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Cortex moutan formula granule standard substance preparation and quality control method

A quality control method and formula granule technology, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, measuring devices, etc., can solve the problems of lack of a reasonable comparison, and achieve quality control, scientific production, and quality assurance Effect

Inactive Publication Date: 2019-06-04
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 Moutan cortex formula granules without losing 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 Moutan Cortex formula granules was prepared by low-temperature concentration, and its HPLC characteristic spectrum was established by high performance liquid chromatography, which was used as a reference for quality control of Moutan Cortex formula granules

Method used

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  • Cortex moutan formula granule standard substance preparation and quality control method
  • Cortex moutan formula granule standard substance preparation and quality control method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Preparation of the formula granules for the reference substance of Cortex Moutan:

[0027] (1) Weigh the raw materials: 3400g of Moutan Bark pieces;

[0028] (2) Put the decoction pieces of Moutan bark into the decocting pot, decoc two times, add 9 times the amount of water for the first time, soak for 30 minutes, decoct for 30 minutes, add 7 times the amount of water for the second time, and cook for 30 Minutes, the medicinal solution is filtered, the filtrate is combined, and the volatile oil is steam distilled for 2 hours. The distilled liquid is collected for use; the medicinal solution is pumped into the concentration tank, concentrated (vacuum -0.090-0.099MPa), concentrated to a relative density of 1.07-1.09 65°C) clear ointment, spare;

[0029] (3) Place the clear paste obtained in step 2 in a stainless steel tray of a certain specification, and place it in a freeze dryer, close the door and turn on the refrigeration, and wait for the temperature of the partition to dr...

Embodiment 2

[0035] The quality control method of the HPLC characteristic map of the reference substance of Moutan bark formula granules:

[0036] (1) Take 0.2g of this product powder, medicinal powder, and decoction pieces powder, respectively, accurately weigh them, place them in a 25ml measuring flask, add 20ml of methanol, ultrasound for 30min, let stand to cool, set the volume, filter, and use the filtrate as the test product;

[0037] (2) Take 0.6mg of paeoniflorin, place it in a 10ml volumetric flask, dissolve it with methanol and dilute to the mark, as a reference; take 1.0mg of paeonol, place it in a 10ml volumetric flask, dissolve it with methanol and dilute to volume Scale, as a reference;

[0038] (3) Refer to "Chinese Pharmacopoeia" 2015 Edition Four General Rules 0512 High Performance Liquid Chromatography test, respectively accurately absorb 5-10μl of the test solution and control solution, inject into the chromatograph, and determine according to the following chromatographic cond...

Embodiment 3

[0045] Determination and determination of moisture, extract and content in the reference material of Moutan bark formula granules:

[0046] The moisture, extract and content of the three batches of Paeonia Suffruticosa formula granule reference materials prepared by the above method were tested. The moisture is tested according to conventional methods. The extract is determined in accordance with the hot dipping method under the alcohol-soluble extract determination method (Chinese Pharmacopoeia 2015 Edition Sibu General Principle 2201), using ethanol as the solvent. The content determination is based on the determination method under the item of Cortex Moutan ("Chinese Pharmacopoeia" 2015 Edition One). The inspection results are shown in Table 3, indicating that all the indicators meet the standards.

[0047] Table 3 Test results

[0048] batch number

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Abstract

The invention discloses a Cortex moutan formula granule standard substance preparation and quality control method. With Cortex moutan decoction pieces as the raw material, the Cortex moutan formula granule standard substance is prepared through a process of twice decoction by water, pressure reduction and concentration, drying and the like, and a high performance liquid chromatography method is adopted for overall quality control. On the basis of traditional Chinese medicine decoction, in combination of modern freezing and drying, a diaphragm vacuum low-temperature concentration high-tech device, a pharmaceutical technology and a high performance liquid chromatography technology and with Cortex moutan chemical constituent research as reference, home decoction process research and HPLC specific chromatogram research are carried out on the Cortex moutan, and a reference substance for Cortex moutan formula granule finishing quality control is acquired. The substance can help to achieve full-constituent extraction, the production is scientific, the quality is controllable, an evaluation basis for consistency between the Cortex moutan formula granules in mass production and home decoction efficacy can be realized, and the Chinese medicine formula granule quality is ensured. The substance has the advantages of simple and hygienic preparation and easy storage.

Description

Technical field [0001] The present invention relates to the technical field of traditional Chinese medicine products, in particular to a method for preparing and quality control of a particle reference substance of a Moutan bark formula. Background technique [0002] Moutan bark, bitter, pungent and slightly cold in nature and taste, has the effects of clearing heat and cooling blood, promoting blood circulation and removing blood stasis. It is used for heat into the camp blood, warming toxins and spotting, vomiting blood, night heat and early cooling, no sweat and bone steaming. Amenorrhea, dysmenorrhea, pain, carbuncle swelling and sore. [0003] Moutan bark is mostly taken as medicine, decoction before use. The quality of the medicine pieces is unstable and uncontrollable, the decoction quality is difficult to guarantee, it is inconvenient to take, and it is not easy to store. The traditional Chinese medicine formula granules are based on high-quality medicinal materials (Chine...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06A61K36/71A61K36/65
Inventor 朱月信陈培胜成守玲张言朋
Owner 安徽济人药业股份有限公司
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