Quality control method for gynecological Qianjin tablets

A quality control method, the technology of Fukeqianjin Tablets, is applied in the field of quality control of Fukeqianjin Tablets, which can solve problems such as difficulty in consistency of effects, and achieve good clinical treatment effects, stable drug effect consistency, and high accuracy

CN109470788APending Publication Date: 2019-03-15ZHUZHOU QIANJIN PHARMA
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Publication Date
2019-03-15

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Abstract

The invention discloses a quality control method for gynecological Qianjin tablets. The method comprises the following steps: S1, selecting angelica sinensis, radix codonopsis and common andrographisherb, respectively grinding into fine powder for later use; S2, selecting zanthoxylum dissitum, radix rosae laevigatae, spatholobus stems, Chinese mahonia stems and philippine flemingia roots, performing water extraction, and concentrating filtrate into clear paste of which CF is 1.08 / 85 DEG C; S3, uniformly mixing the fine powder with the clear paste, and controlling the content of genistin in amixture, the content of at least one of Z-ligustilide and Z-3-butylidenephthalide, and both the total amounts of andrographolide and dehydrated andrographolide to reach the standard content; then drying, performing tabletting, and wrapping the tablets to obtain the gynecological Qianjin tablets. The quality control method disclosed by the invention increases the content of various core componentsin the existing pharmacopoeia standards, and the gynecological Qianjin tablets prepared by using the control method have more stable effect consistency among different batches, and compared with the prior art, the gynecological Qianjin tablets have better clinical treatment effects.
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Description

technical field

[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a quality control method for Fuke Qianjin Tablets. Background technique

[0002] Fukeqianjin Tablets are medicines made from 8 medicinal materials, including Qianjinba, Rosa Radix, Andrographis paniculata, Gongluomu, Shuangmianzhen, Angelica, Millipede Spatholobus, and Codonopsis pilosula. The effect is to clear heat and dehumidify, tonify qi and blood. It is used for leukorrhea and abdominal pain caused by damp heat and blood stasis. Symptoms include profuse leukorrhagia, thick yellow matter, foul smell, lower abdomen pain, lumbosacral pain, mental fatigue and fatigue; chronic pelvic inflammatory disease, endometritis, Chronic cervicitis see the above syndrome.

[0003] In the existing Chinese Pharmacopoeia, for the content identification of Fukeqianjin Tablets, only the total content of andrographolide and dehydroandrographolide is limited, specifically,...

Examples

Embodiment 1

[0033] Example 1 Fuke Qianjin Tablets

[0034] The formula of Fukeqianjin Tablets: Angelica, Codonopsis, Andrographis paniculata and Shuangmianzhen each account for 9% of the total amount of medicinal materials; the dosages of Rosa japonica root, Caulis Spatholobus, Gongluomu and Qianjinba each account for 16% of the total amount of medicinal materials. The total amount of medicinal materials is 500kg. The product is prepared by:

[0035] (1) select Chinese angelica, Codonopsis pilosula, and Andrographis paniculata, grind them into fine powders of more than 100 meshes, and reserve them for later use according to a powder yield of at least 93.3%;

[0036] (2) Select single-faced needle, golden cherry root, Caulis Spatholobus, Gonglaomu and Qianjinba, add water to extract twice, add 10 times the total weight of five-flavored traditional Chinese medicine for the first time, and add 10 times the total weight of five-flavored traditional Chinese medicine for the second time water, ...

Embodiment 2

[0044] A Fuke Qianjin Tablet, in which steps (1) and (2) are the same as in Example 1 during its preparation process, and the difference from Example 1 is that the content of genistin in each mg of mixture is controlled in step S3 to be no less than 0.00007mg, the content of Z-ligustilide not less than 0.0045mg and / or the content of Z-3-butenylphthalide not less than 0.00011mg, the content of andrographolide and dehydroandrographolide not less than 0.00788 mg; then dried, compressed into tablets, and packaged into tablets to obtain the Fukeqianjin Tablets. According to existing products and production indicators as a reference, the quality of each Fukeqianjin Tablets is 0.32g.

[0045] Fuke Qianjin Tablets were prepared according to the above method, and three batches of products were randomly selected from long-term and large quantities of products, and each batch of Fuke Qianjin Tablets was tested referring to the HPLC detection method in Example 1.

[0046] The HPLC detecti...

Embodiment 3

[0055] Embodiment 3 in vitro drug efficacy test

[0056] Drugs or materials used: croton oil, provided by Nanjing Institute of Dermatology; carrageenan, produced by Japan Wako Pure Chemical Industry Co., Ltd.; nutrient broth medium, product of Guangdong Huankai Microbial Technology Co., Ltd.; mold medium, Provided by the China Institute for the Control of Pharmaceutical and Biological Products.

[0057] The Fukeqianjin Tablets prepared in Example 1 (batch 1 and batch 6) and Comparative Example 1 (batch 1) were used as samples respectively. The clean-grade Kunming mice and SD rats used were all provided by the Hunan Drug Inspection Institute; Escherichia coli ATCC25922, Staphylococcus aureus ATCC25923, and beta-hemolytic streptobacter ATCC32172 were all provided by the Provincial Health and Epidemic Prevention Station. Bacteria were isolated clinically and provided by the Bacteriology Laboratory of the Clinical Laboratory Department of the Third Affiliated Hospital of Hunan Me...