Gynecological qianjin capsule and preparation method thereof

A gynecological Qianjin Capsule and Qianjinpu technology, which can be used in capsule delivery, scientific instruments, pharmaceutical formulations, etc., can solve problems such as difficulty in consistency of effects

Pending Publication Date: 2019-02-22
ZHUZHOU QIANJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Among the compatible ingredients of Fuke Qianjin Capsules, Andrographis paniculata is only used as a subordinate drug. Obviously, the existing standards do not stipulate other important ingredients in Qianjin Capsules, which makes it difficult to control the effects of different batches of Fuke Qianjin Capsules. Consistency is difficult

Method used

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  • Gynecological qianjin capsule and preparation method thereof
  • Gynecological qianjin capsule and preparation method thereof
  • Gynecological qianjin capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1 Fuke Qianjin Capsules

[0052] The formula of Fuke Qianjin Capsules: Angelica, Codonopsis, Andrographis paniculata, and Shuangmianzhen each account for 9% of the total amount of medicinal materials; the amount of golden cherry root, Caulis Spatholobus, Gongluomu, and Qianjinba each accounts for 16% of the total amount of medicinal materials. The total amount of medicinal materials is 500kg. The product is prepared by:

[0053] (1) First, extract Angelica sinensis with ethanol percolation method to make clear paste: Angelica sinensis is crushed into coarse powder, passed through an 8-mesh sieve, infiltrated with ethanol with a mass concentration of 70%, put into a percolation cylinder, soaked for 48 hours, and mixed with 0.2mL Percolation at a speed of 1 / min, collecting 10 times the amount of percolation liquid, and concentrating to obtain a relative density of 1.1 (80°C), which is Angelica Clear Paste;

[0054] (2) Extract Andrographis paniculata with ethano...

Embodiment 2

[0065] A Fuke Qianjin Capsule, the steps (1) to (4) in the preparation process are the same as those in Example 1, the difference is that in step (5), the content of Z-ligustilide in each milligram of Qing Gao is controlled to be quite a lot less than 0.015mg, and / or the content of Z-3-butenylphthalide is not less than 0.00025mg, and / or the content of genistin is not less than 0.002mg, and / or the content of jatrorrhizine is not less than 0.006 mg, and / or the content of palmatine is not less than 0.006mg, and / or the content of berberine is not less than 0.006mg, and the total amount of andrographolide and dehydroandrographolide is not less than 0.015mg, spray Dried, then granulated and canned to obtain the Fukeqianjin Capsules, according to the 2015 edition of the "Pharmacopoeia of the People's Republic of China", the content of each Fukeqianjin Capsules is 0.4g.

[0066]Prepare Fuke Qianjin Capsules according to the above method, randomly select multiple batches of products fr...

Embodiment 3

[0077] Embodiment 3 in vitro drug efficacy test

[0078] 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.

[0079] The Qianjin capsules 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 Hunan Provincial Health and Epidemic Prevention Station, white Candida, isolated clinically, was provided by the Bacteria Laboratory of the Clinical Laboratory Department of the Third Affiliated Hospital of Hunan M...

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Abstract

The invention discloses a gynecological qianjin capsule and a preparation method thereof. The capsule is prepared from philippine flemingia root, Chinese mahonia stem, andrographis paniculata, zanthoxylum dissitum, suberect spatholobus stem, angelica, codonopsis pilosula and cherokee rose root. Each gynecological qianjin capsule contains no less than 2.0 mg of Z-ligutilide, and the total amount ofandrographolide and dehydroandrographolide is not less than 1.9 mg. According to the preparation method, a new standard for controlling the quality of the gynecological qianjin capsule is establishedby analyzing chemical components in the gynecological qianjin capsule; limit of the content of other core components is added in the standard based on the existing pharmacopoeia standards; the consistency of the effect between different batches of the gynecological qianjin capsule prepared according to the range is more stable, and the drug effect consistency is more stable with an increase of the limit of types of the core components. Compared with the prior art, the gynecological qianjin capsule has a better clinical treatment effect.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a Fuke Qianjin Capsule and a preparation method thereof. Background technique [0002] Fuke Qianjin Capsule is a drug made from 8 medicinal materials, including Qianjinba, Rosa Radix, Andrographis paniculata, Gongluomu, Shuangmianzhen, Angelica, Millae 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 identification of the content of Fuke Qianjin Capsules, it only limits the total content of andrographolide and dehydroandrographolide, speci...

Claims

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Application Information

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IPC IPC(8): A61K36/758A61K9/48A61P15/00A61P29/00G01N30/02
CPCA61K9/16A61K36/19A61K36/232A61K36/29A61K36/344A61K36/48A61K36/486A61K36/738A61K36/758A61K2236/331A61K2236/333A61K2236/39A61K2236/51A61P15/00A61P29/00G01N30/02A61K2300/00
Inventor 蹇顺伍实花龚云张鹏彭开锋李伏君王康华杨秀伟
Owner ZHUZHOU QIANJIN PHARMA
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