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Quality control method for stringy stonecrop herb preparation

A detection method and technology of C. chinensis, applied in the directions of pill delivery, measuring device, pharmaceutical formulation, etc., can solve the problems of inability to scientifically reflect the curative effect of C. chinensis preparations, unsuitable for preparation quality control, lack of preparation quality control methods, etc.

Active Publication Date: 2012-07-11
BEIJING ASIA EAST BIO PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The national standard "Prescriptions of Traditional Chinese Medicine" Volume 6, page 114, announced the quality standard of Chuipencao Granules, but the standard lacks the quality control method of the preparation; "Content determination and pharmacological research of Chuipencaoside" ("China Medical Journal "August, 2003, the 21st volume, the 8th phase) discloses the content determination method of the glucoside, but the glucoside is unstable and easy to decompose, so it should not be used as an index for the quality control of the preparation; It also contains ingredients such as triterpenoids, which also have hepatoprotective activity. Therefore, simply taking the content of terpenia glycosides as the quality control index cannot scientifically reflect the curative effect of terpenia preparations.

Method used

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  • Quality control method for stringy stonecrop herb preparation
  • Quality control method for stringy stonecrop herb preparation
  • Quality control method for stringy stonecrop herb preparation

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0013] Experimental example 1 qualitative detection experiment

[0014] 1. Determination of the preparation method of the test solution

[0015] Method a. Get the granule obtained in Example 2, pulverize, weigh 5 grams, add 20 milliliters of methanol, shake for 1 h, filter, and the filtrate is concentrated to 2 milliliters as the test solution.

[0016] Method b. Get the granule obtained in Example 2, pulverize, weigh 20 grams, add 50 milliliters of diethyl ether, ultrasonically treat for 30 minutes, suction filter with a Buchner funnel, evaporate the filtrate to dryness, add 1 milliliter of chloroform to the residue as the test solution.

[0017] Method c. Get the granules obtained in Example 2, pulverize, weigh 5 grams, add 20ml 85% ethanol for ultrasonic extraction twice, filter, combine the filtrates, evaporate the solvent, extract 2 times with n-butanol saturated with water, and combine n-butanol Alcoholic solution, evaporated to dryness at low temperature, and added 1 m...

experiment example 2

[0036] Experimental example 2 detection experiment of absolute ethanol extract

[0037] Get the granule obtained in Example 2, pulverize, get 3 parts, each part is about 4 grams, accurately weighed respectively, put in a 250 milliliter round bottom flask, accurately add dehydrated ethanol 100ml, seal it tightly, weigh it, leave standstill for 1 After 1 hour, reflux in a water bath for 0.5, 1, and 2 hours respectively, let cool, weigh, make up for the lost weight with absolute ethanol, shake well, filter, accurately measure 25 ml of the filtrate, put it in an evaporating dish, and evaporate to dryness , Dry at 105°C for 3 hours, transfer to a desiccator, cool for 30 minutes, weigh quickly and accurately, calculate, and obtain.

[0038] Table 4. Determination results of absolute ethanol extracts at different extraction times:

[0039] group Extraction time (h) Content (mg) Relative content (%) 1 0.5 134.4 3.36 2 1.0 174.8 4.37 ...

experiment example 3

[0041] Experimental example 3. Accelerated stability test

[0042]Prepare 3 batches of samples according to the prescription and method described in Examples 2, 3, and 4, wherein the samples obtained in Example 2 are placed at a temperature of 25°C ± 2°C and a relative humidity of 60% ± 10% for 8 months; Place the samples obtained in Example 3 for 4 months at a temperature of 40°C ± 2°C and a relative humidity of 75% ± 5%, and place 4 more samples at a temperature of 25°C ± 2°C and a relative humidity of 60% ± 10%. month; the sample obtained in Example 4 was placed for 8 months under the conditions of temperature 40°C±+2°C and relative humidity 75%±5%. These three batches of samples after carrying out stability test carry out qualitative and quantitative detection with above-mentioned test example 1 and test example 2 gained methods, and the results are shown in the following table:

[0043] Table 5. Accelerated Stability Test Results

[0044] group Qualitative de...

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Abstract

The invention relates to a quality control method for a stringy stonecrop herb preparation. The quality control method effectively controls the quality of a medicament through thin layer authentication for the stringy stonecrop herb preparation and limited detection for absolute ethanol extract, has the characteristics of stability, quickness, sensitivity and reliability, and can fully reflect thecurative effect of the medicament.

Description

technical field [0001] The invention relates to a quality control method of a weeding grass preparation, which belongs to the technical field of traditional Chinese medicines. Background technique [0002] Weeping grass is a perennial herbaceous plant of Crassulaceae, which is used in the folk to treat hepatitis, sore throat, and insect bites. Clinical studies have shown that weeping grass preparations can significantly reduce serum alanine aminotransferase in patients. The national standard "Prescriptions of Traditional Chinese Medicine" Volume 6, page 114, announced the quality standard of Chuipencao Granules, but the standard lacks the quality control method of the preparation; "Content determination and pharmacological research of Chuipencaoside" ("China Medical Journal "August, 2003, the 21st volume, the 8th phase) discloses the content determination method of the glucoside, but the glucoside is unstable and easy to decompose, so it should not be used as an index for t...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K36/41A61K9/16A61K9/20A61K9/48G01N30/90A61P1/16A61P11/04A61P17/02
Inventor 付立家付建家
Owner BEIJING ASIA EAST BIO PHARMA CO LTD
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