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A kind of assay method of Qianlieping capsule

A technology of Qianlieping capsule and determination method, applied in the field of pharmaceuticals, can solve the problem of not formulating other ingredients and the like, and achieve the effects of stable and controllable quality, good accuracy and guaranteed curative effect

Active Publication Date: 2022-04-19
XIAN CHIHO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the existing drugs for the treatment of acute and chronic prostatitis, such as the detection method of Qianlieping Capsules, only the content of Salvia Miltiorrhiza and Radix Paeoniae Rubra has been detected by high performance liquid chromatography (HPLC), but no other ingredients, especially Determination method of Beibai sauce content

Method used

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  • A kind of assay method of Qianlieping capsule
  • A kind of assay method of Qianlieping capsule
  • A kind of assay method of Qianlieping capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment one: prescription and preparation method of Qianlieping Capsules

[0028] prescription:

[0029] Beibaijiang 702g, Danshen 234g, Chishao 234g, Peach Kernel 234g, Safflower 234g

[0030] Zeilan 234g Shiwei 234g Frankincense 47g Myrrh 47g

[0031] Preparation method: the above nine flavors, frankincense and myrrh are crushed into fine powder and set aside. Grind Danshen and Radix Paeoniae Rubra into coarse powder, add ethanol to extract twice, each time for 2 hours, combine the extracts, filter, recover ethanol from the filtrate and concentrate to a thick paste with a relative density of 1.32-1.36 (60°C), and set aside. The other five flavors such as Beibaijiang and the medicinal residue after alcohol extraction are decocted twice, the first time is 2 hours, the second time is 1.5 hours, the decoction is combined, filtered, and the filtrate is concentrated under reduced pressure to a relative density of 1.32-1.36 ( 60°C), add the above-mentioned fine powder ...

Embodiment 2

[0033] Example 2: Content identification of luteolin in Beibaijiang in Qianlieping capsules

[0034] 1. Optimum test of mobile phase and preparation method of test product

[0035] The content of the active ingredient luteolin in Beibaijiang in Qianlieping capsules was determined by HPLC, wherein the chromatographic conditions were:

[0036] Packing agent: octadecylsilane bonded silica gel; column temperature: 35°C; use a UV detector, the detection wavelength is preferably 348nm; the number of theoretical plates should not be less than 4000 based on the luteolin peak. The flow rate was 1 ml / min.

[0037] Mobile phase optimization selection comparison:

[0038] Mobile phase 1: The mobile phase is methanol-water solution with a volume ratio of 30:70.

[0039] Mobile phase 2: The mobile phase is acetonitrile-1.0% (v / v) formic acid solution in a volume of 30:70.

[0040] The following sample processing methods were combined for experimentation:

[0041] The high-performance l...

Embodiment 3

[0121] Example 3: Content Determination and Stability Test of Luteolin in Beibaijiang in Qianlieping Capsules

[0122] The samples produced by Qianlie Pingda (batch numbers: 20180101, 20180102, 20180103, produced by Xi'an Qianhe Pharmaceutical Co., Ltd.) were subjected to accelerated experiments and room temperature placement experiments. Accelerated experiment: Place the sample in a closed environment with a relative humidity of 75% ± 5% and a temperature of 40°C ± 2°C for 6 months. In the 0th, 1st, 2nd, 3rd, and 6th months, samples were taken for character observation. Limit detection; room temperature placement test: placed in a closed environment with a relative humidity of 60% ± 5% and a temperature of 25 °C ± 2 °C for 3 months, at the 0th, 3rd, 6th, 12th, and 18th months, samples were taken for inspection, and the test results are shown in the table 6. The test only retained the content data of luteolin.

[0123] The stability test data table of luteolin content in Tabl...

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Abstract

The invention relates to a method for determining the content of Qianlieping capsules. Liquid chromatography is used to measure the content of luteolin in Qianlieping preparations. On the basis of the original standard, the high-performance liquid chromatography of luteolin in Junyao Beibaijiang is added. As for content determination, methodological investigation proves that the method has good precision and accuracy, and is negative without interference. The whole test process is highly operable and can be used as one of the indicators for controlling the internal quality of this product. The invention has strong specificity for the content detection of Beibaijiang, is simple, fast and reliable, can more effectively control the quality of Qianlieping capsules, makes the quality of Qianlieping capsules stable and controllable, and ensures curative effect, thereby better meeting the needs of medical treatment .

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a content determination method of Qianlieping capsules for treating acute and chronic prostatitis. Background technique [0002] Prostatitis is a common disease in men, most of which occur in young adults. Clinically, prostatitis can be divided into two types: acute and chronic. Acute prostatitis is rare clinically, and chronic prostatitis is more common in adults, accounting for about 1 / 5 of outpatients in urology department. Because chronic prostatitis is often accompanied by seminal vesiculitis, it is also called prostatic seminal vesiculitis. [0003] Qianlieping Capsules, standard WS-10459(ZD-0459)-2012Z-2018, its prescription is Beibaijiang 702g, Salvia miltiorrhiza 234g, Chishao 234g, Peach kernel 234g, Safflower 234g, Eupatorium 234g, Shiwei 234g, Frankincense 47g , Myrrh 47g made into 1000 capsules. It has the effects of clearing heat and dampness, removin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/14
CPCG01N30/02G01N30/06G01N30/14G01N2030/047G01N2030/146
Inventor 刘立张琼吕慧锋谭祥和胡小虎
Owner XIAN CHIHO PHARMA
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