Preparation and quality control method of white paeony root formula granule reference substance

A quality control method and technology of formula granules, which are applied in pharmaceutical formulas, medical preparations containing active ingredients, measuring devices, etc., to achieve the effects of quality control, easy storage, and quality assurance

Inactive Publication Date: 2019-07-12
安徽济人药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, how to ensure the quality of white peony formula granules without the appearance of the decoction pieces and the consistency of the curative effect with home decoction, there is still no reasonable comparison, so we imitate the method of home decoction, using freeze-drying and diaphragm vacuum The reference material of Baishao formula granules was prepared by low-temperature concentration, and its HPLC characteristic map was established by high performance liquid chromatography, which was used as a reference for the quality control of Baishao formula granules

Method used

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  • Preparation and quality control method of white paeony root formula granule reference substance
  • Preparation and quality control method of white paeony root formula granule reference substance

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Preparation of Radix Paeoniae Alba Reference Material Formula Granules:

[0028] (1) Weigh raw materials: Radix Paeoniae Alba decoction pieces 6666g;

[0029] (2) Put the decoction pieces of Radix Paeoniae Alba into the decoction pot, decoct twice, add water 9 times the amount of decoction pieces for the first time, soak for 30 minutes, decoct for 30 minutes, add 7 times the amount of decoction pieces for the second time, decoct for 30 minutes Minutes, the liquid medicine is filtered, the filtrates are combined, pumped into the concentration tank, concentrated (vacuum degree -0.090~-0.099MPa), concentrated to a clear paste with a relative density of 1.07-1.09 (65°C), and set aside;

[0030] (3) Take the clear paste obtained in step 2, place the obtained clear paste in a stainless steel plate of a certain specification, place it in a freeze dryer, close the door panel and turn on the refrigeration, wait for the temperature of the partition to drop to the target temperatu...

Embodiment 2

[0036] The quality control method of the HPLC characteristic spectrum of the reference substance of Baishao Formula Granules:

[0037] (1) Take 0.1g of the powder of this product, weigh it accurately, put it in a 25ml measuring bottle, add methanol and sonicate for 30 minutes; let it stand, filter, and filter with a microporous membrane (0.45µm in pore size), and the filtrate is used as the test sample.

[0038] (2) Take 0.6mg of paeoniflorin, put it in a 10ml volumetric flask, dissolve it with methanol and set the volume to the mark, as a reference;

[0039] (3) Refer to the "Chinese Pharmacopoeia" 2015 edition of the four general rules 0512 high-performance liquid chromatography test, respectively accurately absorb 5-10 µl of the test solution and the control solution, inject it into the chromatograph, and measure it according to the following chromatographic conditions;

[0040] Octadecylsilane bonded silica gel is used as filler; the mobile phase is eluted according to the...

Embodiment 3

[0046] Determination of moisture, extracts and content in the reference material of Baishao Formula Granules:

[0047] The moisture, extracts and content determination in the reference material of 3 batches of Radix Paeoniae Alba Formula Granules prepared by the above method were tested. Moisture was detected by conventional methods. The extracts were determined according to the hot soak method under the alcohol-soluble extracts determination method ("Chinese Pharmacopoeia" 2015 Edition Four General Rules 2201), using ethanol as a solvent. The determination of the content is based on the determination method under the item of Radix Paeoniae Alba ("Chinese Pharmacopoeia" 2015 edition one). The inspection results are shown in Table 3, indicating that all indicators meet the standards.

[0048] Table 3 Various test results

[0049] batch number moisture Leachate Paeoniflorin content (%) 1 4.8 54.05 11.45 2 4.2 49.63 8.85 3 4.3 39.37 12.35 ...

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Abstract

The invention discloses a preparation and quality control method of a white paeony root formula granule reference substance, which comprises the following steps: by taking white paeony root decoctionpieces as raw materials, decocting twice by using water, concentrating under reduced pressure, drying and the like to obtain the white paeony root formula granule reference substance, and carrying outoverall quality control by adopting a high performance liquid chromatography method. On the basis of a traditional Chinese medicine decoction, by combining modern freeze drying, diaphragm vacuum low-temperature concentration high-tech equipment, pharmaceutical technology and high performance liquid chromatography technology and referring to white paeony root chemical component research, the whitepaeony root is subjected to family decoction process research and HPLC characteristic spectrum research, and a reference substance capable of being used for white paeony root formula granule finishing quality control is obtained. The substance can help to realize full-ingredient extraction, is scientific in production and controllable in quality, can realize evaluation basis of consistency of large-scale produced white paeony root traditional Chinese medicine formula granules and household decoction curative effects, and guarantees the quality of the traditional Chinese medicine formula granules. The substance is simple to prepare, sanitary and convenient to store.

Description

technical field [0001] The invention relates to the technical field of traditional Chinese medicine products, in particular to a preparation and quality control method of a reference substance of Radix Paeoniae Alba Formula Granules. Background technique [0002] Radix Paeoniae Alba, bitter in nature and flavor, sour, slightly cold, has the functions of nourishing blood and regulating menstruation, astringing yin and stopping sweating, softening liver and relieving pain, and calming liver yang. Abdominal pain, limb spasm, headache and dizziness. [0003] Radix Paeoniae Alba is mostly used as medicine in decoction pieces, which are decocted before use. The quality of the decoction pieces is unstable and uncontrollable, and the quality of decoction is difficult to guarantee. It is inconvenient to take and difficult to store. Traditional Chinese medicine formula granules are a series of products made of high-quality medicinal materials (Chinese herbal decoction pieces) that me...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06A61K36/71A61K36/65
CPCA61K36/65A61K36/71A61K2236/331A61K2236/37A61K2236/39A61K2236/51G01N30/02G01N30/06
Inventor 朱月信陈培胜成守玲王晓楠
Owner 安徽济人药业股份有限公司
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