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Medicinal composition and its preparation method and quality control method

A quality control method and composition technology, applied in the pharmaceutical composition of ankylosing spondylitis and preparation thereof, in the field of treating rheumatoid arthritis, and can solve the problem that rheumatoid arthritis and ankylosing spondylitis are not effectively controlled, etc. problem, to achieve the effect of accurate dose, stable quality and good curative effect

Inactive Publication Date: 2007-10-24
吴英萍
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the toxic and side effects of this type of western medicine and the limited scope of application, rheumatoid arthritis and ankylosing spondylitis have not been effectively controlled

Method used

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  • Medicinal composition and its preparation method and quality control method

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0031] Experimental example 1 Pharmacodynamic experiment of tablet of the present invention

[0032] Wistar rats were randomly divided into groups according to body weight and sex, and administered by intragastric administration.

[0033] ①Treatment of experimental arthritis

[0034]

[0035] Note: + is the improvement degree of treatment

[0036]Through the rat adjuvant arthritis experiment, Gufengning Tablets had a significant inhibitory effect on the primary and secondary stages of adjuvant arthritis in rats. Compared with the control group, Fengshibikang Capsules were significantly relieved. During the whole experiment, there was no significant reduction in food intake and changes in appearance and morphology of the animals.

[0037] Group, dose (mg / kg)

[0038] Through the experiment on the delayed type hypersensitivity reaction of mouse auricle skin caused by DNCB, Gufengning tablet has obvious inhibitory effect on the delayed type hypersensitivity reacti...

experiment example 3

[0047] Experimental Example 3 Research on the Extraction Process of the Composition of the Present Invention

[0048] 1. Screening of process conditions

[0049] (1) Source, identification and pre-treatment of medicinal materials

[0050] Among the eleven herbs in the prescription, except Kunming Shanhaitang, Yunweiling, Yexiahua, and Zidanshen, which are respectively recorded in "Guangxi Traditional Chinese Medicinal Materials Standard" and "Yunnan Provincial Drug Standard", the remaining seven herbs are all recorded in "China Pharmacopoeia 2005 edition one. The impurities and non-medicinal parts of each medicinal material are picked out, and the dust is screened out, and they are used as medicine after passing the inspection.

[0051] (2) Inspection of the crushed part

[0052] the batch

Total amount of medicinal materials (g)

Powder weight (g)

Powder yield%

1

2

3

5000

5000

5000

4259.1

4413.0

4378.4

85....

experiment example 4

[0063] Experimental example 4 Concentration and drying process research

[0064] 1. Research on concentration process

[0065] The degree of concentration is measured by relative density. If it is too low, it will prolong the drying time. If it is too high, it will stick to the pan or even gelatinize. The composition is different and the properties of the extract are different, so the concentrated relative density will also be different. Therefore, the properties of the concentrated paste directly affect the amount of paste received, the effect of mixing and the difficulty of drying. Through the pilot test, it is determined that the medicinal solution is concentrated to a clear ointment with a relative density of 1.34-1.36 at 50°C, which is easy to collect, mix and dry.

[0066] Weigh each medicinal material according to the proportion of the prescription, and use 70% ethanol (6 times, 4 times, 4 times the amount) for each part of Kunming Begonia to reflux extract three times...

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Abstract

Disclosed is a medicinal composition which is prepared from rhizome of Chinese paris, Malus spectabilis, Clematis chinensis, astragalus root, blattbulume, achyranthes and cyathula root, root of red rooted saliva, safflower, earthworm, buck grass and dipsacus root through steps of ethanol washing, and drying, disintegrating into fines, alcohol extracting, filtering, merging the filter liquors, reclaiming ethanol, merging the filter liquors, merging with the medicinal soup, concentrating the filtrate into thick grease with specific gravity of 1. 34-1. 36 (50 deg C), charging fines, mixing homogenously and drying.

Description

Technical field: [0001] The invention relates to a pharmaceutical composition, a preparation method and a quality control method thereof, in particular to a pharmaceutical composition for treating rheumatoid arthritis and ankylosing spondylitis, a preparation method and a quality control method thereof. Background technique: [0002] Rheumatoid arthritis is a chronic systemic immune disease, more common in young adults. In the early stage, it manifests as joint swelling, pain, and stiffness. In the late stage, it can cause joint stiffness, deformity, and severe functional impairment. In addition, it can also be accompanied by systemic symptoms such as low-grade fever, anemia, and weight loss, as well as rheumatoid arthritis and rheumatoid vasculitis. , Heart, lung and kidney damage and other extra-articular manifestations. From the perspective of incidence, the disease occurs in all parts of the world. According to foreign statistics, the incidence rate is about 1.0%. Dome...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/896A61K9/08A61K9/10A61K9/14A61K9/16A61K9/48A61P19/02A61P29/00A61K35/64G01N30/90G01N33/15A61K35/62
Inventor 吴英萍
Owner 吴英萍
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