Quality control method of heart-tonifying and pulse-restoring granules

A control method and technology for the quality of granules, applied in the field of quality control of Yixin Fumai granules, can solve the problems such as the lack of qualitative or quantitative detection of medicinal materials, and the inability to fully reflect the quality of the product, and achieve simple operation, reliable results, and accurate quantitative methods. Effect

Inactive Publication Date: 2020-08-28
SHANXI HUAKANG PHARMA
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

[0009] Due to the large number of active ingredients, sensitive detection methods are needed to detect the active ingredients of Yixin Fumai Granules, but the existing detection methods only include traits, 2 color identification and related detection items under the inspection items, and no medicinal materials are tested. Qualitative or quantitative testing cannot fully reflect the quality of the product

Method used

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  • Quality control method of heart-tonifying and pulse-restoring granules
  • Quality control method of heart-tonifying and pulse-restoring granules
  • Quality control method of heart-tonifying and pulse-restoring granules

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Embodiment

[0037] Embodiment: a kind of Yixinfumai granule quality control method specifically comprises the following steps: step 1, the preparation of reference substance solution, take ginsenoside Rg 1 Appropriate amount of reference substance, accurately weighed, add methanol to make a solution containing 0.5mg per 1ml, and get it;

[0038]Step 2. Preparation of the test solution, take 45g of the product under the difference in loading amount, accurately weigh it, add 300ml of methanol precisely, weigh it, heat and reflux for 1 hour, let it cool, weigh, make up the weight, and filter , accurately measure 200ml of the continued filtrate and evaporate to dryness, add 40ml of water to the residue to dissolve, extract 3 times with dichloromethane, 25ml each time, discard the dichloromethane solution, then shake and extract with water-saturated n-butanol 3 times, each time 40ml, combined with n-butanol solution, washed 4 times with ammonia test solution, 20ml each time, combined with ammo...

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Abstract

The invention discloses a quality control method of heart-tonifying and pulse-restoring granules. The method comprises the following specific steps: preparing a test solution; selecting chromatographic conditions; and adopting a determination method: precisely sucking 20 [mu]l of the reference substance solution and 20 [mu]l of the test solution respectively, injecting the solutions into a liquidchromatograph, and performing determining to obtain the product. Linear range investigation, precision investigation, repeatability investigation, stability investigation, recovery rate test, thin-layer identification of salvia miltiorrhiza and thin-layer identification of ligusticumwallichii. Corresponding supplement and improvement are carried out on the basis of the original quality standard, and thin-layer identification of salvia miltiorrhiza and ligusticumwallichii is added. Meanwhile, a ginseng content determination item is established. The qualitative method is mature, simple and convenient to operate, reliable in result, negative and free of interference; and the quantitative method is accurate, stable and good in reproducibility.

Description

technical field [0001] The invention relates to a method for quality control of Yixin Fumai granules, in particular to the technical field of quality control of Yixin Fumai granules. Background technique [0002] The function and indication of Yixin Fumai Granule is to nourish qi and nourish yin, activate blood and rejuvenate pulse; it is used for deficiency of both qi and yin, internal resistance of heart and blood, chest obstruction and heartache, chest tightness and discomfort, palpitation and pulse knot. It has the characteristics of high drug loading, fast onset, no peculiar smell, and easy to carry. [0003] Yixin Fumai Granules is a compound preparation composed of 6 medicinal materials: Sun-dried Ginseng, Radix Astragali, Ophiopogon japonicus, Schisandra Fructus, Salvia Miltiorrhiza, and Ligusticum Chuanxiong. Among them, Sun-dried Ginseng has the functions of nourishing vitality, nourishing blood, nourishing the heart and calming the nerves. [0004] Raw sun-dried ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/06G01N30/74G01N30/90
CPCG01N30/06G01N30/74G01N30/90
Inventor 董光明杜双喜郝津芳许信学
Owner SHANXI HUAKANG PHARMA
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