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Traditional Chinese medicine injectable powder and quality control method thereof

A technology of traditional Chinese medicine and powder injection, which is applied in the field of traditional Chinese medicine powder injection preparation and its quality control, which can solve the problems affecting the reliability and stability of the measurement results, multi-step detection time, and large amount of organic solvents, etc.

Active Publication Date: 2014-02-12
TIANJIN TASLY ZHIJIAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the trial standard of Yiqi Fumai Powder Injection, super-macroporous adsorption resin and acidic alumina mixed resin need to receive a large amount of effluent. Stability, unable to express the true content of the preparation product, due to the cumbersome operation, the detection time of more steps is at least 8 hours, which cannot meet the needs of quality inspection
[0005] As above, in the quality standard of Yiqi Fumai preparation, the determination method of total ginseng glycosides is extracted with ether and water-saturated n-butanol. The experimental operation is cumbersome, time-consuming, and the amount of organic solvent is large, which is extremely harmful to the human body and is difficult to meet industrial production. daily inspection

Method used

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  • Traditional Chinese medicine injectable powder and quality control method thereof
  • Traditional Chinese medicine injectable powder and quality control method thereof
  • Traditional Chinese medicine injectable powder and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0133] 1 part of red ginseng, 3 parts of Ophiopogon japonicus, 1.5 parts of schisandra

[0134] Take the above-mentioned three-flavored medicinal materials in the proportion by weight, red ginseng is extracted three times with ethanol reflux, the first and second times are 3 hours respectively, and the third time is 2 hours, the extracts are combined, the ethanol is recovered under reduced pressure until there is no alcohol smell, and water is added to about 500ml, place in cold place, separate and remove the upper layer oil, filter the water layer, concentrate under reduced pressure to a relative density of 1.15-1.20 (50°C), dry under reduced pressure at 70°C to obtain red ginseng extract for injection; Ophiopogon japonicus and Schisandra chinensis add water respectively Decoct three times, 1 hour for the first time, 45 minutes and 30 minutes for the second and third times respectively, combine the extracts, concentrate under reduced pressure to relative densities of 1.15-1.20...

Embodiment 2

[0136] Embodiment 2 Assay method

[0137] 1 Instruments and materials

[0138]1.1 Instruments Waters2695 high performance liquid chromatography unit, equipped with Waters2996 diode array detector (WATERS, USA); XS105 1 / 100,000 electronic analytical balance (Swiss METTLER company) Milli-Q ultrapure water treatment system.

[0139] 1.2 Materials Ginsenoside Rf, Rb 1 , Rb 2 , Rb 3 , Rd, Schisandrin A, F 2 Reference substance (for content determination, provided by China Institute for the Control of Pharmaceutical and Biological Products); Yiqi Fumai (freeze-dried) sample for injection is Example 1; acetonitrile is chromatographically pure; phosphoric acid is analytically pure; water is high-purity water.

[0140] 2 Experimental methods

[0141] 2.1 Chromatographic conditions Chromatographic column: Waters Symmetry C 18 Column (4.6mm×250mm, 5μm), mobile phase: 0.05% phosphoric acid-acetonitrile composition, gradient elution according to the gradient ratio in Table 1; detecti...

Embodiment 3

[0153] Get 0.5 part of Schisandra chinensis, 0.5 part of red ginseng, and 6 parts of Ophiopogon japonicus prepared according to the preparation method of Example 1 to prepare the preparation, and measure 0.35 mg / g of ginsenoside Rf content and 0.35 mg / g of ginsenoside Rb according to the content determination method of Example 2. 1 Content 1.4mg / g, Ginsenoside Rb 2 Content 0.8mg / g, Ginsenoside Rb 3 Content 0.12mg / g, ginsenoside Rd content 1.0mg / g, ginsenoside Rg3 content 0.6mg / g, ginsenoside F 2 content of 0.3mg / g and Schisandrin A content of 0.1mg / g.

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Abstract

The invention relates to Chinese medicinal injectable powder and a quality control method thereof. The Chinese medicinal injectable powder consists of red ginseng, dwarf lilyturf tuber and Chinese magnoliavine fruit in part by weight, wherein the sum of the main active ingredient content of the injectable powder cannot be lower than 4.0mg / g; and the active ingredients comprise ginsenosides Rf, Rb1, Rb2, Rb3, Rd, Rg3 and F2, and schizandrol A. The quality control method comprises the steps of making quality standards, measuring the content, comparing the content of a sample to be measured with the quality standards, and judging whether the content reaches the preset standards or not so as to control the product quality. The method has the advantages of quickness, accuracy, sensitivity, contribution to industrial production inspection, and capability of effectively controlling the quality of a finished product.

Description

technical field [0001] The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine powder injection preparation and a quality control method thereof. Background technique [0002] The records of Chinese medicine quality control methods in my country are the most comprehensive and earliest in the world. However, due to slow technological updates and backward quality analysis and evaluation methods, the current national quality standards for Chinese medicine are still far from perfect and cannot fully reflect the quality of Chinese medicine. The situation is far from meeting the actual needs of the Chinese medicine industry. In the first part of the Chinese Pharmacopoeia of the 2000 edition, a total of 992 kinds of Chinese medicinal materials and Chinese patent medicine preparations have been recorded, 602 kinds have been identified, and 308 kinds have been assayed; among the 458 kinds of Chinese patent medicine preparati...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/8968A61K9/19A61P9/10A61P7/08G01N30/02G01N30/36
Inventor 叶正良杨悦武周大铮周丹丹
Owner TIANJIN TASLY ZHIJIAO PHARMA
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