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Compound Chinese medicine preparation and its preparing process and quality control method

A quality control method and compound technology, applied in pharmaceutical formulas, drug combinations, medical preparations containing active ingredients, etc., can solve problems such as failure to conduct quantitative research, lack of reference substances, and single dosage form.

Inactive Publication Date: 2006-11-08
张友生
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently commercially available Fukean Tablets are pure Chinese herbal medicine preparations, which are used to clear away heat and detoxify, promote dampness and relieve pain. Auxiliary drug: Pomegranate peel is astringent and astringent as an adjuvant drug. All drugs are used together to play a role in clearing away heat and detoxification, diuresis and dampness, astringent and pain relief. It is used for acute gastroenteritis, abdominal pain caused by indigestion, diarrhea, vomiting, and belching. Sour swallowing, thick and greasy tongue coating, etc. have good curative effect, but because there is only one dosage form of tablet in the market, the dosage form is single, which cannot meet the needs of different patients, so it is imperative to develop a new dosage form
However, the quality standard identification (1) and (2) of Fukean Tablets recorded in the Eleventh Volume of Traditional Chinese Medicine Prescriptions in the "Drug Standards of the Ministry of Health" are non-specific reactions, and both pomegranate peel and fotan mother contain gallic acid. , Jiubiying contains syringin, but there is a lack of reference substances, so quantitative research has not been carried out; there are no known reference substances that can be used for quality control of this product in medicinal materials such as twig vine, fotanmu, plantain and so on.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0024] Experimental example 1. Clinical observation summary of 30 cases of acute gastroenteritis treated by capsules of the present invention

[0025] 1. Diagnosis and dialectical standards

[0026] 1. Western medicine diagnosis

[0027] It is formulated based on the textbook "Chinese Medicine Internal Medicine" (related chapters on diarrhea) and the "Key Points of Disease Diagnosis and Treatment and Criteria for Efficacy" published by the Hebei Provincial Department of Health. Acute gastroenteritis diagnosed by traditional Chinese medicine is mostly caused by the intake of food contaminated by bacteria or their toxins. It usually develops within a few hours after eating. The clinical symptoms include abdominal pain, bloating, diarrhea, nausea, vomiting, fever, dehydration, and even shock. The stools are watery or mucus-like, several times a day. Suspicious food and stool culture can be positive for pathogens.

[0028] 2. TCM syndrome differentiation

[0029] Damp-heat type: stoma...

experiment example 2

[0066] Experimental example 2: TLC identification of Twig

[0067] 1. Preparation of test solution: Take the contents of 10 Chinese medicine compound capsules of the present invention, add 30ml of methanol, heat to reflux for 30 minutes, filter, evaporate the filtrate, add 20ml of water to the residue to dissolve, shake and extract with ethyl acetate 2 times, 20ml each time, combine the ethyl acetate solution, evaporate to dryness, add 1ml methanol to the residue to dissolve it, and use it as the test solution.

[0068] 2. Preparation of the control medicinal material solution of Tengdu Teng: Take 1g of Tengdu Teng control medicine, add 50ml of water, decoct for 30 minutes, filter, and concentrate the filtrate to 20ml, and prepare the control medicine solution by the same method.

[0069] 3. Preparation of blank control solution of Tengdu Teng: According to the prescription ratio and preparation method described in the technical plan, starch was used instead of Tengdu Teng to make...

experiment example 3

[0072] Experimental example 3: TLC identification of Jiu Bing

[0073] I. Test with reference to the method under [Identification] (2) contained in the quality standard of Fu Ke'an film-coated tablets, take the contents of 15 Chinese medicine compound capsules of the present invention, add 30 ml of methanol, heat and reflux for 30 minutes, filter, The filtrate was evaporated to dryness, and the residue was dissolved by adding 20ml of water. Shaking and extracting twice with ethyl acetate, 20ml each time, combined the ethyl acetate solution, evaporated to dryness, and the residue was dissolved by adding 1ml of methanol to dissolve it. ). In addition, take 1g of Bing control medicinal material, add 30ml of water, decoct for 30 minutes, filter, concentrate the filtrate to 20ml, filter, and make a control medicinal solution in the same way. According to thin-layer chromatography (according to thin-layer chromatography (Chinese Pharmacopoeia 2000 edition one appendix VIB) test, draw 10...

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Abstract

The present invention discloses a kind of compound Chinese medicine capsule for treating acute gastroenteritis and its preparation process and quality control method. The compound Chinese medicine capsule is prepared with amplexicaul jasmine leaf, Chinese knotweed, plantain, holly bark and pomegranate rind and through specific technological process. The quality control method has increased thin-layer chromatography analysis of amplexicaul jasmine leaf and holly bark, increased flavonid content measurement and no test reaction.

Description

Technical field [0001] The invention relates to a traditional Chinese medicine compound preparation, in particular to a traditional Chinese medicine compound capsule for treating acute gastroenteritis, and a preparation method and quality control method thereof. Background technique [0002] Acute gastroenteritis belongs to the category of "vomiting" and "diarrhea" in traditional Chinese medicine. It is a common clinical disease and frequently-occurring disease. At present, the commercially available Fu Ke'an tablets are pure Chinese herbal preparations, which are used to save Bing, clearing away heat and detoxification, dispelling dampness and relieving pain, and are the main medicines of twisting vines and fondue for clearing heat and dampness. Plantago diuresis and dampness can be used for urination. Adjuvant; pomegranate peel is astringent and astringent as an adjuvant. It is used in combination to clear heat and detoxify, dilute dampness, astringent and relieve pain. It is u...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/68A61K9/48A61P1/04A61P1/12
Inventor 张友生张思宁
Owner 张友生
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