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Asarum medicinal material and quality control method of aristolochic acid A in tincture for reducing swellings and easing pains

A quality control method, the technology of aristolochic acid, applied in the field of medicine, can solve the problems of human nephrotoxicity and non-inclusion, and achieve the effects of improving detection sensitivity, reducing interference, and improving extraction efficiency

Inactive Publication Date: 2011-06-01
广西壮族自治区花红药业集团股份公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] The anti-swelling and pain-relieving tincture is the exclusive product of Huahong Pharmaceutical Co., Ltd. in Guangxi Zhuang Autonomous Region. According to the existing research data, some Asarum contains aristolochic acid A, which can cause nephrotoxicity to humans. The quality control method in the original standard did not include the detection of aristolochic acid A.

Method used

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  • Asarum medicinal material and quality control method of aristolochic acid A in tincture for reducing swellings and easing pains
  • Asarum medicinal material and quality control method of aristolochic acid A in tincture for reducing swellings and easing pains
  • Asarum medicinal material and quality control method of aristolochic acid A in tincture for reducing swellings and easing pains

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Experimental program
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Effect test

Embodiment 1

[0031] Asarum

[0032] 1. Chromatographic conditions:

[0033] Chromatographic column: silica gel column bonded with octadecylsilane.

[0034] The composition of the mobile phase is: an aqueous solution containing 1ml / L phosphoric acid and 0.05mol / L sodium dihydrogen phosphate, acetonitrile, and tetrahydrofuran. The ratio of these three solutions is 65.4:26.6:8 as mobile phase A; acetonitrile as mobile phase B , carry out gradient elution according to the table below.

[0035]

[0036] Column temperature: 10-40°C.

[0037] Detection wavelength: 319nm

[0038] The number of theoretical plates should not be less than 4000 based on the peak A of aristolochic acid

[0039] 2. Preparation of the reference solution: Accurately weigh an appropriate amount of aristolochic acid A, add methanol to make a solution containing 1 μg of aristolochic acid A per ml.

[0040] 3. Preparation of the test solution: take about 5.0 g of the powder of this product (passed through a No. 3 siev...

Embodiment 2

[0044] Test product: use swelling and pain-relieving tincture, a commercially available product, produced by Huahong Pharmaceutical Co., Ltd. of Guangxi Zhuang Autonomous Region, batch number: 20080703.

[0045] 1. Chromatographic conditions:

[0046] Chromatographic column: silica gel column bonded with octadecylsilane.

[0047] The composition of the mobile phase is: an aqueous solution containing 1ml / L phosphoric acid and 0.05mol / L sodium dihydrogen phosphate, acetonitrile, and tetrahydrofuran. The ratio of these three solutions is 65.4:26.6:8 as mobile phase A; acetonitrile as mobile phase B , carry out gradient elution according to the table below.

[0048]

[0049] Column temperature: 10-40°C.

[0050] Detection wavelength: 319nm

[0051] The number of theoretical plates should not be less than 4000 based on the peak A of aristolochic acid

[0052] 2. Preparation of the reference solution: Accurately weigh an appropriate amount of aristolochic acid A, add methanol...

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Abstract

The invention relates to an asarum medicinal material and a quality control method of aristolochic acid A in a tincture for reducing swellings and easing pains, aiming to control the quality of aristolochic acid A in the asarum medicinal material and the tincture for reducing swellings and easing pains and guarantee that the content of the aristolochic acid A in the tincture for reducing swellings and easing pains meets the safety requirement of a product. The method solves the detection problem of trace aristolochic acid A, thus a high-sensitivity, accurate and reliable quality control method of the aristolochic acid A is established. Viewing from operations, the method has the advantages of simplicity, easiness of application, accuracy, reliability, high precision and higher practical value.

Description

technical field [0001] The invention relates to the field of medicine, and is a quality control method for plant raw materials and medicinal products derived from plant raw materials, in particular to a quality control method for aristolochic acid A in asarum medicinal materials and Chinese patent medicine antitumor and pain-relieving tincture containing asarum components. Background technique [0002] The anti-swelling and pain-relieving tincture is the exclusive product of Huahong Pharmaceutical Co., Ltd. in Guangxi Zhuang Autonomous Region. According to the existing research data, some Asarum contains aristolochic acid A, which can cause nephrotoxicity to humans. The quality control method in the original standard did not include the detection of aristolochic acid A. . [0003] Therefore, it is necessary to ensure that the content limit of aristolochic acid A in Asarum, one of the raw materials of the anti-tumor and pain-relieving tincture, does not exceed the standard, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K36/264A61K36/9066A61P29/00G01N1/28G01N30/36A61K31/125
Inventor 罗维早阳勇陆晖
Owner 广西壮族自治区花红药业集团股份公司
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