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A kind of rifapentine capsule and preparation method thereof

A technology for rifapentine and capsules, which is applied in the field of rifapentine capsules and their preparation, can solve the problems of large differences in the loading of rifapentine capsules and the like

Active Publication Date: 2021-03-02
SHANGHAI SINE WANXIANG PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The present invention provides a rifapentine capsule and a preparation method thereof in order to solve the problem in the prior art that the filling capacity of rifapentine capsules produced by direct mixing and granulation of the original powder is large.

Method used

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  • A kind of rifapentine capsule and preparation method thereof
  • A kind of rifapentine capsule and preparation method thereof
  • A kind of rifapentine capsule and preparation method thereof

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preparation example Construction

[0031]The preparation method of rifapentin capsules provided by the present invention is to use fluidized bed granulation method to produce rifapentin capsules, and combine Tween 80, HPMC and K12Add pure ethanol to dissolve into a binder, use the binder to spray rifapentin raw materials to prepare rifapentin granules; then add HPMC, BHA and vitamin C into pure ethanol to dissolve into a coating liquid, and Use the coating solution to spray-coat the rifapentin granules to prepare rifapentin coated granules; finally, mix the rifapentin coated granules with pregelatinized starch for total mixing. Fill it to prepare rifapentin capsules. It solves the problem of large difference in rifapentin capsules caused by direct mixing and granulation of the original powder, and at the same time, the dissolution rate and the quality of related substances are also improved.

[0032]The amounts and sources of the raw and auxiliary materials used in the embodiments of the present invention are shown in T...

Embodiment 1

[0037]Example 1 Preparation of Rifapentin Capsules

[0038](1) Prescription of raw materials and excipients (per 10,000 tablets)

[0039]Based on parts by weight, rifapentin granules are formulated with the following components:

[0040]

[0041]Based on parts by weight, rifapentin coated granules are prepared from the following components:

[0042]

[0043](2) Specific preparation process

[0044]1) Add Tween 80, HPMC and K12 to pure ethanol to dissolve into a binder, pass through a 100-mesh sieve, and set aside;

[0045]2) Put the prescription amount of rifapentin in the granulating coating pan. When the temperature of the material in the granulating coating pan reaches 35℃, the top spray granulation will be started. The temperature of the material will be controlled at 40℃ during the whole granulation process. Until all the spraying is finished, the material is passed through a 20-mesh screen, and particles larger than 20-mesh are removed to obtain rifapentin particles;

[0046]3) Add HPMC, BHA and vitamin...

Embodiment 2

[0049]Example 2 Preparation of Rifapentin Capsules

[0050](1) Prescription of raw materials and excipients (per 10,000 tablets)

[0051]Based on parts by weight, rifapentin granules are formulated with the following components:

[0052]

[0053]Based on parts by weight, rifapentin coated granules are prepared from the following components:

[0054]

[0055](2) Specific preparation process

[0056]1) Add Tween 80, HPMC and K12 to pure ethanol to dissolve into a binder, pass through a 100-mesh sieve, and set aside;

[0057]2) Put the prescription amount of rifapentin in the granulating coating pan. When the temperature of the material in the granulating coating pan reaches 35℃, the top spray granulation will start, and the temperature of the material will be controlled at 30-35 during the whole granulation process. ℃, until all spraying is finished, the material is passed through a 20-mesh screen, and particles larger than 20-mesh are removed to obtain rifapentin particles;

[0058]3) Add HPMC, BHA and vitamin...

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Abstract

The invention discloses a rifapentine capsule and a preparation method thereof. Tween 80, HPMC and K 12 Add pure ethanol to dissolve into a binder, use the binder to spray rifapentine to obtain rifapentine granules; then add HPMC, BHA and vitamin C to dissolve into pure ethanol to form a coating solution, and use The coating solution sprays and coats the rifapentine granules to obtain rifapentine coated granules; finally mixes the rifapentine coated granules with pregelatinized starch for total mixing and then fills , to prepare rifapentine capsules. Adopting the method of the present invention to prepare rifapentine capsules solves the problem of fluidity of the intermediate powder of the original preparation of rifapentine capsules, so as to solve the problems of related substances exceeding the standard and large differences in loading, and at the same time, the dissolution rate is also relatively large improvement.

Description

Technical field[0001]The invention relates to the field of pharmaceutical preparations, in particular to a rifapentin capsule and a preparation method thereof.Background technique[0002]The traditional preparation process of rifapentin capsules is direct powder mixing, which involves mixing the raw and auxiliary materials through a multi-directional motion mixer for several minutes after being sieved. Because the characteristic factors of the main drug in the product (brick red or dark red crystalline powder, fine powder and specific viscosity) increase the difficulty of the filling process, the physical and chemical properties of the main drug itself affect the difference in its loading. It also affects the dissolution rate. The original process is difficult to effectively improve the fluidity of the powder, and it is very easy to cause the phenomenon of excessive difference in capsule volume and large difference in pill weight during the production of the filling process. At the sa...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/496A61K47/38A61K47/26A61K47/20A61K47/36A61K47/22A61K47/10
CPCA61K9/4866A61K9/5015A61K9/5047A61K31/496
Inventor 于昊姚敏周莉花
Owner SHANGHAI SINE WANXIANG PHARMA
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