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Quality standard of Sinopanax formosanus pills

A quality standard and technology of ginseng dripping pills, applied in the field of quality standards of Huashan ginseng dripping pills, can solve the problems of difference in reproducibility of results, complicated operation, lengthy operation time, etc., and achieve shortened operation time, simple operation steps, and repeatability. good effect

Inactive Publication Date: 2010-01-06
津药达仁堂集团股份有限公司第六中药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] 1. The operation is complex, involving many steps such as preparation, extraction, color development, and colorimetry;
[0019] 2. The operation time is long, usually the detection time of a batch of products is about 4.5 hours;
[0020] 3. There are many human factors in the operation process, especially the slight inconsistency between the extraction time and the operation method of the separating funnel during the extraction process, which can lead to a large difference in the reproducibility of the final result

Method used

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  • Quality standard of Sinopanax formosanus pills
  • Quality standard of Sinopanax formosanus pills
  • Quality standard of Sinopanax formosanus pills

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1: Determining detectable target components

[0042] The core structures of several components of tropanes are the same, and the only difference is the difference in the substituent groups. Their chemical properties are very similar, so we chose liquid chromatography as the experimental scheme. Two main problems to be solved in our experiment It is a screening determination to determine the target components and experimental conditions that can be detected.

[0043] Select the object or combination by examining the degree of separation and content level. Preliminary experiments have found that the total alkaloids in Huashan Ginseng Dripping Pills mainly contain atropine, scopolamine and anisodamine. Therefore, these three components are used as the object of investigation, as shown in the table 1

[0044] Table 1 Results of separation investigation

[0045] Resolution (r)

content level

Atropine

＞1.5

can be detected

Scopolam...

Embodiment 2

[0051] Embodiment 2: Determine the best experimental conditions

[0052] 1. Instruments and reagents

[0053] ① Instrument

[0054] HP1100 liquid chromatograph, VWD ultraviolet-visible detector, HP Chemstation chemical workstation, Sartorius R200D electronic analytical balance; KQ-400DB numerical control ultrasonic cleaner

[0055] ②Reagent: standard product: anisodamine hydrobromide: purchased from China Institute for the Control of Pharmaceutical and Biological Products, batch number: 0051-94097; atropine sulfate: purchased from China Institute for the Control of Pharmaceutical and Biological Products, batch number: 200510. Reagent: acetonitrile for chromatography pure; sodium lauryl sulfate is analytically pure; water is double distilled water; sample: Huashan ginseng dripping pills, provided by our factory, batch numbers are: experiment 06001, 07001, 07002, 07003, 07004, 07005.

[0056] 2. Methods and results

[0057] Chromatographic conditions and system suitability te...

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Abstract

The invention relates to a quality standard of Sinopanax formosanus pills. In the quality standard, the physical and chemical distinction with poor specificity in the prior standard is deleted, thin-layer identification of scopoletin is added, a method for determining the content of alkaloid by acid dye colorimetry in the prior standard is cancelled, and the contents of the scopoletin and atropine are determined by liquid chromatography. The method for determining the contents of the atropine and the scopoletin has the advantages that: the operation step is simple; the operation time is shortened compared with the prior art, and the detection time for a batch of products is generally about 2 hours; in the whole operation process, manual operation is less, the error resulted from individual difference is decreased to the lowest degree, and the data is completely viewed and processed by computer software; and the method is accurate, reliable, easy in operation and good in reproduction. The quality standard can be used in the daily quality control of the Sinopanax formosanus pills to further guarantee the inner quality of the products and have great meaning for guaranteeing the safe administration to patients.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine, in particular to the quality standard of Huashan ginseng dripping pills made of Huashan ginseng paste and matrix (polyethylene glycol) in an appropriate amount Background technique [0002] Huashan Ginseng Dropping Pill is a medicine for relieving asthma, relieving cough and expectorant. Since it was put on the market, it has been widely recognized by patients with its advantages of definite curative effect and quick effect. The original standard was included in the 1995 edition of the Pharmacopoeia 1997 Supplement. In the standard, the quality standard of Huashan Ginseng Dropping Pills is recorded as: This product is a drop pill made of Huashan Ginseng paste and base (polyethylene glycol) in an appropriate amount. [0003] 【Properties】This product is a brown dripping pill; the taste is slightly bitter. [0004] [Identification] Take 10 pills of this product, add 5ml of etha...

Claims

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Application Information

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IPC IPC(8): A61K36/81A61K9/20A61P11/06A61P11/10A61P11/14G01N30/90G01N33/02A61K125/00
Inventor 李平胜王鑫王向红
Owner 津药达仁堂集团股份有限公司第六中药厂
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