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Compound danshen oral disintegrant tablet and its preparation method

A technology of oral disintegration and compound salvia miltiorrhiza, applied in medical formulas, medical preparations containing active ingredients, pill delivery, etc., can solve the problems of low bioavailability, reduced dissolution rate, inconvenient taking, etc., and achieve high bioavailability , increase compliance, and take convenience

Inactive Publication Date: 2003-12-10
BEIJING BOERDA BIO TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The extraction and preparation process of Compound Danshen Tablets is relatively backward. The main active ingredient in the extract of Danshen is fat-soluble tanshinone, whose biological activity is lower than that of water-soluble Danshensu, and the notoginseng in Compound Danshen Tablets is the original medicinal powder Without extraction, it is directly compressed into tablets, so there are problems of slow dissolution and low bioavailability
The main active ingredient of compound Danshen granules is also tanshinone with low biological activity, and the granules are inconvenient to take
The main active ingredient of Compound Danshen Dropping Pills is Danshensu, which uses PEG material as a carrier to form a solid dispersion with the main drug in a molten state, and then drop it into liquid paraffin to condense and shrink to make a drop pill. Because the main drug is highly dispersed In the water-based carrier PEG, the dissolution rate and bioavailability of Compound Danshen Dripping Pills are significantly higher than those of Compound Danshen Tablets, and can be used for the rescue of acute attack of angina pectoris. Aging phenomenon such as decreased degree, which will affect the absorption of drugs, and compound Danshen dripping pills take 10 pills each time, most patients with such diseases are old and dizzy, and it is quite inconvenient to take

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Example 1 Extraction Process of Salvia Miltiorrhiza

[0035] The medicinal material of Danshen is crushed into coarse powder, decocted (twice) with (8 times the amount) in water (2 hours each time), the water extract is filtered, and the dregs are discarded; the decoction is concentrated to a thick paste, and 95 Adjust the alcohol content of the solution to 60% with ethanol, let stand, refrigerate for 24 hours, pour the supernatant, and filter the precipitate, combine the filtrate and supernatant, discard the precipitate, and recover the combined filtrate and supernatant Ethanol until there is no alcohol smell, add dilute hydrochloric acid to adjust the pH of the solution to acidic (pH3~4), extract with ethyl acetate saturated with water (three times), keep the ethyl acetate layer, wash with water saturated with ethyl acetate (three times), and combine For each ethyl acetate layer, the ethyl acetate was recovered to dryness and dried to obtain the c...

Embodiment 2

[0036] The cyclodextrin inclusion method of embodiment 2 borneol

[0037] After borneol is clathrated with cyclodextrin, the clathrate dissolves quickly and absorbs quickly, which covers the pungent smell of borneol and prevents the content of borneol from decreasing due to volatilization during long-term storage. At the same time, borneol is made into cyclodextrin clathrate Finally, the fluidity increases, which is conducive to further tableting.

[0038] Packing method: according to the ratio of β-cyclodextrin and borneol to 7.4:1, weigh a certain amount of β-cyclodextrin and add 3 times the amount of distilled water, then add borneol ethanol solution, and ball mill at 42r / min for 1 Hours, the clathrate was vacuum-dried at low temperature for 24 hours, ground and passed through a 80-mesh sieve, and the crude clathrate was obtained. The crude clathrate was washed 3 times with ethyl acetate and then dried to obtain a loose white clathrate powder.

Embodiment 3

[0039] Example 3 Different disintegrants Disintegration test of the present invention Salvia miltiorrhiza extract 40g Panax notoginseng saponins 160g Borneocyclodextrin inclusion compound 200g Aspartame 1.2g Microcrystalline cellulose See the table below Disintegrants see the table below Lemon essence 1.2g Magnesium stearate 6g

[0040] Preparation method: Mix the above-mentioned raw and auxiliary materials except microcrystalline cellulose and disintegrant through a 100-mesh sieve. Divide into 40 parts, each 10.2g, add sodium carboxymethyl starch, crospovidone, croscarmellose sodium, low-substituted hydroxypropyl cellulose and micro Crystalline cellulose, mixed uniformly and passed through a 100-mesh sieve, and compressed into tablets respectively, 200 tablets per prescription. See Table 1 to Table 4 for the results of the above-mentioned disintegration assay.

[0041] prescription

[0042]

[0043]

[0044]

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PUM

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Abstract

The present invention relates to a compound salvia oral disintegrant tablet capable of being disintegrated quickly in oral cavity to release medicine. It composition includes the salvia root extract, notoginseng total saponin, borneol and excipient, and its disintegration time is within 40 sec, in which the excipient includes filling agent, disintegrant, glidant and corrective. Its filling agent is of microcrystalline cellulose, its dose is 40%-90% of total weight of the prescription, and the disintegrant is selected from sodium carboxymethylstarch, cross-linked carboxymethylcellulose sodium, cross-linked polyvinylpyrrolidone and low-substituted hydroxypropyl cellulose, and its dose is 5%-25% of total weight of prescription.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, specifically a compound salvia miltiorrhiza orally disintegrating tablet, and at the same time, the invention also relates to a preparation method of the preparation. Background technique [0002] Compound Danshen preparations mainly include Compound Danshen Tablets, Compound Danshen Dripping Pills, and Compound Danshen Granules, etc., which are made by extracting or processing Danshen, Panax notoginseng and borneol. Due to their definite curative effects, these preparations have always been important drugs for cardiovascular diseases. But all there is defective in varying degrees in these several kinds of preparations. The extraction and preparation process of Compound Danshen Tablets is relatively backward. The main active ingredient in the extract of Danshen is fat-soluble tanshinone, whose biological activity is lower than that of water-soluble Danshensu, and the notoginseng in Co...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61P9/10
Inventor 张成飞
Owner BEIJING BOERDA BIO TECH DEV
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