JP5301205B2 - Gel ointment composition - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a gel ointment targeting the mitigation or the like of pain at laser therapy. <P>SOLUTION: The gel ointment contains (1) an external medicament, (2) one or a combination of propylene carbonate, N-methyl-2-pyrrolidone and polyoxyethylene hydrogenated castor oils in which the average molar number of the added ethylene oxide is &ge;40, and which is miscible with water, (3) a surfactant, (4) an adhesive high-molecular polymer and (5) water, and is in a suspended state. Preferably, the external medicament is a local anesthetic such as lidocaine. <P>COPYRIGHT: (C)2010,JPO&amp;INPIT

Description

  The present invention relates to a gel ointment. More specifically, the present invention relates to a highly adhesive gel ointment (composition) for local anesthesia for the purpose of pain relief during laser therapy.

In recent years, laser therapy has been widely used in the skin treatment field. Since laser therapy has the property of being selectively absorbed by melanin pigments, it has been applied to topical skin treatment and has achieved remarkable therapeutic effects. In particular, the therapeutic effects on Ota nevus and tattoos, senile pigment spots, moles, buckwheat, warts and the like are remarkable. Laser therapy is less invasive than general surgical therapy, and depending on the affected area, laser irradiation can be repeated. However, it is necessary to perform anesthesia because the patient is painful at the time of laser irradiation. However, if the general anesthesia is performed each time, the physical burden is large. Therefore, in many cases, a local anesthetic preparation is administered before the treatment.
As a local anesthetic preparation used to relieve pain during this laser therapy, external preparations (liquids, jellies, sprays, ointments, etc.) that are currently marketed and are used for mucosal surface anesthesia such as during endoscope insertion Although diverted and used, it cannot be said that the effect is sufficient for application to the skin surface. In addition, when a local anesthetic for application (tape preparation containing 60% lidocaine: application is pain relief at the time of venous indwelling needle puncture) is used for the purpose of alleviating this pain, a sufficient effect is not obtained similarly. Is the current situation.
Under these circumstances, some medical facilities have reported in-hospital formulations of ointments containing local anesthetics as active ingredients (Non-patent Document 1).
Hospital pharmacy preparation (5th edition) P186-P188

  As described above, several local anesthetic preparations are provided in laser therapy, but many problems have been recognized such as insufficient effect. That is, since laser therapy is generally performed on the surface of normal skin, it is necessary to penetrate and absorb normal skin when a preparation for pain relief during laser irradiation is administered to the skin. However, since percutaneous absorption from normal skin is generally difficult, in order to obtain a rapid and sufficient local anesthetic effect, a preparation containing a local anesthetic at a constant high concentration is required. In consideration of better percutaneous absorption, the preparation is required to contain a local anesthetic in a dissolved state at a high concentration. However, in the case of a poorly soluble local anesthetic, it is difficult to prepare a preparation in a dissolved state at a high concentration. Even if it is dissolved using a solvent having a high ratio of alcohols and polyols, the local anesthetic If the solubility is not sufficient, crystals of the local anesthetic will precipitate, which may cause problems with the stability of the formulation. In addition, when a high concentration of alcohols or polyols is contained in a solvent, there is a possibility that a problem may arise in safety including skin irritation caused by the solvent.

Therefore, it is conceivable to use suspension preparations that do not use alcohols or polyols, as in the hospital preparations prepared in some medical facilities. In the case of suspension preparations, It is generally known that stability, onset of action, persistence, and strength of effects are not satisfactory.
In addition, for example, in the case of an ointment, since it is applied relatively thickly to the application site, an ordinary formulation is poor in adhesion and tends to drop off.
Further, the tape agent has a problem that it is easy to cause a rash, and the hair portion is not easy to use.

  Thus, the problem to be solved by the present invention is that a local anesthetic can be stably contained at a high concentration, and the uniformity / stability of the preparation, the onset of action, the sustainability, and the strength of the effect are satisfactory. An object of the present invention is to provide a local anesthetic for the purpose of pain relief at the time of laser therapy in the form of an ointment with high adhesion.

  As a result of intensive studies to provide an adhesive ointment that can be applied clinically for the purpose of alleviating pain during laser therapy, the inventors of the present invention have a high solubility in a local anesthetic and a small amount. Use a specific solubilizing (dispersing) agent that can completely dissolve high concentrations of local anesthetics, and then mix the dissolved local anesthetics with a gel-based base prepared from water and an adhesive polymer. As a result, the solubility of the local anesthetic was lowered, thereby finding a gel ointment in which the local anesthetic particles were in a fine suspended state, and the present invention was completed.

That is, the present invention completely dissolves a local anesthetic once using a solubilizing (dispersing) agent, re-disperses it in a gel-like base comprising water and an adhesive polymer containing a surfactant, A gel ointment for local anesthesia in which an anesthetic is in a stable suspension state is provided. Specifically, any one of propylene carbonate, N-methyl-2-pyrrolidone, and polyoxyethylene hydrogenated castor oil miscible with water having an average addition mole number of ethylene oxide of 40 or more, or a combination thereof , Using a small amount capable of completely dissolving the local anesthetic, dissolve the local anesthetic once, and in a gel-like base prepared separately with water and an adhesive polymer containing a surfactant, It has been discovered that by introducing a local anesthetic solution, it is possible to create a very fine suspension state of local anesthetic particles. When the gel ointment obtained in this way is actually used for pretreatment with laser therapy, it has been shown that it has a significant pain relieving effect that has never been seen before, and the effect is manifested in a short time. Excellent results were also observed in the strength and duration of the treatment, and a uniform and stable effect was maintained in the applied affected area. In addition, there was no sagging or rash of the affected area after application, and it was easy to use.
Furthermore, the gel ointment and the production method are not limited to local anesthetics, but are also applicable to general external medicines because the same formulation state and effects can be obtained.

  The present invention provides a gel ointment comprising (1) a topical medicine; (2) a solubilizing (dispersing) agent; (3) a surfactant; (4) an adhesive polymer and (5) water.

  Specifically, in the present invention, (1) a topical medicine; (2) a solubilizing (dispersing) agent; (3) a surfactant; (4) an adhesive polymer and (5) water, There is provided a gel ointment characterized by being. More specifically, the solubilizing (dispersing) agent is a polyoxyethylene hydrogenated castor oil that is miscible with water in which the average number of added moles of propylene carbonate, N-methyl-2-pyrrolidone, and ethylene oxide is 40 or more. A gel ointment that is any one of or a combination thereof is provided.

  Furthermore, in the present invention, the composition contains (1) a local anesthetic; (2) a solubilizing (dispersing) agent; (3) a surfactant; (4) an adhesive polymer and (5) water, and is in a suspended state. A gel ointment for local anesthesia is provided. More specifically, the solubilizing (dispersing) agent is a polyoxyethylene hydrogenated castor oil that is miscible with water in which the average number of added moles of propylene carbonate, N-methyl-2-pyrrolidone, and ethylene oxide is 40 or more. A gel ointment for local anesthesia, which is any one of or a combination thereof.

  Further, in the present invention, in the gel ointment for local anesthesia, the local anesthetic is lidocaine, dibucaine, procaine, chloroprocaine, tetracaine, bupivacaine, propitocaine, ethyl aminobenzoate, oxybuprocaine, parabutylaminobenzoic acid. A gel ointment for local anesthesia is provided that is one or more selected from the group consisting of diethylaminoethyl, mepivacaine, oxesazein, and ethyl piperidinoacetylaminobenzoate.

  In the present invention, the gel ointment or the local anesthesia gel ointment is characterized in that, in the suspended state of the gel ointment or the gel ointment for local anesthesia, oil droplets in the suspended state are 1 to 10 μm. Provide the agent.

  Furthermore, in this invention, the polyoxyethylene hydrogenated castor oil which mixes external medicine (or local anesthetic) with the water whose average added mole number of propylene carbonate, N-methyl-2-pyrrolidone, and ethylene oxide is 40 or more. In addition to a gel-like base material containing a surfactant, an adhesive polymer, and water separately prepared by dissolving the solution in any one or a combination thereof, an external medicine (or local anesthetic) is added. Provided is a production method for obtaining the gel ointment (or gel ointment for local anesthesia) characterized by being in a suspended state. More specifically, a polyoxyethylene cure in which an external medicine (or local anesthetic) is mixed with a small amount of propylene carbonate, N-methyl-2-pyrrolidone, and water having an average added mole number of ethylene oxide of 40 or more. Once completely dissolved in any one or a combination of castor oils, the solution is separately added to a gel-like base prepared with a surfactant, an adhesive polymer, water and the like while stirring. Provided is a production method for obtaining the gel ointment (or gel ointment for local anesthesia), characterized in that a fine external medicine (or local anesthetic) is suspended.

  Moreover, in this invention, the gel ointment (or gel ointment for local anesthesia) manufactured with the said manufacturing method is provided.

  The gel ointment used in the present invention refers to a gel ointment. Here, the ointment refers to an external preparation to be applied to the skin made into a semi-solid form having an appropriate consistency and full quality.

  The external medicine used in this gel ointment is not particularly limited. For example, local anesthetics, antihistamines, analgesics, anti-inflammatory agents, antibacterial agents, antifungal agents, immunosuppressive agents, vitamin agents, antiallergic agents, etc. Specific examples include but are not limited to lidocaine, dibucaine, procaine, chloroprocaine, tetracaine, bupivacaine, propitocaine, ethyl aminobenzoate, oxybuprocaine, ropivacaine, diethylaminoethyl parabutylaminobenzoate, Local anesthetics of mepivacaine, oxesazein, ethyl piperidinoacetylaminobenzoate, cocaine, etc. and their hydrochlorides; diphenhydramine, diphenhydramine tannate, diphenhydramine hydrochloride, diphenhydramine laurate, diphenylpyralin hydrochloride, diphtheol Antihistamines such as nilpyralin, clemastine fumarate, chlorpheniramine maleate, triprolidine hydrochloride, promethazine hydrochloride, alimemazine tartrate, istipendyl hydrochloride, hydroxyzine hydrochloride, hydroxyzine pamoate, homochlorcyclidine hydrochloride, cyproheptacin hydrochloride; cortisone acetate , Hydrocortisone, hydrocortisone sodium phosphate, hydrocortisone sodium succinate, prednisolone, prednisolone sodium succinate, methylprednisolone, methylprednisolone sodium succinate, triamcinolone, triamcinolone acetonide, dexamethasone sodium phosphate, dexamethasone palmitate, dexamethasone palmitate , Halopredon acetate, clobetazo propionate , Diflorazone acetate, dexamethasone propionate, betamethasone dipropionate, diflupredonate, fluocinonide, diflucortron valerate, amsinonide, harsinonide, hydrocortisone butyrate propionate, betamethasone butyrate propionate, mometasone furanate, betamethasone furanate, Steroidal drugs such as beclomethasone acid, fluocinolone acetonide, deprodon propionate, hydrocortisone butyrate, clobetasone butyrate, alcromethasone propionate, flunisolide, betamethasone phosphate, fluticasone propionate, budesonide, ciclesonide, fluticasone furanate; aspirin, , Indomethacin, piroxicam, felbinac, diclofenac sodium, ketoprof Non-steroidal compounds such as phen, flurbiprofen, ipprofen piconol, suprofen, bufexamac, bendazac, ufenamate, naproxen, pranoprofen, loxoprofen sodium, aluminoprofen, zaltoprofen, meloxicam, lornoxicam, celecoxib, rofecoxib Analgesic / anti-inflammatory drugs: nadifloxacin, ofloxacin, levofloxacin, orbifloxacin, sparfloxacin, salazosulfapyridine, sulfadiazine, silver sulfadiazine, clindamycin phosphate, sodium fusidate, amoxiline, sultamicillin tosylate, sodium cefazolin, hydrochloric acid Cefotiam, cefmetazole sodium, flomoxef sodium, cephalexin, cefaclor, cefuji Antibacterial agents such as lempivoxil, kanamycin sulfate, gentamicin sulfate, fradiomycin sulfate, erythromycin, clarithromycin, azithromycin, tetracycline hydrochloride, oxytetracycline hydrochloride, minocycline hydrochloride, chloramphenicol; amphotericin B, flucytosine, miconazole, fluconazole, itraconazole , Micafungin sodium, terbinafine hydrochloride, griseofulvin, nystatin, tolnaftate, ciclopirox olamine, clotrimazole, econazole nitrate, isoconazole nitrate, sulconazole nitrate, oxyconazole nitrate, croconazole hydrochloride, bifonazole, ketoconazole, neticoconazole hydrochloride, liranaftate hydrochloride Butenafine, amorolfine hydrochloride, lanocona Anti-fungal agents such as urol, luliconazole; immunosuppressive agents such as tacrolimus, pimecrolimus, mycophenolate mofetil, cyclosporine; vitamins such as vitamin A, etretinate, tacalcitol, calcipotriol, maxacalcitol; sodium cromoglycate; Tranilast, ketotifen fumarate, amlexanox, azelastine hydrochloride, oxatomide, fexofenadine hydrochloride, epinastine hydrochloride, ebastine, cetirizine hydrochloride, bepotastine besylate, olopatadine hydrochloride, loratadine, ozagrel hydrochloride, seratrodast, pranlukast hydrate, montelukast sodium, etc. Antiallergic drugs can be mentioned.

  Further, the local anesthetic used in the present invention is not particularly limited. For example, lidocaine, dibucaine, procaine, chloroprocaine, tetracaine, bupivacaine, propitocaine, ethyl aminobenzoate, oxybuprocaine, diethylaminoethyl parabutylaminobenzoate. , Mepivacaine, oxesazein, ethyl piperidinoacetylaminobenzoate and the like, and one or more are selected. Particularly preferred is lidocaine.

Further, the content of the external medicine in the present gel ointment can be appropriately changed according to the type and purpose of the external medicine, but in general, 1.0 of the composition of the gel ointment. -30.0% by mass is preferred, 2.0-20.0% by mass is particularly preferred, and 4.0-10.0% by mass is often very suitable.
As described above, the gel ointment can contain a relatively large amount of an external medicine, but if it is excessively contained, there is a concern about the safety of the skin due to the external medicine. When contained in a large amount, from the viewpoint of safety, the upper limit of the content is defined according to the type of externally applied medicine.

  It is considered that a topical medicine in a suspended state in this gel ointment exists as oil droplet particles partially dissolved in the oil phase, and the particle size of the oil droplets is 1 to 10 μm. In addition, the particle diameter calculated | required here is measured by the method used normally, For example, the method of performing by observation with a microscope etc. is mentioned.

  In addition, some of the external medicines suspended in the gel ointment are in a dissolved state in the oil phase and / or aqueous phase, and the external medicine in the dissolved state is percutaneously absorbed and dissolved. It is considered that a topical medicine not included in the above is redissolved and absorbed percutaneously, and good percutaneous absorption is achieved.

In the present invention, the adhesive high molecular polymer means a high molecular polymer exhibiting adhesiveness when arbitrarily applied. For example, but not limited to, gum arabic, sodium alginate, propylene glycol ester alginate, carboxyvinyl Examples include polymers, sodium carmellose, xanthan gum, gellan gum, gelatin, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyvinyl alcohol, methylcellulose and the like. A combination of these may be used. Of these adhesive polymer polymers, suitable adhesive polymer polymers that have adhesiveness to the skin and are resistant to dripping of the preparation from the application site even when applied relatively thickly are particularly preferred. Water-soluble polymers such as vinyl polymer, hydroxyethylcellulose, hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, and methylcellulose are preferred, and the present gel ointment base using carboxyvinyl polymer is particularly preferred.
Examples of the carboxyvinyl polymer used as the adhesive polymer of the present invention include hydrophilic polymers obtained by polymerizing acrylic acid as a main component, and those usually used, for example, carbopol (available from Noveon, USA) Registered trademark) can be used. The use concentration of the carboxyvinyl polymer is not limited to these, but is usually 0.1 to 2.0% by mass.

Examples of the solubilizing (dispersing) agent used in the present invention include propylene carbonate, N-methyl-2-pyrrolidone, and polyoxyethylene hydrogenated castor oil miscible with water having an average addition mole number of ethylene oxide of 40 or more. These may be used alone or in combination of two or more.
Propylene carbonate is a solvent that is a colorless and clear liquid and is miscible with water in an appropriate amount, and may be one generally used in pharmaceuticals. N-methyl-2-pyrrolidone is a colorless and clear liquid and is a solvent that is miscible with water in an appropriate amount. For example, N-methyl-2-pyrrolidone may be an ordinary solvent such as Pharmasolve (registered trademark) commercially available from ISP. it can. The use concentration of the solubilizing (dispersing) agent is usually 1.0 to 20.0% by mass, but an amount sufficient for once dissolving the external medicine is sufficient.

Further, in the present invention, it is desirable to contain a surfactant, and as a surfactant, it is possible to maintain one or more kinds of nonionic surfactants to maintain a stable suspension state of the external medicine. It is suitable for further stabilization of the formulation.
The nonionic surfactant is not particularly limited, and any nonionic surfactant that can be contained in an external composition can be used.
For example, polyoxyethylene alkyl phenyl ethers such as polyoxyethylene lauryl ether, polyoxyethylene oleyl ether, polyoxyethylene stearyl ether, polyoxyethylene alkyl ethers, polyoxyethylene octyl phenyl ether, polyoxyethylene nonyl phenyl ether, etc. , Sucrose fatty acid ester, sorbitan monooleate, sorbitan monoisostearate, sorbitan monolaurate, sorbitan monopalmitate, sorbitan monostearate, sorbitan sesquioleate, sorbitan fatty acid esters of sorbitan trioleate, glycerin sesquioleate , Glycerin fatty acid esters such as glyceryl monostearate, and propylene glycol monostearate Glycol fatty acid esters, hydrophilic nonionic surfactants such as Pluronic type such pluronic etc., and the like.
The content when the nonionic surfactant is contained in the present gel ointment composition is preferably 0.1 to 10.0% by mass of the composition of the gel ointment, and particularly preferably 0.1% by mass. 5 to 5.0% by mass.

  In the present specification, the gel-like base means a base capable of stably maintaining a suspended state of an external medicine, and is a semi-solid containing a surfactant, an adhesive polymer and water. A shape.

  In the present gel ointment, other components that can be generally contained in the composition for external use, if necessary, for example, surfactants other than the above components, cooling agents, antioxidants, chelating agents, absorption enhancers, Powders, thickeners, pH adjusters, preservatives, fragrances, colorants, and the like can be contained within a range that does not impair the intended effect of the present invention. Further, the addition of these additives is possible in any intermediate in the production process as long as no particular disadvantage occurs.

  The form of the present gel ointment is not particularly limited as long as it is a semi-solid external composition, but various materials such as tubes, jars of various materials, lotion containers, spray containers and the like are suitable.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、これにポリオキシエチレンラウリルエーテルを加えて均一にゲル状の基剤を製する。このゲル状基剤にＮ−メチル−２−ピロリドンに溶解したリドカインの溶液を攪拌しながら、少量ずつ添加していき微細なリドカインの懸濁ゲル軟膏組成物を調製する。 EXAMPLES Hereinafter, although this invention is demonstrated concretely based on an Example and a test example, this invention is not limited to this.
Example 1

Disperse and swell carboxyvinyl polymer in a portion of purified water, then thicken it with sodium hydroxide dissolved in purified water, and add polyoxyethylene lauryl ether to this to make a uniform gel-like base . While stirring, a solution of lidocaine dissolved in N-methyl-2-pyrrolidone in this gel base is added little by little to prepare a fine lidocaine suspension gel ointment composition.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、これにポリオキシエチレンラウリルエーテルを加えて均一にゲル状の基剤を製する。このゲル状基剤に炭酸プロピレンに溶解したジブカインの溶液を攪拌しながら、少量ずつ添加していき微細なジブカインの懸濁状態を作り、最後に精製水に溶解した塩化ベンザルコニウムを加えゲル軟膏組成物を調製する。 (Example 2)

Disperse and swell carboxyvinyl polymer in a portion of purified water, then thicken it with sodium hydroxide dissolved in purified water, and add polyoxyethylene lauryl ether to this to make a uniform gel-like base . While stirring a solution of dibucaine dissolved in propylene carbonate to this gel base, add small amounts to make a fine dibucaine suspension, and finally add benzalkonium chloride dissolved in purified water to add gel ointment A composition is prepared.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、これにポリオキシエチレンオレイルエーテルを加えて均一にゲル状の基剤を製する。このゲル状基剤にポリオキシエチレン硬化ヒマシ油６０に溶解したアミノ安息香酸エチルの溶液を攪拌しながら、少量ずつ添加していき微細なアミノ安息香酸エチルの懸濁ゲル軟膏組成物を調製する。 (Example 3)

Disperse and swell the carboxyvinyl polymer in a portion of purified water, then thicken it with sodium hydroxide dissolved in purified water, and add polyoxyethylene oleyl ether to it to make a uniform gel-like base . To this gel base, a solution of ethyl aminobenzoate dissolved in polyoxyethylene hydrogenated castor oil 60 is added little by little with stirring to prepare a fine suspension gel ointment composition of ethyl aminobenzoate.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、これにポリオキシエチレンラウリルエーテルを加えて均一にゲル状の基剤を製する。このゲル状基剤にＮ−メチル−２−ピロリドン及び炭酸プロピレンに溶解したリドカインの溶液を攪拌しながら、少量ずつ添加していき微細なリドカインの懸濁状態を作り、最後に精製水に溶解した塩化ベンゼトニウムを加えゲル軟膏組成物を調製する。 Example 4

Disperse and swell carboxyvinyl polymer in a portion of purified water, then thicken it with sodium hydroxide dissolved in purified water, and add polyoxyethylene lauryl ether to this to make a uniform gel-like base . While stirring, a solution of lidocaine dissolved in N-methyl-2-pyrrolidone and propylene carbonate was gradually added to this gel base to create a fine lidocaine suspension, and finally dissolved in purified water. A gel ointment composition is prepared by adding benzethonium chloride.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、これにポリオキシエチレンラウリルエーテルとともに乳鉢で粉砕しておいたリドカインを加えてゲル軟膏組成物を調製する。 (Comparative Example 1: Pharmacy preparation generally used as in-hospital preparation)

Disperse and swell carboxyvinyl polymer in a portion of purified water, thicken it with sodium hydroxide dissolved in purified water, and add lidocaine that has been ground in a mortar with polyoxyethylene lauryl ether to add gel An ointment composition is prepared.

精製水の一部にカルボキシビニルポリマーを分散・膨潤させた後、精製水に溶解した水酸化ナトリウムで増粘させ、１，３−ブチレングリコールを加え、加温する。この水相にリドカインをオクチルドデカノール、モノステアリン酸グリセリン及びモノステアリン酸ポリエチレングリコールに加温して溶解した油相を加え、乳化させた後、冷却しリドカインクリーム剤とする。 (Comparative Example 2)

After carboxyvinyl polymer is dispersed and swollen in a portion of purified water, the solution is thickened with sodium hydroxide dissolved in purified water, 1,3-butylene glycol is added, and the mixture is heated. An oil phase in which lidocaine is heated and dissolved in octyldodecanol, glyceryl monostearate and polyethylene glycol monostearate is added to this aqueous phase and emulsified, and then cooled to obtain a lidocaine cream.

(Comparative product) Commercial lidocaine tape: Penless (registered trademark, Wyeth Co., Ltd.)
(Tape preparation containing 18 mg of lidocaine (30.5 × 50.0 mm))

Test example 1
Using Example 1 and Comparative Examples 1 and 2 and a comparative product, the pain alleviation effect during laser irradiation was evaluated from the self-report of the subject.
(Test method)
After the test part was wiped with rubbing alcohol, about 6.0 g of each ointment preparation of Example 1 and Comparative Examples 1 and ² was applied to about 15 cm ² and sealed with a wrap film for food packaging (Saran Wrap (registered trademark)). Bandaged. Also, one comparative product was attached. 30 minutes after application or application, the ointment preparation or tape is removed, and laser irradiation is started.
(Evaluation method)
The following four levels are evaluated according to the degree of pain during laser irradiation.
1: Great effect (no pain)
2: Effective (slightly painful)
3: Slightly effective (painful enough to be confused)
4: Invalid (very painful)
(Evaluation results)
Of the 15 subjects, the total proportion of subjects who were judged to be effective or effective was summarized below. The subject using Example 1 had a significant pain relieving effect as compared with Comparative Examples 1 and 2 and the subject using the comparative product as a tape.
Example 1: 80.0% (12/15)
Comparative Example 1: 53.3% (8/15)
Comparative Example 2: 33.3% (5/15)
Comparative product: 20.0% (3/15)

Test example 2
Usability tests were performed using Example 1 and Comparative Examples 1 and 2. Five volunteers evaluated the sagging drop by applying the test article to the back.
(Test method)
After the test part was wiped with rubbing alcohol, about 6.0 g of each ointment preparation of Example 1 and Comparative Examples 1 and ² was applied to about 15 cm ² , and sagging was observed after 5 minutes.
(Evaluation method)
When it moved 2 cm or more down from the application site, it was judged that there was dripping.
(Evaluation results)
For each test ointment sample, the results of dripping of the samples of 5 subjects are shown below. In Comparative Examples 1 and 2, dripping was observed, but in Example 1, no dripping was observed.
Example 1: No sagging drop was confirmed in any one of the five people.
Comparative Example 1: A sagging drop was confirmed in one of five people.
Comparative Example 2: A sagging drop was confirmed in all of the five people.

Claims (5)

(1) From lidocaine, dibucaine, procaine, chloroprocaine, tetracaine, bupivacaine, propitocaine, ethyl aminobenzoate, oxybuprocaine, diethylaminoethyl parabutylaminobenzoate, mepivacaine, oxesazein, and ethyl piperidinoacetylaminobenzoate One or more local anesthetics selected from the group consisting of : (2) polyoxyethylene curing miscible with water in which the average added moles of propylene carbonate, N-methyl-2-pyrrolidone, and ethylene oxide are 40 or more A gel ointment characterized by comprising any one of castor oil or a combination thereof; (3) a surfactant; (4) an adhesive polymer and (5) water, and in a suspended state. The gel ointment according to claim 1, wherein oil droplets in a suspended state are 1 to 10 µm. The topical medicine is dissolved in one or a combination of propylene carbonate, N-methyl-2-pyrrolidone, and polyoxyethylene hydrogenated castor oil that is miscible with water having an average addition mole number of ethylene oxide of 40 or more. , surfactants and the solution was separately prepared and added to the gel-form base including an adhesive high polymer and water, characterized in that the external pharmaceutical in suspension, to produce a gel ointment Method. Topical drugs include lidocaine, dibucaine, procaine, chloroprocaine, tetracaine, bupivacaine, propitocaine, ethyl aminobenzoate, oxybuprocaine, diethylaminoethyl parabutylaminobenzoate, mepivacaine, oxesasein, and ethyl piperidinoacetylaminobenzoate 4. The method of claim 3, wherein the method is one or more local anesthetics selected from the group consisting of: A gel ointment produced by the method according to claim 3 or 4 .