CN112336698A - Rapidly disintegrating vaginal soft capsule composition and preparation method thereof - Google Patents
Rapidly disintegrating vaginal soft capsule composition and preparation method thereof Download PDFInfo
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- CN112336698A CN112336698A CN201910735004.7A CN201910735004A CN112336698A CN 112336698 A CN112336698 A CN 112336698A CN 201910735004 A CN201910735004 A CN 201910735004A CN 112336698 A CN112336698 A CN 112336698A
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- soft capsule
- carrageenan
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4816—Wall or shell material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
Abstract
The invention relates to a fast disintegrating hormone vaginal soft capsule shell, which consists of a compound capsule shell capable of fast disintegrating in a small amount of weakly acidic vaginal fluid and functional contents, wherein the capsule shell consists of 6-12% of carrageenan, 10-40% of modified starch, 10-25% of plasticizer, 3-5% of disintegrant, 0-0.2% of preservative and water, and the functional contents can be progesterone, estriol, norethindrone, megestrol and other hormone medicines. The invention also discloses a method for preparing the soft capsule shell by using the composition and a soft capsule prepared by using the soft capsule shell. The capsule shell of the vaginal soft capsule has the advantages of rapid disintegration, excellent aging resistance, stable composition and the like.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and relates to a composition of a compound soft capsule shell and a preparation method thereof, in particular to a hormone soft capsule shell capable of rapidly disintegrating in vagina.
Background
The soft capsule is prepared by processing liquid medicine or semisolid medicine and sealing the processed medicine in a soft capsule material, the preparation is widely used in the fields of medicine, food, health products, cosmetics and the like at present, and the formula of the rubber of the soft capsule adopts the traditional preparation mode of gelatin, glycerol and water. However, the soft capsule prepared by the method has the advantages that the polypeptide chain of the gelatin molecule is easy to crosslink in the storage process to form a network structure, so that the solubility of the gelatin in water is reduced, and the in-vitro drug release is delayed although the in-vivo drug release is not influenced. Particularly in an acidic solution, such as a weakly acidic medium for artificially simulating vaginal fluid, the crosslinking phenomenon is more obvious, the in vivo-in vitro correlation degree is reduced, and the evaluation of the preparation is influenced. In addition, since the gelatin soft capsule shell contains a large amount of moisture (up to 35%), moisture in the capsule shell gradually enters the contents during storage, possibly causing a decrease in solubility of the drug and crystallization. Gelatin, as a main capsule material of the traditional soft capsule shell, is prepared from raw materials such as animal skin, bones and the like, is difficult to be accepted by vegetarians and people with related religious beliefs, and has the risk of spreading mad cow disease.
The preparation of non-gelatin soft capsule shells is of increasing interest to researchers, based on the many drawbacks of gelatin soft capsules. The occurrence of cross-linking of the capsule shell can be avoided by using modified gelatin-acylated gelatin; chemically or enzymatically modified starch may also be used as a shell material to avoid cross-linking; the soft capsule prepared by hydroxypropyl methylcellulose can reduce the water in the capsule shell to enter the content; the soft capsule shell with specific physical properties can be obtained by combining different types and proportions of edible gums, such as carrageenan, gellan gum, xanthan gum, konjac gum and the like; alginate can also be used as a capsule wall material, which can perform ion exchange with most of divalent metal ions to generate gelated alginate.
On the basis, the inventor develops the vaginal soft capsule shell which is not easy to crosslink in the storage process and can be quickly disintegrated in a small amount of acidic vaginal fluid according to the vaginal administration environment, the defects of the gelatin soft capsule shell and the characteristics of the medicine.
Disclosure of Invention
The invention relates to a stable and rapidly disintegrating capsule shell of a vaginal soft capsule.
The invention utilizes the characteristics that carrageenin is hydrolyzed under acidic condition to break off 3, 6-dehydration-D-galactose and lose viscosity and gel strength, and the carrageenin is selected as a capsule shell material to promote the capsule shell to be quickly disintegrated in weak acidic vaginal fluid with low water content. The carrageenan has stable character and lower hydrophilicity, is not easy to absorb moisture in the storage process, and the capsule shell and the content are not easy to transfer components. Meanwhile, hydrophilic modified starch is selected to provide a tough part of the capsule shell, and a proper amount of disintegrant is added into the capsule shell to further accelerate the disintegration speed of the capsule shell in vaginal fluid.
Specifically, the technology of the invention is realized as follows:
a rapidly disintegrating vaginal soft capsule shell comprises 6-12% of carrageenan, 10-40% of modified starch, 10-25% of plasticizer, 3-5% of disintegrating agent and 0-0.2% of preservative;
further, the carrageenan is one or more of kappa-type carrageenan and iota-type carrageenan, preferably the weight ratio of kappa-type carrageenan to iota-type carrageenan is = 1: 30-70, and more preferably the weight ratio of kappa-type carrageenan to iota-type carrageenan is = 1: 35;
further, the modified starch is hydroxyethyl modified corn starch, hydroxypropyl modified potato starch, hydroxypropyl modified corn starch, and more preferably hydroxypropyl modified corn starch;
further, the disintegrating agent is one or more of low-substituted hydroxypropyl cellulose (L-HPC), methylcellulose, croscarmellose sodium, microcrystalline cellulose, agar, tragacanth, alginate, and sodium carboxymethyl starch;
further, the plasticizer is one or more of glycerol, sorbitol and propylene glycol;
further, the preservative is one or more of methylparaben, potassium sorbate, ethyl p-hydroxybenzoate and propyl p-hydroxybenzoate.
The invention provides a method for preparing a quick-disintegrating vaginal hormone soft capsule shell by using the composition, which comprises the following steps:
step a: pretreating glue solution: adding purified water into a gelatin melting pot, heating to 50-80 deg.C, adding antiseptic, disintegrant and plasticizer, stirring to dissolve completely, and stopping heating;
step b: preparing glue solution: under the stirring state, the hydroxypropyl modified corn starch is rapidly added into the solution in a plurality of times, then the carrageenan is rapidly added, and the total adding time is controlled within 10 min. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; stirring at 15-25r/min for 2-5 h;
step c: defoaming: starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
step d: preparing the soft capsule: and (3) taking the prepared soft capsule content and the capsule shell solution, and preparing the progesterone vaginal soft capsule by adopting a conventional pressing method. Cooling, molding, washing, and drying at 20-25 deg.C and humidity of 15-20% for 48 hr.
Compared with the prior art, the invention has the advantages of remarkable progress and the following:
(1) provides a vaginal soft capsule which can be disintegrated quickly, and is beneficial to the immediate action of the medicine after administration.
(2) Avoid the generation of the cross-linking of the gelatin soft capsule and the component transfer between the soft capsule shell and the content, increase the stability of the progesterone soft capsule and improve the in vivo-in vitro correlation.
(3) Simplifies the preparation process of the compound plant soft capsule, can be prepared by the traditional preparation process of the gelatin soft capsule, reduces the difficulty of sample research and development, and is convenient for industrial production.
The specific implementation method comprises the following steps:
the present invention is further described with reference to the following examples, which should not be construed as limiting the invention thereto.
Example 1
Prescription dose (g)
kappa carrageenan 4
iota carrageenan 140
Hydroxypropyl modified corn starch 300
Glycerol 150
Sodium starch glycolate 48
Hydroxyphenyl Ethyl ester 2.2
Purified water 600
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription into a glue melting pot, heating to 50-80 ℃, adding ethylparaben, glycerol and sodium carboxymethyl starch, stirring until the materials are completely dissolved, and stopping heating;
(2) under the stirring state, within 10min, the hydroxypropyl corn starch, the kappa-type carrageenan and the iota-type carrageenan are rapidly added into the solution in times. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared progesterone solution and capsule shell solution by a full-automatic soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Example 2
Prescription dose (g)
kappa carrageenan 4
iota carrageenan 140
Hydroxyethyl modified corn starch 300
Glycerol 110
Sorbitol 14
Sodium starch glycolate 48
Hydroxyphenyl Ethyl ester 2.2
Purified water 600
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription amount into a glue melting pot, heating to 50-80 ℃, adding ethylparaben, glycerol, sorbitol and sodium carboxymethyl starch, stirring until the materials are completely dissolved, and stopping heating;
(2) under the stirring state, within 10min, the hydroxyethyl modified corn starch, the kappa-type carrageenan and the iota-type carrageenan are rapidly added into the solution in a fractional manner. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared estradiol solution and the capsule shell solution by adopting a full-automatic soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Example 3
Prescription dose (g)
kappa carrageenan 4
iota carrageenan 200
Hydroxypropyl modified corn starch 300
Glycerol 150
Sodium starch glycolate 48
Hydroxyphenyl Ethyl ester 2.2
Purified water 600
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription into a glue melting pot, heating to 50-80 ℃, adding ethylparaben, glycerol and sodium carboxymethyl starch, stirring until the materials are completely dissolved, and stopping heating;
(2) under the stirring state, within 10min, the hydroxypropyl modified corn starch, the kappa-type carrageenan and the iota-type carrageenan are rapidly added into the solution in a fractional manner. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared norethindrone solution and capsule shell solution by adopting a full-automatic soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Comparative example 1
Prescription dose (g)
Hydroxypropyl modified corn starch 624
Glycerol 120
Hydroxyphenyl Ethyl ester 2.2
Purified water 600
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription amount into a glue melting pot, heating to 50-80 ℃, adding ethylparaben and glycerol, stirring until the materials are completely dissolved, and stopping heating;
(2) under the stirring state, within 5min, the hydroxypropyl corn starch is rapidly added into the solution in several times. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared progesterone solution and capsule shell solution by a full-automatic soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Comparative example 2
Prescription dose (g)
Hydroxypropyl modified corn starch 624
Glycerol 120
L-HPC 40
Hydroxyphenyl Ethyl ester 2.2
Purified water 600
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription into a glue melting pot, heating to 50-80 ℃, adding L-HPC, ethylparaben and glycerol, stirring until the L-HPC, ethylparaben and glycerol are completely dissolved, and stopping heating;
(2) under the stirring state, within 5min, the hydroxypropyl corn starch is rapidly added into the solution in several times. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared progesterone solution and capsule shell solution by a full-automatic soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Comparative example 3
Prescription dose (g)
kappa carrageenan 4
iota carrageenan 500
Glycerol 200
L-HPC 40
Hydroxyphenyl Ethyl ester 2.0
Purified water 500
Making into 1000 soft capsules
(1) Adding the purified water according to the prescription into a glue melting pot, heating to 50-80 ℃, adding L-HPC, ethylparaben and glycerol, stirring until the L-HPC, ethylparaben and glycerol are completely dissolved, and stopping heating;
(2) while stirring, kappa-type and iota-type carrageenans were added rapidly to the above solution in portions over 5 min. Continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; the stirring speed is 25r/min, and the stirring time is 3 h;
(3) starting a vacuum pump, eliminating bubbles in the glue solution, defoaming until the vacuum degree is-0.09 MPa, and putting into a heat-preserving container for later use;
(4) and pressing the prepared progesterone solution and capsule shell solution by a conventional soft capsule machine to obtain the vaginal soft capsule. Cooling, molding, washing, and drying at 25 deg.C and 15% humidity for 48 hr.
Disintegration Performance test
Examples 1 to 3 and comparative examples 1 to 3 were subjected to disintegration time test according to disintegration time test method under the item of soft capsule of "chinese pharmacopoeia 2015 edition" using a medium of acetic acid-sodium acetate buffer salt solution of ph4.3 in a similar vaginal environment. The results are shown in Table 1.
TABLE 1 Soft Capsule Shell disintegration test of different compositions
From the experimental results, it can be seen that the disintegration time period of examples 1 to 3 is significantly shorter than that of the comparative example, and there is no significant increase in the disintegration time period during storage. The soft capsule shell with starch as main component is easy to absorb moisture during storage, and the carrageenan has low moisture absorption.
Claims (9)
1. A hormone vaginal soft capsule shell capable of rapidly disintegrating in vagina is characterized in that the capsule shell is a compound capsule shell containing carrageenan as a gelling agent.
2. The shell of claim 1, which is used to encapsulate hormonal drugs such as progesterone, estriol, norethindrone and megestrol.
3. The soft capsule shell according to claim 1, wherein the capsule shell comprises 6-12% of carrageenan, 10-40% of modified starch, 10-25% of plasticizer, 3-5% of disintegrant and 0-0.2% of preservative.
4. The capsule shell of the vaginal soft capsule according to claim 2, characterized in that the carrageenan is a kappa-carrageenan and iota-carrageenan compound, and further preferably comprises the following components in parts by weight: 1 part by weight of kappa-type carrageenan and 35 parts by weight of iota-type carrageenan.
5. The shell of claim 2, wherein the modified starch is one or more of hydroxyethyl or hydroxypropyl modified starch, preferably hydroxypropyl modified corn starch.
6. The shell of claim 2, wherein the disintegrant is one or more of low-substituted hydroxypropyl cellulose, croscarmellose sodium, microcrystalline cellulose, alginate, and sodium carboxymethyl starch.
7. The shell of claim 2, wherein the plasticizer is one or more of glycerin, sorbitol, and propylene glycol.
8. The shell of claim 2, wherein the preservative is one or more of methylparaben, potassium sorbate, ethylparaben, and propylparaben.
9. The process for the preparation of a soft capsule according to any one of claims 2 to 7, characterized in that it comprises the following steps:
(1) adding purified water into a gelatin melting pot, heating to 50-80 deg.C, adding antiseptic, disintegrant and plasticizer, stirring to dissolve completely, and stopping heating;
(2) under the stirring state, rapidly adding hydroxypropyl corn starch and carrageenan into the solution in several times, and continuously stirring, wherein the total adding time is less than 10 min; continuously stirring in a vacuum state, and introducing circulating water at 60-80 ℃ for heating; stirring at 15-25r/min for 2-5 h; the solution is used as capsule shell solution for standby;
(3) and (3) preparing the contents of the prepared vaginal soft capsule and the capsule shell solution into the progesterone vaginal soft capsule by adopting a conventional pressing method, cooling, forming, washing the pill, and drying for 48 hours at the temperature of 20-25 ℃ and under the humidity of 15-20%.
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| CN201910735004.7A CN112336698A (en) | 2019-08-09 | 2019-08-09 | Rapidly disintegrating vaginal soft capsule composition and preparation method thereof |
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| CN201910735004.7A CN112336698A (en) | 2019-08-09 | 2019-08-09 | Rapidly disintegrating vaginal soft capsule composition and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114504563A (en) * | 2022-02-23 | 2022-05-17 | 博睿先锋(北京)生物科技有限公司 | Chlorogenic acid self-emulsifying composition capsule and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1649572A (en) * | 2002-01-18 | 2005-08-03 | 贝纳制药公司 | Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan |
| CN104337793A (en) * | 2014-10-16 | 2015-02-11 | 浙江春宝胶囊有限公司 | Formula of non-gelatin soft capsule shell |
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- 2019-08-09 CN CN201910735004.7A patent/CN112336698A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1649572A (en) * | 2002-01-18 | 2005-08-03 | 贝纳制药公司 | Non-gelatin capsule shell formulation comprising iota-carrageenan and kappa-carrageenan |
| CN104337793A (en) * | 2014-10-16 | 2015-02-11 | 浙江春宝胶囊有限公司 | Formula of non-gelatin soft capsule shell |
Non-Patent Citations (1)
| Title |
|---|
| 徐元贞等: "《新全实用药物手册》", 31 August 2018, 河南科学技术出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114504563A (en) * | 2022-02-23 | 2022-05-17 | 博睿先锋(北京)生物科技有限公司 | Chlorogenic acid self-emulsifying composition capsule and preparation method thereof |
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Application publication date: 20210209 |