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Slow-release medicine system of compound rifampicin

A rifampicin and preparation technology, applied in the field of anti-tuberculosis drugs, can solve the problem that it is difficult to achieve rifampicin equality

Inactive Publication Date: 2005-05-18
SICHUAN LONG MARCH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

3. The bioavailability of rifampicin must be considered
Moreover, the current capsule filling machine has only four workers at most, and can only fill three kinds of materials in one capsule (the other station is used to put the capsule), so it is difficult to realize the accurate filling dose of rifampicin.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] A quadruple compound rifampicin capsule, in which rifampicin is enteric-coated small tablets, ethambutol hydrochloride is ordinary small tablets, isoniazid and pyrazinamide are made into granules, and the granules are dissolved in the stomach to ensure the dosage Coat the coating, then fill the capsules. By the way, the granules do not have to be coated with gastric solution at all.

[0054] (1) Prescription and preparation process of rifampicin enteric-coated tablets:

[0055] (1) Prescription and process of rifampicin tablet (tablet core):

[0056] (A) Prescription:

[0057] Rifampicin 75.0g

[0058] Low-substituted hydroxypropyl cellulose 20.0g

[0059] Starch 10.0g

[0060] Sodium Lauryl Sulfate 6.5g

[0061] 10% starch slurry appropriate amount

[0062] Magnesium Stearate Appropriate amount

[0063] Makes 1000 pieces

[0064] (B) Preparation process:

[0065] Pass the above-mentioned raw materials and auxiliary materials through a 200-mesh sieve, weigh th...

Embodiment 2

[0113] A compound rifampicin micropill capsule, each member of the quadruple group is individually made into micropills and coated after testing, wherein the rifampicin is enteric-coated and the other members are gastric-coated. The final product of this embodiment has quadruple capsules, triple capsules and double capsules respectively.

[0114] (1) Preparation of rifampicin enteric-coated pellets

[0115] Preparation of rifampicin pills:

[0116] ①The composition of the prescription of rifampicin pills: 1 part of rifampicin, 0.0867 parts of pill core, 0.2 part of microcrystalline cellulose, 0.1333 parts of sodium lauryl sulfate, 0.0667 parts of CMS-Na, 1% PVP (ethanol: water = 1: 1) appropriate amount. (Or write: rifampin 150g, ball core 13g, microcrystalline fiber 30g, sodium lauryl sulfate 20g, CMS-Na 10g, 1% PVP (ethanol: water = 1: 1) appropriate amount.)

[0117] ② Preparation process of rifampicin pills:

[0118] A Weigh the above-mentioned raw materials and auxili...

Embodiment 3

[0158] A compound rifampicin micropill capsule, each member of the quadruple group is independently made into micropills and coated after testing, in which isoniazid is enteric-coated and the other members are gastric-soluble coated. The final product of this embodiment has quadruple capsules, triple capsules and double capsules respectively. In this example, except that the isoniazid pills are enteric-coated using the same process as the rifampicin enteric-coated pellets in Example 2, the rifampicin pills are coated with the same process as the isoniazid gastric-coated pellets in Example 2 Gastric coating was carried out, and the rest of the content was completely the same as in Example 2. Due to space limitations, details will not be repeated here. Of course, due to the exchange of the coating materials of isoniazid pills and rifampicin pills, the small changes in the content of the drug in the pellets will also cause small changes in the filling amount of the pellets in the...

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Abstract

A compound rifampicin preparation, which can be interpreted as a drug delivery system for a compound rifampicin preparation, comprising rifampicin and isoniazid, optionally further comprising pyrazinamide or pyrazinamide and ethyl hydrochloride Ambutol, wherein each dose meets the latest compatibility dose requirements proposed by the WHO 2001 No. 1 (No. 1, Volume 7) bulletin, it is characterized in that isoniazid, pyrazinamide, ethambutol hydrochloride are gastric dissolved While rifampicin is enteric-coated, or isoniazid is enteric-coated and others are gastric-coated, the enteric coating of enteric-coated drugs begins at the upper part of the small intestine, to be exact, when the pH of the external environment of the drug is From 5.0 to 5.5, the enteric-coated film began to dissolve, and the drug began to be released gradually. The dosage form of the preparation of the present invention is selected from capsules, granules, tablets, multi-layer tablets or suspensions. The invention also provides a preparation method of compound rifampicin.

Description

field of invention [0001] This application is actually a continuation application. The invention title of the previous application is a prescription composition of a compound rifampicin preparation, which was submitted on April 15, 2002, and the application number is 02116616.1, the contents of which are incorporated herein by reference. [0002] The invention relates to an anti-tuberculosis drug, in particular to a compound rifampicin preparation, which is more accurately expressed in modern pharmacy as a drug release system for the compound rifampicin preparation and its composition and preparation method. technical background [0003] Tuberculosis is a chronic infectious disease that seriously endangers people's health. Since the middle and late 1980s, the global epidemic situation has deteriorated sharply and formed a new rising peak. According to the latest estimate of the World Health Organization (WHO) Bulletin (2001), there are 8 million new tuberculosis patients in ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/36A61K9/48A61K31/496A61K31/4965A61P31/06
Inventor 高华鲁同红
Owner SICHUAN LONG MARCH PHARMA CO LTD
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