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Direct orally taken pseudo-ginseng powder traditional Chinese Medicine decoction pieces

A technology of traditional Chinese medicine decoction pieces and Panax notoginseng powder, applied in the field of medicine, can solve the problems of different quality, no expiration date, lack of scientific basis for design and selection, etc.

Inactive Publication Date: 2017-08-11
江苏苏轩堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Alcohol or organic solvents are often used in the preparation of "extracts" and content determination samples in the quality standards of Panax notoginseng powder. Therefore, the measured results can only reflect the quality of itself, and cannot indicate that the index components or active ingredients have been taken orally. The fact that the "quantity" can be dissolved or released in the body afterward makes the design and selection of the optimal production process of Panax notoginseng powder as a direct oral decoction piece lack scientific basis. Therefore, the health care function and clinical curative effect of Panax notoginseng powder are also widely received. big impact or not guaranteed
Physical sterilization methods such as dry heat and high-pressure steam, chemical sterilization methods such as ethylene oxide, and gamma ray sterilization methods such as cobalt-60 all have major defects. If the sterilization effect of some sterilization methods is not good, Some have a destructive effect on the active ingredients contained in traditional Chinese medicine, some leave residues, some have pollution, and so on
[0008] Direct oral Chinese herbal decoction pieces are a new type of modern Chinese herbal decoction pieces that have just been defined by the state in recent years. In addition to the microbial limit standards for direct oral decoction pieces listed in the fourth part of the "Chinese Pharmacopoeia" 2015 edition, there is still no national unified quality enforcement of direct oral Chinese herbal medicine decoction pieces. standard, Panax notoginseng powder products are no exception
In addition, because the chemical components contained in each herb are very complex, and the quality varies from place to place, the content quality requirements are often based on the content of its index components or active components reaching a certain value (except for toxic components), plus Most of the active ingredients are stored in its cells. For various reasons, Panax notoginseng powder, as a medicine, has no scientific "expiration date" so far.

Method used

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  • Direct orally taken pseudo-ginseng powder traditional Chinese Medicine decoction pieces
  • Direct orally taken pseudo-ginseng powder traditional Chinese Medicine decoction pieces
  • Direct orally taken pseudo-ginseng powder traditional Chinese Medicine decoction pieces

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0060] Preparation of reference substance solution Accurately weigh ginsenoside Rg 1 Reference substance, ginsenoside Rb 1 Reference substance and notoginseng saponin R 1 Appropriate amount of reference substance, add methanol to make each 1ml contains ginsenoside Rg 1 0.4mg, Ginsenoside Rb l 0.4mg, Panax notoginsenoside R 1 A mixed solution of 0.1 mg was obtained.

[0061] Preparation of the test solution Take 0.6g of the powder of this product (passed through a No. 4 sieve), weigh it accurately, add 50ml of methanol precisely, weigh it, let it stand overnight, put it on a water bath at 80°C and keep it slightly boiling for 2 hours, let it cool, and then Weigh the weight, make up the lost weight with methanol, shake well, filter, and take the filtrate to obtain the final product.

[0062] Determination method Accurately draw the reference substance solution and the test solution respectively 10μl, inject the liquid chromatograph, measure, that is.

[0063] This product ...

Embodiment 1

[0078] 100 kilograms of raw medicinal materials of Panax notoginseng were divided into 3 experimental batches (33.3 kilograms per batch), and were purified, washed, dried and crushed according to the drug GMP standard (D-level clean area, using dust-absorbing low-temperature crushing technology, Respectively crushed into 100, 150, 200-300 mesh), intermediate (inspection), quantitative packaging (3 grams / bag, D-level clean area), electron beam irradiation sterilization (30% of the quantitative packaging left in each batch Sterilization process is not carried out), the obtained product (test product) is used for the best GMP production technology of Radix Notoginseng powder of the present invention and its quality standard experimental research.

[0079] 1. The optimal production process of "Panax notoginseng powder" for direct oral administration of traditional Chinese medicine decoction pieces:

[0080] (1) Optimum fineness (mesh number) production process:

[0081] The cell ...

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PUM

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Abstract

The invention provides direct orally taken pseudo-ginseng powder traditional Chinese Medicine decoction pieces. A preparation process of the decoction pieces comprises the following steps that 1, a raw medicinal pseudo-ginseng material is cleaned, cleaned and dried and then is smashed to obtain an intermediate; 2, the intermediate is inspected, and electron beam irradiation sterilization is performed after package; 3, standard inspection is performed, and a finished product is obtained after package. In the step 1, the smashing conditions are as follows: a dust collection type low-temperature smashing technology is applied in a level-D clean zone, and the raw medicinal pseudo-ginseng material is smashed to be 100-300 mesh. In the step 2, the exposure dose of the electron beam irradiation sterilization is 3-10 kGy. The total amount of water extract and the total dissolving amount of total saponins in water extract of a pseudo-ginseng powder product are increased by 20-30% compared with the fine powder standard (100 mesh) of Chinese Pharmacopoeia, and microbial limit inspection results can completely meet the standards of relevant direct orally taken decoction pieces.

Description

technical field [0001] The invention relates to a direct oral Chinese herbal decoction piece of Panax notoginseng powder, which belongs to the technical field of medicine. Background technique [0002] Panax notoginseng (B u r k.) F.H.C h e n), also known as Panax notoginseng, Tianqi, Tusanqi, Xueshancao, Junelin, scorpion grass, also known as Zhaoshen, blood ginseng, ginseng in ancient times Panax notoginseng, panax notoginseng, mountain lacquer, panax notoginseng, etc., belong to the perennial herb of the Araliaceae ginseng genus. It is one of the important commonly used traditional Chinese medicines recorded in the 2015 edition of the "Chinese Pharmacopoeia", and it is a rare and precious Chinese medicinal material unique to China. , is also one of the earliest medicinal and edible plants in my country. Because it is dug three to seven years after sowing and each plant has three petioles, and each petiole has seven leaves, it is named Sanqi. [0003] Radix Notoginseng has...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/258A61K9/14A61K125/00
CPCA61K9/14A61K36/258A61K2236/15
Inventor 邓京振周建平于冬生
Owner 江苏苏轩堂药业有限公司