JPH0380930A - Composition of gelatin coating - Google Patents
Composition of gelatin coatingInfo
- Publication number
- JPH0380930A JPH0380930A JP1173668A JP17366889A JPH0380930A JP H0380930 A JPH0380930 A JP H0380930A JP 1173668 A JP1173668 A JP 1173668A JP 17366889 A JP17366889 A JP 17366889A JP H0380930 A JPH0380930 A JP H0380930A
- Authority
- JP
- Japan
- Prior art keywords
- molecular weight
- polyethylene glycol
- gelatin
- capsule
- capsules
- 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.)
- Granted
Links
- 108010010803 Gelatin Proteins 0.000 title claims abstract description 16
- 229920000159 gelatin Polymers 0.000 title claims abstract description 16
- 239000008273 gelatin Substances 0.000 title claims abstract description 16
- 235000019322 gelatine Nutrition 0.000 title claims abstract description 16
- 235000011852 gelatine desserts Nutrition 0.000 title claims abstract description 16
- 239000000203 mixture Substances 0.000 title claims description 22
- 239000011248 coating agent Substances 0.000 title abstract 2
- 238000000576 coating method Methods 0.000 title abstract 2
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 35
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 33
- 239000007903 gelatin capsule Substances 0.000 claims abstract description 18
- 108010025899 gelatin film Proteins 0.000 claims description 19
- 239000002775 capsule Substances 0.000 abstract description 44
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract description 8
- 238000002360 preparation method Methods 0.000 abstract description 2
- 239000008199 coating composition Substances 0.000 abstract 2
- 238000005336 cracking Methods 0.000 description 10
- 238000012360 testing method Methods 0.000 description 8
- 238000011049 filling Methods 0.000 description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- 239000007902 hard capsule Substances 0.000 description 5
- 239000007788 liquid Substances 0.000 description 5
- 238000004519 manufacturing process Methods 0.000 description 5
- 238000007789 sealing Methods 0.000 description 5
- 235000020046 sherry Nutrition 0.000 description 5
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 4
- 239000000546 pharmaceutical excipient Substances 0.000 description 4
- 239000003814 drug Substances 0.000 description 3
- 238000001035 drying Methods 0.000 description 3
- 238000009472 formulation Methods 0.000 description 3
- 239000004014 plasticizer Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000000126 substance Substances 0.000 description 3
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 230000007423 decrease Effects 0.000 description 2
- 238000007598 dipping method Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 235000013305 food Nutrition 0.000 description 2
- 235000011187 glycerol Nutrition 0.000 description 2
- 150000004667 medium chain fatty acids Chemical class 0.000 description 2
- 239000012528 membrane Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- -1 polyoxyethylene Polymers 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 239000007901 soft capsule Substances 0.000 description 2
- 239000000600 sorbitol Substances 0.000 description 2
- 230000003068 static effect Effects 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- UFTFJSFQGQCHQW-UHFFFAOYSA-N triformin Chemical compound O=COCC(OC=O)COC=O UFTFJSFQGQCHQW-UHFFFAOYSA-N 0.000 description 2
- VZSRBBMJRBPUNF-UHFFFAOYSA-N 2-(2,3-dihydro-1H-inden-2-ylamino)-N-[3-oxo-3-(2,4,6,7-tetrahydrotriazolo[4,5-c]pyridin-5-yl)propyl]pyrimidine-5-carboxamide Chemical compound C1C(CC2=CC=CC=C12)NC1=NC=C(C=N1)C(=O)NCCC(N1CC2=C(CC1)NN=N2)=O VZSRBBMJRBPUNF-UHFFFAOYSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 238000005354 coacervation Methods 0.000 description 1
- 230000003111 delayed effect Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000576 food coloring agent Substances 0.000 description 1
- 239000008187 granular material Substances 0.000 description 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 1
- 238000005304 joining Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
Abstract
Description
【発明の詳細な説明】
〔産業上の利用分野〕
本発明はゼラチン皮膜の新規組成物に関し、殊にハード
ゼラチンカプセルまたは当該カプセルのバンドシール剤
として好適に利用し得るゼラチン皮膜組成物に関するも
のである。DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a new gelatin film composition, and in particular to a gelatin film composition that can be suitably used as a hard gelatin capsule or a band sealing agent for the capsule. be.
医薬品の固形製剤の１つとしてハードカプセル剤がある
。このものは、通常ゼラチン皮膜で形成された互いに一
端の開いた帽状容体の内部に粉末、顆粒または液状（油
状）の医薬または食品を所定量充填した後、それら容体
を同軸的に結合して完成される。Hard capsules are one of the solid pharmaceutical preparations. This product is made by filling a predetermined amount of powder, granules, or liquid (oily) medicine or food into a cap-shaped container that is usually formed of gelatin film and having one end open, and then coaxially joining the containers. be completed.
このハードゼラチンカプセル剤は、製剤化のし易さと医
薬活性成分の矯味および／または矯臭作用による服用の
し易さから近年広く利用されている。These hard gelatin capsules have been widely used in recent years because they are easy to formulate and are easy to take due to the taste-masking and/or odor-masking effects of pharmaceutically active ingredients.
ところで、このカプセル剤に利用される前記ハードゼラ
チンカプセルは、一般に当該ゼラチン皮膜中の含有水分
が少なくなると極端にその機械的強度が低下するといっ
た欠点を持っている。すなわち、既存のハードゼラチン
カプセルは、通常そのカプセル皮膜中に約１３〜１５％
程度の水分を保有しているが、これが１０％以下になる
と皮膜の柔軟性が低下してきわめて脆くなる。従って、
カプセル成形後における例えば内容物充填作業でのカプ
セルの機械的取扱に際して、ひび、割れまたは欠は等の
カプセル皮膜に損傷を生じることがある。By the way, the hard gelatin capsules used in this capsule generally have a drawback in that when the water content in the gelatin film is reduced, the mechanical strength thereof is extremely reduced. That is, existing hard gelatin capsules usually contain about 13-15% in their capsule shell.
It retains a certain amount of moisture, but when this content is less than 10%, the flexibility of the film decreases and it becomes extremely brittle. Therefore,
During mechanical handling of the capsule after capsule molding, for example during filling operations, damage to the capsule film such as cracks, breaks or chips may occur.
このような不都合を防止もしくは抑制するための方策と
しては、日本薬局方にも記載されているとおりゼラチン
を基剤とし、これにグリセリンまたはソルビトール等の
可塑剤を添加することが知られているが、これらの可塑
剤をハードゼラチンカプセルの製造時に添加すると、そ
の添加量によっては当該カプセル皮膜が柔らかくなり過
ぎたり、またその乾燥速度が遅くなることもあり、現実
の使用に当っては種々の問題が残されている。As a measure to prevent or suppress such inconveniences, it is known to use gelatin as a base and add a plasticizer such as glycerin or sorbitol to it, as described in the Japanese Pharmacopoeia. If these plasticizers are added during the production of hard gelatin capsules, depending on the amount added, the capsule film may become too soft or the drying speed may be slow, leading to various problems in actual use. is left behind.
以上のような背景から前記可塑剤の添加による難点を解
消する手段として°、前記グリセリンに加えてポリオキ
シエチレンソルビトールもしくはボッエチレングリコー
ル、またはその両者を添加する方法が既に提案されてい
る（特公昭３３−５６４９号）。From the above background, a method of adding polyoxyethylene sorbitol, bocethylene glycol, or both in addition to the glycerin has already been proposed as a means of solving the problems caused by the addition of plasticizers (Tokuko Sho et al. No. 33-5649).
しかしながら、かかる特公昭３３−５６４９号の発明は
、分子量２００〜８００のポリエチレングリコールを添
加することによりゼラチン皮膜の強度と乾燥性の向上を
目的として案出されたものであるが、このゼラチン皮膜
はソフトカプセルに関するものである。However, the invention of Japanese Patent Publication No. 33-5649 was devised for the purpose of improving the strength and drying properties of the gelatin film by adding polyethylene glycol having a molecular weight of 200 to 800. It concerns soft capsules.
一方、周知のとおり近年における液状物用カプセル充填
機と同封緘機の開発によって、ハードゼラチンカプセル
へ液状物を充填したカプセル剤も実用化されている。On the other hand, as is well known, with the recent development of capsule filling machines and enclosing machines for liquid substances, capsules in which liquid substances are filled into hard gelatin capsules have also been put into practical use.
ところで、平均分子量が２００〜６００の範囲にある常
温で液状のポリエチレングリコールや中鎖脂肪酸トリグ
リセライドは、共に優れた溶解作用と吸収性を有し、賦
形剤として好適なものであるが、前者はそれ自体の吸湿
性によりカプセル皮膜から水分を奪うために、また後者
はカプセル皮膜の材質を脆くする性質を持っており、従
って、これらの賦形剤を充填したハードカプセルは経時
的に割れを発生する不安が多々あり、前記のソフトカプ
セルの場合と興なり現実にはその使用が敬遠されている
ような状況である。また、公知のハードゼラチンカプセ
ルにおいては、水分に対して不安定な薬物を充填する場
合、安定性確保のために水分を低めに保つ必要があるが
、前述したとおり低水分下のゼラチン皮膜は割れを発生
し易く製剤化が困難となるのを避は得ない。By the way, polyethylene glycol and medium-chain fatty acid triglyceride, which are liquid at room temperature and have an average molecular weight in the range of 200 to 600, both have excellent dissolving action and absorbability, and are suitable as excipients. Because they take water away from the capsule membrane due to their own hygroscopic properties, and the latter has the property of making the capsule membrane material brittle, hard capsules filled with these excipients tend to crack over time. There are many concerns, and as with the case of the soft capsules mentioned above, in reality, their use is avoided. In addition, in known hard gelatin capsules, when filling drugs that are unstable with respect to moisture, it is necessary to keep the moisture content low to ensure stability, but as mentioned above, the gelatin film under low moisture conditions cracks. It is unavoidable that this is likely to occur, making formulation difficult.
本発明はこのような状況に鑑みて提案されたものであっ
て、上記ハードゼラチンカプセルにおける皮膜の低含有
水分下での機械的強度の脆さ、および水分に対して不安
定な薬物の充填製剤化が困難であるといった不都合を解
消しようとするものである。The present invention was proposed in view of the above-mentioned circumstances, and the present invention addresses the fragility of the mechanical strength of the film in the above-mentioned hard gelatin capsules under low moisture content, and the filling formulation of drugs that is unstable to moisture. This is an attempt to resolve the inconvenience that it is difficult to convert.
本発明者等は上記課題解決のための具体的手段について
鋭意検討した結果、分子量２００〜２００００のポリエ
チレングリコールを含有したゼラチン皮膜組成物を用い
ることによりその含有水分量が少なくても充分な機械的
強度を備えたカプセル皮膜が得られ、吸湿性物質の充填
にも充分適合し、上述のハードゼラチンカプセルにおけ
る欠点、不都合をほぼ解消し得るものであることが分か
った。すなわち、本発明・によれば分子量２００〜２０
０００のポリエチレングリコールを含有することを特徴
とするゼラチン皮膜組成物が提供される。As a result of intensive studies on specific means for solving the above problems, the present inventors have found that by using a gelatin film composition containing polyethylene glycol with a molecular weight of 200 to 20,000, sufficient mechanical strength can be achieved even with a low water content. It has been found that a capsule film with strength can be obtained, that it is fully suitable for filling with hygroscopic substances, and that the drawbacks and inconveniences of the above-mentioned hard gelatin capsules can be almost eliminated. That is, according to the present invention, the molecular weight is 200 to 20
000 polyethylene glycol is provided.
上記手段を採用することにより低水分下でも充分な柔軟
性を備えたカプセル皮膜を得ることができ、また機械的
強度にも優れたものとなる。従って、分子量２００〜４
００の低分子ポリエチレングリコールのような吸湿性賦
形剤や中鎖脂肪酸トリグリセライド等を用いた製剤の提
供が可能となる。By employing the above means, it is possible to obtain a capsule film that has sufficient flexibility even under low moisture conditions and also has excellent mechanical strength. Therefore, the molecular weight is 200-4
It becomes possible to provide formulations using hygroscopic excipients such as 00 low molecular weight polyethylene glycol, medium chain fatty acid triglycerides, and the like.
本発明において使用されるポリエチレングリコールは分
子量２００〜２００００、特に分子量２００．３００．
４００．６００．１０００．１５００．１５４０．４０
００．６０００または２００００から選ばれた１種もし
くは２種以上の混合物である。このポリエチレングリコ
ールの添加量は、使用される該ポリエチレングリコール
の分子量によって下記のとおり若干具なる。すなわち、
組成物中のゼラチンに対して、
イ８分子量が２００〜１５４０である場合：ｌ〜５０！
ｌ量％口１分子量が４０００である場合：０．５〜１５
重量％ハ９分子量が６０００である場合＝０．５〜１０
重量％二５分子量が２００００である場合：０．１〜５
１（量％の範囲が好適である。The polyethylene glycol used in the present invention has a molecular weight of 200 to 20,000, particularly 200.300.
400.600.1000.1500.1540.40
00.6000 or 20000, or a mixture of two or more thereof. The amount of polyethylene glycol added varies depending on the molecular weight of the polyethylene glycol used, as shown below. That is,
For gelatin in the composition: i8 When the molecular weight is 200 to 1540: l to 50!
When the molecular weight is 4000: 0.5 to 15
Weight% C9 When the molecular weight is 6000 = 0.5 to 10
When the weight%25 molecular weight is 20000: 0.1-5
A range of 1 (amount %) is suitable.
上記のとおり一般に使用されるポリエチレングツコール
の分子量が大きくなるほど、その添加量は少なくてよい
、それぞれ上記分子量のポリエチレングリコールの最適
添加量を越えてポリエチレングリコールを使用すればゼ
ラチン溶液は白濁し、その粘度が急激に低下してポリエ
チレングリコールを均一に混合させることができなくな
り、いわゆるコアセルベーションを惹起する。もちろん
この状態で均一なカプセル皮膜を成形することはできな
い、また、前記添加量に満たないポリエチレングリコー
ルの使用量では目的とするカプセル皮膜の割れ防止効果
を充分には発揮することができない、なお、分子量が異
なる２種以上のポリエチレングリコールを混合して併用
する場合には、その混合比率にもよるがそれ−ぞれ単独
使用の場合の各最適使用量より若干少なくてよい。As mentioned above, the larger the molecular weight of commonly used polyethylene glycol, the smaller the amount needed to be added.If polyethylene glycol is used in excess of the optimum amount of polyethylene glycol with the above molecular weight, the gelatin solution will become cloudy and The viscosity decreases rapidly, making it impossible to mix polyethylene glycol uniformly, causing so-called coacervation. Of course, it is not possible to form a uniform capsule film in this state, and if the amount of polyethylene glycol used is less than the amount added above, the desired effect of preventing cracking of the capsule film cannot be sufficiently exhibited. When two or more types of polyethylene glycols having different molecular weights are mixed and used together, the amount may be slightly smaller than the optimum amount when each is used alone, although it depends on the mixing ratio.
本発明ゼラチン皮膜組成物は、そのゼラチン皮膜がハー
ドゼラチンカプセルである場合と、当該カプセルのバン
ドシールを構成する場合とを含むものである。該組成物
をバンドシール液として使用すれば乾燥性が改善された
シールフィルムを得ることが可能であり、また、シール
したハードカプセルの割れ発生を防止することもできる
。なお、この場合において本発明ゼラチン皮膜組成物に
は、従来のハードゼラチンカプセルの場合と同様に所望
によりその他の添加剤、例えば薬事法あるいは食品衛生
法などで指定された食用色素や不透明化剤等を適宜添加
することができる。The gelatin film composition of the present invention includes cases where the gelatin film is a hard gelatin capsule and cases where the gelatin film forms a band seal of the capsule. If the composition is used as a band sealing liquid, it is possible to obtain a sealing film with improved drying properties, and it is also possible to prevent cracking of sealed hard capsules. In this case, as in the case of conventional hard gelatin capsules, the gelatin film composition of the present invention may optionally contain other additives such as food colorants and opacifying agents specified by the Pharmaceutical Affairs Law or the Food Sanitation Law. can be added as appropriate.
以下に実施例により本発明をさらに具体的番こ詳述する
。EXAMPLES The present invention will be explained in further detail with reference to Examples below.
Ｘ量里ユ
（１）ゼラチンシェリーの調製
（ａ）シェリー：Ａ
ゼラチン７ｋｇに精製水１４２を加え、約１〜２時間放
置して吸水膨潤させる。ゼラチンが充分に膨潤した後、
６０°Ｃに加温し、攪拌してゼラチンを均一に溶解させ
る。さらに、予め市販の分子量４００のポリエチレング
リコールの５０を量％水溶液を上記ゼラチン溶液中にそ
れぞれ０．７．１．４．２，１．２．８ｋｇずつ加えて
攪拌し、その粘度を調整した後、常法どおり脱泡舛理し
てジエ１ノーを得る。X amount (1) Preparation of gelatin sherry (a) Sherry: A Add 142 kg of purified water to 7 kg of gelatin and leave for about 1 to 2 hours to absorb water and swell. After gelatin is sufficiently swollen,
Heat to 60°C and stir to uniformly dissolve gelatin. Furthermore, 0.7, 1, 4.2, and 1.2.8 kg of commercially available polyethylene glycol having a molecular weight of 400 in an aqueous solution of 50% by weight were added to the gelatin solution in advance, and the viscosity was adjusted by stirring. Then, defoaming was carried out in the usual manner to obtain 1 NO.
（ｂ）シェリー、Ｂ＃Ｇ
上記分子量４００のポリエチレングリコールの代わりに
分子量１０００〜２００００の６種のポリエチレングリ
コールをシェリーＡの場合に準じてそれぞれ第１表に記
載する量を添加して数種のシェリーを調製した。(b) Sherry, B#G Instead of the polyethylene glycol with a molecular weight of 400, six types of polyethylene glycols with a molecular weight of 1,000 to 20,000 were added in the amounts listed in Table 1 in the same manner as in the case of Sherry A. Sherry was prepared.
（２）ハードゼラチンカプセルの製造
上記■で得た各種ポリエチレングリコール含有のシェリ
ーのゼラチン濃度を２７重量％に調整した後、該溶液を
約６０℃に保持して通常の浸漬法によるカプセル製造機
によりそれぞれサイズ３号の／Ｍ−ドカプセルを得る。(2) Manufacture of hard gelatin capsules After adjusting the gelatin concentration of the various polyethylene glycol-containing sherry obtained in ① above to 27% by weight, the solution was kept at about 60°C and put into a capsule making machine using a normal dipping method. /M-do capsules of size 3 are obtained, respectively.
（３）ハードカプセルのバンドシール
上記■のシェリー：Ｅで得たポリエチレングリコール添
加量１．４ｋｇのゼラチン濃度を約２２重量％にＩ！し
た後、日本エランコ（株）製／１−ドカプセル用高速バ
ンドシール機を用いてカプセルのボディ部とキャップ部
の継目部分にシールを施す。(3) Hard Capsule Band Seal Sherry from ■ above: Adjust the gelatin concentration of 1.4 kg of polyethylene glycol obtained in E to approximately 22% by weight I! After that, a high-speed band sealing machine for 1-do capsules manufactured by Nippon Elanco Co., Ltd. is used to seal the joint between the body and cap of the capsule.
（ωカプセルの割れ試験
上記■で得た各種ポリエチレングリコール含有ハードゼ
ラチンカプセルと従来公知のカプセルを対照カプセルと
して、各々カプセルに分子量４００のポリエチレングリ
コールを充填しバンドシールして７日間保存した後、こ
れを横方向に置いてテスター産業製加圧試験機で静圧荷
重５ｋｇをカプセル全体に徐々に加え、その時の割れの
発生を確認し、第１表に示すような結果を得た（供試カ
プセル数はそれぞれ５０個）。(Crack test on ω capsules Various polyethylene glycol-containing hard gelatin capsules obtained in ① above and conventionally known capsules were used as control capsules. Each capsule was filled with polyethylene glycol having a molecular weight of 400, band-sealed, and stored for 7 days. was placed horizontally, and a static pressure load of 5 kg was gradually applied to the entire capsule using a pressure testing machine manufactured by Tester Sangyo, and the occurrence of cracks was confirmed at that time, and the results shown in Table 1 were obtained (test capsule The number is 50 each).
（以下余白）
第１表（１）
第１表（２）
第１表に示すとおり分子量４００〜２００００のポリエ
チレングリコールをそれぞれ所定量含有したハードゼラ
チンカプセルは、たとえ皮膜中の含有水分量が適正値よ
り少なくなっても皮膜の割れは殆ど認められない。(Leaving space below) Table 1 (1) Table 1 (2) As shown in Table 1, hard gelatin capsules containing a specified amount of polyethylene glycol with a molecular weight of 400 to 20,000, even if the water content in the film is at an appropriate value. Even if the amount is reduced, almost no cracking of the film is observed.
■バンドシール用シェリーに対する割れ試験上記■で作
製したシール後のカプセルを、生℃、５０％ＲＨで４８
時間放置した後、カプセルの割れ試験の場合と同様の装
置を用いて、静圧荷重５ｋｇを該シール部に徐々に加え
て割れの発生を観察したところ下記のような結果を得た
。■ Cracking test for sherry for band sealing The sealed capsules prepared in the above ■ were heated to 48 °C and 50% RH.
After standing for a period of time, a static pressure load of 5 kg was gradually applied to the sealed portion using the same apparatus as in the capsule cracking test, and the occurrence of cracking was observed, and the following results were obtained.
■溶状試験
前記シェリー：Ｅによる本発明組成物を使用して得たカ
プセルと前記対照カプセルについて日本薬局方規定の標
準条件で、３７±１°Ｃに加温した精製水を用いた溶状
試験を行い、下記のような結果を得た（供試カプセル数
５個）。■Solubility test The capsules obtained using the composition of the present invention according to Sherry:E and the control capsules were subjected to a solubility test using purified water heated to 37±1°C under the standard conditions stipulated by the Japanese Pharmacopoeia. The following results were obtained (number of test capsules: 5).
上表の結果からも明らかなように本発明組成物によるカ
プセルは対照カプセルに比べて皮膜の溶解時間にそれほ
どの遅延は認められない。As is clear from the results in the above table, the dissolution time of the film in the capsules prepared from the composition of the present invention is not significantly delayed compared to the control capsules.
Ｘ夏型１
実施例１の（１）、（つに準じて分子量２００〜６００
のボッエチレングリフールをそれぞれ１〜１０１ｉ量％
の範囲に添加したゼラチン組成物を用いて浸漬法による
ハードゼラチンカプセル製造時のカプセルの割れの発生
状況を調べた。X summer type 1 Molecular weight 200-600 according to (1) and (1) of Example 1
1 to 101i amount% of bot ethylene glycol, respectively.
The occurrence of capsule cracking during production of hard gelatin capsules by the dipping method was investigated using gelatin compositions added in the following range.
実験はカプセル製造機を故意に停止させ、浸漬した成形
ビンを乾燥装置内に通常運転時よりも長時間放置しく約
１０分間）、カプセル皮膜が乾燥過度となるようにして
からピンより該カプセルを剥ぎ取り、その際生じるカプ
セル皮膜の縦方向の割れを調べた。結果は下表のとおり
である。In the experiment, the capsule making machine was intentionally stopped, and the immersed molded bottles were left in the dryer for a longer time than during normal operation (approximately 10 minutes), so that the capsule film became excessively dry, and then the capsules were removed using a pin. The capsule film was peeled off, and longitudinal cracks in the capsule film that occurred during the peeling process were examined. The results are shown in the table below.
上表のとわり分子量２００〜６００のポリエチレングリ
コールを添加した場合には、カプセル製造時におけるカ
プセルの割れ発生を防止することができる。When polyethylene glycol having a molecular weight of 200 to 600 is added as shown in the above table, it is possible to prevent the capsule from cracking during capsule production.
以上詳述したとおり本発明ゼラチン組成物によれば製造
時および／または使用時における割れの発生が少なく、
しかも溶解性も改善されたハードカプセルを提供するこ
とができる。このことは該カプセル内に吸水性賦形剤で
ある低分子ポリエチレングリコールや、あるいはゼラチ
ン皮膜を脆化させる中鎖脂肪酸トリグリセライド等を充
填した場合において顕著となり、かつまた、本組成物を
ハードゼラチンカプセルのバンドシールとして使用した
場合には、該カプセル剤の割れ発生を抑制するなど、そ
の実用的効果は多大である。As detailed above, the gelatin composition of the present invention has less cracking during production and/or use;
Moreover, hard capsules with improved solubility can be provided. This becomes noticeable when the capsule is filled with low-molecular polyethylene glycol, which is a water-absorbing excipient, or medium-chain fatty acid triglyceride, which embrittles the gelatin film. When used as a band seal, it has great practical effects, such as suppressing cracking of the capsule.
Claims (5)
ールを含有することを特徴とするゼラチン皮膜組成物。(1) A gelatin film composition characterized by containing polyethylene glycol having a molecular weight of 200 to 20,000.
る請求項（１）記載のゼラチン皮膜組成物。(2) The gelatin film composition according to claim 1, wherein the gelatin film is a hard gelatin capsule.
ンドシールを構成するものである請求項（１）または（
２）記載のゼラチン皮膜組成物。(3) Claim (1) or (3) wherein the gelatin film constitutes a band seal of a hard gelatin capsule.
2) Gelatin film composition as described.
００、４００、６００、１０００、１５００、１５４０
、４０００、６０００、または２００００から選ばれた
１種もしくは２種以上の混合物である請求項（１）、（
２）または（３）記載のゼラチン皮膜組成物。(4) The polyethylene glycol has a molecular weight of 200, 3
00, 400, 600, 1000, 1500, 1540
, 4,000, 6,000, or 20,000 or a mixture of two or more of them.
The gelatin film composition described in 2) or (3).
に対して下記のいずれかである請求項（４）記載のゼラ
チン皮膜組成物。 イ、ポリエチレングリコールの分子量が２００〜１５４
０である場合：１〜５０重量％。ロ、ポリエチレングリ
コールの分子量が４０００である場合：０．５〜１５重
量％。 ハ、ポリエチレングリコールの分子量が６０００である
場合：０．５〜１０重量％。 ニ、ポリエチレングリコールの分子量が２００００であ
る場合：０．１〜５重量％。(5) The gelatin film composition according to claim (4), wherein the content of the polyethylene glycol relative to gelatin is one of the following. B. The molecular weight of polyethylene glycol is 200 to 154.
When it is 0: 1 to 50% by weight. B. When the molecular weight of polyethylene glycol is 4000: 0.5 to 15% by weight. C. When the molecular weight of polyethylene glycol is 6000: 0.5 to 10% by weight. D. When the molecular weight of polyethylene glycol is 20,000: 0.1 to 5% by weight.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1173668A JPH0611696B2 (en) | 1989-07-04 | 1989-07-04 | Gelatin film composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1173668A JPH0611696B2 (en) | 1989-07-04 | 1989-07-04 | Gelatin film composition |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10136056A Division JPH1149667A (en) | 1998-04-30 | 1998-04-30 | Hard gelatin capsule |
| JP13605598A Division JP3594111B2 (en) | 1998-04-30 | 1998-04-30 | Manufacturing method of hard gelatin capsule |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0380930A true JPH0380930A (en) | 1991-04-05 |
| JPH0611696B2 JPH0611696B2 (en) | 1994-02-16 |
Family
ID=15964886
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP1173668A Expired - Fee Related JPH0611696B2 (en) | 1989-07-04 | 1989-07-04 | Gelatin film composition |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH0611696B2 (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005084649A1 (en) * | 2004-03-04 | 2005-09-15 | Takeda Pharmaceutical Company Limited | Stable capsule preparation |
| WO2006070578A1 (en) * | 2004-12-28 | 2006-07-06 | Qualicaps Co., Ltd. | Band seal for hard capsule |
| KR100614032B1 (en) * | 2005-02-21 | 2006-08-22 | 주식회사 서흥캅셀 | Gelatin hard capsule enhancing the surface strength |
| JP2019006726A (en) * | 2017-06-27 | 2019-01-17 | 持田製薬株式会社 | Capsule for easy taking |
| RU2801054C1 (en) * | 2022-06-06 | 2023-08-01 | ФЕДЕРАЛЬНОЕ ГОСУДАРСТВЕННОЕ БЮДЖЕТНОЕ НАУЧНОЕ УЧРЕЖДЕНИЕ "ФЕДЕРАЛЬНЫЙ ИССЛЕДОВАТЕЛЬСКИЙ ЦЕНТР ИНСТИТУТ ЦИТОЛОГИИ И ГЕНЕТИКИ СИБИРСКОГО ОТДЕЛЕНИЯ РОССИЙСКОЙ АКАДЕМИИ НАУК" (ИЦиГ СО РАН) | Biopolymer films with carbon nanomaterials |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS58185648A (en) * | 1982-03-26 | 1983-10-29 | ワ−ナ−−ランバ−ト・コンパニ− | Polymer composition for injection molding |
| EP0110502A2 (en) * | 1982-10-29 | 1984-06-13 | Warner-Lambert Company | Foam capsules and their production |
-
1989
- 1989-07-04 JP JP1173668A patent/JPH0611696B2/en not_active Expired - Fee Related
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS58185648A (en) * | 1982-03-26 | 1983-10-29 | ワ−ナ−−ランバ−ト・コンパニ− | Polymer composition for injection molding |
| EP0110502A2 (en) * | 1982-10-29 | 1984-06-13 | Warner-Lambert Company | Foam capsules and their production |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005084649A1 (en) * | 2004-03-04 | 2005-09-15 | Takeda Pharmaceutical Company Limited | Stable capsule preparation |
| JPWO2005084649A1 (en) * | 2004-03-04 | 2007-11-29 | 武田薬品工業株式会社 | Stable capsule |
| WO2006070578A1 (en) * | 2004-12-28 | 2006-07-06 | Qualicaps Co., Ltd. | Band seal for hard capsule |
| KR100614032B1 (en) * | 2005-02-21 | 2006-08-22 | 주식회사 서흥캅셀 | Gelatin hard capsule enhancing the surface strength |
| EP1693055A3 (en) * | 2005-02-21 | 2006-09-27 | Suheung Capsule Co Ltd. | Gelatin hard capsule having enhanced film strength |
| JP2010159296A (en) * | 2005-02-21 | 2010-07-22 | Suheung Capsule Co Ltd | Gelatin hard capsule having enhanced film strength |
| JP2019006726A (en) * | 2017-06-27 | 2019-01-17 | 持田製薬株式会社 | Capsule for easy taking |
| RU2801054C1 (en) * | 2022-06-06 | 2023-08-01 | ФЕДЕРАЛЬНОЕ ГОСУДАРСТВЕННОЕ БЮДЖЕТНОЕ НАУЧНОЕ УЧРЕЖДЕНИЕ "ФЕДЕРАЛЬНЫЙ ИССЛЕДОВАТЕЛЬСКИЙ ЦЕНТР ИНСТИТУТ ЦИТОЛОГИИ И ГЕНЕТИКИ СИБИРСКОГО ОТДЕЛЕНИЯ РОССИЙСКОЙ АКАДЕМИИ НАУК" (ИЦиГ СО РАН) | Biopolymer films with carbon nanomaterials |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0611696B2 (en) | 1994-02-16 |
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