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Effervescence tablet having hawthorn, preparation process and testing method thereof

A technology of effervescent tablets and big hawthorn, which is applied in the field of big hawthorn effervescent tablets and its preparation, can solve the problems of narrow adaptability to the crowd, lack of detection methods, and limitations of drug quality control, and achieve novel dosage forms, expanded applicable crowd, and interesting strong effect

Inactive Publication Date: 2007-05-23
上海复星临西药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, traditional Chinese medicine preparations used to treat indigestion, such as Dashanzha Granules, use sucrose as one of the excipients. The use of certain diseases such as diabetes is limited to a certain extent, and the adaptability to the population is narrow.
At the same time, there is no suitable detection method, which limits the quality control of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) Ingredients Weigh 500kg of hawthorn, 100kg of malt, 100kg of Divine Comedy, 100kg of maltodextrin, 100kg of citric acid, 20kg of sodium carbonate, 10kg of sodium bicarbonate, 20kg of polyethylene glycol 6000, 2kg of acesulfame potassium, cyclamate 5kg, leucine 20kg.

[0031] (2) Extraction and concentration Take the weighed hawthorn, malt (stir-fried), and Divine Comedy and add water to extract twice, add 8 times the amount of water for the first time, add 6 times the amount of water for the second time, decoct for 1 hour each time, The extract was concentrated to a relative density of 1.05 (20°C).

[0032] (3) Spray drying Take the concentrated clear paste, add 100kg of maltodextrin and spray dry it.

[0033] (4) Granulation: Mix the spray-dried powder with 100kg of citric acid, 20kg of sodium carbonate, 10kg of sodium bicarbonate, 20kg of polyethylene glycol 6000, 2kg of acesulfame potassium, and 5kg of cyclamate, and dry granulate.

[0034] (5) Tablet compressi...

Embodiment 2

[0036] Weigh 800kg of hawthorn, 200kg of malt (fried), 200kg of Divine Comedy, 200kg of maltodextrin, 20kg of citric acid, 40kg of sodium carbonate, 20kg of sodium bicarbonate, 40kg of polyethylene glycol 6000, 4kg of acesulfame potassium, 10kg of cyclamate, and Amino acid 40kg.

[0037] Take the weighed hawthorn, malt (stir-fried), and Divine Comedy and add water to extract twice, add 8 times the amount of water for the first time, add 6 times the amount of water for the second time, each time for 1 hour, and concentrate the extract to a relative density of 1.10 .

[0038] Take the concentrated clear cream, add maltodextrin and spray dry it.

[0039] Mix the spray-dried powder with citric acid, sodium carbonate, sodium bicarbonate, polyethylene glycol 6000, acesulfame potassium and cyclamate, and dry granulate.

[0040] The granules are mixed with leucine and compressed into tablets.

Embodiment 3

[0042] Qualitative Identification of Hawthorn Effervescent Tablets

[0043] Get 8g of the product of Example 1, grind it finely, add 50ml of water to dissolve, extract with 50ml of chloroform, separate the chloroform layer, evaporate to dryness in a water bath, add 0.5ml of acetone to dissolve as the test solution.

[0044] Take 5 grams of hawthorn medicinal material, add 100ml of water to boil for 1 hour, extract with 100ml of chloroform, and prepare the reference medicinal material solution in the same way.

[0045] Take 10 μl of the above two solutions respectively, spot on the same silica gel GF254 thin-layer plate, develop with chloroform-methanol (35:1, volume ratio) as the developer, take it out, dry it, and inspect it under an ultraviolet lamp (254nm). . In the chromatogram of the test product, the main spot of the same color appears at the position corresponding to the control medicinal material.

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Abstract

The invention relate to effervescent tablets of haw thorn, process of preparation, method for detection and quality control, wherein the effervescent tablets are the conversion to the dose form of electuary, and are prepared from prescription of haw thorn, medicated leaven and malt through steps of extracting, concentrating, spray drying, charging pharmaceutically acceptable excipient, palletizing and tabletting.

Description

technical field [0001] The invention relates to a hawthorn effervescent tablet and a preparation method, quality control and detection method thereof. Background technique [0002] Indigestion is a relatively general concept. Various diseases can cause symptoms of indigestion and loss of appetite. Each patient's chief complaint has different connotations. Including loss of appetite, abdominal distension after eating, dull pain or discomfort, accompanied by nausea and belching, physical examination often has thick and greasy tongue coating and deep upper abdominal tenderness or discomfort. These non-specific symptoms and signs can be the performance of certain organic lesions or neurological dyspepsia, so the incidence rate is high. [0003] At present, traditional Chinese medicine preparations for treating dyspepsia, such as Dashanzha Granules, use sucrose as one of the excipients, which is limited to a certain extent in the use of patients with certain diseases such as dia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/899A61K9/20A61K9/46A61P1/14G01N30/90G01N30/02G01N21/33
Inventor 李德强刘金强张玉民
Owner 上海复星临西药业有限公司
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