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Method for establishing radix-scrophulariae pharmaceutical-preparation fingerprint chromatography

A technology for pharmaceutical preparations and fingerprints, applied in measuring devices, instruments, scientific instruments, etc., can solve the problems of detection and control quality, difficult production practice, inability to detect indicators, etc., to improve safety, stability, and high precision. , the effect of high stability

Inactive Publication Date: 2016-11-09
CHINA RESOURCES SANJIU MEDICAL & PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] For this reason, what the present invention is to solve is that the single detection index of existing Scrophulariaceae formula granules cannot detect and control its quality as a whole, and the joint detection of multiple detection indexes is time-consuming and laborious, and is difficult to be widely used in production practice. technical problems, thereby proposing a method for establishing the fingerprint of medicinal preparations of Scrophulariaceae Scrophulariae

Method used

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  • Method for establishing radix-scrophulariae pharmaceutical-preparation fingerprint chromatography
  • Method for establishing radix-scrophulariae pharmaceutical-preparation fingerprint chromatography
  • Method for establishing radix-scrophulariae pharmaceutical-preparation fingerprint chromatography

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Embodiment 1

[0053] In the following examples and experimental examples, the preparation method of Scrophulariaceae formula granules is as follows: take Scrophulariaceae, heat and reflux extraction twice, add 8 times the amount of water for extraction for 2.0 hours for the first time, and add 6 times the amount of water for the second time Extract with water for 1.5 hours, filter, combine the filtrates, concentrate the filtrates to a relative density of 1.10-1.15 at 60°C, add conventional excipients, and make granules according to conventional processes.

Embodiment 2

[0055] The present embodiment establishes the method for the fingerprint of Scrophulariaceae formula granule, comprises the following steps:

[0056] (1) Take 0.5g of the medicinal preparation of Scrophulariaceae to be tested, accurately weigh it, accurately add 50mL of 50% methanol aqueous solution, weigh it, ultrasonically extract it for 30 minutes, let it cool, and weigh it again, take 50% methanol water solution to make up the weight Lost weight, shake up, filter, get the continued filtrate, as the test solution;

[0057] (2) Accurately weigh the reference substance of harpaside, add 50% methanol aqueous solution to make a solution containing 0.00006g per 1mL, shake well, and use it as the reference substance A solution;

[0058] Accurately weigh harpagoside reference substance, add 50% methanol aqueous solution to make a solution containing 0.00002g per 1mL, shake well, and use it as reference substance B solution;

[0059] Precisely weigh the cinnamic acid reference sub...

Embodiment 3

[0064] The present embodiment establishes the method for the fingerprint of Scrophulariaceae formula granule, comprises the following steps:

[0065] (1) Take 0.4g of the medicinal preparation of Scrophulariaceae to be tested, accurately weigh it, add 60mL of 40% methanol aqueous solution precisely, weigh it, extract it ultrasonically for 20 minutes, let it cool, weigh it again, take 40% methanol water solution to make up the Lost weight, shake up, filter, get the continued filtrate, as the test solution;

[0066] (2) Accurately weigh the reference substance of harpaside, add 40% methanol aqueous solution to make a solution containing 0.00004g per 1mL, shake well, and use it as the reference substance A solution;

[0067] Accurately weigh the reference substance of harpagoside, add 40% methanol aqueous solution to make a solution containing 0.00001g per 1mL, shake well, and use it as the reference substance B solution;

[0068] Accurately weigh the cinnamic acid reference sub...

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Abstract

The invention relates to a method for establishing radix-scrophulariae pharmaceutical-preparation fingerprint chromatography. According to the method, radix-scrophulariae formula granules serve as detection objects, the method for the pharmaceutical-preparation fingerprint chromatography is established, full chromatography information is obtained, common characteristic peaks S peaks harpagoside, first peaks harpagoside, second peaks cinnamic acid and third peaks cinnamic acid are determined, the S peaks harpagoside are selected, and the relative retention time of the common characteristic peaks of the radix-scrophulariae formula granules is determined; according to information of the multiple chromatographic peaks in the fingerprint chromatography, the quality of the radix-scrophulariae formula granules can be fully and rapidly detected, full quality detection and total quality control over the radix-scrophulariae formula granules can be achieved, and therefore the safety and the stability of pharmaceutical using can be improved. Meanwhile, the method has the advantages of being high in stability and accuracy, good in repeatability and the like.

Description

technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to a method for establishing a fingerprint of a medicinal preparation of Scrophulariaceae Scrophulariae. Background technique [0002] Scrophulariae formula granules are obtained by extracting, concentrating and granulating the traditional Chinese medicine Scrophulariaceae. Scrophulariaceae is the dry root of Scrophularia ningpoensis Hemsl., which was first recorded in "Shen Nong's Materia Medica". Scrophulariaceae is mainly distributed in Northeast China, North China and East China; It is used in the treatment of febrile disease and injury of yin, crimson tongue and polydipsia, warm toxin and spots, constipation due to fluid injury, cough due to bone steaming, red eyes, sore throat, scrofula, diphtheria, carbuncle and sore. Scrophulariaceae mainly contains iridoid glycosides, phenylpropanoid glycosides, aromatic glycosides, etc. Among them, iridoid glycosides mainly contai...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8809
Inventor 张辉郑晓英谭沛蔡少青马鹏岗
Owner CHINA RESOURCES SANJIU MEDICAL & PHARMA
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