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No-sugar Mailuoning granule and its preparing process and quality control method

A Mailuoning, sugar-free technology, applied in measuring devices, pharmaceutical formulations, testing pharmaceutical preparations, etc., can solve the problems of difficult storage of oral liquid dosage forms, inconvenient clinical medication, inconvenient portability, etc., and achieve easy industrial production and accurate dosage. , good drying effect

Inactive Publication Date: 2006-11-08
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are two dosage forms of Mailuoning in the market: injection and oral liquid. The injection is quick and reliable, but it is inconvenient to use and painful to inject. The oral liquid dosage form has disadvantages such as not easy to store, prone to rancidity and contamination by bacteria, and inconvenient to carry. Mailuoning oral liquid and injection have certain limitations in use, which brings inconvenience to clinical medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] (Example 1, sugar-free Mailuoning granule and preparation method thereof)

[0048] Achyranthes bidentata 1700g, Scrophulariaceae 1700g, Dendrobium 1700g, Honeysuckle 1700g;

[0049] The auxiliary materials are: 576g of lactose, 115g of mannitol, 3g of aspartame, and 95% ethanol by weight.

[0050] Soak the above-mentioned four-flavor medicinal materials in 6 times the weight of water for 2 hours, then decoct twice, each time for 1.5 hours, and filter; combine the filtrate after two decoctions; conduct the combined filtrate at 80°C Concentrate for the first time to obtain a concentrated solution with a relative density of 1.16g / ml; add ethanol to the concentrated solution after concentrating for the first time until the concentration by weight of the alcohol content is 66%, let it stand, and take it up for the first time Operation of supernatant liquid: recover ethanol in the supernatant obtained for the first time and concentrate for the second time at 80°C to obtain a...

Embodiment 2

[0052] (Example 2, sugar-free Mailuoning granule and preparation method thereof)

[0053] The weight of raw materials used is 10 times that of Example 1, and the preparation method is the same as Example 1.

Embodiment 3

[0054] (Example 3, the quality control method of sugar-free Mailuoning Granules)

[0055] The quality control method of sugar-free Mailuoning granules includes three parts: identification, inspection and content determination in sequence.

[0056] First, identify according to the following steps: Take 5g of sugar-free Mailuoning Granules, grind it finely, add 30ml of ethanol, 5ml of hydrochloric acid, reflux in a water bath for 1 hour, filter, evaporate the filtrate to dryness, add 20ml of water to the residue, shake and extract twice with chloroform , 30ml each time; combined chloroform extracts, evaporated to dryness, and the residue was dissolved with 2ml of ethanol as the test solution; another oleanolic acid reference substance was added, and ethanol was added to make 1ml of a solution containing 1mg, as the reference substance solution; Chinese Pharmacopoeia 2000 edition one appendix VI B thin-layer chromatography test, absorb each 10 μ l of above-mentioned two kinds of ...

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Abstract

The present invention provides a kind of no-sugar Mailuoning granule and its preparation process and quality control method. The no-sugar Mailuoning granule is prepared with four kinds of Chinese medicinal materials, including achyranthes root, figwort, dendrobium stem and honeysuckle, and supplementary material. It has high effective component content, including cinnamic acid content not less than 1.5mg each bag. The present invention has optimized production process and low production cost, and is suitable for industrial production. The quality control method results in good look and stable quality of the no-sugar Mailuoning granule.

Description

technical field [0001] The invention relates to a sugar-free Mailuoning traditional Chinese medicine, a preparation method and a quality control method thereof, and belongs to the field of traditional Chinese medicine pharmacy. Background technique [0002] Cardiovascular and cerebrovascular diseases claim the lives of 12 million people every year and become the number one enemy of human health. Therefore, the development of drugs that can be used for a variety of cardiovascular and cerebrovascular diseases, are applicable to a wide range of people, and have definite clinical curative effects has broad market prospects. Mailuoning is a traditional Chinese medicine compound preparation successfully developed on the basis of the famous medical prescription "Simiao Yong'an Decoction". It has the effects of nourishing yin and clearing away heat, nourishing liver and kidney, promoting blood circulation and removing blood stasis. And thromboembolic vascular diseases, especially va...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/8984A61K9/16A61P7/02A61P9/10G01N30/90G01N33/15
Inventor 郭卫芹张育高志峰齐新英
Owner CSPC OUYI PHARM CO LTD
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