Preparation method and quality control method of traditional Chinese medicine Danmo capsule

A technology of traditional Chinese medicine and Danmo, applied in the field of preparation and quality control of traditional Chinese medicine Danmo capsules, can solve problems such as difficulty in swallowing, large volume, and no production process optimization.

Active Publication Date: 2011-10-12
THE FIRST AFFILIATED HOSPITAL OF SUN YAT SEN UNIV
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Danmo Capsules are composed of Eclipta chinensis, Ligustrum lucidum, Salvia miltiorrhiza, honeysuckle, motherwort, rehmannia glutinosa, madder, Digupi, and scorpion. The original production process of Danmo capsules as hospital preparations is simple and has not been carried out. The production process has been optimized, so it is not suitable for industrial production; the empty hard capsules used for the original preparations are No. The quality standard only has microbiological inspection items, no component identification and content determination items, which is not conducive to the quality control of Danmo capsules

Method used

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  • Preparation method and quality control method of traditional Chinese medicine Danmo capsule
  • Preparation method and quality control method of traditional Chinese medicine Danmo capsule
  • Preparation method and quality control method of traditional Chinese medicine Danmo capsule

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Effect test

Embodiment 1

[0019] Take Eclipta, Ligustrum lucidum, Danshen, honeysuckle, motherwort, rehmannia glutinosa, madder, Digupi and Scorpion nine herbs, add 12 times the water, decoct once for 2.5 hours in total, combine the decoction, filter, Concentrate the filtrate to a relative density of 1.05-1.10g / mL (50°C) clear paste, add ethanol to make the alcohol content reach 60%, stir while adding, let stand for 15 hours, take the supernatant to recover ethanol, concentrate to a relative density of 1.15-1.20g / mL (50°C) thick paste for later use, add auxiliary materials (starch, lactose and talcum powder, wherein the dosage of starch and lactose is 3:2, and the dosage of talc powder is 5%) in a one-step granulator to preheat Finally, keep the air inlet temperature at 80°C, use the above-mentioned thick paste as a binder, spray into the thick paste for one-step granulation, granulate after drying, add additional auxiliary materials (0.5% magnesium stearate and 0.5% talcum powder), and mix well , fill...

Embodiment 2

[0021] Take Eclipta, Ligustrum lucidum, Danshen, honeysuckle, motherwort, rehmannia glutinosa, madder, Digupi and Scorpion nine herbs, add 8 times the water, decoct 3 times, 1.5 hours each time, combine the decoction, filter , the filtrate is concentrated to a relative density of 1.15 ~ 1.20g / mL (50 ℃) clear paste, add ethanol to make the alcohol content reach 80%, stir while adding, let stand for 30 hours, take the supernatant to recover ethanol, concentrate to the relative density To make a thick paste of 1.20-1.25g / mL (50°C) for later use, add auxiliary materials (starch, lactose and talcum powder, wherein the dosage of starch and lactose is 4:1, and the dosage of talcum powder is 15%) in a one-step granulator. After heating, keep the air inlet temperature at 90°C, use the above-mentioned thick paste as a binder, spray into the thick paste for one-step granulation, granulate after drying, add additional auxiliary materials (0.5% magnesium stearate and 0.5% talcum powder), an...

Embodiment 3

[0023]Take Eclipta, Ligustrum lucidum, Salvia, Honeysuckle, Motherwort, Rehmannia glutinosa, Rubia, Digupi and Scorpion nine herbs, add 10 times of water, decoct twice, each time for 2 hours, combine the decoction, filter , the filtrate is concentrated to a relative density of 1.10 ~ 1.15g / mL (50 ℃) clear paste, add ethanol to make the alcohol content reach 70%, stir while adding, let stand for 24 hours, take the supernatant to recover ethanol, concentrate to the relative density To make a thick paste of 1.25-1.30g / mL (50°C) for later use, add auxiliary materials (starch, lactose and talcum powder, wherein the dosage of starch and lactose is 3:1, and the dosage of talcum powder is 10%) in a one-step granulator. After heating, keep the air inlet temperature at 80°C, use the above-mentioned thick paste as a binder, spray into the thick paste for one-step granulation, granulate after drying, add additional auxiliary materials (0.5% magnesium stearate and 0.5% talcum powder), and m...

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Abstract

The invention relates to a preparation method and a quality control method of a traditional Chinese medicine Danmo capsule for treating chronic kidney disease. The prescription of the traditional Chinese medicine compound preparation is composed of 9 traditional Chinese medicines, namely yerbadetajo, glossy privet fruit, salvia root, honeysuckle, motherwort, rehmannia root, madder, wolfberry bark and scorpion. The preparation method of the Danmo capsule comprises the steps of: pretreatment by water extraction and alcohol precipitation, forming of capsule content particles by one-step granulation, encapsulation, sub-packaging and external packaging. In the quality control method, thin layer identification of the yerbadetajo, the glossy privet fruit, the salvia root and the honeysuckle is established, and the content of salvianolic acid B is determined by high performance liquid chromatography. Compared with the original preparation process and quality standard, the traditional Chinese medicine Danmo capsule prepared in the invention is the I capsule, so that the compliance of patients in administration is improved, the moisture resistance of the capsule is improved, the content of the effective component salvianolic acid B is also greatly improved, and the quality standard of the preparation is improved.

Description

technical field [0001] The invention belongs to the field of traditional Chinese medicine preparations, and relates to the preparation and quality control method of a traditional Chinese medicine Danmo capsule for treating chronic kidney disease. Background technique [0002] Chronic glomerulonephritis and nephrotic syndrome are autoimmune diseases and common diseases that seriously endanger people's health. The main Western medicine treatment plan for this type of disease is symptomatic treatment, including hormone therapy, but this plan has a large adverse reaction, a long course of treatment, and is easy to relapse after being cured. Chinese scholars have developed original Chinese and Western medicine treatment methods in long-term treatment practice, and achieved better curative effect than pure Western medicine treatment. However, these traditional Chinese medicine treatments are mostly based on prescriptions, and there is a lack of convenient and effective Chinese pa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/815A61K9/48G01N30/36G01N30/90A61P13/12A61K35/64A61K35/646
Inventor 陈孝李瑞明
Owner THE FIRST AFFILIATED HOSPITAL OF SUN YAT SEN UNIV
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