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Chinese medicinal dispersible tablet, its preparation process and quality control method

A quality control method and technology for dispersible tablets, which can be used in pharmaceutical formulations, testing pharmaceutical preparations, and medical preparations containing active ingredients, etc., and can solve the problems of non-disintegration, easy aging of capsule shells, and bioavailability. Improve and other problems, to achieve the effect of fast absorption, favorable dissolution and absorption, and high bioavailability

Inactive Publication Date: 2006-07-12
张红
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the soft capsule can completely disintegrate within the specified disintegration time limit, the bioavailability of the drug is very high. However, at present, the soft capsules developed in my country generally have disintegration problems. The increase of the aging degree of the capsule shell increases, and some do not even disintegrate. Therefore, the soft capsule preparation still has a large defect in the stability problem. The capsule is the same as the ordinary tablet, which is a traditional process. There is no qualitative improvement compared with tablets, so the existing unique oral preparations have the above obvious deficiencies, and there is an urgent need to develop new oral preparations with better effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Take the unique medicinal material, crush it, add water to decoct three times, add water respectively 10, 8, and 8 times, each time for 1 hour, combine the decoction, filter, and concentrate the filtrate into a clear paste with a relative density of about 1.30 (85°C) , dried (60°C, -0.08Mpa), and the dry paste was powdered into fine powder. Take 240g of fine powder, add 60g of cross-linked polyvinylpyrrolidone, 40g of low-substituted hydroxypropyl cellulose, 100g of microcrystalline cellulose, mix well, and granulate with 75% ethanol; add 40g of cross-linked polyvinylpyrrolidone to wet granules, mix well , dried (60°C), sized, added 1g of micropowdered silica gel, and an appropriate amount of cross-linked polyvinylpyrrolidone to 500g, mixed evenly, and compressed into tablets.

Embodiment 2

[0043] Take the unique medicinal material, crush it, add water to decoct three times, add water respectively 10, 8, and 8 times, each time for 1 hour, combine the decoction, filter (160 mesh sieve), and the filtrate is concentrated to a relative density of about 1.30 (85 ℃), dry (60 ℃, -0.08Mpa), dry paste powder into fine powder. Get 280kg of fine powder, add 120kg of cross-linked polyvinylpyrrolidone, 50kg of low-substituted hydroxypropyl cellulose, 60kg of microcrystalline cellulose, mix well, and granulate with 75% ethanol; add 40kg of sodium starch glycolate to wet granules, mix well, Dry (60°C), granulate, add 1kg of micropowder silica gel, and add an appropriate amount of sodium carboxymethyl starch, mix well, and compress into tablets.

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Abstract

The invention discloses a dispersible tablet of Phlomis rotata Benth, which is prepared from Phlomis rotata Benth extract, cross bonding polyvinylpyrrolidone, low substituted methylcellulose propylene glycol ether, crystalline cellulose and micro powder silica gel. The invention also discloses the process for preparing the dispersing tablet and the quality control method.

Description

technical field [0001] The invention relates to a raw material composition of a dispersible tablet of traditional Chinese medicine, and also relates to a preparation method and a quality control method of the dispersible tablet, belonging to the field of traditional Chinese medicine. Background technique [0002] A Supplement to the 2000 Edition of the Pharmacopoeia of the People's Republic of China announced a unique traditional Chinese medicine unique tablet, which has been proved to be effective in hemostasis, analgesia, bacteriostasis, acute and subacute toxicity tests, immune function tests and anti-tumor tests. It has better hemostatic, analgesic and antibacterial effects, less toxicity, fewer side effects, and can also improve specific and non-specific immune functions. Its modified formulation, Duyiwei Capsules, can significantly prolong the appearance time of pain response, significantly shorten the bleeding time of mice, increase the phagocytosis rate of macrophage...

Claims

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Application Information

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IPC IPC(8): A61K36/53A61K9/20A61P7/04A61P29/00A61P31/04G01N30/90G01N33/15A61K125/00
Inventor 张红
Owner 张红
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