CN113018275B - Povidone empty capsule and production process thereof - Google Patents
Povidone empty capsule and production process thereof Download PDFInfo
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- CN113018275B CN113018275B CN202110263503.8A CN202110263503A CN113018275B CN 113018275 B CN113018275 B CN 113018275B CN 202110263503 A CN202110263503 A CN 202110263503A CN 113018275 B CN113018275 B CN 113018275B
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- povidone
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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
Abstract
The invention relates to the technical field of medical capsules, and provides a povidone hollow capsule and a production process thereof, the povidone hollow capsule has good fluency and uniformity, can meet the requirement of 'Chinese pharmacopoeia' 2020 edition, can realize quick disintegration in human body, and accelerates the exertion of drug effect, and comprises the following components in percentage by weight: 95% -99.0% of polyvidone; 0.5 to 5.0 percent of gel; 0.5 to 5.0 percent of coagulant aid; the balance of water. The povidone hollow capsule provided by the invention has the advantages that the disintegration time is accelerated, the smoothness of the capsule surface is good, the static electricity is less, the upper rate of the capsule is high when the capsule is filled with medicinal powder, the medicinal powder does not adhere to the capsule surface, and the povidone hollow capsule is a preferred capsule of an inhalation capsule and has higher social use value and application prospect.
Description
Technical Field
The invention relates to the technical field of medical capsules, in particular to a povidone hollow capsule and a production process thereof.
Background
With the coming and further promotion of the national policy on the correlation evaluation of pharmaceutic adjuvants, the medicine enterprises need the hollow capsules to be more closely compatible with the medicines, so the variety diversification of the medicine enterprises to the hollow capsules is inevitable.
The currently marketed hypromellose hollow capsules and pullulan hollow capsules added with gelling agents and coagulant aids are poor in fluency and dissolution property, slow in disintegration test, start to break shells after 10 minutes in phosphate buffer solution with pH6.8 or artificial acid solution with pH1.2, start to disintegrate and dissolve after 30 minutes, and have long dissolution time.
Povidone, also known as polyvinylpyrrolidone, PVP for short, is a synthetic water-soluble polymer compound, and has the general properties of water-soluble polymer compounds, such as colloid protection, film-forming properties, cohesiveness, hygroscopicity, solubilization or coacervation, but the most distinctive feature, and thus the superior solubility and physiological compatibility are regarded as important matters. The povidone has the advantages of excellent physiological inertia, no participation in human metabolism, excellent biocompatibility, film forming property, flow aid, lubricity, water solubility, most of organic solvents and the like, and low raw material price, and is widely applied in the field of medicines. Therefore, we propose a povidone hollow capsule and a production process thereof.
Disclosure of Invention
Technical problem to be solved
Aiming at the defects of the prior art, the invention provides a povidone hollow capsule and a production process thereof, overcomes the defects of the prior art, has good fluency and uniformity, can meet the requirement of '2020 edition of Chinese pharmacopoeia', can realize rapid disintegration in human body and accelerate the exertion of drug effect.
(II) technical scheme
In order to realize the purpose, the invention is realized by the following technical scheme:
the povidone hollow capsule comprises the following components in percentage by weight:
95% -99.0% of polyvidone;
0.5 to 5.0 percent of gel;
0.5 to 5.0 percent of coagulant aid;
the balance of water.
Preferably, the povidone is one of a type K12, a type K15, a type K17, a type K25 and a type K30.
Preferably, the gelling agent is one or a mixture of more of carrageenan, xanthan gum, gellan gum, locust bean, guar gum, arabic gum, konjac gum and pectin.
Preferably, the coagulant aid is one or a mixture of potassium chloride, calcium chloride, potassium citrate, calcium citrate and sodium acetate.
The invention also provides a production process of the povidone hollow capsule, which comprises the following steps:
s1, weighing 95-99% of povidone, 0.5-5% of gel and 0.5-5% of coagulant aid by weight percentage for later use;
s2, mixing the povidone, the gelling agent and the coagulant aid in the step S1, uniformly stirring, adding purified water with the temperature of more than 85-90 ℃, stirring until the purified water is completely dissolved, and then placing the mixture in a water bath with the temperature of 50-55 ℃ for stabilizing for 1-2 hours to form a glue solution;
s3, dipping the glue solution in the S2 for forming, and placing the glue solution in a drying oven for forming a glue blank, wherein the drying time is 60-90min, and the drying temperature is 25-35 ℃;
and S4, taking the dried rubber blank in the S3, and carrying out demoulding, cutting and sleeving to obtain the povidone hollow capsule.
Preferably, after the step S4, a dissolution characteristic test is performed on the povidone hollow capsule, and the test method includes:
the povidone hollow capsule is filled with medicinal powder and then is respectively placed in four mediums of a PH1.2 hydrochloric acid solution, a PH4.5 acetic acid-sodium acetate buffer solution, purified water and a PH6.8 phosphate buffer solution, the initial disintegration and shell breaking time and the complete dissolution time are respectively detected, and the functional quality indexes can all accord with the 2020 edition of Chinese pharmacopoeia.
(III) advantageous effects
The embodiment of the invention provides a povidone hollow capsule and a production process thereof, and the povidone hollow capsule has the following beneficial effects:
1. the povidone hollow capsule provided by the invention has the core point that the disintegration time is accelerated, the raw material povidone can be quickly disintegrated in a phosphate buffer solution with the pH of 6.8 or an artificial acid solution with the pH of 1.2, and the povidone hollow capsule can completely meet the dissolution requirements of four media of a medicament which is used as a consistency evaluation capsule in the 2020 edition of Chinese pharmacopoeia.
2. The povidone hollow capsule has good surface smoothness and less static electricity, has high loading rate when the capsule is filled with medicinal powder, does not stick the medicinal powder on the surface of the capsule, and is the preferred capsule of an inhalation capsule.
3. The povidone raw material is not from animals, so that the problem of giving up religious belief is avoided, and the povidone is not protein, so that the gelatin hollow capsule is not easy to have a cross-linking reaction with a medicament, and the capsule is not disintegrated.
4. In the invention, the povidone is a good film-forming material, but the povidone cannot be gelled, so a certain amount of gelling agent is required to be added for dipping and forming, and the coagulant aid can effectively improve the gelling effect of the gelling agent.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.
Example 1
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 198 parts of povidone K12 in percentage by weight; 1 part of gelling agent, including carrageenan, xanthan gum and gellan gum (mixed according to the proportion of 1; 1 part of coagulant aid, which comprises potassium chloride, calcium chloride and potassium citrate (mixed according to the proportion of 1;
s2, mixing the povidone, the gel and the coagulant aid, uniformly stirring, adding 500 parts of purified water at 85 ℃, stirring until the purified water is completely dissolved, and then placing the mixture in a water bath at 50-55 ℃ for 2 hours to stabilize and form a glue solution;
s3, dipping the glue solution for forming, and drying in an oven at the temperature of 30 ℃ for 60min to obtain a dry capsule cap body blank;
and S4, taking the dried rubber blank, and carrying out demoulding, cutting and sleeving on the rubber blank to obtain the povidone hollow capsule.
Example 2
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 196 parts of povidone K15 in percentage by weight; 2 parts of a gelling agent, which comprises locust bean, guar gum and arabic gum (mixed according to the proportion of 1; 2 parts of coagulant aids, including potassium chloride, calcium chloride and potassium citrate (mixed according to the proportion of 1;
s2, mixing the povidone, the gelling agent and the coagulant aid, uniformly stirring, adding 600 parts of purified water at 85 ℃, stirring until the purified water is completely dissolved, and then placing the mixture in a water bath at 50-55 ℃ for 2 hours to stabilize and form a glue solution;
s3, dipping the glue solution for forming, and drying in an oven at the temperature of 30 ℃ for 70min to obtain a dry capsule cap body blank;
and S4, taking the dried rubber blank, and carrying out demoulding, cutting and sleeving on the rubber blank to obtain the povidone hollow capsule.
Example 3
A preparation method of povidone hollow capsule comprises the following steps:
s1, weighing 194 parts of povidone K17 in percentage by weight; 3 parts of a gelling agent, which comprises arabic gum, konjac gum and pectin (mixed according to the proportion of 1; 3 parts of coagulant aid, including calcium chloride, potassium citrate and calcium citrate (mixed according to the proportion of 1;
s2, mixing the povidone, the gel and the coagulant aid, uniformly stirring, adding 700 parts of purified water at 85 ℃, stirring until the purified water is completely dissolved, and then placing the mixture in a water bath at 50-55 ℃ for 2 hours to stabilize and form a glue solution;
s3, dipping the glue solution for forming, and drying in an oven at 35 ℃ for 75min to obtain a dry capsule cap body blank;
and S4, taking the dried rubber blank, and carrying out demoulding, cutting and sleeving on the rubber blank to obtain the povidone hollow capsule.
Example 4
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 192 parts of povidone K15 according to the weight percentage; 4 parts of a gelling agent comprising gellan gum, locust bean, guar gum, gum arabic (mixed in a ratio of 1; 4 parts of coagulant aids, including potassium citrate, calcium citrate and sodium acetate (mixed according to the proportion of 1;
s2, mixing the povidone, the gel and the coagulant aid, uniformly stirring, adding 800 parts of purified water at 90 ℃, stirring until the purified water is completely dissolved, and then placing the mixture in a water bath at 50-55 ℃ for 2 hours to stabilize and form a glue solution;
s3, dipping the glue solution for forming, and drying in a drying oven at 35 ℃ for 80min to obtain a dry capsule cap body blank;
and S4, taking the dried rubber blank, and carrying out demoulding, cutting and sleeving on the rubber blank to obtain the povidone hollow capsule.
Example 5
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 190 parts of povidone K15 according to weight percentage; 5 parts of a gelling agent, which comprises guar gum, arabic gum, konjac gum and pectin (mixed according to the proportion of 1; 5 parts of coagulant aids, including potassium chloride, calcium chloride, potassium citrate and calcium citrate (mixed according to the proportion of 1;
s2, mixing the povidone, the gelling agent and the coagulant aid, uniformly stirring, adding 900 parts of purified water at 90 ℃, stirring until the purified water is completely dissolved, and then placing in a water bath at 50-55 ℃ for stabilizing for 2 hours to form a glue solution;
s3, dipping the glue solution for forming, and drying in an oven at 35 ℃ for 85min to obtain a dry capsule cap body blank;
and S4, taking the dried rubber blank, and carrying out demoulding, cutting and sleeving on the rubber blank to obtain the povidone hollow capsule.
The dissolution characteristics of the povidone-hollow capsules prepared in examples 1 to 5 were tested, and the specific data are shown in table 1:
TABLE 1
As can be seen from table 1, the povidone hollow capsule provided by the invention has the core point that the disintegration time is shortened, the raw material povidone is quickly disintegrated in a phosphate buffer solution with a PH of 6.8 or an artificial acid solution with a PH of 1.2, and the dissolution requirements of four media of the medicine for making the capsule for consistency evaluation in the 2020 edition of the chinese pharmacopoeia can be completely met;
compared with the currently marketed hypromellose hollow capsules and pullulan hollow capsules added with gelling agents and coagulant aids, the disintegration is particularly slow when the dissolution test is carried out on the powder contained in the hypromellose hollow capsules and the pullulan hollow capsules, the shell breaking is started after 10 minutes in phosphate buffer solution with the pH of 6.8 or artificial acid solution with the pH of 1.2, the disintegration and the dissolution are started after 30 minutes, the dissolution time is long, and the dissolution standard within 30 minutes is not reached when the dissolution test required by pharmacopoeia is carried out.
According to the four stomach-soluble hollow capsules recorded in the 'Chinese pharmacopoeia' 2020 edition and the povidone hollow capsule provided by the invention, the smoothness test values are respectively detected by an instrument, the smaller the test value is, the better the smoothness is, and the specific data are shown in the table 2:
| variety of capsule | Test 1 | Test 2 | Test 3 | Mean value of |
| Povidone hollow capsule | 22.1 | 23.5 | 21.8 | 22.47 |
| Gelatin hollow capsule | 52.3 | 55.7 | 59.4 | 55.8 |
| Hydroxypropyl methyl hollow capsule | 72.8 | 76.9 | 80.6 | 76.77 |
| Hydroxypropyl methyl starch hollow capsule | 90.5 | 91.6 | 95.2 | 92.43 |
| Pullulan hollow capsule | 65.1 | 66.9 | 70.8 | 67.6 |
TABLE 2
As can be seen from table 2, the analysis of the detection values of the five hollow capsules shows that the povidone detection value is the smallest, the povidone hollow capsule of the present invention has good surface smoothness and low static electricity, the loading rate of the capsule is high when the capsule is filled with medicinal powder, and the medicinal powder does not stick to the surface of the capsule, which is the preferred capsule for inhalation capsules.
Meanwhile, the povidone raw material is not from animals, so that the problem of giving up religion belief is avoided;
the povidone is not protein, and the gelatin hollow capsule is not easy to have cross-linking reaction with the medicine, so that the capsule is not disintegrated;
in the invention, the povidone is a good film-forming material, but the povidone cannot be gelled, so a certain amount of gelling agent is required to be added for dipping and forming, and the coagulant aid can effectively improve the gelling effect of the gelling agent.
It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.
Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.
Claims (3)
1. The production process of the povidone hollow capsule is characterized by comprising the following steps:
s1, weighing 95-99% of povidone, 0.5-5% of gel and 0.5-5% of coagulant aid by weight percentage for later use;
s2, mixing the povidone, the gel and the coagulant aid in the S1, uniformly stirring, adding purified water with the temperature of more than 85 ℃, stirring until the purified water is completely dissolved, then placing the mixture in a water bath with the temperature of 50-55 ℃ for stabilizing for 1-2 hours, and forming into a glue solution;
s3, dipping the glue solution in the S2 for forming, and placing the glue solution in a drying oven for forming a glue blank, wherein the drying time is 60-90min, and the drying temperature is 25-35 ℃;
s4, taking the dried rubber blank in the S3, and carrying out demoulding, cutting and sleeving to obtain the povidone hollow capsule;
wherein the gelling agent is one or more of carrageenan, xanthan gum, gellan gum, locust bean, guar gum, arabic gum, konjac gum and pectin; the coagulant aid is one or a mixture of potassium chloride, calcium chloride, potassium citrate, calcium citrate and sodium acetate;
after the step S4, performing dissolution characteristic test on the povidone hollow capsule, wherein the test method comprises the following steps:
the povidone hollow capsule is filled with medicinal powder and then is respectively placed in four mediums of a PH1.2 hydrochloric acid solution, a PH4.5 acetic acid-sodium acetate buffer solution, purified water and a PH6.8 phosphate buffer solution, the initial disintegration and shell breaking time and the complete dissolution time are respectively detected, and the functional quality indexes can all accord with the 2020 edition of Chinese pharmacopoeia.
2. The povidone hollow capsule is characterized by comprising the following components in percentage by weight:
95% -99.0% of polyvidone;
0.5 to 5.0 percent of gel;
0.5 to 5.0 percent of coagulant aid;
the balance of water;
wherein the gelling agent is one or more of carrageenan, xanthan gum, gellan gum, locust bean, guar gum, arabic gum, konjac gum and pectin; the coagulant aid is one or a mixture of potassium chloride, calcium chloride, potassium citrate, calcium citrate and sodium acetate.
3. The povidone-empty capsule as defined in claim 2, wherein: the povidone is one of K12 type, K15 type, K17 type, K25 type and K30 type.
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| CN113599365A (en) * | 2021-09-16 | 2021-11-05 | 安徽黄山胶囊股份有限公司 | Hydroxypropyl methylcellulose hollow capsule and preparation process thereof |
| CN114259471A (en) * | 2021-12-28 | 2022-04-01 | 江苏力凡胶囊有限公司 | Formula for accelerating dissolution of hollow capsules and preparation method thereof |
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| CN111920780A (en) * | 2020-07-22 | 2020-11-13 | 青岛益青生物科技股份有限公司 | Instant hypromellose empty capsule and preparation method thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20070298095A1 (en) * | 2004-05-24 | 2007-12-27 | Shionogi Qualicaps Co., Ltd. | Surface-Modified and Solubility-Improved Hard Capsule |
| WO2009021377A1 (en) * | 2007-08-10 | 2009-02-19 | Shanghai Huiyuan Vegetal Capsule Co., Ltd | Non-gelatin shell material of hard capsule and process for preparing thereof |
| CN101485643A (en) * | 2009-02-25 | 2009-07-22 | 刘松林 | Plant hollow capsule |
| CN105878208A (en) * | 2016-04-14 | 2016-08-24 | 中国科学院海洋研究所 | Forming agent for starch-based hard medicinal vegetable capsule and application of forming agent |
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Denomination of invention: A hollow capsule of povidone and its production process Effective date of registration: 20230830 Granted publication date: 20230214 Pledgee: Agricultural Bank of China Limited Jingde County Branch Pledgor: ANHUI HUANGSHAN CAPSULE Co.,Ltd. Registration number: Y2023980054456 |
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