Quality control method of astragalus-leech capsules capable of regulating collaterals

A quality control method and capsule technology, which can be applied to measuring devices, instruments, scientific instruments, etc., can solve the problems of imperfect quantitative determination and small number of constituent drugs for chemical identification, and achieve easy operation, strong specificity, and reproducibility. Good results

Inactive Publication Date: 2013-07-10
山西振东五和堂制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] The above quality standards have relatively serious defects: first, the quantitative determination of the active ingredient content of the main drug in this standard is not perfect; second, the number of constituent drugs for chemical identification is small

Method used

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  • Quality control method of astragalus-leech capsules capable of regulating collaterals
  • Quality control method of astragalus-leech capsules capable of regulating collaterals
  • Quality control method of astragalus-leech capsules capable of regulating collaterals

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Example 1: Preparation of Qizhi Tongluo Capsules.

[0042] Prescription: Astragalus 325g, Leech 130g, Ginseng 130g, Ophiopogon japonicus 32.5g, Schisandra chinensis 65g, Angelica 65g, Chuanxiong 65g, Maodongqing 325g, Radix Paeoniae Rubra 65g, Spatholobus 65g, Salvia miltiorrhiza 65g, Polygonum multiflorum 162.5g, Safflower 32.5g , Zeilan 32.5g, Eucalyptus 32.5g, Dilong 32.5g, Silkworm 6.5g, Curcuma 65g, Turmeric 32.5g, Scorpion 13g, Gastrodia elata 13g, Cinnamon 13g, Notopterygium 32.5g, Pig tooth soap 6.5g, Dannanxing 13g, borneol 13g.

[0043] Preparation method: the above twenty-six flavors, except borneol, leech, ground beetle, cinnamon, scorpion, stiff silkworm, and Dannanxing, are crushed into fine powder, sieved, and mixed; Add 10 times the amount of water for the first time, add 5 times the amount of water for the second time, decoct for 2 hours each time, collect the volatile oil at the same time during the decoction process, and use the β-cyclodextrin to cov...

Embodiment 2

[0049] Example 2: TLC identification of leeches.

[0050] Take 5 g of the drug content of Example 1, add 3 g of diatomaceous earth, mix well, add 30 ml of methanol, ultrasonically treat for 20 minutes, filter, evaporate the filtrate to dryness in a water bath, add 30 ml of water to the residue to dissolve, shake and extract 3 times with ether, 20ml each time, the aqueous solution is for later use, the ether extracts are combined, the ether is evaporated, and the residue is dissolved by adding 1ml of methanol, which is used as the test solution. Take another 1.5 g of leech reference drug, add 10 ml of methanol, sonicate for 20 minutes, filter, and concentrate the filtrate to about 1 ml, as the reference drug solution. According to the thin-layer chromatography (Appendix VI B of "Chinese Pharmacopoeia" 2010 edition), draw 3 μl of the test solution and 2 μl of the reference medicinal material solution, respectively spot on the same silica gel G thin-layer plate, and use chlorofor...

Embodiment 3

[0051] Example 3: TLC identification of Radix Paeoniae Rubra.

[0052]Get the aqueous solution after diethyl ether extraction in Example 2, shake and extract 3 times with water-saturated n-butanol (20ml, 10ml, 10ml), combine the n-butanol extract, extract 3 times with ammonia test solution, each 15ml, discard Remove the ammonia solution, evaporate the n-butanol solution to dryness, add 3ml of water to the residue to dissolve, put it on a D101 macroporous adsorption resin column (inner diameter 2cm, length 12cm), elute with 50ml of water, discard the water, and then use 40% Elute with 30ml of ethanol, discard the 40% ethanol eluate, continue to elute with 50ml of 70% ethanol, collect the eluate, evaporate to dryness, add 1ml of methanol to the residue to dissolve, and use it as the test solution. Take another paeoniflorin reference substance, add ethanol to make a solution containing 2mg per 1ml, as the reference substance solution. According to the thin-layer chromatography (...

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Abstract

The invention discloses a quality control method of astragalus-leech capsules capable of regulating collaterals. The quality control method comprises the steps of: respectively differentiating leech, red peony root, astragalus root, ginseng, chuanxiong rhizome, red sage root, ground beetle, cinnamon, borneol and polygonum multiflorum in medicaments by using a thin-layer chromatography; determining the content of astragaloside in the medicaments by using a thin-layer scanning method; and determining the content of tanshinol and paeoniflorin in the medicaments by using a liquid-phase chromatography. According to the quality control method disclosed by the invention, the medicinal material differentiation method is mature, feasible, negative and non-interfering and is strong in specificity, and the content determination method is easy to operate, high in precision and good in reproducibility, so that the quality control method disclosed by the invention can be used for controlling the quality of the medicaments accurately and stably, thereby being adaptable to the industrial stable production of the medicaments.

Description

technical field [0001] The invention relates to a traditional Chinese medicine for treating stroke sequelae, in particular to a quality control method of the medicine. Background technique [0002] Qizhi Tongluo Capsule is a kind of drug for nourishing qi, promoting blood circulation and dredging collaterals. It is suitable for adjuvant treatment for patients with hemiplegia, numbness of limbs, crooked mouth and eyes, poor speech, and physical fatigue in the sequelae of stroke recovery. Its current implementation standard is the State Drug Administration Standard (Trial Implementation), and the following contents are formulated in this quality standard. [0003] 1) Take this product and observe under a microscope: body wall fragments are yellow or brown, with round hairy dimples, 5-32 μm in diameter, and some have setae of different lengths. The dorsal and abdominal muscle fibers are elongated or long lanceolate, mostly broken, with a diameter of 20-33 μm, mostly single an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90G01N30/02
Inventor 王六贵吕建英
Owner 山西振东五和堂制药有限公司
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