CN101711875A - Soft capsule shell composition, soft capsule prepared from same and method for preparing soft capsule shell composition and soft capsule - Google Patents
Soft capsule shell composition, soft capsule prepared from same and method for preparing soft capsule shell composition and soft capsule Download PDFInfo
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Abstract
The invention provides a soft capsule shell composition which comprises the following components in percentage by weight: about 37-43 percent of gelatin, about 20-30 percent of plasticizer, about 1.5-3 percent of lysine and about 35-40 percent of water, wherein the plasticizer comprises the following components in percentage by weight: about 10-15 percent of glycerol, about 4-6 percent of sorbitol and about 6-9 percent of maltitol; wherein all the percentage of the components are all calculated relative to the total weight of the soft capsule shell composition. The invention also provides a soft capsule prepared from the soft capsule shell composition and a method for preparing the soft capsule shell composition and the soft capsule.
Description
Technical field
Relate generally to soft capsule peel composition of the present invention, soft capsule prepared therefrom and the method for preparing them.
Background technology
Soft capsule is meant a certain amount of medicine, active component, nutrient, medicinal substances extract etc. is sealed in the dosage form of making in the soft capsule material of sphere, ellipse or other shapes together with suitable adjuvant.For soft capsule, but but chewiness after chewiness and dissolubility are placed especially for a long time and dissolubility are two important performance indications.For example, the vitamin AD soft capsule is a topmost dosage form in the vitamin AD preparation in the market, and its inclusions is vitamin A and the D that is dissolved in cod-liver oil or vegetable oil and adjusts concentration.Vitamin AD soft capsule product in the market, but but the existence chewiness is not good and/or have problems such as chewiness reduction, disintegrate or stripping delay in long-term put procedure.Especially when the child takes medicine, but the pleased degree when the good soft capsule of chewiness can improve children taking.Just as chewing chewing gum, but the child generally is willing to take the good vitamin AD of chewiness when taking.And take and when directly swallowing when not chewing, the release that delays to cause medicine of disintegrate stripping, absorb corresponding problem such as delay, even may influence bioavailability of medicament.It mainly is because the self property problem of soft capsule peel main component gelatin causes that the disintegrate stripping delays, and gelatin easily takes place aging in long-term put procedure.But chewiness is relevant with the not good composition with soft capsule peel of dissolubility.
But soft capsule in the market especially the vitamin AD soft capsule still can not the above-mentioned ubiquitous chewiness of fine solution not good and/or disintegrate stripping delay problem.Therefore, in the art for after placing a period of time, still having good chewiness and there is demand in deliquescent soft capsule.
Summary of the invention
An object of the present invention is to provide a kind of new soft capsule peel composition, it can prepare and has good chewiness and deliquescent soft capsule, especially after placing a period of time, still have good chewiness and deliquescent soft capsule, particularly vitamin AD soft capsule.
The inventor is surprised to find that the soft capsule peel composition with following composition can realize the foregoing invention purpose, addresses the above problem well.
The invention provides a kind of soft capsule peel composition, it comprises the lysine of the plasticizer of the gelatin of about 37-43%, about 20-30%, about 1.5-3% and the water of about 35-40%, wherein said plasticizer comprises the sorbitol of the glycerol of about 10-15%, about 4-6% and the maltose alcohol of about 6-9%, and all percentage ratios are all based on the total weight of soft capsule peel composition.
In addition, the present invention also provides following embodiment:
1. soft capsule peel composition, it comprises the gelatin of 37-43%, the glycerol of 10-15%, sorbitol and the maltose alcohol of 6-9%, the lysine of 1.5-3% and the water of 35-40% of 4-6%, and all percentage ratios are all based on the total weight of soft capsule peel composition.
2. embodiment 1 described soft capsule peel composition, it comprises the glycerol of 11-14%, the sorbitol of 4.5-5.5% and the maltose alcohol of 7-8.5%.
3. embodiment 2 described soft capsule peel compositions, it comprises about 12% glycerol, about 5% sorbitol and about 8% maltose alcohol.
4. embodiment 1 to 3 each described soft capsule peel composition, it comprises about 2% lysine.
5. soft capsule, it comprises the capsule skin and encloses inclusions in the capsule skin, and wherein said capsule skin is made by each described capsule peel composition of embodiment 1-4.
6. method for preparing soft capsule peel composition, it comprises that the gelatin that makes 37-43%, the glycerol of 10-15%, sorbitol and the maltose alcohol of 6-9%, the lysine of 1.5-3% and the water of 35-40% of 4-6% contact, and all percentage ratios are based on the total weight of described soft capsule peel composition.
7. method for preparing soft capsule, it comprises that water that (1) make the lysine of maltose alcohol, 1.5-3% of the sorbitol of glycerol, 4-6% of gelatin, the 10-15% of 37-43% and 6-9% and 35-40% contacts being suitable for being pressed under the condition of adhesive tape, and all percentage ratios are based on the total weight of said components; (2) mixture that step (1) is obtained is pressed into adhesive tape; (3) inclusions and the described adhesive tape of effective dose are carried out pelleting, obtain described soft capsule.
The specific embodiment
Unless definition in addition herein, employed all technology of this paper and scientific terminology have the common implication of understanding of those of ordinary skills.Although those methods and the material similar or of equal value with material to method described herein also can be used in the practice of the present invention, preferable methods and material are still described in this article.In addition, as used herein, term " ", " one " or " a kind of " comprise a plurality of or multiple, point out in addition unless context is clear and definite.Numerical range comprises the numeral that defines this scope.Subhead of the present invention is just to the purpose of setting forth, and is not intended to limit the scope of the invention.
As used herein, unless context spells out, all percentage ratios are all calculated by weight.
As used herein, term " soft capsule " is meant a certain amount of medicine, active component, nutrient, medicinal substances extract etc. is sealed in the dosage form of making in the soft capsule material of sphere, ellipse or other shapes together with suitable adjuvant.Soft capsule of the present invention can be used for sealing for example inclusions in animal oil (such as Adeps Sus domestica, Adeps Caprae seu ovis, Adeps Bovis seu Bubali, cod-liver oil etc.) or the vegetable oil (such as Oleum Arachidis hypogaeae semen, olive oil, soybean oil, Oleum Ricini, sunflower seed wet goods) of any oil-soluble, it includes but not limited to medicine, active component, nutritional labeling, medicinal substances extract etc., such as vitamin A, D and E, carotene, unsaturated fatty acid etc.
As used herein, term " gelatin " is meant a kind of goods that the collagen that contains in skin, bone, tendon and the ligament of animal obtains after partial hydrolysis.In one embodiment, gelatin has the kinematic viscosity of about 24-28mPas, such as under the following conditions mensuration: aqueous gelatin solution concentration is 66.7g/L, and bath temperature is 60 ℃, adopts rotating cylinder viscometer well known to those skilled in the art to measure.In one embodiment, gelatin accounts for about 37-43% of the gross weight of soft capsule peel composition.
As used herein, term " plasticizer " is to make polymeric material increase the material of plasticity, and they are boiling point height, more difficult evaporable liquid or low-melting solid normally.In one embodiment, plasticizer accounts for about 20-30% of the gross weight of soft capsule peel composition, and wherein based on the gross weight of soft capsule peel composition, plasticizer comprises the sorbitol of the glycerol of about 10-15%, about 4-6% and the maltose alcohol of about 6-9%.One preferred embodiment in, based on the gross weight of soft capsule peel composition, plasticizer comprises the sorbitol of the glycerol of about 11-14%, about 4.5-5.5% and the maltose alcohol of about 7-8.5%.In one even preferred embodiment, based on the gross weight of soft capsule peel composition, plasticizer comprises about 12% glycerol, about 5% sorbitol and about 8% maltose alcohol.
As used herein, term " lysine " is used in the compositions of the present invention as antioxidant.In one embodiment, lysine accounts for about 1.5-3% of the gross weight of soft capsule peel composition.One preferred embodiment in, lysine account for soft capsule peel composition gross weight about 2%.
In one embodiment, the invention provides a kind of soft capsule peel composition, it comprises the lysine of the plasticizer of the gelatin of about 37-43%, about 20-30%, about 1.5-3% and the water of about 35-40%, wherein said plasticizer comprises the sorbitol of the glycerol of about 10-15%, about 4-6% and the maltose alcohol of about 6-9%, and all percentage ratios are based on the total weight of soft capsule peel composition.
In one embodiment, the invention provides a kind of soft capsule, it comprises the inclusions in capsule skin and the inclosure capsule skin, wherein said capsule suitcase contains the lysine of the plasticizer of the gelatin of about 37-43%, about 20-30%, about 1.5-3% and the water of about 35-40%, wherein said plasticizer comprises the sorbitol of the glycerol of about 10-15%, about 4-6% and the maltose alcohol of about 6-9%, and all percentage ratios are based on the total weight of soft capsule peel composition.In one embodiment, described inclusions is dissolved in oil for example in animal oil (such as Adeps Sus domestica, Adeps Caprae seu ovis, Adeps Bovis seu Bubali, cod-liver oil etc.) or the vegetable oil (such as Oleum Arachidis hypogaeae semen, olive oil, soybean oil, Oleum Ricini, sunflower seed wet goods), and include but not limited to any medicine in the above-mentioned oil, active component, nutritional labeling, medicinal substances extract etc. of dissolving in, such as vitamin A, D and E, carotene, unsaturated fatty acid etc.
In one embodiment, the invention provides a kind of method for preparing soft capsule peel composition, it comprises that the lysine of the maltose alcohol of the sorbitol of the glycerol of the gelatin that makes about 37-43%, about 10-15%, about 4-6% and about 6-9%, about 1.5-3% and the water of about 35-40% contact, and all percentage ratios are based on the total weight of soft capsule peel composition.
In one embodiment, the invention provides a kind of method for preparing soft capsule, it comprises that water that (1) make the lysine of the maltose alcohol of the sorbitol of the glycerol of the gelatin of about 37-43%, about 10-15%, about 4-6% and about 6-9%, about 1.5-3% and about 35-40% contacts being suitable for being pressed under the condition of adhesive tape, and all percentage ratios are based on the total weight of soft capsule peel composition; (2) mixture that step (1) is obtained is pressed into adhesive tape; (3) inclusions and the described adhesive tape of effective dose are carried out pelleting, obtain described soft capsule.
Unexpectedly, the fine problem that has solved soft capsule existence in the prior art of the adding of plasticizer lysine binding of the present invention.But the soft capsule chewiness that is prepared from by the soft capsule peel composition of the present invention with specific composition is good, be easy to chew mashed, but and after long-term the placement chewiness and disintegrate dissolution time keep good.But soft capsule peel composition of the present invention has improved the chewiness of soft capsule and has improved stability.
Embodiment:
Further specify the present invention below by embodiment.Yet scope of the present invention is not limited to these embodiment.Unless stated otherwise, all commercially available acquisition of all reagent.
By following preparation steps, according to the prescription of table 1, be example with vitamin A and D, prepare 7 kinds of different vitamin AD soft capsules (amount of various compositions is that benchmark converts with 100kg capsule peel composition).
Table 1: the composition of different capsule peel compositions
| Composition | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 |
| Gelatin | ??40％ | ??40％ | ??40％ | ??40％ | ??40％ | ??40％ | ??40％ |
| Glycerol | ??25％ | ??18％ | ??15％ | ??12％ | ??18％ | ??12％ | ??12％ |
| Sorbitol | ??- | ??7％ | ??5％ | ??5％ | ??5％ | ??5％ | ??3％ |
| Composition | Prescription 1 | Prescription 2 | Prescription 3 | Prescription 4 | Prescription 5 | Prescription 6 | Prescription 7 |
| Maltose alcohol | ??- | ??- | ??5％ | ??8％ | ??- | ??8％ | ??10％ |
| Lysine | ??- | ??- | ??- | ??- | ??2％ | ??2％ | ??2％ |
| Water | ??35％ | ??35％ | ??35％ | ??35％ | ??35％ | ??33％ | ??33％ |
| Total amount | ??100％ | ??100％ | ??100％ | ??100％ | ??100％ | ??100％ | ??100％ |
Preparation process:
According to above-mentioned prescription, prepare soft capsule according to the following step with the inclusions of 0.3g/ grain and the capsule peel composition of 0.2g/ grain.For each prescription, get gelatin respectively, add suitable quantity of water and make the gelatin water absorption and swelling.Get other compositions except that gelatin in each prescription respectively in addition, place glue pot, and be heated to 70 ℃.Behind the dissolving mixing, to glue pot add swollen gelatin, stir evenly, fusion and keep jar in about 70 ℃ of temperature, being evacuated to glue does not again have bubble.Put glue then, 100 orders filter, and leave standstill more than 2 hours the filtrate insulation standby.Vitamin A and D are dissolved in respectively in the vegetable oil, stir, standby.Respectively the fused gelatin frozen glue of above-mentioned each prescription liquid is pressed capsule machine (RGY6-20 type encapsulating machine, Changzheng Tianmin High Science ﹠ Technology Co., Ltd., Beijing) by rotating automatically, cast on the cold drum, the wide frozen glue bar of the preparation about 5～6in of twice.The frozen glue bar passes across roller, provides suitable bar to arrange, and the rotation automatically of then capsule heart vitamin AD medicinal liquid being packed into is pressed in the capsule machine.Capsule psychological treatment liquid temp is controlled at about 25 ℃, carries out pelleting.Extrude soft gelatin capsule and, use 95% washing with alcohol by after the typing.Dry, treat the ethanol volatilization after, enter dry 3-5 hour of the exsiccator that automatic rotation presses the capsule machine.Dried soft gelatin capsule is selected ball.After selecting qualified ball, carry out aluminum-plastic packaged, outer package promptly.The step that comprises is as follows:
1. prepare burden: accurately take by weighing various supplementary materials in the prescription ratio and add the material-compound tanks batching, and carry out the inspection of semifinished product.
2. colloidal sol: according to dosage what, press colloidal sol prescription colloidal sol, temperature is about 70 ℃ in keeping jar, makes peptizationization, being evacuated to glue does not again have bubble, puts glue, 100 orders filter, be incubated leave standstill more than 2 hours standby.
3. the inspection of semifinished product.
4. pelleting: feed liquid can be carried out pelleting after the assay was approved.
5. typing, rinsing, drying: extrude soft gelatin capsule by after finalizing the design, wash with 95% ethanol.Advance centrifuge and dry, treat the ethanol volatilization after, entered drying machine dry 3-5 hour.
6. select ball: dried soft gelatin capsule will select ball, selects qualified ball (outward appearance is qualified).
8. aluminum-plastic packaged, outer package.
With following 2 kinds of indexs, 7 kinds of vitamin AD soft capsules of above-mentioned acquisition are investigated:
Index 1: but chewiness
Evaluation methodology: several experimenters taste, and feeling when chewing marked.Grading system is as follows: A, and chewiness is fine, easily chews, and mouthfeel is good; B, chewiness is better, suitably chews, and more easily chews; C, chewiness is general, and the capsule skin needs firmly to chew repeatedly and can chew; D, chewiness is bad, and the capsule skin is difficult to chew, and the child is difficult to swallow; E, chewiness is very poor, and it is whole that the capsule skin becomes, and chews not brokenly, and the child is difficult for swallowing.
Index 2: dissolubility
Evaluation methodology: each group vitamin AD soft capsule is placed in the intelligent disintegration tester (ZB-1D/ZB-2, Tianda Tianfa Technology Co., Ltd.), investigate the length of soft capsule disintegration time.
To investigating of above-mentioned acquisition through the stability of vitamin AD soft capsule after room temperature condition is placed 1 year aluminum-plastic packaged, outer package.
Evaluation result is as follows:
Table 2: the evaluation result after preparation is finished
Table 3: room temperature condition is placed the evaluation result after 1 year down
As can be seen from the above results, the vitamin AD soft capsule that the vitamin AD soft capsule of being made by capsule peel composition of the present invention is made than other compositions, but significantly improved dissolubility chewiness and stability.The stability and the chewiness of the vitamin AD soft capsule that the capsule peel composition with specific composition of the present invention is made all are significantly improved, and have solved the not good or stable bad technical problem of chewiness that present vitamin AD soft capsule exists.
As what it will be apparent to those skilled in the art that, can make many modifications and variations of the present invention and do not deviate from its spirit and scope.Specific embodiments described herein only provides in the mode of example, and gamut restriction the present invention of the equivalent that only is awarded together with these claim with claims.
Claims (7)
1. soft capsule peel composition, it comprises the gelatin of 37-43%, the glycerol of 10-15%, sorbitol and the maltose alcohol of 6-9%, the lysine of 1.5-3% and the water of 35-40% of 4-6%, and all percentage ratios are all based on the total weight of soft capsule peel composition.
2. the described soft capsule peel composition of claim 1, it comprises the glycerol of 11-14%, the sorbitol of 4.5-5.5% and the maltose alcohol of 7-8.5%.
3. the described soft capsule peel composition of claim 2, it comprises about 12% glycerol, about 5% sorbitol and about 8% maltose alcohol.
4. each described soft capsule peel composition of claim 1 to 3, it comprises about 2% lysine.
5. soft capsule, it comprises the capsule skin and encloses inclusions in the capsule skin, and wherein said capsule skin is made by each described capsule peel composition of claim 1-4.
6. method for preparing soft capsule peel composition, it comprises that the gelatin that makes 37-43%, the glycerol of 10-15%, sorbitol and the maltose alcohol of 6-9%, the lysine of 1.5-3% and the water of 35-40% of 4-6% contact, and all percentage ratios are based on the total weight of described capsule peel composition.
7. method for preparing soft capsule, it comprises that water that (1) make the lysine of maltose alcohol, 1.5-3% of the sorbitol of glycerol, 4-6% of gelatin, the 10-15% of 37-43% and 6-9% and 35-40% contacts being suitable for being pressed under the condition of adhesive tape, and all percentage ratios are based on the total weight of said components; (2) mixture that step (1) is obtained is pressed into adhesive tape; (3) inclusions and the described adhesive tape of effective dose are carried out pelleting, obtain described soft capsule.
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| JP5977470B1 (en) * | 2015-08-05 | 2016-08-24 | 富士カプセル株式会社 | Composition for soft capsule film |
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| JP5977470B1 (en) * | 2015-08-05 | 2016-08-24 | 富士カプセル株式会社 | Composition for soft capsule film |
| JP2017031139A (en) * | 2015-08-05 | 2017-02-09 | 富士カプセル株式会社 | Composition for soft capsule coating |
| WO2017022230A1 (en) * | 2015-08-05 | 2017-02-09 | 富士カプセル株式会社 | Composition for soft capsule coating |
| CN107847455A (en) * | 2015-08-05 | 2018-03-27 | 富士胶囊股份有限公司 | Soft capsule is by film composition |
| US20180214384A1 (en) * | 2015-08-05 | 2018-08-02 | Fuji Capsule Co., Ltd. | Composition for Soft Capsule Shell |
| TWI699219B (en) * | 2015-08-05 | 2020-07-21 | 日商富士膠囊股份有限公司 | Composition for soft capsule film |
| CN108606135A (en) * | 2018-04-10 | 2018-10-02 | 汉臣氏（沈阳）儿童制品有限公司 | A kind of low-sugar type DHA algal oil gel candy and preparation method thereof |
| CN108617834A (en) * | 2018-05-14 | 2018-10-09 | 汉臣氏（沈阳）儿童制品有限公司 | A kind of low-sugar type milk calcium walnut oil gel candy and preparation method thereof |
| CN109349673A (en) * | 2018-10-22 | 2019-02-19 | 辽渔南极磷虾科技发展有限公司 | A kind of antarctic krill oil soft capsule peel, soft capsule and preparation method thereof |
| CN109349673B (en) * | 2018-10-22 | 2021-10-08 | 辽渔南极磷虾科技发展有限公司 | Euphausia superba oil soft capsule shell, soft capsule and preparation method thereof |
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