CN114259471A - Formula for accelerating dissolution of hollow capsules and preparation method thereof - Google Patents
Formula for accelerating dissolution of hollow capsules and preparation method thereof Download PDFInfo
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- CN114259471A CN114259471A CN202111625647.XA CN202111625647A CN114259471A CN 114259471 A CN114259471 A CN 114259471A CN 202111625647 A CN202111625647 A CN 202111625647A CN 114259471 A CN114259471 A CN 114259471A
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- dissolution
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- water
- glue solution
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- 239000002775 capsule Substances 0.000 title claims abstract description 42
- 238000004090 dissolution Methods 0.000 title claims abstract description 27
- 238000002360 preparation method Methods 0.000 title abstract description 10
- 239000003292 glue Substances 0.000 claims abstract description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 26
- 239000002738 chelating agent Substances 0.000 claims abstract description 14
- 238000003756 stirring Methods 0.000 claims abstract description 14
- 239000000463 material Substances 0.000 claims abstract description 13
- 239000000499 gel Substances 0.000 claims abstract description 12
- 108010010803 Gelatin Proteins 0.000 claims abstract description 11
- 239000008273 gelatin Substances 0.000 claims abstract description 11
- 229920000159 gelatin Polymers 0.000 claims abstract description 11
- 235000019322 gelatine Nutrition 0.000 claims abstract description 11
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 11
- 238000010438 heat treatment Methods 0.000 claims abstract description 11
- 238000005303 weighing Methods 0.000 claims abstract description 11
- 238000005520 cutting process Methods 0.000 claims abstract description 7
- 238000007598 dipping method Methods 0.000 claims abstract description 7
- 238000001035 drying Methods 0.000 claims abstract description 7
- 238000000465 moulding Methods 0.000 claims abstract description 6
- 238000004321 preservation Methods 0.000 claims abstract description 6
- 238000000034 method Methods 0.000 claims abstract description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
- 239000000203 mixture Substances 0.000 claims description 12
- 239000008367 deionised water Substances 0.000 claims description 9
- 229910021641 deionized water Inorganic materials 0.000 claims description 9
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 8
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 8
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 8
- 235000010418 carrageenan Nutrition 0.000 claims description 7
- 239000000679 carrageenan Substances 0.000 claims description 7
- 229920001525 carrageenan Polymers 0.000 claims description 7
- 229940113118 carrageenan Drugs 0.000 claims description 7
- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 claims description 7
- 239000004373 Pullulan Substances 0.000 claims description 6
- 229920001218 Pullulan Polymers 0.000 claims description 6
- 235000019423 pullulan Nutrition 0.000 claims description 6
- 229920002148 Gellan gum Polymers 0.000 claims description 5
- 235000010492 gellan gum Nutrition 0.000 claims description 5
- 239000000216 gellan gum Substances 0.000 claims description 5
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 4
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 3
- 229920000161 Locust bean gum Polymers 0.000 claims description 3
- 239000001110 calcium chloride Substances 0.000 claims description 3
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 3
- 235000010420 locust bean gum Nutrition 0.000 claims description 3
- 239000000711 locust bean gum Substances 0.000 claims description 3
- 229920001277 pectin Polymers 0.000 claims description 3
- 239000001814 pectin Substances 0.000 claims description 3
- 235000010987 pectin Nutrition 0.000 claims description 3
- 239000001508 potassium citrate Substances 0.000 claims description 3
- 229960002635 potassium citrate Drugs 0.000 claims description 3
- QEEAPRPFLLJWCF-UHFFFAOYSA-K potassium citrate (anhydrous) Chemical compound [K+].[K+].[K+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O QEEAPRPFLLJWCF-UHFFFAOYSA-K 0.000 claims description 3
- 235000011082 potassium citrates Nutrition 0.000 claims description 3
- 239000001509 sodium citrate Substances 0.000 claims description 3
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims 4
- 239000003814 drug Substances 0.000 abstract description 3
- 239000007963 capsule composition Substances 0.000 abstract description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 2
- 239000003349 gelling agent Substances 0.000 description 3
- 229960003943 hypromellose Drugs 0.000 description 3
- 230000000087 stabilizing effect Effects 0.000 description 3
- 241001474374 Blennius Species 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 235000010489 acacia gum Nutrition 0.000 description 1
- 239000001785 acacia senegal l. willd gum Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
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- Medicinal Preparation (AREA)
Abstract
The invention discloses a formula for accelerating dissolution of an empty capsule and a preparation method thereof. Belongs to the field of biological medicine manufacture, and comprises the following components: film forming material, gel, chelating agent and the balance of water. The method comprises the following specific steps: weighing gel, stirring in water, heating in 50-60 deg.C water bath, adding film forming material, stirring, and keeping temperature at 50-55 deg.C to obtain heat-insulating glue solution; weighing a chelating agent, dissolving with water, heating to 50-55 ℃, and adding into a heat-preservation glue solution at 50-55 ℃ to obtain a glue solution containing the chelating agent; carrying out mould dipping molding on the glue solution, and drying in an oven at the temperature of 25-35 ℃ to obtain a capsule cap body blank; then, demoulding, cutting and sleeving are carried out by using a demoulding device, and the hollow capsule can be obtained. The invention provides a hollow capsule formula which can keep stable dissolution property under four pH conditions (pH1.2, pH4.0, pH6.8 and water) and is close to gelatin.
Description
Technical Field
The invention belongs to the field of biological medicine manufacturing, and relates to a formula for accelerating dissolution of an empty capsule and a preparation method thereof.
Background
In the prior art, in order to reduce the safety risk of the hollow capsule raw material, a proper plant-derived capsule material is continuously researched and developed; such as hydroxypropyl methylcellulose (HPMC), pullulan and starch, the hollow capsules manufactured by the method are produced in a large scale, and are characterized in that: has the advantages of low water content, high toughness, no brittleness, high chemical stability, good coating performance, etc.
However, due to the difference between the properties of the gelatin and the gelatin, the formula of the hollow capsule prepared by the other film materials is more complex, and some gelling agents such as arabic gum, carrageenan (seaweed gel), xanthan gum and the like are required to be added; therefore, the HPMC hollow capsule shell has dissolution problem, and the drug dissolution of the capsule is further influenced.
Under the existing technical conditions, a common hollow capsule can not achieve the technical effect of the same dissolution property as gelatin, so that the application range is limited, and the hollow capsule can not be applied to a capsule preparation with a strict requirement on dissolution.
Disclosure of Invention
The purpose of the invention is as follows: the invention aims to provide a formula for accelerating dissolution of an empty capsule and a preparation method thereof.
The technical scheme is as follows: the invention relates to a formula for accelerating dissolution of an empty capsule,
the weight percentages of the components are as follows: 20 to 25 percent of film forming material, 0 to 5 percent of gel, 0.1 to 30 percent of chelating agent and the balance of water.
Further, the film forming material is one or a mixture of more of gelatin, hypromellose and pullulan.
Further, the gelling agent is one or a mixture of more of gellan gum, carrageenan, locust bean gum or pectin.
Further, the chelating agent is one or more of citric acid, sodium citrate, potassium citrate and calcium chloride.
Further, the water is deionized water.
Further, a preparation method of the formula for accelerating dissolution of the hollow capsule comprises the following specific preparation steps:
(1) weighing the gel agent in deionized water, stirring until the gel agent is dissolved, heating in a water bath at 50-60 ℃, adding the film forming material, stirring uniformly, and then preserving heat at 50-55 ℃ to obtain heat preservation glue solution;
(2) weighing the chelating agent, dissolving with part of deionized water, heating to 50-55 ℃, and then adding into the heat-preservation glue solution at 50-55 ℃ to obtain a glue solution containing the chelating agent;
(3) carrying out mould dipping molding on the glue solution obtained in the step (2), and drying in an oven for 30-90 minutes at the temperature of 25-35 ℃ to obtain a capsule cap body blank;
then, demoulding, cutting and sleeving are carried out by using a demoulding device, and the formula for accelerating the dissolution of the hollow capsule can be obtained.
Has the advantages that: compared with the prior art, the invention has the characteristics that the invention provides a hollow capsule formula which can keep stable dissolution property under four pH conditions (pH1.2, pH4.0, pH6.8 and water) and is close to gelatin.
Detailed Description
The present invention will be further described with reference to the following examples.
The invention relates to a formula for accelerating dissolution of an empty capsule,
the weight percentages of the components are as follows: 20 to 25 percent of film forming material, 0 to 5 percent of gel, 0.1 to 30 percent of chelating agent and the balance of water.
Further, the film forming material is one or a mixture of more of gelatin, hypromellose and pullulan.
Further, the gelling agent is one or a mixture of more of gellan gum, carrageenan, locust bean gum or pectin.
Further, the chelating agent is one or more of citric acid, sodium citrate, potassium citrate and calcium chloride.
Further, the water is deionized water.
Further, a preparation method of the formula for accelerating dissolution of the hollow capsule comprises the following specific preparation steps:
(1) weighing 0-5 wt% of gel in deionized water, stirring until the system is completely dissolved, heating in 50-60 deg.C water bath, adding 20-25 wt% of film-forming material, stirring, and keeping at 50-55 deg.C;
(2) weighing 0.1-30% of chelating agent, dissolving with part of deionized water, heating to 50-55 ℃, and adding into 50-55 ℃ heat-preservation glue solution;
(3) and carrying out mould dipping molding on the stable glue solution, drying in an oven for 30-90 minutes at the temperature of 25-35 ℃ to obtain a capsule cap body blank, and carrying out demoulding, cutting and sleeving by using a demoulding device to obtain the hollow capsule, namely the formula for accelerating the dissolution of the hollow capsule.
Example one
An instant hypromellose empty capsule: weighing 5 parts of disintegration aid, stirring to completely dissolve the system, heating at 60 ℃ for 3 hours, adding 10 parts of gellan gum and 250 parts of hydroxypropyl methylcellulose, stabilizing at 60 ℃ for 5 hours, adding 25 parts of citric acid, and stirring uniformly; finally, dipping the glue solution in a mould for forming, drying for 60min at the temperature of 30 ℃ to obtain a capsule cap body glue blank, and demoulding, cutting and sleeving by using a demoulding device to obtain the capsule cap body glue blank;
the test dissolution data are compared as follows:
example two
An instant gelatin empty capsule: weighing 5 parts of carrageenan and 200 parts of gelatin, dissolving the carrageenan and the gelatin in water, heating the mixture at 60 ℃ for 2 hours after a stirring treatment system is completely dissolved, adding 10 parts of citric acid, uniformly stirring the mixture, stabilizing the mixture at 60 ℃ for 2 hours, finally carrying out glue dipping molding on glue solution through a mould, drying the glue solution for 60min at the temperature of 30 ℃ to obtain a capsule cap body glue blank, and carrying out demoulding, cutting and sleeving by using a demoulding device to obtain the capsule cap body glue blank.
The test dissolution data are compared as follows:
EXAMPLE III
A rapidly disintegrating pullulan empty capsule: weighing 7 parts of gellan gum, heating at 60 ℃ for 3 hours after a stirring treatment system is completely dissolved, adding 2 parts of carrageenan and 250 parts of pullulan, uniformly stirring, stabilizing at 55 ℃ for 2 hours, adding 25 parts of citric acid, finally carrying out glue dipping molding on glue solution through a mold, drying at 25-30 ℃ for 60min to obtain a capsule cap body glue blank, and carrying out demolding, cutting and sleeving by using a demolding device to obtain the capsule cap body glue blank.
The test dissolution data are compared as follows:
the above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the above-mentioned embodiments, and all technical solutions belonging to the idea of the present invention belong to the protection scope of the present invention. It should be noted that modifications and embellishments within the scope of the invention may be made by those skilled in the art without departing from the principle of the invention.
Claims (6)
1. A formula for accelerating the dissolution of a hollow capsule, which is characterized in that,
the weight percentages of the components are as follows: 20 to 25 percent of film forming material, 0 to 5 percent of gel, 0.1 to 30 percent of chelating agent and the balance of water.
2. The formulation for accelerating the dissolution of an empty capsule according to claim 1,
the film forming material is one or a mixture of more of gelatin, hydroxypropyl methylcellulose and pullulan.
3. The formulation for accelerating the dissolution of an empty capsule according to claim 1,
the gel is one or more of gellan gum, carrageenan, locust bean gum or pectin.
4. The formulation for accelerating the dissolution of an empty capsule according to claim 1,
the chelating agent is one or more of citric acid, sodium citrate, potassium citrate and calcium chloride.
5. The formulation for accelerating the dissolution of an empty capsule according to claim 1,
the water is deionized water.
6. The method for preparing the formula for accelerating the dissolution of the empty capsules according to claims 1 to 5, which comprises the following steps:
(1) weighing the gel agent in deionized water, stirring until the gel agent is dissolved, heating in a water bath at 50-60 ℃, adding the film forming material, stirring uniformly, and then preserving heat at 50-55 ℃ to obtain heat preservation glue solution;
(2) weighing the chelating agent, dissolving with part of deionized water, heating to 50-55 ℃, and then adding into the heat-preservation glue solution at 50-55 ℃ to obtain a glue solution containing the chelating agent;
(3) carrying out mould dipping molding on the glue solution obtained in the step (2), and drying in an oven for 30-90 minutes at the temperature of 25-35 ℃ to obtain a capsule cap body blank;
then, demoulding, cutting and sleeving are carried out by using a demoulding device, and the formula for accelerating the dissolution of the hollow capsule can be obtained.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111625647.XA CN114259471A (en) | 2021-12-28 | 2021-12-28 | Formula for accelerating dissolution of hollow capsules and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202111625647.XA CN114259471A (en) | 2021-12-28 | 2021-12-28 | Formula for accelerating dissolution of hollow capsules and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN114259471A true CN114259471A (en) | 2022-04-01 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202111625647.XA Pending CN114259471A (en) | 2021-12-28 | 2021-12-28 | Formula for accelerating dissolution of hollow capsules and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN114259471A (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432096A (en) * | 2013-08-11 | 2013-12-11 | 重庆衡生药用胶囊有限责任公司 | Hydroxypropyl methylcellulose enteric empty capsule jellied by carrageenan and potassium citrate |
| CN106166143A (en) * | 2016-06-22 | 2016-11-30 | 石家庄华加药用胶囊有限公司 | A kind of plant hollow and hard capsule shell material and preparation method thereof |
| CN113018275A (en) * | 2021-03-11 | 2021-06-25 | 安徽黄山胶囊股份有限公司 | Povidone empty capsule and production process thereof |
-
2021
- 2021-12-28 CN CN202111625647.XA patent/CN114259471A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103432096A (en) * | 2013-08-11 | 2013-12-11 | 重庆衡生药用胶囊有限责任公司 | Hydroxypropyl methylcellulose enteric empty capsule jellied by carrageenan and potassium citrate |
| CN106166143A (en) * | 2016-06-22 | 2016-11-30 | 石家庄华加药用胶囊有限公司 | A kind of plant hollow and hard capsule shell material and preparation method thereof |
| CN113018275A (en) * | 2021-03-11 | 2021-06-25 | 安徽黄山胶囊股份有限公司 | Povidone empty capsule and production process thereof |
Non-Patent Citations (1)
| Title |
|---|
| 姚静 等，: "《药用辅料应用指南》", 31 August 2011, 中国医药科技出版社 * |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20220401 |