinds selected from the group consisting of corn starch, talc and titanium oxide as the powder component. In particular, the combined use of talc and titanium oxide is desirable. By using two or more kinds of powder components in combination in such a manner, it is possible to further improve the formation of a smooth application surface in the affected skin area and slippage in the affected skin area when the external pharmaceutical composition is applied. it can. Thus, when using two or more kinds of powder components together, the combination ratio of each powder component is not limited, but the following combination ratio is exemplified as an example: talc and titanium oxide are used in combination. In this case, 1 to 30 parts by weight, preferably 5 to 25 parts by weight of titanium oxide with respect to 100 parts by weight of talc; if corn starch and titanium oxide are used in combination, 100 parts by weight of corn starch On the other hand, titanium oxide is 1 to 30 parts by weight, preferably 5 to 30 parts by weight.

  About the ratio of the powder component contained in the external pharmaceutical composition of this invention, it sets suitably according to the kind of powder component to be used, the form of this composition, etc. As an example of the blending ratio of the powder component, the total amount of the powder component is usually 20 to 70% by weight, preferably 25 to 60% by weight, more preferably 30 to 50% by weight, based on the total weight of the external pharmaceutical composition. The ratio becomes. If the powder component is contained within the above range, it exerts an excellent drying action on the affected skin area, and is easy to remove the external pharmaceutical composition with fingers, slips on the affected skin area, and has a smooth applied surface. In terms of formation and the like, it becomes favorable and an excellent feeling of use can be obtained.

  In addition, the external pharmaceutical composition of the present invention contains (D) wax as an oily base component. The wax used in the present invention is not particularly limited as long as it is solid at ordinary temperature and is pharmaceutically acceptable and can solidify an external pharmaceutical composition. Specific examples of the wax include plant waxes such as carnauba wax, candelilla wax, rice wax, molasses, jojoba oil; animal waxes such as beeswax, gay wax, lanolin wax, shellac, minchiro; solid paraffin, microcrystalline wax, Petroleum waxes such as petroleum jelly; mineral waxes such as ceresin, montan wax, ozokerite, hectorite, bentonite, montmorillonite; higher alcohols such as stearyl alcohol, behenyl alcohol, cetanol; myristic acid, palmitic acid, stearic acid, behenic acid, etc. And higher fatty acids. These waxes can be used singly or in combination of two or more. Among these, carnauba wax, ceresin, microcrystalline wax, and petrolatum are preferable.

  About the ratio of the wax contained in the external pharmaceutical composition of this invention, it sets suitably according to the kind of wax to be used, the form of this composition, the hardness of this composition, etc. For example, the proportion of the wax is 1 to 20% by weight, preferably 2 to 15% by weight, more preferably 3 to 10% by weight based on the total weight of the external pharmaceutical composition Is mentioned. When the powder component is contained within the above range, it is possible to impart a desired hardness to the external pharmaceutical composition and to provide a solid form.

  Furthermore, the pharmaceutical composition for external use of the present invention further contains (E) liquid oil as an oily base. By containing liquid oil as the oily base, the stability and feeling of use of the external pharmaceutical composition of the present invention can be further improved. Here, the liquid oil may be any of plant-based, animal-based and petroleum-based oils as long as it is liquid at 20 ± 5 ° C. Whether or not it is liquid at 20 ± 5 ° C is determined by the dangerous goods confirmation test implementation manual, Chapter 3, other confirmation methods. It can be confirmed according to liquid confirmation [New Japan Law Publishing Co., Ltd., dangerous goods technology study group, p91-92]. Specific examples of liquid oils include isocetyl isostearate, isopropyl isostearate, isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, (capryl capric acid) glycerin, diisopropyl adipate, ethyl oleate, octyldodecanol, Squalane, liquid paraffin, light liquid paraffin, liquid lanolin, dimethylpolysiloxane, methylphenylpolysiloxane, cyclic silicone, olive oil, jojoba oil, castor oil, avocado oil, almond oil, cacao oil, sesame oil, safflower oil, soybean oil, Examples are camellia oil, persic oil, mink oil, cottonseed oil, coconut oil and egg yolk oil. These liquid oil agents can be used alone or in combination of two or more. Among these, isocetyl isostearate, isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, squalane, liquid paraffin, and light liquid paraffin are preferable.

  When blending liquid oil, the blending ratio varies depending on the type of liquid oil used, the form and hardness of the composition, etc., and cannot be specified uniformly, but for example, relative to the total weight of the external pharmaceutical composition The ratio of the liquid oil is 20 to 70% by weight, preferably 25 to 65% by weight, more preferably 30 to 60% by weight.

  In the pharmaceutical composition for external use of the present invention, a moisturizer, a fragrance, a colorant, a refreshing agent, an essential oil component, if necessary, in addition to the above-described blending components, as long as the effects of the present invention are not hindered. Warmth, thermal components, extracts, surfactants, solvents, solubilizers, pH adjusters, buffers, bases, foaming agents, antifoaming agents, emulsifiers, suspension agents, softeners, thickeners, dispersants , Excipients, lubricants, antioxidants, preservatives, preservatives, plasticizers, and other optional components may be blended in appropriate amounts.

The external pharmaceutical composition of the present invention is solid, and the hardness thereof is not particularly limited as long as it can be used as an external pharmaceutical composition. From the viewpoint of ease of use of the pharmaceutical composition for external use with a finger and good usability such as slipping on the affected skin, the hardness is 50 to 750 g / mm ² , preferably 75 to 650 g / mm ² , Preferably it is 100-550 g / mm ² . In the present invention, the hardness of the solid composition is measured using a rheometer (CR-500DX; manufactured by San Kagaku Co., Ltd.) at a specimen storage temperature of 25 ° C., a maximum load of 2 kg, a pressure sensitive shaft (adapter) needle diameter of 3 mmφ, and a table. This is the load (g / mm ² ) applied to the pressure sensitive shaft when the pressure sensitive shaft is pushed down to a depth of 1 mm in the penetration test at a moving speed of 20 mm / min.

  The topical pharmaceutical composition of the present invention is a rash, rash, diaper rash, itch, itch, worm, dermatitis, eczema, pruritus, prurigo, itch, hives, sunburn, hot flashes, itching, itching, athlete's foot, It is used as a therapeutic agent for skin diseases such as sea urchins, silkworms and peanuts. In particular, since the external pharmaceutical composition of the present invention can exhibit a combination of the pharmacological action by the pharmacologically active ingredient and the drying action of the affected skin part by the powder ingredient, skin diseases exhibiting particularly wet-type symptoms (for example, It is also highly useful as a therapeutic agent for rashes, rashes, diaper rashes, athlete's foots, and insects.

The pharmaceutical composition for external use of the present invention can be produced according to a conventional method by blending the above-described components. In particular, in order to produce a pharmaceutical composition for external use which has no oil floating and is more excellent in stability over time, it is desirable to produce it according to the following steps (1) to (3):
Step (1) (B) A step of obtaining a translucent gel mixture by mixing metal soap, (D) wax and (E) liquid oil while heating to about 90 ° C. or higher, preferably 90 to 110 ° C. ,
Step (2) To the translucent gel mixture obtained in the step (1), (A) a pharmacologically active ingredient, (C) a powder ingredient and other optional ingredients are added and mixed, and (A) to (A E) a step of obtaining a mixture containing the component, and step (3) a step of cooling the mixture obtained in the step (2) to obtain a solid external pharmaceutical composition.

  Note that the mixing in step (2) of the above production method is preferably performed in a reduced-pressure atmosphere. Examples of such a reduced pressure atmosphere include 50 mmHg to 400 mmHg, preferably 50 mmHg to 300 mmHg.

  Since the pharmaceutical composition for external use of the present invention exhibits a pharmacological action based on a pharmacologically active ingredient and a drying action on an affected skin part based on a powder ingredient, the therapeutic effect on skin diseases is excellent.

In addition, the pharmaceutical composition for external use of the present invention has the following excellent effects in terms of stability and feeling of use:
(i) Excellent stability over time, and no property change such as oil floatation is observed even after storage.
(ii) In use, an appropriate amount of the external pharmaceutical composition can be easily taken with a finger.
(iii) The sliding of the external pharmaceutical composition is good in the affected skin area, and a uniform coated surface of the composition can be easily formed.
(iv) In the affected skin area, there is no stickiness and a smooth application surface can be formed.
(v) Since it is solid and is applied by spreading on the affected area by hand, it can be used in a sanitary manner without containing components scattered during application.

  EXAMPLES Hereinafter, although a test example and an Example are given and this invention is demonstrated, this invention is not limited to these Examples. In addition, unless otherwise indicated, the unit of the numerical value shown in the following table | surfaces is a weight (g).

Test Example 1 Usability and Evaluation of Stability A solid external pharmaceutical composition (Example 1-6 and Comparative Example 1-10) having a formulation shown in Tables 1 and 2 was prepared. The hardness according to the rheometer measurement value of each external pharmaceutical composition was measured under the following conditions: Measurement conditions: rheometer (CR-500DX; manufactured by San Kagaku Co., Ltd.), specimen storage temperature 25 ° C., needle diameter of pressure sensitive shaft 3 mmφ, Needle penetration speed 20mm / min, needle penetration length 1mm, maximum load 2kg.

In addition, the stability and feeling of use of each external pharmaceutical composition were evaluated according to the following methods.
(1) Stability Evaluation Method Each external pharmaceutical composition (about 10 g) filled in a container was stored for 1 week under conditions of 40 ° C. and 75% relative humidity. After storage, the external appearance property of each external pharmaceutical composition was visually confirmed and judged according to the following evaluation criteria.
<Stability evaluation criteria>
○: No oil floating is observed on the surface of the external pharmaceutical composition.
X: Oil floating is recognized on the surface of the external pharmaceutical composition.

(2) Evaluation method of feeling of use Twelve subjects (10 healthy subjects and 2 patients with wet skin disease) evaluated the feeling of use of each external pharmaceutical composition by the following method. Specifically, an appropriate amount of each external pharmaceutical composition was taken with a finger and applied to the inside of the elbow. Each subject has (1) ease of taking each external pharmaceutical composition, (2) degree of slipping on the skin when applying each external pharmaceutical composition, and (3) each external use formed on the skin. The smooth feeling of the coated surface of the pharmaceutical composition was determined in five levels: “good”, “slightly good”, “normal”, “slightly bad”, and “bad”. The obtained determination results for each subject were statistically processed according to the following criteria to evaluate the feeling of use of each external pharmaceutical composition.
<Evaluation criteria for usability>
○: 9 or more people who answered “good” “somewhat good” Δ: 5-8 people who answered “good” “somewhat good” ×: “good” The number of people who answered "Slightly good" is 4 or less.

  The obtained results are shown in Tables 1 and 2. From these results, it can be seen that the external pharmaceutical composition (Example 1-6) of the present invention is excellent in stability even when stored at 40 ° C., with no change in appearance such as oil floating. It was. Furthermore, the pharmaceutical composition for external use (Examples 1-6) of the present invention has (1) excellent ease of taking with a finger, (2) good degree of slipping on the skin, and uniform It was confirmed that the coated surface can be easily formed, and that (3) the coated surface is formed on the skin, and that the feeling of use is also good.

  On the other hand, it was confirmed that the external pharmaceutical composition of Comparative Example 1-10 cannot have both excellent stability and good usability.

Test Example 2 Examination of Production Method A solid external pharmaceutical composition (Example 7) shown in Table 3 was produced according to the following method. That is, in a vacuum emulsifier, aluminum stearate (component (B)), ceresin (component (D)), light liquid paraffin (component (E)), squalane (component (E)), and isocetyl isostearate (( A predetermined amount of component E) was mixed and stirred while heating to 100 ° C. under atmospheric pressure to prepare a translucent gel-like mixture. Next, after this gel-like mixture was cooled to 80 ° C., it was added to bufexamac (component (A)), chlorpheniramine maleate (component (A)), tocopherol acetate (component (A)), talc. (Component (B)), titanium oxide (component (B)), and silica (component (B)) were added in predetermined amounts, the pressure was reduced to 100 mmHg, and the mixture was stirred at 80 ° C. for 60 minutes. Next, a solid external pharmaceutical composition (Example 7) was produced by filling the mixture thus obtained in a predetermined container and cooling.

  The solid external pharmaceutical composition produced by the above-mentioned method is extremely stable with no change in appearance such as floating even when stored for 1 week under severe conditions of 50 ° C. and 60% relative humidity. It turns out that it has sex.

Claims (9)

(A) pharmacologically active ingredient, (B) metal soap, (C) powder ingredient, (D) wax and (E) liquid oil, and with respect to the total weight of the external pharmaceutical composition,
(B) 0.1 to 10% by weight of metal soap, and
(D) 3 to 10% by weight of wax
A solid external pharmaceutical composition characterized by containing.   The external pharmaceutical composition according to claim 1, wherein (A) the pharmacologically active ingredient is at least one selected from the group consisting of an anti-inflammatory agent, an antihistamine, an antibacterial agent, a local anesthetic, an astringent, and vitamins. .   (B) The external pharmaceutical composition according to claim 1, wherein the metal soap is a salt of stearic acid.   (C) The external pharmaceutical composition according to claim 1, wherein the powder component is two or more selected from the group consisting of corn starch, talc and titanium oxide.   The external pharmaceutical composition according to claim 1, wherein the wax (D) is at least one selected from the group consisting of carnauba wax, ceresin, microcrystalline wax, and petrolatum.   (E) The liquid oil is at least one selected from the group consisting of isocetyl isostearate, isopropyl myristate, octyldodecyl myristate, isopropyl palmitate, squalane, liquid paraffin, and light liquid paraffin. The external pharmaceutical composition as described. (A) 0.02 to 20% by weight of pharmacologically active ingredient, (C) 20 to 70% by weight of powder component, and (E) 20 to 70% by weight of liquid oil based on the total weight of the external pharmaceutical composition The external pharmaceutical composition according to any one of claims 1 to 6. Rheometer measurements by hardness 50 to 750 g / mm ² (Measurement conditions: sample temperature 25 ° C., sensitive application shaft needle diameter 3 mm.phi, penetration rate of 20 mm / min, needle Iricho 1mm) which is, of claims 1 to 7 The external pharmaceutical composition in any one. Solid external medicine containing (A) pharmacologically active ingredient, (B) metal soap, (C) powder ingredient, (D) wax and (E) liquid oil, comprising the following steps (1) to (3) Method for producing the composition:
Step (1) (B) Metal soap in an amount corresponding to 0.1 to 10% by weight based on the total weight of the external pharmaceutical composition , (D) 3 to 10% by weight based on the total weight of the external pharmaceutical composition A step of obtaining a translucent gel-like mixture by mixing the wax corresponding to the above and (E) liquid oil while heating to 90 ° C. or higher,
Step (2) A mixture containing the components (A) to (E) by adding the (A) pharmacologically active component and the (C) powder component to the translucent gel mixture obtained in the step (1). And (3) a step of cooling the mixture obtained in the step (2) to obtain a solid external pharmaceutical composition.