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Gynecological Qianjin capsule and preparation method thereof

A Fuke Qianjin Capsule and Qianjinba technology, which is applied in the fields of capsule delivery, medical formula, medical preparations containing active ingredients, etc., can solve the problems of difficulty in consistency of effect, unclear and unstable treatment effect of traditional Chinese medicine, etc.

Pending Publication Date: 2019-01-11
ZHUZHOU QIANJIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Apparently, the existing standards-related research did not conduct research and analysis on the influence of other important ingredients in Fuke Qianjin Capsules, and made clear regulations, which made it difficult to control the consistency of effects between different batches of Fuke Qianjin Capsules , a more effective means is needed to improve the stability and consistency of the treatment effect of Fuke Qianjin Capsules as a whole, and at the same time overcome the long-standing technical prejudice about the unclear and unstable treatment effect of traditional Chinese medicine

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

[0046] Example 1 Fuke Qianjin Capsules

[0047] 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:

[0048] S1. First, extract Angelica sinensis with ethanol percolation method to make a 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 48h, and mixed with 0.2mL / Percolate at a speed of 1 min, collect 8 times the amount of percolation liquid, and concentrate to obtain a relative density of 1.1 (80°C), which is Angelica Clear Paste;

[0049] S2. Extract Andrographis paniculata with ethanol reflux m...

Embodiment 2

[0059] The preparation method is the same as in Example 1, except that in S5:

[0060] S5. Combine the above four clear ointments S1., S2., S3., and S4., mix them evenly, and perform detection to control when the content of genistin in each mg of ointment is not less than 0.0025mg, and / or When the content of rhizine is not less than 0.0009mg, and / or the content of palmatine is not less than 0.007mg, and / or the content of berberine is not less than 0.0085mg, and the total of andrographolide and dehydroandrographolide When the content is not less than 0.02 mg, it is spray-dried, then granulated and canned to obtain the Fuke Qianjin Capsules. According to the 2015 edition of "Pharmacopoeia of the People's Republic of China", the content of each Fuke Qianjin Capsule is 0.4g.

[0061] Prepare Fuke Qianjin Capsules according to the above method, randomly select multiple batches of products from long-term and large quantities of products, and detect each batch of Fuke Qianjin Capsule...

Embodiment 3

[0071] Embodiment 3 in vitro drug efficacy test

[0072] In order to further verify whether the efficacy of the Fukeqianjin Capsules in the embodiment is consistent with that of the Fukeqianjin Capsules prepared by the original method, related experiments were carried out.

[0073] 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.

[0074] The Fukeqianjin capsules prepared in Example 1 (batch 1 and batch 9) and the comparative example were respectively used as samples.

[0075]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 ...

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Abstract

The invention discloses a gynecological Qianjin capsule which is prepared from herba Lysimachiae Chinensis, herba Mahoniae, herba Andrographis Paniculatae, needle, caulis Spatholobi, radix Angelicae sinensis, radix Codonopsis, and radix Rosae Laevigatae as raw materials, and contains not less than 0.025 mg of genistein and not less than 1.9 mg of andrographolide and dehydroandrographolide in eachcapsule. The invention defines the important influence of the content of the monarch drug core component in the gynecological Qianjin capsule on the product, and determines the reasonable content of the core component. Compared with the prior art, the effect consistency among different batches of the product of the invention is more stable, and the clinical effect is improved.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicines, in particular to Fuke Qianjin Capsules 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, specif...

Claims

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Application Information

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IPC IPC(8): A61K36/758A61K9/48A61P15/00A61P31/04A61P31/10A61P29/00
CPCA61K9/48A61K36/19A61K36/232A61K36/29A61K36/344A61K36/48A61K36/486A61K36/738A61K36/758A61K2236/33A61K2236/331A61K2236/39A61P15/00A61P29/00A61P31/04A61P31/10A61K2300/00
Inventor 江端预彭开锋李伏君龚云张鹏伍实花王康华杨秀伟
Owner ZHUZHOU QIANJIN PHARMA
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