Flavescent sophora root essence dispersion tablet

A technology of matrine and dispersible tablets, applied in the field of medicine, can solve the problems of long disintegration time, slow disintegration and dissolution, and no disintegration, and achieve rapid drug dissolution, high bioavailability and short disintegration time. Effect

Inactive Publication Date: 2004-12-29
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the disintegration time of capsules is generally longer, and soft capsules generally disintegrate within 1 hour, and hard capsules generally disintegrate within 30 minutes ("Pharmacopoeia of the People's Republic of China" 2000 edition two appendix XA disintegration time limit inspection method) In addition, due to the particularity of the production process of the capsule shell, there is generally a serious aging phenomenon. After 1.5 years of storage, the disintegration time is longer, or even does not disintegrate, which affects the full absorption of the drug due to slow disintegration and dissolution; liquid preparations Although it absorbs quickly, it requires injection, which is inconvenient to use, has poor stability, and is inconvenient for packaging, transportation, and storage.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: matrine dispersible tablet, component is as follows (all are weight ratio):

[0023] Matrine 43.6%

[0024] Starch 17.4%

[0025] Microcrystalline Cellulose 17.4%

[0026] Croscarmellose Sodium 17.4%

[0027] Magnesium Stearate 1.3%

[0028] Silica 2.2%

[0029] Hypromellose 0.7%

[0030] The preparation method is as follows:

[0031] (1) Pass matrine, starch, and microcrystalline cellulose through a 100-mesh sieve for later use.

[0032] (2) Weigh 400g of starch and 400g of microcrystalline cellulose according to the prescription, and mix them evenly. Add 1000g of matrine in the prescribed amount, mix well, add 1500g of binder 1% hypromellose aqueous solution to make soft material, granulate with 20 mesh sieve, dry at 50-60°C, granulate with 20 mesh sieve, add Mix 400 g of croscarmellose sodium, 30 g of magnesium stearate, and 50 g of silicon dioxide.

[0033] (3) Take a sample to test the particle content, calculate the tablet weight according t...

Embodiment 2

[0037] Embodiment 2: matrine dispersible tablets, the components are as follows (all are weight ratio):

[0038] Matrine 36.9%

[0039] Microcrystalline Cellulose 38.9%

[0040] Croscarmellose Sodium 29.0%

[0041] Calcium Stearate 0.9%

[0042] Micronized silica gel 2.3%

[0043] Polyvinylpyrrolidone 8.6%

[0044] The preparation method is the same as in Example 1.

[0045] Disintegration time limit

[0046] It completely disintegrates within 2 minutes in water at 37°C and passes through the No. 2 sieve, which meets the requirements of the disintegration time limit for dispersible tablets in the appendix of the Pharmacopoeia.

Embodiment 3

[0047] Embodiment 3: matrine dispersible tablet, component is as follows (all are weight ratio):

[0048] Matrine 19.2%

[0049] Starch 38.3%

[0050] Sodium Carboxymethyl Starch 19.2%

[0051] Low-substituted hydroxypropyl cellulose 23.0%

[0052] Hypromellose 0.3%

[0053] The preparation method is the same as in Example 1.

[0054] Disintegration time limit

[0055] It completely disintegrates within 2 minutes in water at 37°C and passes through the No. 2 sieve, which meets the requirements of the disintegration time limit for dispersible tablets in the appendix of the Pharmacopoeia.

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PUM

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Abstract

The present invention relates to kurarinol dispersing tablet, and belongs to the field of medicine technology. The kurarinol dispersing tablet consists of kurarinol 1-65 wt%, disintegrating agent 2-90 wt%, lubricant and flow assistant 0-20 wt% and adhesive 0-20 wt%. The preparation process of the kurarinol dispersing tablet includes sieving the said components, mixing kurarinol and disintegrating agent, adding adhesive to form soft material, pelletizing, stoving, finishing, mixing with disintegrating agent, lubricant and flow assistant, measuring the content of kurarinol in pellet, weighing, and tablet pressing to obtain kurarinol dispersing tablet. The medicine may be taken after being dispersed in water, chewed or swallowed, and is used clinically in treating chronic viral hepatitis B, leucopenia caused by different reasons and allergic dermatosis. The medicine has the advantages of good dispersing state, high bioavailability, etc.

Description

(1) Technical field [0001] The invention relates to matrine dispersible tablets and belongs to the technical field of medicine. (2) Background technology [0002] Matrine, oxymatrine, is an active ingredient extracted from the traditional Chinese medicine Sophora flavescens. Because of its special oxygen structure, it changes the polarity of the drug molecule, and therefore has a more unique mechanism of action than matrine. curative effect. The currently marketed dosage forms of matrine in China include matrine injection, matrine for injection, matrine sodium chloride or glucose injection and matrine capsules. Clinical studies of matrine preparations in recent years have shown that its In the treatment of chronic hepatitis B, leukopenia caused by radiotherapy and chemotherapy in cancer patients, leukopenia caused by other reasons, and allergic skin diseases, it has remarkable curative effect and good safety. Especially matrine capsules are popular among patients because o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4375A61P1/16A61P7/00A61P17/00A61P31/12A61P37/08
Inventor 肖广常张颖
Owner 肖广常
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