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A preparation method of spherical formula granules and related products

A formula granule, spherical technology, applied in the directions of non-active ingredients medical preparations, pharmaceutical formulas, microcapsules, etc., can solve the problems of fluidity, large particle size differences, obvious differences in production, affecting the therapeutic effect of traditional Chinese medicine, etc. The effect of good particle size, good meltability, excellent compliance

Active Publication Date: 2021-11-16
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the drying section after concentration of this kind of process, the extract will be dried at a temperature above 60°C for a long time, while traditional Chinese medicine decoctions do not have this part of drying. Therefore, compared with traditional Chinese medicine, the production of traditional formula granules is still significantly different. , may affect the clinical efficacy
[0005] At present, the mainstream of formula granules in the market is dry granulation or a small amount of wet granulation. The granules produced by the dry granulation process are irregular, and the fluidity and particle size of different prescriptions are quite different. Disparity and other serious adjustment problems
[0006] Many Chinese herbal decoction pieces contain aromatic ingredients, which are active ingredients in traditional Chinese medicine decoction pieces such as relieving the exterior, eliminating dampness, invigorating the spleen, and relieving pain. , most of the aromatic components are lost, which affects the properties of the medicine and seriously affects the therapeutic effect of traditional Chinese medicine.

Method used

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  • A preparation method of spherical formula granules and related products
  • A preparation method of spherical formula granules and related products
  • A preparation method of spherical formula granules and related products

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] Example 1: Danshen moisture-proof spherical formula granules

[0061] The salvia miltiorrhiza is extracted with water, and the extract is centrifuged at 2700 rpm, then concentrated under the condition of vacuum degree -0.08MPa, and the water content of the extract is controlled at 25%.

[0062] Take 4250g of the above-prepared salvia miltiorrhiza extract, take 750g of PEG-6000, mix evenly while heating, keep the material at 75°C, and filter the material under pressure to 100 mesh. The filtered material is dripped by high-frequency vibration dripping device or high-pressure atomization and spraying. The dripping device is kept at 70°C, and the particle size is controlled at 800 microns; the atomization type can reach 50 microns; 20~-140℃, 10~20m cold well, freeze the microspheres into solid microspheres; solid microspheres are dried by gradient temperature increase, and water is removed by sublimation to avoid adhesion and gradually transition to dry air and low temperat...

Embodiment 2

[0063] Example 2: Salvia Miltiorrhiza Moisture-proof Spherical Formula Granules

[0064] The salvia miltiorrhiza is extracted with water, and the extract is centrifuged at 3000 rpm and then concentrated under the condition of a vacuum of 0.09 MPa, and the water content of the extract is controlled at 31%.

[0065] Take 4250g of the extract of Salvia miltiorrhiza after centrifugal refining, take 425g of lactose, mix well while heating, keep the material at 85°C, and filter the material under pressure to 100 mesh. The filtered material is dripped by high-frequency vibration dripping device or high-pressure atomization and spraying. The dripping device is kept at 80°C, and the particle size is controlled at 800 microns; the atomization type can reach 400 microns; 20~-140℃, after 10~20m cold well, freeze the microspheres into solid microspheres; solid microspheres are dried by gradient temperature increase, and gradually transition from sublimation and water removal to dry air low...

Embodiment 3

[0066] Example 3: Salvia Miltiorrhiza Moisture-proof Spherical Formula Granules

[0067] The salvia miltiorrhiza is extracted with water, and the extract is centrifuged at 2700-3000 rpm, then concentrated under the condition of a vacuum of -0.08-0.09 MPa, and the water content of the extract is controlled at 25-31%.

[0068] Take 4250g of the extract of Salvia miltiorrhiza after centrifugal refining, take 425g of maltodextrin, mix evenly while heating, keep the material at 75-85°C, and filter the material under pressure to 100 mesh. After filtering, the material is dripped by high-frequency vibration dripping device or high-pressure atomization and spraying. The dripping device is kept warm at 70-80°C, and the particle size is controlled at 400-800 microns; the atomization type can reach 50-400 microns; The microspheres are frozen into solid microspheres through the low temperature -20~-140℃, 10~20m cold well; the solid microspheres are dried by gradient temperature increase, ...

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Abstract

The invention relates to a method for preparing spherical formula granules and related products. The spherical formula granules are intermediates of Chinese patent medicines and have good moisture-proof function. The preparation method is as follows: step 1), preparation of extract: Chinese medicine water Extract, centrifuge to remove impurities, concentrate the centrifuge to contain the extract that adapts to the moisture; step 2), mix the extract and auxiliary materials: take the extract, mix with auxiliary materials, heat, homogenize, filter, and make a mixture with good surface compatibility Step 3) preparation of microspheres: through high-frequency oscillation equipment or pressure atomization equipment, the mixture prepared in step 2) is dropped or sprayed into the cold well to form semi-solid microspheres of a certain particle size, and pass through a certain distance. The cold well environment of the temperature forms solid microspheres and collects them in the collector; step 4) drying: the solid particles are dehydrated at a suitable temperature to make spherical particles; step 5) coating: the spherical particles are coated Coat and get formula granules.

Description

technical field [0001] The invention belongs to the field of pharmacy, and specifically relates to a preparation process of formula granules and a series of products. Background technique [0002] Traditional Chinese medicine formula granules are granules made by extracting and concentrating traditional Chinese medicine decoction pieces for clinical formula of traditional Chinese medicine. [0003] The active ingredients, nature, taste, meridian distribution, indications, and efficacy of traditional Chinese medicine formula granules are consistent with those of traditional Chinese medicine decoction pieces, and basically maintain the characteristics of traditional Chinese medicine decoction pieces, which can not only ensure the traditional Chinese medicine of monarch, minister, assistant, envoy, syndrome differentiation and treatment, flexible addition and subtraction. Features, the extraction process also draws on the traditional decoction of traditional Chinese medicine, s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/50A61K47/10
CPCA61K9/5031
Inventor 闫希军孙小兵朱永宏王苹章顺楠董海鸥鞠伟张永洁陈冲刘冰任强杨建会
Owner TIANJIN TASLY PHARMA CO LTD
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