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A kind of raspberry formula granule and its preparation method and quality control method

A technology of formula granules and raspberries, which is applied to the quality control of thin-layer chromatography identification, its preparation, and the field of novel raspberry formula granules, can solve problems such as uneven quality of raspberry formula granules, and achieve large-scale production, Easy to store, produce scientific effects

Active Publication Date: 2015-12-09
安徽宏方药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no unified standard, and all manufacturers carry out production and quality control according to enterprise standards, resulting in uneven quality of raspberry formula granules

Method used

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  • A kind of raspberry formula granule and its preparation method and quality control method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation of Raspberry Formula Granules:

[0023] (1) Weigh raw materials: raspberry 10000g;

[0024] (2) Put the raspberry decoction pieces into the extraction tank, add water to decoct twice, add water 12 times the amount of decoction pieces for the first time, soak for 40 minutes, and decoct for 1.5 hours; add water 10 times the amount of decoction pieces for the second time, decoct After 1.5 hours, add water 8 times the amount of the decoction pieces for the third time, decoct for 1.5 hours, filter the medicinal liquid, combine the filtrate, pump the filtrate into the concentration tank, and concentrate (the steam pressure is between 0.04 and 0.2Mpa, and the vacuum degree is -0.04~ -0.08MPa), the extract concentrated to a relative density of 1.03-1.06 (80°C), passed through a 180-mesh sieve while hot, and set aside;

[0025] (3) Take the extract obtained in step (2), add 0.2Kg of dextrin, mix well, heat to 70°C, and spray dry (control the inlet air temperature at...

Embodiment 2

[0028] Quality control method for TLC identification of raspberry formula granules:

[0029] (1) Take 2g of raspberry formula granule powder, add 40ml of 2mol / L hydrochloric acid, warm soak for 1 hour, filter, and extract the filtrate twice with chloroform, 20ml each time, evaporate the chloroform to dryness, add trichloromethane to the residue Methane 1ml to dissolve, as the test solution, standby;

[0030] (2) Take 5g of raspberry reference medicinal material, add 100ml of water, boil for 30 minutes, filter, evaporate the filtrate to dryness, add 40ml of 2mol / L hydrochloric acid to the residue, and prepare the reference medicinal material solution in the same way as (1), and set aside;

[0031] (3) Referring to the "Chinese Pharmacopoeia" 2010 edition, appendix VIB thin-layer chromatography test, absorb 15 μl of the two solutions of the test solution and the reference medicinal solution, respectively, and spot them on the same silica gel G thin-layer plate. 12:1 trichlorome...

Embodiment 3

[0034] Determination of moisture, particle size, solubility, loading variance and extractables in raspberry formula granules:

[0035] The moisture, particle size, solubility and extractive substances in the finished products of 6 batches of raspberry formula granules prepared by the above method were detected. Water content, solubility, and loading differences are tested by conventional methods. The extracts were determined according to the hot soak method (Appendix XA of the 2010 edition of the Chinese Pharmacopoeia) under the alcohol-soluble extracts determination method, using 70% ethanol as the solvent. The inspection results are shown in the table, indicating that all indicators meet the standards.

[0036] The test results of the table

[0037] batch number moisture Solubility Loading difference granularity Leachate 1 3.6 qualified qualified qualified 41.4 2 3.5 qualified qualified qualified 42.0 3 3.5 qualified qua...

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Abstract

The invention discloses raspberry formula granules, and a preparation method and quality control method thereof. The preparation method comprises the following steps: extracting the raw material raspberry herbal pieces with water three times, concentrating under reduced pressure, carrying out spray drying, granulating by a dry process, and the like to obtain the raspberry formula granules. Every gram of raspberry formula granules is equivalent to 9-12 grams of crude drug. The raspberry formula granules are subjected to quality identification by thin-layer chromatography. On the basis of the traditional Chinese medicine decoction, the invention combines the modern high-tech extractor, pharmaceutical technology and thin-layer chromatographic scanning technology, refers to the research of raspberry chemical composition to perform extraction process research and thin-layer chromatography identification method research on the raspberry, thereby obtaining the raspberry formula granules which can be taken by being directly dissolved before use. The medicine can implement complete component extraction, scientific production and controllable quality, and can implement large-scale production. The medicine is convenient and sanitary to take, and convenient for storage.

Description

technical field [0001] The invention relates to the field of traditional Chinese medicine products, and more specifically relates to novel raspberry formula granules, a preparation method thereof and a quality control method for identification by thin-layer chromatography. Background technique [0002] Raspberry: "sweet, sour, warm" in nature and flavor (the current version of the Pharmacopoeia of the People's Republic of China). Efficacy and Indications "Tonify the kidney, strengthen the essence and reduce urination, nourish the liver and improve eyesight. It is used for spermatorrhea, enuresis, frequent urination, impotence and premature ejaculation, and dim eyesight." (The current edition of the Pharmacopoeia of the People's Republic of China). [0003] Most raspberries are used as medicine in decoction pieces, which are decocted before use. The quality of the decoction pieces is unstable and uncontrollable, and the quality of decoction is difficult to guarantee. It is in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/73A61K9/16G01N30/90A61P15/00A61P15/10A61P13/00A61P1/14
Inventor 朱月信陈培胜廖彩震成守玲
Owner 安徽宏方药业有限公司
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