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Quality control method of Gongyankang grannule

A quality control method, Gongyankang's technology, is applied in the field of quality control of Gongyankang granules, which can solve problems such as insufficient purification of solutions, many impurities, and insufficient separation

Active Publication Date: 2009-01-07
广西厚德药业有限公司
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AI Technical Summary

Problems solved by technology

[0003] The original quality standard only carried out TLC identification on paeoniflorin, the characteristic component of the traditional Chinese medicine Paeoniae Rubra in the prescription, but the background of the identification map is dark, and the identification effect is not satisfactory. The test solution needs to be further purified.
So far, many documents have disclosed the content determination method of paeoniflorin, the characteristic component of the traditional Chinese medicine Paeoniae Rubra, but the purification of the disclosed test solution is still insufficient, and there are many impurities. The chromatographic column is easily polluted during the determination. Peaks are easily interfered by miscellaneous peaks, and the resolution is not good enough
The documents "Research on the Quality Standards of Gongyankang Granules Heilongjiang Medicine 2005.3" and "TLC Identification of Gongyankang Granules Heilongjiang Traditional Chinese Medicine 2006.5" disclosed the TLC identification of the traditional Chinese medicines Angelica and Corydalis and the prescriptions of Chinese medicines Angelica and Chuanxiong respectively. The TLC identification and the TLC identification of Yanhusuo, but it was found that the identification spots of Angelica and Chuanxiong were not round, the reproducibility was not good, and the negative background was darker
To sum up, the existing Gongyankang quality control method only establishes a quality inspection method for 4 of the 12 medicinal materials in the prescription. Not only the inspection items are not comprehensive enough, but the method does not achieve the desired effect. quality control methods

Method used

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preparation example Construction

[0047] The preparation method comparison of need testing solution:

[0048] Method 1: Take 9g of this product, grind it finely, add 30ml of ethanol, heat and reflux for 1 hour, let it cool, filter, evaporate the filtrate to dryness, add 10ml of water to dissolve the residue, add water-saturated n-butanol to extract twice, 25ml each time, Combine the n-butanol solution, extract twice with n-butanol-saturated water, 10ml each time, discard the water solution, evaporate the n-butanol layer to dryness, add 1ml methanol to the residue to dissolve, and use it as the test solution.

[0049] Method 2: Take 9g of this product, grind it finely, add methanol 40ml, sonicate for 20 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of heated water, put it in a separatory funnel, let it cool, and shake it with ether to extract 3 Once, 20ml each time, discard the ether extract, shake the aqueous solution twice with water-saturated n-butanol, 20ml each time, comb...

Embodiment 1

[0199] [Identification] (1)——TLC identification of Bupleurum chinensis: Take 9g of this product, grind it finely, add 40ml of methanol, ultrasonicate for 20 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of heated water, set aside Put it in a liquid funnel, let it cool, shake and extract with diethyl ether 3 times, 20ml each time, discard the diethyl ether extract, shake the aqueous solution with n-butanol saturated with water, extract 2 times, 20ml each time, combine the n-butanol extracts, and use Wash twice with water saturated with n-butanol, 20ml each time, discard the water, evaporate the n-butanol solution to dryness, add 1ml methanol to the residue to dissolve, add 1g neutral alumina (100-200 mesh), mix well, evaporate Dry, add to a neutral alumina column (3g, 100-200 mesh, inner diameter 9mm, dry packing), elute with 30ml of 80% methanol, collect the eluate, evaporate to dryness, add 1ml of methanol to the residue to dissolve , as the...

Embodiment 2

[0218] [Identification] (1)——TLC identification of Bupleurum chinensis: Take 9g of this product, grind it finely, add 30ml of ethanol, heat and reflux for 30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 20ml of heated water, set aside Put it in a liquid funnel, let it cool, shake and extract with toluene twice, 20ml each time, discard the toluene extract, and shake the aqueous solution with water-saturated n-butanol for three times, 15ml each time, combine the n-butanol extracts, and use normal Wash with butanol-saturated water three times, 25ml each time, discard the water, evaporate the n-butanol solution to dryness, add 2ml of methanol to the residue to dissolve, add 2g of neutral alumina (100-200 mesh), mix well, and evaporate to dryness , added to a neutral alumina column (6g, 100-200 mesh, inner diameter 9mm, dry-packed column), eluted with 50ml of 50% methanol, collected the eluate, evaporated to dryness, added 2ml of methanol to the residu...

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Abstract

The invention discloses a method for controlling the quality of the Gongyankang granules, revises and enlarges the thin layer chromatography (TLC) identification of bupleurum, semen plantaginis and baked ginger, purifies the method for extracting the sample of the content determination and the TLC identification of paeoniflorin which is a characteristic component of red paeony root, and revises and enlarges the method for examining the microorganism as well. The method for preparing the sample solution of the TLC identification of semen plantaginis and red paeony root in the quality control method is consistent with that of bupleurum, while the method for preparing the sample solution of the TLC identification of rhizoma corydalis is consistent with that of baked ginger, therefore, the quality control method has the advantages of more comprehensive detection items, higher resolution of content determination method, clearer TLC identification of red paeony root, more scientific and more reasonable quality control index, more simplified operation and further confirmed medicament curative effect.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular relates to a quality control method of Gongyankang granules. Background technique [0002] The prescription of Gongyankang Granules is recorded on page 228 of the Ministry of Health’s Drug Standards for Traditional Chinese Medicine Prescriptions Volume 20. The standard code is WS3-B-3921-98. . It has been used clinically for many years and has achieved satisfactory results. The prescription of this product consists of 90g of Angelica, 90g of Radix Paeoniae Rubra, 240g of Beibaijiang, 90g of Rhizoma Cyperi (made from vinegar), 90g of Paojiang, 90g of Eupatorium, 60g of Chuanxiong, 60g of Safflower, 90g of Bupleurum, 90g of Seaweed, and Plantago Seed ( Salt roast) 120g, Corydalis Corydalis 60g, a total of 12 medicinal materials, prepared according to the following process: Corydalis Corydalis is crushed into fine powder, sieved; Angelica, Rhizoma Cyperi, Rh...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/9068A61P15/00G01N30/36G01N30/90
CPCY02A50/30
Inventor 唐弟光廖厚知梁山丹莫少红陈晓军吴伟蒙华英王婵
Owner 广西厚德药业有限公司
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