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Detection method of pharmaceutical composition mammary lump relieving capsule for treating hyperplasia of mammary glands and mastitis

A technology for breast hyperplasia and detection method, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of content determination, poor specificity of quality control standards, and inability to control clinical efficacy indicators, and achieves good reproducibility and specificity. Strong and sensitive detection method

Active Publication Date: 2020-03-27
XIAN CHIHO PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, in the existing detection methods for Rupishu Capsules, only the TLC identification of the ministerial medicine Tubeimu, the adjuvant Salvia Miltiorrhiza and Radix Paeoniae Rubra, and the determination of the content of paeoniflorin in the adjuvant Radix Radix Paeoniae Rubra were carried out; The current quality control standards are poorly specific and cannot fully reflect the quality of the drug and cannot control the clinical efficacy indicators. Therefore, it is necessary to further improve the detection method of this product, and combine the control indicators with the To further ensure the quality and curative effect of the product

Method used

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  • Detection method of pharmaceutical composition mammary lump relieving capsule for treating hyperplasia of mammary glands and mastitis
  • Detection method of pharmaceutical composition mammary lump relieving capsule for treating hyperplasia of mammary glands and mastitis
  • Detection method of pharmaceutical composition mammary lump relieving capsule for treating hyperplasia of mammary glands and mastitis

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Embodiment 1: Prescription and preparation method of Rupishu Capsules

[0041] Prescription: Gualou skin 450g, Fritillaria 150g, Dandelion 450g, Salvia miltiorrhiza 225g, Radix Paeoniae Rubra 225g, Yuanhu 135g, Bupleurum 135g

[0042] Preparation method: take the above seven flavors, take Corydalis Corydalis and grind them into fine powder; add ethanol to reflux extraction of salvia miltiorrhiza and red peony for two times, add 5 times the amount of ethanol each time, extract for 2 hours each, combine the ethanol extracts, filter, and recover ethanol from the filtrate and concentrate To a thick paste with a relative density of 1.33-1.36 (60°C); for the other four flavors such as melon and wilted skin, add water and cook three times, add 10 times the amount of water for the first time, cook for 2 hours, and add 8 times the amount of water for the second time , decoct for 1.5 hours, add 6 times the amount of water for the third time, decoct for 1 hour, combine the decocti...

Embodiment 2

[0043] Embodiment 2: the selection of wavelength and mobile phase for determination of quercetin content in Rupishu capsules

[0044] 2.1 Selection of wavelength

[0045] The quercetin reference substance solution was scanned in the wavelength range of 200-500nm, and the results showed that there were maximum absorptions at 254nm and 370nm. Considering that other ingredients in the prescription also have a large absorption at 254nm, there is more interference, so Choose 370nm with less interference as the detection wavelength.

[0046] 2.2 Selection of mobile phase

[0047] Preliminary tests show that using acetonitrile-water-1.0% phosphoric acid aqueous solution, methanol-water-1.0% phosphoric acid aqueous solution, methanol-4% phosphoric acid aqueous solution, methanol-acetonitrile-0.2% phosphoric acid aqueous solution, acetonitrile-0.2% HAc aqueous solution, methanol-0.2% Experiments were carried out with different gradients of HAc aqueous solution and methanol-water. Th...

Embodiment 3

[0051] Example 3: Specificity Study

[0052] 3.1 Preparation of negative samples:

[0053] Prescription: Tu Fritillaria 150g, Salvia miltiorrhiza 225g, Chishao 225g, Yuanhu 135g, Bupleurum 135g

[0054] Preparation method: take the above six flavors, take Corydalis Corydalis and grind them into fine powder; Salvia miltiorrhiza and red peony plus ethanol reflux extraction twice, add 5 times the amount of ethanol each time, extract for 2 hours each time, combine the ethanol extracts, filter, and recover ethanol from the filtrate and concentrate To a thick paste with a relative density of 1.33-1.36 (60°C); for the other two flavors such as Fritillaria, add water and decoct three times, add 10 times the amount of water for the first time, decoct for 2 hours, and add 8 times the amount of water for the second time , decoct for 1.5 hours, add 6 times the amount of water for the third time, decoct for 1 hour, combine the decoction, filter, and concentrate the filtrate under reduced ...

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Abstract

The invention relates to a detection method of a pharmaceutical composition for treating hyperplasia of mammary glands and mastitis, in particular to a detection method of a mammary lump relieving capsule for treating hyperplasia of mammary glands and mastitis, which adds high performance liquid chromatography content determination of active ingredient quercetin in monarch drug trichosanthes peeland minister drug dandelion on the basis of the original quality standard. The detection method is sensitive, strong in specificity, accurate and good in reproducibility, and can make up for the defects of the existing method, effectively control the quality of the medicine and enable the quality of the medicine to be associated with effective components of clinical treatment, so that the stable,controllable, efficient and safe standard is achieved, and the medical requirements are further better met.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a method for detecting a pharmaceutical composition for treating mammary gland hyperplasia and mastitis, in particular to a method for detecting Rupishu capsules for treating mammary gland hyperplasia and mastitis. Background technique [0002] Breast hyperplasia and mastitis are the most common breast diseases in women. In recent years, the incidence of this disease has been increasing year by year, and the age is getting younger and younger. According to epidemiological research, adult women aged 20-55 are about About 70% of women have different degrees of breast hyperplasia. Among all breast diseases, mammary gland hyperplasia is the most common, accounting for more than 90% of breast outpatients, and the survey of asymptomatic women in the childbearing age shows that 52.4% of patients with various breast diseases, among them women suffering from mammary gland hyp...

Claims

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Application Information

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IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8634
Inventor 吕慧锋胡小虎张琼谭祥和
Owner XIAN CHIHO PHARMA
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