Dispersion tablets of traditional Chinese medicine composition

A technology for dispersible tablets and compositions, which can be used in drug combinations, plant/algae/fungus/moss ingredients, pharmaceutical formulations, etc., and can solve problems such as adverse reactions, long disintegration time, and large dosage.

Active Publication Date: 2011-10-19
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there is no specific drug for the treatment of hepatitis B. Hundreds of Chinese and Western medicines are used to treat hepatitis nationwide. Hugan Tablets have definite curative effects and stable quality. It is a sugar-coated tablet

Method used

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  • Dispersion tablets of traditional Chinese medicine composition
  • Dispersion tablets of traditional Chinese medicine composition
  • Dispersion tablets of traditional Chinese medicine composition

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0033] Experimental example 1 Prescription Screening Experiment

[0034] 1. Instruments and raw materials

[0035] Tablet press: (Model: DP30);

[0036] Disintegration instrument: (model: ZB6);

[0037] Balance: (Model: FA1004, manufacturer: Shanghai Balance Instrument Factory).

[0038] Table 1 Sources of raw and auxiliary materials

[0039]

[0040]

[0041] 2 methods:

[0042] (1), disintegrant selection:

[0043] In the case of constant drug powder and filler in this prescription, the drug powder and disintegrant were mixed according to the ratio of 1:1, compressed into tablets, and the disintegration time was used as the investigation index. The results are shown in Table 2:

[0044] Table 2 Screening of disintegrants

[0045]

[0046] The results showed that the disintegration effects of cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl cellulose, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose and microcrystalline ...

experiment example 2

[0067]Experimental Example 2 Bioequivalence Experiment

[0068] Dispersible tablet of the present invention has carried out human body bioequivalence test result with certain listed common tablet and shows: the InC of two kinds of preparations max 、InAUC 0→24 The three-factor analysis of variance showed that the InC of the two preparations max 、InAUC 0 →24 There are significant differences. The average maximum blood drug concentration of the tested preparations was higher than that of ordinary tablets. T of the two formulations max Using non-parametric test, the test results have significant difference, the peak time T of the tested preparation max Significantly faster than conventional tablets; InC max 、InAUC 0→24 The double one-sided t test showed that the dispersible tablet was superior to the ordinary tablet.

[0069] The following embodiments can achieve the effects of the above experimental examples.

Embodiment 1

[0071] Liver extract fine powder 60g

[0072] Sodium carboxymethyl starch 30g

[0073] Cross-linked polyvinylpyrrolidone 45g

[0074] Croscarmellose Sodium 20g

[0075] Microcrystalline Cellulose 40g

[0076] Low-substituted hydroxypropyl cellulose 20g

[0077] Magnesium Stearate 4g

[0078] Lactose 160g

[0079]

[0080] Makes 1000 pieces

[0081] Preparation:

[0082] Preparation of liver-protecting tablet extract powder: Bupleurum 313g, capillary root 313g, isatidis 313g, schisandra 168g, pig gall powder 20g, mung bean 128g; Bupleurum, capillary, isatidis, and mung bean (crushed) were decocted twice, each time for 2 hours, Filtrate, combine the filtrates, and concentrate under reduced pressure to obtain a clear cream A with a relative density of 1.30 (80°C); grind Schisandra chinensis into coarse powder and soak pig bile powder in 90% ethanol for 4 hours, reflux extraction for 1 hour, and dynamic heat reflux for 6 hours , rec...

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Abstract

The invention discloses dispersion tablets of a traditional Chinese medicine composition, Chinese thorowax root, virgate wormwood herb, indigowoad root and mung bean (pulverized) are decocted with water twice with 2 hours for every time, thereby obtaining clear paste A; and Chinese magnoliavine fruit is pulverized into coarse powder, and extraction with 90% ethanol is performed on the coarse powder and porcine gall powder to obtain extract B. The clear paste A and the extract B are uniformly mixed, dried at the temperature of 70 DEG C and pulverized into fine powder, thus obtaining the fine powder of the extract of the traditional Chinese medicine composition; the fine powder is further uniformly mixed with sodium carboxymethyl starch, crosslinked polyethylene pyrrolidone, crosslinked sodium carboxymethyl cellulose, microcrystalline cellulose, low substituted hydroxypropy cellulose, lactose and other auxiliary materials; and granulation is performed through the dry pressing process, 16-mesh size granulation is performed, magnesium stearate is added, and uniform mixing and tabletting are performed, thus obtaining the dispersion tablets.

Description

technical field [0001] The invention relates to a traditional Chinese medicine composition dispersible tablet, which belongs to the field of preparations. Background technique [0002] The morbidity and mortality of viral hepatitis have taken the first place among the communicable diseases notifiable by law in my country. Hepatitis viruses include hepatitis A, B, C, D, E, and G viruses. Viruses invade the liver, replicate and proliferate in liver cells, and cause inflammatory reactions. Among them, hepatitis B virus (HBV) infection is the most common in the population, and the prevalence of hepatitis B varies from region to region. The incidence is high in China, Southeast Asia, and Africa, and low in Western Europe, North America, and Australia. There are about 350 million hepatitis B virus carriers in the world, and it is concerning that about 3 / 4 of them are in Asia. [0003] my country is a high-incidence area of ​​HBV infection. According to the 1992-1995 national vi...

Claims

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Application Information

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IPC IPC(8): A61K36/57A61K9/20A61K47/38A61P1/16A61P31/20A61K35/413
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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