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Chinese medicine granule containing total phenolic acids in salvia root and preparation method thereof

A technology of total phenolic acids of salvia miltiorrhiza and traditional Chinese medicine granules is applied in the directions of medical formulations containing active ingredients, pharmaceutical formulations, and medical formulations with non-active ingredients, etc. Unsightly and other problems, to achieve the effects of good physical properties, good particle fluidity, and short dissolution time

Active Publication Date: 2012-07-04
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Several common granule preparation processes and their existing defects: 1. Traditional granule preparation process, due to the high viscosity of traditional Chinese medicine extracts, most of the traditional granule preparation methods have low drug loading, unsightly appearance, and poor taste , easy to absorb moisture and other problems
5. In the field of preparations, there are also fluidized bed bottom spraying or side spraying techniques to manufacture western medicine pellets or spherical granules, which are mostly used in the development of sustained release preparations. Therefore, the developed products generally have slow and controlled release characteristics, and do not have immediate release characteristics.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Preparation of total phenolic acids of salvia miltiorrhiza: 5 kg of salvia miltiorrhiza was crushed into coarse powder, added with deionized water and heated at 90-100° C. for extraction three times. Add 30L water for the first time and heat for 1 hour; add 15L water for the second and third times and heat for 1 / 2 hour respectively. The extract was concentrated under reduced pressure at 40-45°C to 5L, after cooling, 14L of 95% ethanol was added, allowed to stand overnight, and filtered. The filtrate reclaims ethanol under reduced pressure at 40-45°C, and the resulting concentrated solution passes through RA type macroporous adsorption resin (produced by Beijing No. If there is no α-naphthol reaction in the solution, continue to elute with 50% ethanol until the eluent is added with ferric trichloride potassium ferricyanide reagent and there is no obvious phenolic hydroxyl reaction. The eluate was concentrated under reduced pressure at 40-45°C, then placed in the refrige...

Embodiment 2

[0058] Preparation of total phenolic acid of salvia miltiorrhiza: with the same method as in Example 1, the difference is that the extraction temperature of the coarse powder of salvia miltiorrhiza after adding deionized water is 70°C, and the extraction is performed 4 times, and the heating time is respectively: 1.2 for the first extraction. hour, 1 hour during the second extraction, and 0.8 hour for the third and fourth extractions; the preparation obtains the total phenolic acid of salvia miltiorrhiza;

[0059]Preparation of masterbatch: Take a mixture of micropowder silica gel and chitosan with a weight ratio of 1:1 to pass through a 200-mesh sieve, 65% of which is used as a base material and put into the side spray pot of the fluidized bed, and another PVP K30 is added with water, extract, and prepared Adhesive forming agent-spray in as slurry, and sieve out small particles with a particle size of 120-180μ as the mother nucleus, then put the mother nucleus into the pot, co...

Embodiment 3

[0062] Preparation of total salvianolic acid: take 200 g of total salvianolic acid obtained according to the method of Example 1.

[0063] Preparation of masterbatch: take a mixture of dextrin and starch with a weight ratio of 1:1 and pass through a 200 mesh sieve, 65% of which is put into the side spray pot of the fluidized bed as the bottom material, and starch and extract (after being folded and dried to account for the mother batch) 15% of the grain weight) and water to make a slurry and spray it in, and sieve out small particles (180-250μ) as the mother nucleus, then put the mother nucleus into the pot, continue to spray the starch slurry, and at the same time, spray it from the powder gun Sprinkle the remaining 35% dextrin and starch fine powder to make the particle size of the mother core grow, and screen out the master batch with a particle size of 300μ-400μ for future use.

[0064] Preparation of the product: Take 450g of masterbatch, 50g of microcrystalline cellulose...

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Abstract

The invention provides a traditional Chinese medicine granular preparation with total salvianolic acid and a preparation method thereof. Traditional Chinese medicine spheroidized particles are prepared by using the total salvianolic acid and a pharmaceutically acceptable carrier. The shapes of the traditional Chinese medicine spheroidized particles are spherical or similar to spheres, and the density of the traditional Chinese medicine spheroidized particles ranges from 0.6 g / ml to 1.3 g / ml. A single dose of the spheroidized particles is small, the medicine taking is convenient, and the granular preparation can be used as a semifinished product of capsules and can also be used for developing sustained and controlled release preparations of traditional Chinese medicine.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation and a preparation method thereof, in particular to a traditional Chinese medicine granule containing salvianolic acid and a preparation method thereof. Background technique [0002] Salvia miltiorrhiza and its various preparations are traditional Chinese medicines commonly used in clinical treatment of cardiovascular and cerebrovascular diseases. Since the 1980s, we have systematically studied the water-soluble components of Salvia miltiorrhiza and its genus, and obtained salvianolic acids A(1), B(2), C(3), D(4), E(5), F (8), G(9), H(11)I(12), J(13), rosmarinic acid(6), shikonic acid(7), iso-salvianolic acid C(10), rosmarinic acid glucoside (14) and other phenolic acid compounds. (Lian-Niang Li, J. Chinese Pharmaceutical Sciences 1997, 6, 57-64). The results of pharmacological experiments show that these phenolic acid compounds have strong anti-lipid peroxidation, anti-thrombosis, a...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K47/04A61K47/36A61K47/38A61K47/40A61K36/537A61P9/10
Inventor 李永强郑永锋
Owner TIANJIN TASLY PHARMA CO LTD
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