CN113018275A - Povidone empty capsule and production process thereof - Google Patents
Povidone empty capsule and production process thereof Download PDFInfo
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- CN113018275A CN113018275A CN202110263503.8A CN202110263503A CN113018275A CN 113018275 A CN113018275 A CN 113018275A CN 202110263503 A CN202110263503 A CN 202110263503A CN 113018275 A CN113018275 A CN 113018275A
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- povidone
- capsule
- hollow
- coagulant aid
- hollow capsule
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- 239000002775 capsule Substances 0.000 title claims abstract description 84
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 title claims abstract description 69
- 229920000036 polyvinylpyrrolidone Polymers 0.000 title claims abstract description 69
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 title claims abstract description 65
- 229940069328 povidone Drugs 0.000 title claims abstract description 64
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000000701 coagulant Substances 0.000 claims abstract description 23
- 239000000843 powder Substances 0.000 claims abstract description 9
- 239000000243 solution Substances 0.000 claims description 25
- 239000003292 glue Substances 0.000 claims description 18
- 239000008213 purified water Substances 0.000 claims description 16
- 238000001035 drying Methods 0.000 claims description 15
- 238000003756 stirring Methods 0.000 claims description 14
- 238000004090 dissolution Methods 0.000 claims description 12
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 claims description 10
- 239000003349 gelling agent Substances 0.000 claims description 10
- 239000000203 mixture Substances 0.000 claims description 10
- 238000007598 dipping method Methods 0.000 claims description 9
- 238000005520 cutting process Methods 0.000 claims description 7
- 238000002156 mixing Methods 0.000 claims description 7
- 239000001508 potassium citrate Substances 0.000 claims description 7
- 229960002635 potassium citrate Drugs 0.000 claims description 7
- 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 7
- 235000011082 potassium citrates Nutrition 0.000 claims description 7
- 238000005303 weighing Methods 0.000 claims description 7
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims description 6
- 235000010489 acacia gum Nutrition 0.000 claims description 6
- 239000001785 acacia senegal l. willd gum Substances 0.000 claims description 6
- 239000001110 calcium chloride Substances 0.000 claims description 6
- 229910001628 calcium chloride Inorganic materials 0.000 claims description 6
- 235000011148 calcium chloride Nutrition 0.000 claims description 6
- 239000008055 phosphate buffer solution Substances 0.000 claims description 6
- 229920002907 Guar gum Polymers 0.000 claims description 5
- FNAQSUUGMSOBHW-UHFFFAOYSA-H calcium citrate Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O.[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O FNAQSUUGMSOBHW-UHFFFAOYSA-H 0.000 claims description 5
- 239000001354 calcium citrate Substances 0.000 claims description 5
- 239000000665 guar gum Substances 0.000 claims description 5
- 235000010417 guar gum Nutrition 0.000 claims description 5
- 229960002154 guar gum Drugs 0.000 claims description 5
- 239000001103 potassium chloride Substances 0.000 claims description 5
- 235000011164 potassium chloride Nutrition 0.000 claims description 5
- 235000013337 tricalcium citrate Nutrition 0.000 claims description 5
- 235000013912 Ceratonia siliqua Nutrition 0.000 claims description 4
- 240000008886 Ceratonia siliqua Species 0.000 claims description 4
- 229920002148 Gellan gum Polymers 0.000 claims description 4
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims description 4
- 229920002752 Konjac Polymers 0.000 claims description 4
- 235000010492 gellan gum Nutrition 0.000 claims description 4
- 239000000216 gellan gum Substances 0.000 claims description 4
- 239000000252 konjac Substances 0.000 claims description 4
- 239000001814 pectin Substances 0.000 claims description 4
- 235000010987 pectin Nutrition 0.000 claims description 4
- 229920001277 pectin Polymers 0.000 claims description 4
- VMHLLURERBWHNL-UHFFFAOYSA-M Sodium acetate Chemical compound [Na+].CC([O-])=O VMHLLURERBWHNL-UHFFFAOYSA-M 0.000 claims description 3
- 235000010418 carrageenan Nutrition 0.000 claims description 3
- 239000000679 carrageenan Substances 0.000 claims description 3
- 229920001525 carrageenan Polymers 0.000 claims description 3
- 229940113118 carrageenan Drugs 0.000 claims description 3
- 235000019823 konjac gum Nutrition 0.000 claims description 3
- 239000001632 sodium acetate Substances 0.000 claims description 3
- 235000017281 sodium acetate Nutrition 0.000 claims description 3
- 229920001285 xanthan gum Polymers 0.000 claims description 3
- 239000000230 xanthan gum Substances 0.000 claims description 3
- 235000010493 xanthan gum Nutrition 0.000 claims description 3
- 229940082509 xanthan gum Drugs 0.000 claims description 3
- 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 3
- 239000007974 sodium acetate buffer Substances 0.000 claims description 2
- BHZOKUMUHVTPBX-UHFFFAOYSA-M sodium acetic acid acetate Chemical compound [Na+].CC(O)=O.CC([O-])=O BHZOKUMUHVTPBX-UHFFFAOYSA-M 0.000 claims description 2
- 230000000087 stabilizing effect Effects 0.000 claims description 2
- 238000000034 method Methods 0.000 claims 3
- 230000005611 electricity Effects 0.000 abstract description 3
- 238000011068 loading method Methods 0.000 abstract description 3
- 230000003068 static effect Effects 0.000 abstract description 3
- 230000000857 drug effect Effects 0.000 abstract description 2
- 239000000499 gel Substances 0.000 description 11
- 239000003814 drug Substances 0.000 description 8
- 238000002360 preparation method Methods 0.000 description 5
- 239000002994 raw material Substances 0.000 description 5
- 230000006641 stabilisation Effects 0.000 description 5
- 238000011105 stabilization Methods 0.000 description 5
- 239000004373 Pullulan Substances 0.000 description 4
- 229920001218 Pullulan Polymers 0.000 description 4
- 239000002253 acid Substances 0.000 description 4
- 235000019423 pullulan Nutrition 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 3
- -1 colloid protection Chemical class 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000011156 evaluation Methods 0.000 description 3
- 239000008273 gelatin Substances 0.000 description 3
- 229920000159 gelatin Polymers 0.000 description 3
- 235000019322 gelatine Nutrition 0.000 description 3
- 235000011852 gelatine desserts Nutrition 0.000 description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 3
- 229960003943 hypromellose Drugs 0.000 description 3
- 241001465754 Metazoa Species 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 238000004132 cross linking Methods 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000007922 dissolution test Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000000463 material Substances 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 229920003169 water-soluble polymer Polymers 0.000 description 2
- LUEWUZLMQUOBSB-FSKGGBMCSA-N (2s,3s,4s,5s,6r)-2-[(2r,3s,4r,5r,6s)-6-[(2r,3s,4r,5s,6s)-4,5-dihydroxy-2-(hydroxymethyl)-6-[(2r,4r,5s,6r)-4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxan-3-yl]oxy-4,5-dihydroxy-2-(hydroxymethyl)oxan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol Chemical compound O[C@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@@H](O[C@@H]2[C@H](O[C@@H](OC3[C@H](O[C@@H](O)[C@@H](O)[C@H]3O)CO)[C@@H](O)[C@H]2O)CO)[C@H](O)[C@H]1O LUEWUZLMQUOBSB-FSKGGBMCSA-N 0.000 description 1
- 244000247812 Amorphophallus rivieri Species 0.000 description 1
- 235000001206 Amorphophallus rivieri Nutrition 0.000 description 1
- 229920002581 Glucomannan Polymers 0.000 description 1
- 229920003078 Povidone K 12 Polymers 0.000 description 1
- 229920003079 Povidone K 17 Polymers 0.000 description 1
- 229920002472 Starch Polymers 0.000 description 1
- 238000004458 analytical method Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000005354 coacervation Methods 0.000 description 1
- 239000000084 colloidal system Substances 0.000 description 1
- 229940046240 glucomannan Drugs 0.000 description 1
- 235000010485 konjac Nutrition 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 239000003960 organic solvent Substances 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 1
- 238000005063 solubilization Methods 0.000 description 1
- 230000007928 solubilization Effects 0.000 description 1
- 235000019698 starch Nutrition 0.000 description 1
- 239000008107 starch Substances 0.000 description 1
- 238000010998 test method Methods 0.000 description 1
Classifications
-
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
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 bodies, 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 core points that the disintegration time is accelerated, the smoothness of the capsule surface is good, the static electricity is less, the loading rate of the capsule is high when the capsule is filled with medicinal powder, the medicinal powder is not stuck on 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 of the correlation evaluation of the pharmaceutic adjuvant, the medicine enterprises need the hollow capsules to be more closely compatible with the medicines, so the medicine enterprises are inevitable about the variety diversification of the hollow capsules.
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 achieve 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 K12, K15, K17, K25 and 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 wt% of povidone, 0.5-5 wt% of gelling agent and 0.5-5 wt% of coagulant aid 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 85-90 ℃, 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 ℃;
s4, taking the dried rubber blank in S3, demolding, cutting and sleeving to obtain the povidone hollow capsule.
Preferably, after step S4, the dissolution characteristics of the povidone hollow capsule are tested by the following test methods:
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 is 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 dissolution requirements of four media of the medicine for making the capsule for consistency evaluation in the 2020 version of Chinese pharmacopoeia can be completely met.
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 according to the weight percentage; 1 part of gelling agent comprising carrageenan, xanthan gum and gellan gum (mixed according to the proportion of 1:1: 1); 1 part of coagulant aid comprising potassium chloride, calcium chloride and potassium citrate (mixed according to the proportion of 1:1: 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 stabilization for 2 hours to form a glue solution;
s3, dipping the glue solution for forming, and drying in a drying oven at 30 ℃ for 60min to obtain a dry capsule cap body blank;
s4, taking the dried rubber blank, demolding, cutting and sleeving to obtain the povidone hollow capsule.
Example 2
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 196 parts by weight of povidone K15; 2 parts of gel, including locust bean, guar gum and Arabic gum (mixed according to the proportion of 1:1: 1); 2 parts of coagulant aid, including potassium chloride, calcium chloride and potassium citrate (mixed according to the proportion of 1:1: 1);
s2, mixing the povidone, the gel 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 stabilization for 2 hours to form a glue solution;
s3, dipping the glue solution for forming, and drying in an oven at 30 ℃ for 70min to obtain a dry capsule cap body blank;
s4, taking the dried rubber blank, demolding, cutting and sleeving to obtain the povidone hollow capsule.
Example 3
A preparation method of a povidone hollow capsule comprises the following steps:
s1, weighing 194 parts of povidone K17 according to the weight percentage; 3 parts of gel, including Arabic gum, konjac glucomannan and pectin (mixed according to the proportion of 1:1: 1); 3 parts of coagulant aid, including calcium chloride, potassium citrate and calcium citrate (mixed according to the proportion of 1:1: 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 stabilization for 2 hours to form a glue solution;
s3, dipping the glue solution for forming, and drying in a drying oven at 35 ℃ for 75min to obtain a dry capsule cap body blank;
s4, taking the dried rubber blank, demolding, cutting and sleeving 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 gel, including gellan gum, locust bean, guar gum and arabic gum (mixed according to the proportion of 1:1:1: 1); 4 parts of coagulant aid, including potassium citrate, calcium citrate and sodium acetate (mixed according to the proportion of 1:1: 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 stabilization for 2 hours to 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;
s4, taking the dried rubber blank, demolding, cutting and sleeving 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 the weight percentage; 5 parts of gel, including guar gum, Arabic gum, konjac gum and pectin (mixed according to the proportion of 1:1:1: 1); 5 parts of coagulant aid, including potassium chloride, calcium chloride, potassium citrate and calcium citrate (mixed according to the proportion of 1:1:1: 1);
s2, mixing the povidone, the gel 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 the mixture in a water bath at 50-55 ℃ for stabilization for 2 hours to form a glue solution;
s3, dipping the glue solution for forming, and drying in a drying oven at 35 ℃ for 85min to obtain a dry capsule cap body blank;
s4, taking the dried rubber blank, demolding, cutting and sleeving 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 (6)
1. 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.
2. The povidone-empty capsule as defined in claim 1, wherein: the povidone is one of K12 type, K15 type, K17 type, K25 type and K30 type.
3. The povidone-empty capsule as defined in claim 1, wherein: the gel is one or more of carrageenan, xanthan gum, gellan gum, locust bean, guar gum, arabic gum, konjac gum and pectin.
4. The povidone-empty capsule as defined in claim 1, wherein: the coagulant aid is one or a mixture of potassium chloride, calcium chloride, potassium citrate, calcium citrate and sodium acetate.
5. The process for the production of empty capsules of povidone according to any one of claims 1 to 4, comprising the following steps:
s1, weighing 95-99 wt% of povidone, 0.5-5 wt% of gelling agent and 0.5-5 wt% of coagulant aid 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 85-90 ℃, 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 ℃;
s4, taking the dried rubber blank in S3, demolding, cutting and sleeving to obtain the povidone hollow capsule.
6. The process of claim 5, wherein after step S4, the dissolution characteristics of the hollow povidone capsule are tested by the following method:
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.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110263503.8A CN113018275B (en) | 2021-03-11 | 2021-03-11 | Povidone empty capsule and production process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110263503.8A CN113018275B (en) | 2021-03-11 | 2021-03-11 | Povidone empty capsule and production process thereof |
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| Publication Number | Publication Date |
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| CN113018275A true CN113018275A (en) | 2021-06-25 |
| CN113018275B CN113018275B (en) | 2023-02-14 |
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Cited By (2)
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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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| 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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| CN113018275B (en) | 2023-02-14 |
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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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Granted publication date: 20230214 Pledgee: Agricultural Bank of China Limited Jingde County Branch Pledgor: ANHUI HUANGSHAN CAPSULE Co.,Ltd. Registration number: Y2023980054456 |