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Quality control method for Chinese medicine preparation Xinnaojing tabelets

A quality control method and technology for traditional Chinese medicine preparations, which are applied in pharmaceutical formulations, measuring devices, drug combinations, etc., can solve the problems of imperfect identification items and identification methods, and achieve the effect of improving quality control and product quality.

Active Publication Date: 2011-05-25
津药达仁堂集团股份有限公司乐仁堂制药厂
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Problems solved by technology

[0013] But have not yet seen the Ministry of Health standard WS disclosed above 3 - B-0234-90 Xinnaojing Tablets have similar or identical prescriptions, different proportions, and similar product standards. However, there are still shortcomings in

Method used

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  • Quality control method for Chinese medicine preparation Xinnaojing tabelets
  • Quality control method for Chinese medicine preparation Xinnaojing tabelets
  • Quality control method for Chinese medicine preparation Xinnaojing tabelets

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Embodiment 2

[0067] Embodiment 2 Xinnaojing tablet quality standard drafting instructions:

[0068] The quality standard of Xinnaojing Tablets is recorded in the second volume of the Ministry of Health Drug Standards for Traditional Chinese Medicine Prescriptions. Using three enterprises, a total of 10 batches of samples are shown in Table (1). The quality standards for Xinnaojing Tablets were improved and perfected, and the quality standards for Xinnaojing Tablets were drafted and formulated. Compared with the ministerial standard, the TLC identification method of Phellodendron Phellodendri, Borneol and Sophora japonica in the prescription was added; the content determination method of Scutellaria baicalensis was formulated with baicalin as the quantitative index. The drafting work is now described as follows: 1. The description of the sample is shown in Table (1).

[0069] Table 1)

[0070]

[0071] 2. Prescription: revision. The total revision is made according to 1000 pieces. E...

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Abstract

The invention belongs to the technical field of Chinese patent drugs, relating to a quality control method for Xinnaojing tabelets as Chinese medicine preparation, which are prepared from Chinese herbal medicines as raw materials; the method comprises the following steps: with the microscopic characteristics of nacre mother of pearl and cinnabar set in the quality standard as contrasts, distinguishing whether the prescription of the Xinnaojing tabelets contains nacre mother of pearl and cinnabar with a microscope; with berberine hydrochloride, borneol and flos sophorae as contrasts, distinguishing whether the prescription of the Xinnaojing tabelets contains the distinguishing items of berberine hydrochloride, borneol and flos sophorae with thin layer chromatography; and with baicalin as a contract, detecting the content of baicalin in the medicine with high efficient liquid chromatography; therefore, the checking method and the quantitative index that the sample contains not less than 10.0mg of baicalin (C21H18O11) perfect the quality standard, and the amended quality standard improves the quality control of medicine.

Description

technical field [0001] The invention belongs to the technical field of Chinese patent medicines, and relates to a quality control method of Xinnaojing Tablets, a traditional Chinese medicine preparation made from Chinese medicinal materials. Background technique [0002] Xinnaojing Tablet is a classic Chinese patent medicine, the Ministry of Health standard WS 3 -B-0234-90 records the prescription and quality standard: [0003] Prescription: 15g lotus seed heart, 65g mother-of-pearl, 90g pagoda seed, 90g cork 90g [0004] Woody fragrance 10g Scutellaria baicalensis 400g Prunella vulgaris 300g Uncaria 300g [0005] Gentian 100g, light bamboo leaves 50g, wire clematis 250g, made Tiannanxing 80g [0006] Licorice 20g Bezoar 10g Cinnabar 10g Borneol 27g [0007] Preparation method: the above sixteen flavors, cinnabar water fly or crushed into very fine powder; lotus seed heart, mother of pearl, pagoda tree, cork and woody powder crushed into fine powder, and sieved; bezoa...

Claims

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Application Information

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IPC IPC(8): A61K36/899A61P9/10G01N30/36G01N30/90A61K31/045A61K33/28A61K35/413A61K35/56A61K35/618
Inventor 陈坚王磊赵艳李林
Owner 津药达仁堂集团股份有限公司乐仁堂制药厂
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