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Method for checking oral traditional Chinese medicine formulation and applications thereof

A detection method and a technology for oral preparations, applied in the field of analytical chemistry, to achieve the effects of good repeatability, good logarithmic linearity and good intermediate precision

Active Publication Date: 2009-12-23
HENGKANG MEDICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, there is still a lack of a detection method that can effectively control the product quality of Duerwei Capsules and ensure the effectiveness of the product

Method used

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  • Method for checking oral traditional Chinese medicine formulation and applications thereof
  • Method for checking oral traditional Chinese medicine formulation and applications thereof
  • Method for checking oral traditional Chinese medicine formulation and applications thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 :Identification of Duerwei Capsules of the Invention

[0046] This example is to identify Duyiwei and Panax notoginseng in the Duerwei capsule of the present invention. In the following, combined with the characteristics of this product, a thin-layer chromatography identification study was carried out on Duerwei capsules (sample batch numbers: 080301, 080302, 080303). The Duerwei control medicinal material was used as a control to identify the product, and different development systems were used to investigate its thin layer. Expand behavior.

[0047] 1. Unique identification method

[0048] Preparation of test solution: Take 1.0g of the contents of this product, grind it, add 15ml of ethanol, heat to reflux for 15 minutes, take it out, filter, and use the filtrate as the test solution.

[0049] The preparation of negative sample solution (lack of Duyiwei): According to the manufacturing method of Duerwei capsules, prepare a capsule sample that does not contain ...

Embodiment 2

[0056] Example 2 :Resin residues of the Duerwei capsule of the present invention

[0057] According to the "Technical Requirements for Separation and Purification of Chinese Medicine Extracts by Macroporous Adsorption Resin (Interim)" issued by the National Medical Products Administration with Yaoguanzhu [2000] No. 56 on February 17, 2000, it is necessary to deal with large styrene framework Porous resin residue inspection items are benzene, toluene, xylene, styrene, alkanes, diethylbenzene (divinyl) and other organic residues that may be introduced by resin. The limit cannot be higher than the national standard. Or international standards. The residues that may be introduced by the styrene skeleton type macroporous resin used in the process of Duerwei capsules and their limits are shown in Table 1.

[0058] Table 1 Introduced resin residue limit results

[0059]

[0060] The residues introduced by the styrene skeleton type macroporous resin need to be controlled to a limit du...

Embodiment 3

[0112] Example 3 :Determination of the main ingredient content of the Duerwei capsule of the present invention

[0113] This example is the determination of the content of the main ingredients of the Duerwei capsule of the present invention. Duerwei Capsules are processed from Duyiwei and Panax notoginseng. With reference to the pharmacopoeia and related literature, high performance liquid chromatography (HPLC method) is used to determine the luteolin and the saponins in the Panax notoginseng. The content of the ingredients is used as a control method.

[0114] 1. Determination of luteolin content

[0115] (1) Instruments and reagents

[0116] Instrument: Agilent 1100 High Performance Liquid Chromatograph and supporting workstation

[0117] Sartorius CP225D electronic balance

[0118] Luteolin reference substance batch number: 111520-200504, for content determination, purchased from the China Inspection Institute.

[0119] Reagents: chromatographic methanol is chromatographically...

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Abstract

The invention provides a method for checking an oral traditional Chinese medicine formulation which is selected from granules, capsules and tablets, and prepared by lamiophlomis rotata and pseudo-ginseng, wherein the capsule is a preferably selection. The method for checking the oral traditional Chinese medicine formulation comprises one or a plurality of the following steps of: measuring the contents of digitoflavone and saponins; and distinguishing the lamiophlomis rotata and / or checking resin residues. The method for checking the oral traditional Chinese medicine formulation has good repeatability and middle precision degree, high specificity, good logarithm linear relationship and higher recovery rate, is suitable for controlling the quality of lamiophlomis rotata capsules, effectively controls the product quality of related products and ensures the effectiveness of the products.

Description

Technical field [0001] The invention relates to a method for detecting oral preparations of traditional Chinese medicine, and belongs to the technical field of analytical chemistry. Background technique [0002] The traditional Chinese medicine oral preparation "Duerwei Capsule" is made of Duyiwei and Panax notoginseng medicinal materials. It is a new drug variety that the applicant has combined with long-term medication experience, and has undergone pharmacological and toxicological test research and new technology research. The main functions are: promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding. It is used for the treatment of blood stasis syndrome (soft tissue damage, irregular menstruation), symptoms such as swelling and pain, blood stasis, restricted joint movement, heavy menstrual flow, irregular menstruation, lower abdominal pain, purple tongue, and ecchymoses. [0003] The medicinal material used in Duerwei Capsules Duyiwei is a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/53A61K9/16A61K9/48A61K9/20A61P15/00G01N30/36G01N30/90
Inventor 张康宁廖立东邓艳
Owner HENGKANG MEDICAL GROUP CO LTD
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