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Notoginsen triterpenes capsule as well as preparation method thereof and method for measuring content

A technology of Panax notoginseng saponins and capsules, which can be used in capsule delivery, measuring devices, and pharmaceutical formulations, etc. It can solve the problems of affecting the detection method and not applicable to the detection of the content of Panax notoginseng saponins in capsules, and achieves low operating costs and improved quality control. The effect of good level and powder fluidity

Active Publication Date: 2012-09-26
HARBIN ZHENBAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, we know that the type and dosage form of the preparation affect the accuracy of the detection method to a certain extent, so these methods are not suitable for the content detection of Panax notoginseng saponins capsules

Method used

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  • Notoginsen triterpenes capsule as well as preparation method thereof and method for measuring content
  • Notoginsen triterpenes capsule as well as preparation method thereof and method for measuring content
  • Notoginsen triterpenes capsule as well as preparation method thereof and method for measuring content

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Take notoginseng, moderately pulverize it, add 2.5 times the volume fraction of 85% ethanol solution, heat and reflux for extraction and concentration for 10 hours, and concentrate under reduced pressure until it has no alcohol smell. The dregs are directly passed through the steam to recover ethanol. Dilute the concentrated ointment with purified water to 0.25g crude drug / ml, sink in water for 18 hours, and filter with filter paper. The filtrate is adsorbed by D-101 macroporous adsorption resin through the column at a flow rate of 1.3BV / h, and then purified with 1 times the amount of resin Rinse the resin column with water, then soak the resin with 1 times the amount of 85% ethanol solution for 30 minutes, and then use 3 times the amount of 85% ethanol solution to elute at a flow rate of 1.0BV / h. The eluate flowing out from the D-101 resin directly passes through the D900 decolorizing resin at a flow rate of 6.5BV / h. When the resin surface is exposed, add 85% ethanol s...

Embodiment 2

[0026] Panax notoginseng saponins mainly contain ginsenoside Rg 1 , Ginsenoside Rb 1 and notoginsenoside R 1 , the applicant refers to the content determination method of Panax notoginseng saponins injection provided in the quality standard of WS-10986 (ZD-0986)-2002 (see Table 1), and the content of the ginseng medicinal materials provided in the Chinese Pharmacopoeia 2005 edition. Content determination method (see table 2) detects Panax notoginseng saponins capsule of the present invention, and the result shows, the former can not effectively separate the chromatographic peak of active ingredient and impurity peak, and serious drift occurs in baseline; The latter ginsenoside Rb 1Chromatographic peaks have large differences in peak areas due to the use of different chromatographic columns, which shows that ginsenoside Rb 1 The separation of chromatographic peaks is greatly affected by the chromatographic column, and the chromatographic conditions are not durable. After adj...

Embodiment 3

[0034] 1 to 10 batches of samples prepared in Example 1 were detected by the following content determination method.

[0035] Determination according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition one attached VI D).

[0036] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler, and the number of theoretical plates is based on ginsenoside Rg 1 Peak calculation should not be lower than 6000, using acetonitrile-water as the mobile phase, wherein acetonitrile is mobile phase A, water is mobile phase B, and the detection wavelength is 203nm, including column balance, sample loading, and elution steps. In the step, first use 19% by volume of phase A and 81% of phase B as the mobile phase to elute 2 to 6 column volumes; then gradually increase the volume percentage of mobile phase A to elute 1 to 3 column volumes to The volume percentage of mobile phase A is 29% and the volume percentage of mobile phas...

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Abstract

The invention relates to capsules of panax notoginseng saponins, a preparation method and a content determination method thereof. The contents of ingredients of panax notoginseng saponins R1, ginsenoside Rg1 and ginsenoside Rb1 in the capsules of the panax notoginseng saponins are reasonable, the efficacy is good; the preparation process is simple and easy to operate, the extraction efficiency is high, the operation cost is low, the fluidity of medicinal powder is good and the capsule content is stable. The content determination method of the invention uses the high performance liquid chromatography method to determine the contents of the three main ingredients of the panax notoginseng saponins R1, the ginsenoside Rg1 and the ginsenoside Rb1 in the capsules of the panax notoginseng saponins, thereby having strong specificity and high determination precision, solving the problems of baseline drift, incomplete separation of chromatograph peaks and the like in the chromatographic conditions for determining other preparations of the panax notoginseng saponins and further improving the quality control level of the capsules.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine, and more specifically relates to a notoginseng total saponin capsule and a preparation method thereof, and also relates to a content determination method of the capsule. Background technique [0002] The total saponins of Panax notoginseng are extracted from Panax notoginseng of Araliaceae, and more than 65% of the saponins are Panax notoginsenoside R 1 , Ginsenoside Rg 1 and ginsenoside Rb 1 . Pharmacological studies have shown that Panax notoginseng saponins can reduce the body's oxygen consumption, inhibit platelet aggregation and increase cerebral blood flow, lower blood lipids and blood sugar, resist fatigue and improve macrophage function. In clinical application, Panax notoginseng saponins preparation (trade name: Xueshuantong preparation) prepared with Panax notoginseng saponins as the active ingredient has become an ideal new drug for treating ischemic cardiovascular and ce...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/704A61K36/258A61K9/48A61P9/10A61P7/02G01N30/02
Inventor 方同华项彦华周雪峰岳大彪代喜国周广红
Owner HARBIN ZHENBAO PHARMA