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Rifapentine capsule and preparation method thereof

A rifapentine and capsule technology, which is applied in the field of rifapentine capsules and its preparation, can solve the problems of large differences in the filling amount of rifapentine capsules, and achieves the solution of excessive substances, large differences in filling amounts, and improved dissolution rate. Effect

Active Publication Date: 2017-07-04
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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  • Rifapentine capsule and preparation method thereof
  • Rifapentine capsule and preparation method thereof
  • Rifapentine capsule and preparation method thereof

Examples

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Effect test

preparation example Construction

[0031] The preparation method of rifapentine capsule provided by the present invention is to use fluidized bed granulation method to produce rifapentine capsule, and Tween 80, HPMC and K 12 Add pure ethanol to dissolve into a binder, use the binder to spray rifapentine raw materials 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 liquid to carry out spray coating on the rifapentine granules to obtain rifapentine coated granules; finally mix the rifapentine coated granules with pregelatinized starch for total mixing Fill to prepare rifapentine capsules. It solves the problem of large differences in the filling capacity of rifapentine capsules caused by the 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 amount of each raw and auxiliary material used in the embodiment...

Embodiment 1

[0037] The preparation of embodiment 1 rifapentine capsule

[0038] (1) Prescription of raw and auxiliary materials (per 10,000 capsules)

[0039] In terms of parts by weight, the rifapentine granules are formulated from the following components:

[0040]

[0041] In terms of parts by weight, the rifapentine coated granules are formulated from the following components:

[0042]

[0043] (2) Specific preparation process

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

[0045] 2) Put the prescribed amount of rifapentine in the granulation coating pan, and start top-spray granulation when the material temperature in the granulation coating pan reaches 35°C, and control the material temperature at 40°C during the entire granulation process. Until all spraying is finished, the material passes through a 20-mesh sieve, and particles larger than 20 mesh are removed to obtain rifapentine granules...

Embodiment 2

[0049] Embodiment 2 Preparation of Rifapentine Capsules

[0050] (1) Prescription of raw and auxiliary materials (per 10,000 capsules)

[0051] In terms of parts by weight, the rifapentine granules are formulated from the following components:

[0052]

[0053] In terms of parts by weight, the rifapentine coated granules are formulated from the following components:

[0054]

[0055] (2) Specific preparation process

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

[0057] 2) Put the prescribed amount of rifapentine in the granulation coating pan, and start the top spray granulation when the temperature of the material in the granulation coating pan reaches 35°C, and control the temperature of the material at 30-35°C during the whole granulation process. ℃, until all the spraying is finished, the material passes through a 20-mesh sieve, and particles larger than 20 mesh are removed to obt...

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Abstract

The invention discloses a rifapentine capsule and a preparation method of the rifapentine capsule. The preparation method comprises the following steps: adding Tween80, HPMC and K12 into absolute alcohol, thus obtaining an adhesive after dissolving, and atomizing rifapentine by adopting the adhesive, thus obtaining rifapentine particles; adding HPMC, BHA and vitamin C into absolute alcohol, thus obtaining a coating solution after dissolving, and carrying out liquid-spraying coating on the rifapentine particles by adopting the coating solution, thus obtaining rifapentine coated particles; and finally, blending the rifapentine coated particles with pregelatinized starch for total blending, and carrying out filling, thus obtaining the rifapentine capsule. With the adoption of the method for preparing the rifapentine capsule, the problem that in the original method for preparing the rifapentine capsule, the intermediate powder is poor in fluidity is solved, further, the problems that related substances exceed the standard and the content differences are large are solved, and meanwhile, the dissolution rate is greatly improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a rifapentine capsule and a preparation method thereof. Background technique [0002] The traditional preparation process of rifapentine capsules is direct mixing of powders. In this process, the raw and auxiliary materials are sieved and mixed for several minutes by a multi-directional motion mixer. Due to the characteristic factors of the main drug in this product (brick red or dark red crystalline powder, fine powder and specific viscosity), the production difficulty of the filling process is increased, so the physical and chemical properties of the main drug itself affect the difference in its loading capacity, and at the same time 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 that the difference in capsule loading exceeds the standard and the dif...

Claims

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Application Information

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Patent Type & Authority Applications(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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