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JPH0755898B2 - Method for producing sugar-coated solid preparation - Google Patents
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JPH0755898B2 - Method for producing sugar-coated solid preparation - Google Patents

Method for producing sugar-coated solid preparation

Info

Publication number
JPH0755898B2
JPH0755898B2 JP60106000A JP10600085A JPH0755898B2 JP H0755898 B2 JPH0755898 B2 JP H0755898B2 JP 60106000 A JP60106000 A JP 60106000A JP 10600085 A JP10600085 A JP 10600085A JP H0755898 B2 JPH0755898 B2 JP H0755898B2
Authority
JP
Japan
Prior art keywords
sugar
solid preparation
coating
coated
maltitol
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
JP60106000A
Other languages
Japanese (ja)
Other versions
JPS61263915A (en
Inventor
正和 三橋
俊雄 三宅
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Hayashibara Seibutsu Kagaku Kenkyujo KK
Original Assignee
Hayashibara Seibutsu Kagaku Kenkyujo KK
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Hayashibara Seibutsu Kagaku Kenkyujo KK filed Critical Hayashibara Seibutsu Kagaku Kenkyujo KK
Priority to JP60106000A priority Critical patent/JPH0755898B2/en
Publication of JPS61263915A publication Critical patent/JPS61263915A/en
Publication of JPH0755898B2 publication Critical patent/JPH0755898B2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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  • Formation And Processing Of Food Products (AREA)
  • Medicinal Preparation (AREA)

Description

【発明の詳細な説明】 (産業上の利用分野) 本発明は、糖衣固形製剤の製造方法、とりわけ、純度90
w/w%以上の高純度マルチトールとともに糖衣補強剤を
含有した水溶液によって芯剤をコーティングし、次い
で、これを乾燥してマルチトールを晶出させることを特
徴とする糖衣固形製剤の製造方法に関する。
DETAILED DESCRIPTION OF THE INVENTION (Industrial field of application) The present invention relates to a method for producing a sugar-coated solid preparation, in particular, a purity of 90.
The present invention relates to a method for producing a solid sugar-coated preparation, which comprises coating a core agent with an aqueous solution containing a sugar-coating reinforcing agent together with high-purity maltitol of w / w% or more, and then drying this to crystallize maltitol. .

(従来の技術) 従来の糖衣固形製剤の製造方法としては、例えば、特開
昭49−108225号公報、特開昭59−219220号公報などに記
載されているように、その糖成分としてはショ糖が使用
されている。
(Prior Art) As a conventional method for producing a sugar-coated solid preparation, for example, as described in JP-A-49-108225 and JP-A-59-219220, the sugar component is Sugar is used.

(発明が解決しようとする問題点) 従来のショ糖を使用した糖衣固形製剤は、意外に破損、
ひび割れを起し易いこと、耐熱性に弱く経日変化を起し
易いことなどの欠点のあることが知られている。
(Problems to be solved by the invention) The conventional sugar-coated solid preparation using sucrose is unexpectedly damaged,
It is known to have defects such as easy cracking, weak heat resistance and easy change over time.

本発明は、これらの欠点を解決するため、糖衣固形製剤
における糖衣用糖成分に関して改善するものである。
In order to solve these drawbacks, the present invention improves the sugar component for sugar coating in the sugar-coated solid preparation.

(問題を解決するための手段) 本発明者等は、優れた糖衣固形製剤を開発するため、そ
の糖衣用糖成分として各種糖アルコールの使用に着目し
て鋭意研究した。
(Means for Solving the Problem) In order to develop an excellent sugar-coated solid preparation, the inventors of the present invention have diligently studied focusing on the use of various sugar alcohols as sugar components for sugar coating.

その結果、マルチトールとともに糖衣補強剤を含有した
水溶液によって芯剤をコーティングし、次いで、このマ
ルチトールを晶出させて糖衣固形製剤を製造することに
より、本目的を達成し得ることを見いだし、本発明を完
成させた。
As a result, it was found that this object can be achieved by coating a core agent with an aqueous solution containing a sugar coating reinforcing agent together with maltitol, and then crystallizing this maltitol to produce a sugar coating solid preparation. Completed the invention.

コーティング用の水溶液に使用するマルチトールとして
は、純度90w/w%以上、とりわけ93w/w%以上の高純度マ
ルチトールが好適である。マルチトールの純度が90w/w
%未満では、その晶出速度が遅いなど作業性が悪くなる
だけでなく、得られる糖衣固形製剤が吸湿を受け易いな
どの不都合が生じる。
As the maltitol used in the aqueous solution for coating, high-purity maltitol having a purity of 90 w / w% or more, particularly 93 w / w% or more is suitable. The purity of maltitol is 90w / w
If it is less than%, not only the workability is deteriorated due to its slow crystallization rate, but also the obtained sugar-coated solid preparation is liable to be absorbed by moisture.

また、その水溶液におけるマルチトール濃度は、約40乃
至95w/w%が適しており、より望ましくは約60乃至90w/w
%である。
The maltitol concentration in the aqueous solution is preferably about 40 to 95 w / w%, more preferably about 60 to 90 w / w.
%.

さらには、その水溶液に対してマルチトールとともに使
用する糖衣補強剤としては、種々の水溶性高分子物質、
例えば、ゼラチン、アラビアガム、ヒドロキシメチルセ
ルローズ、プルランなどが用いられる。とりわけ、プル
ランの使用は、マルチトールの晶出を実質的に阻害する
ことなく、しかも、得られる糖衣固形製剤のひび割れ、
欠けなどの破損を防止し、耐熱性を向上すると共に経日
変化を抑えることができるので好都合である。糖衣補強
剤の使用量は、マルチトールに対して固形物当り0.01〜
15.0w/w%、とりわけ、0.1〜10.0w/w%の範囲が好適で
ある。
Furthermore, as a sugar coating reinforcing agent to be used with maltitol for the aqueous solution, various water-soluble polymer substances,
For example, gelatin, gum arabic, hydroxymethyl cellulose, pullulan and the like are used. In particular, the use of pullulan does not substantially inhibit the crystallization of maltitol, and moreover, the obtained sugar-coated solid preparation is cracked,
It is convenient because damage such as chipping can be prevented, heat resistance can be improved, and change over time can be suppressed. The amount of sugar coating reinforcing agent used is 0.01-
A range of 15.0 w / w%, especially 0.1-10.0 w / w% is preferred.

また、マルチトールとともに糖衣補強剤を含有した水溶
液は、芯剤に対し、そのままコーティングして糖衣固形
製剤を製造することができることは勿論であるが、必要
ならば、常法に従って、例えば、タルク、カオリン、炭
酸カルシウム、澱粉などの水不溶物をマルチトールの当
重量未満を共存させた懸濁液としてコーティングするこ
とも、更に必要ならば、適量の着色料、着香料、呈味料
などを共存させてコーティングすることも自由に実施で
きる。
Further, it is a matter of course that an aqueous solution containing a sugar coating reinforcing agent together with maltitol can be directly coated on a core agent to produce a sugar coating solid preparation, but if necessary, according to a conventional method, for example, talc, Coating with water-insoluble matter such as kaolin, calcium carbonate, and starch as a suspension in which less than the equivalent weight of maltitol is allowed to coexist, and if necessary, appropriate amounts of colorants, flavors, flavors, etc. coexist. It is also possible to freely perform coating.

本発明でいう糖衣固形製剤とは、各種形状、大きさの固
形芯剤に対して、マルチトールとともに糖衣補強剤を含
有する水溶液をコーティングし、次いで、このマルチト
ールを晶出させることにより得られる固形製剤、例え
ば、錠剤、丸剤、顆粒、細粒などを言い、その医薬用途
としては、内服用剤、口腔用剤などがあり、食品用途と
しては、ゼリービーンズ、甘納豆、松露などの糖衣菓
子、チョコレート、チューインガム、キャンディー、乾
燥果実、錠菓などへの糖衣掛け物などがある。
The sugar-coated solid preparation as referred to in the present invention is obtained by coating a solid core having various shapes and sizes with an aqueous solution containing a sugar-coating reinforcing agent together with maltitol, and then crystallizing this maltitol. Solid preparations, such as tablets, pills, granules, fine granules, etc., whose pharmaceutical uses include internal medicines and oral preparations, and food applications include sugar-coated confectionery such as jelly beans, natto and matsudoro. , Chocolate, chewing gum, candy, dried fruits, sugar confectionery on tablets, etc.

水溶液のコーティング方法としては、本発明におけるマ
ルチトールとともに糖衣補強剤を含有する水溶液が、安
定性に特に優れていることから、芯剤中の有効成分に悪
影響を与えない限りできるだけ昇温した水溶液、望まし
くは約30乃至80℃の水溶液を常圧でコーティングし、乾
燥、晶出させて糖衣固形製剤を得ることができる。
As a coating method of the aqueous solution, an aqueous solution containing a sugar coating reinforcing agent together with maltitol in the present invention is particularly excellent in stability, so an aqueous solution heated as much as possible without adversely affecting the active ingredient in the core agent, Desirably, a sugar-coated solid preparation can be obtained by coating an aqueous solution at about 30 to 80 ° C. under atmospheric pressure, drying and crystallization.

必要ならば、更に常法に従って、その表面をミツロウ、
カルナウバロウなどで艶出しすればよい。
If necessary, beeswax on the surface according to a conventional method,
Carnauba wax may be used to polish.

本発明の方法によって製造された糖衣固形製剤は、従来
のショ糖を使用したものと比較して、耐衝撃性が大き
く、ひび割れ、破損が少ないだけでなく、経日変化を起
しにくいので製造直後の高品質を長期にわたって安定に
維持し得るきわめて優れた糖衣固形製剤である。
The sugar-coated solid preparation produced by the method of the present invention has a large impact resistance, is less likely to be cracked or damaged, and is less likely to undergo a daily change, as compared with the one using conventional sucrose. It is an extremely excellent sugar-coated solid preparation capable of stably maintaining the high quality immediately after it for a long period of time.

このため、ショ糖を使用した場合よりも、糖衣に必要と
する糖量、糖衣補強剤の使用量を約1/2〜1/3に減少させ
ることができる。
Therefore, the amount of sugar required for sugar coating and the amount of sugar coating reinforcing agent used can be reduced to about 1/2 to 1/3 as compared with the case of using sucrose.

また、マルチトールを使用していることから、ショ糖を
使用する場合とは違って、甘過ぎることもなく、虫歯を
起す懸念もない。
In addition, since maltitol is used, unlike the case of using sucrose, it is neither too sweet nor has a concern of causing tooth decay.

本発明の糖衣固形製剤は、錠剤、丸剤などの医薬用途、
錠菓、ゼリー菓子などの食品用途などに限定されること
なく、広範囲の用途に利用できる。
The sugar-coated solid preparation of the present invention has a pharmaceutical use such as tablets and pills,
It can be used for a wide range of applications without being limited to food applications such as tablet confectionery and jelly confectionery.

以下、実験例に基づいて本発明を説明する。Hereinafter, the present invention will be described based on experimental examples.

実験1. 糖衣用糖類の比較 糖衣用糖類として、各種糖類を用いて比較した。Experiment 1. Comparison of sugar coating sugars Various sugars were used as sugar coating sugars for comparison.

即ち、各種糖類について、重量180mgの素錠を芯剤とし
てその約3,000錠を直径30cmの糖衣パンに取り、これら
芯剤に対し、常法に従い第1表に示すA液を用いて下掛
け糖衣を施し、次いで、第1表に示しB液を用いて上掛
け糖衣を施し、更に、ロウ液を用いて艶出しして、重量
約300mgの光沢のある外観の優れた糖衣錠を得た。
That is, for various saccharides, about 3,000 tablets of uncoated tablets weighing 180 mg were used as core materials, and about 3,000 tablets were placed in a sugar-coated bread with a diameter of 30 cm. Then, the solution B shown in Table 1 was used for overcoat sugar coating, and the solution was waxed for wax to obtain a sugar-coated tablet having a weight of about 300 mg and having an excellent glossy appearance.

得られた白色の各糖衣錠を用いて、耐衝撃性及び苛酷条
件下での経日変化についてテストした。耐衝撃性は、ガ
ラス管(内径2.5cm、高さ20cm)をガラス製シャーレに
立て、そのガラス管の上部から糖衣錠を落下させ、糖衣
層に生じる割れ、欠けなどの破損の発生数を調べ、総落
下糖衣錠50個に対する破損発生割合いを破損発生率
(%)として求めた。
Each of the obtained white sugar-coated tablets was tested for impact resistance and aging under severe conditions. For impact resistance, stand a glass tube (inner diameter 2.5 cm, height 20 cm) on a glass petri dish, drop the sugar-coated tablet from the upper part of the glass tube, and check the number of breaks such as cracks and chips in the sugar-coated layer, The breakage occurrence ratio (%) was calculated as the breakage occurrence ratio for the total 50 dragees.

また、糖衣錠の経日変化は、50℃で4ケ月維持した後の
外観を観察した。
Further, the change with time of the sugar-coated tablet was observed by observing its appearance after maintaining it at 50 ° C. for 4 months.

以上の結果を第2表に示す。The above results are shown in Table 2.

第2表の結果から明らかなように、マルチトールを用い
て糖衣した固形製剤は、耐衝撃性に優れ、経日変化を起
しにくいきわめて優れた固形製剤であることが判明し
た。
As is clear from the results in Table 2, the solid preparation sugar-coated with maltitol was found to be an extremely excellent solid preparation having excellent impact resistance and being less likely to change over time.

実験2. 糖衣用マルチトール純度の比較 糖衣方法は、糖類として各種純度のマルチトールを用い
た意外は実験1と同様に行った。
Experiment 2. Comparison of purity of maltitol for sugar coating The sugar coating method was performed in the same manner as in Experiment 1 except that maltitol of various purities was used as the sugar.

判定方法としては、糖衣掛け時における水溶液の乾燥
性、晶出の容易性などによる作業性の良否を比較し、更
には、得られた糖衣錠の耐衝撃性、経日変化を実験1と
同様に比較した。
As the determination method, the dryness of the aqueous solution at the time of sugar coating, the workability due to the easiness of crystallization, etc. were compared, and further, the impact resistance of the obtained sugar-coated tablet and the change with time were examined in the same manner as in Experiment 1. Compared.

以上の結果を第3表に示す。The above results are shown in Table 3.

第3表の結果から明らかなように、純度90w/w%以上の
マルチトールを用いて糖衣した固形製剤は、作業性、耐
衝撃性に優れ、経日変化を起しにくいきわめて優れた固
形製剤であることが判明した。
As is clear from the results shown in Table 3, the solid preparation coated with maltitol having a purity of 90 w / w% or more is excellent in workability and impact resistance, and is an extremely excellent solid preparation which does not easily change over time. It turned out to be

次に、本発明における1〜2の実施例を示す。Next, Examples 1 and 2 of the present invention will be shown.

実施例 1. 150mgの素錠を芯剤とし、これに第4票に示すA液を用
いて錠剤重量が約230mgになるまで下掛け糖衣し、次い
で、第4表に示すB液を用いて錠剤重量が約300mgにな
るまで上掛け糖衣し、更に、ロウ液で艶出しして光沢の
ある外観の優れた糖衣錠を得た。
Example 1. 150 mg of uncoated tablets was used as a core agent, and the solution A shown in the fourth vote was used to undercoat the tablet until the tablet weight became about 230 mg, and then the solution B shown in Table 4 was used. It was overcoated with sugar until the tablet weight became about 300 mg, and then it was polished with a wax solution to obtain a sugar-coated tablet having an excellent glossy appearance.

本品は、糖衣掛けする時の作業性が優れているだけでな
く、得られた糖衣錠の耐衝撃性にも優れており、製造直
後における高品質を長期間維持することができた。
This product was excellent not only in workability during sugar coating, but also in impact resistance of the resulting sugar-coated tablet, and high quality immediately after production could be maintained for a long time.

実施例 2. 100mgの素錠を芯剤とし、これに第5表に示すA液およ
び散布剤を用いて錠剤重量が約160mgになるまで下掛け
糖衣し、次いで、第5表に示すB液を用いて錠剤重量が
約200mgになるまで上掛け糖衣し、更にカルナバロウで
艶出しして光沢のある外観の優れた糖衣錠を得た。
Example 2. A 100 mg uncoated tablet was used as a core agent, and the solution A and the spraying agent shown in Table 5 were used for undercoating sugar coating until the tablet weight was about 160 mg, and then the solution B shown in Table 5 was used. Was coated with sugar until the tablet weight reached about 200 mg, and then further polished with carnauba wax to give a sugar-coated tablet having an excellent glossy appearance.

本品は、実施例1によって得られた糖衣錠と同様に、糖
衣掛けする時の作業性が優れているだけでなく、得られ
た糖衣錠の耐衝撃性にも優れており、製造直後における
高品質を長期間維持することができた。
Similar to the sugar-coated tablet obtained in Example 1, this product not only has excellent workability when sugar-coated, but also the impact resistance of the obtained sugar-coated tablet was high, and high quality immediately after production. Could be maintained for a long time.

(発明の効果) 上述したことから明らかなように、本発明の方法によっ
て製造された糖衣固形製剤は、従来のショ糖を使用した
ものと比較して、耐衝撃性が大きく、ひび割れ、破損が
少ない効果を有する。
(Effect of the invention) As is clear from the above, the sugar-coated solid preparation produced by the method of the present invention has a high impact resistance, cracking, and damage as compared with those using conventional sucrose. Has little effect.

また、本発明の方法によって製造された糖衣固形製剤
は、経日変化を起しにくいので製造直後の高品質を長期
にわたって安定に維持し得る効果を有する。
Further, the sugar-coated solid preparation produced by the method of the present invention is less likely to undergo aging, and thus has the effect of being able to stably maintain high quality immediately after production for a long period of time.

更に、本発明の方法による時には、ショ糖を使用した場
合よりも、糖衣に必要とする糖量、糖衣補強剤の使用量
を約1/2〜1/3に減少させることができる効果を有する。
Further, according to the method of the present invention, the amount of sugar required for sugar coating and the amount of sugar coating reinforcing agent used can be reduced to about 1/2 to 1/3 as compared with the case of using sucrose. .

また、本発明の方法による時には、糖類としてマルチト
ールを使用していることから、ショ糖を使用する場合と
は違って、甘過ぎることもなく、虫歯を起す懸念もない
効果を有する。
Further, according to the method of the present invention, maltitol is used as a saccharide, so unlike the case of using sucrose, it has neither an excessively sweet effect nor a fear of causing tooth decay.

従って、本発明の糖衣固形製剤は、医薬用途、食品用途
などに限定されることなく、広範囲の用途に利用できる
のである。
Therefore, the sugar-coated solid preparation of the present invention can be used in a wide range of applications without being limited to pharmaceutical applications, food applications and the like.

Claims (3)

【特許請求の範囲】[Claims] 【請求項1】糖衣固形製剤の製造に際し、純度90w/w%
以上の高純度マルチトールとともに糖衣補強剤を含有し
た水溶液によって芯剤をコーティングし、次いで、これ
を乾燥してマルチトールを晶出させることを特徴とする
糖衣固形製剤の製造方法。
1. Purity of 90 w / w% in the production of sugar-coated solid preparation
A method for producing a sugar-coated solid preparation, which comprises coating the core agent with an aqueous solution containing the above-mentioned high-purity maltitol and a sugar coating reinforcing agent, and then drying this to crystallize maltitol.
【請求項2】糖衣補強剤が、マルチトールに対して固形
物当たり0.1乃至10.0w/w%の範囲であることを特徴とす
る特許請求の範囲第(1)項記載の糖衣固形製剤の製造
方法。
2. The method for producing a sugar-coating solid preparation according to claim 1, wherein the sugar-coating reinforcing agent is in the range of 0.1 to 10.0 w / w% based on the solid content relative to maltitol. Method.
【請求項3】糖衣補強剤が、プルランであることを特徴
とする特許請求の範囲第(1)項または第(2)項記載
の糖衣固形製剤の製造方法。
3. The method for producing a sugar-coated solid preparation according to claim (1) or (2), wherein the sugar-coating reinforcing agent is pullulan.
JP60106000A 1985-05-20 1985-05-20 Method for producing sugar-coated solid preparation Expired - Lifetime JPH0755898B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP60106000A JPH0755898B2 (en) 1985-05-20 1985-05-20 Method for producing sugar-coated solid preparation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP60106000A JPH0755898B2 (en) 1985-05-20 1985-05-20 Method for producing sugar-coated solid preparation

Publications (2)

Publication Number Publication Date
JPS61263915A JPS61263915A (en) 1986-11-21
JPH0755898B2 true JPH0755898B2 (en) 1995-06-14

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
JP60106000A Expired - Lifetime JPH0755898B2 (en) 1985-05-20 1985-05-20 Method for producing sugar-coated solid preparation

Country Status (1)

Country Link
JP (1) JPH0755898B2 (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002047174A (en) * 2000-05-26 2002-02-12 Towa Chem Ind Co Ltd Sugar-free coated preparation and method for producing the same
JP2005523713A (en) * 2002-04-27 2005-08-11 セレスタール・ホルデイング・ベー・フアウ Sugar-free hard coating made from liquid maltitol containing DP4 + fraction
JP5038541B1 (en) * 2012-03-22 2012-10-03 秋山錠剤株式会社 Dragee manufacturing method

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Publication number Priority date Publication date Assignee Title
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FR2705208B1 (en) * 1993-05-17 1995-07-28 Roquette Freres Sugar-free coating process and products obtained according to the process.
FR2740300B1 (en) 1995-10-30 1998-01-02 Roquette Freres SUGAR-FREE COATING OBTAINED BY HARD DRAGEIFICATION AND PROCESS FOR OBTAINING SAME
FR2745981B1 (en) * 1996-03-15 1998-06-05 ADSORBENT AGENT REDUCING OR ELIMINATING SIDE EFFECTS LINKED TO THE ABSORPTION OF SWEETENERS
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JP5860480B2 (en) 2011-01-11 2016-02-16 キャプシュゲル・ベルジウム・エヌ・ヴィ New hard capsule containing pullulan
CA3059529A1 (en) 2017-04-14 2018-10-18 Capsugel Belgium Nv Process for making pullulan
CN110678170A (en) 2017-04-14 2020-01-10 比利时胶囊公司 Pullulan Capsules
FR3111768B1 (en) 2020-06-30 2022-08-26 Roquette Freres Sugar coated confectionery with improved crispiness

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JPS59219220A (en) * 1983-05-28 1984-12-10 Zeria Shinyaku Kogyo Kk Method for coating solid pharmaceutical with sugar

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JP2002047174A (en) * 2000-05-26 2002-02-12 Towa Chem Ind Co Ltd Sugar-free coated preparation and method for producing the same
JP2005523713A (en) * 2002-04-27 2005-08-11 セレスタール・ホルデイング・ベー・フアウ Sugar-free hard coating made from liquid maltitol containing DP4 + fraction
JP5038541B1 (en) * 2012-03-22 2012-10-03 秋山錠剤株式会社 Dragee manufacturing method

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