CN103308645B - Detection method of yupingfeng oral liquid - Google Patents
Detection method of yupingfeng oral liquid Download PDFInfo
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- CN103308645B CN103308645B CN201310287470.6A CN201310287470A CN103308645B CN 103308645 B CN103308645 B CN 103308645B CN 201310287470 A CN201310287470 A CN 201310287470A CN 103308645 B CN103308645 B CN 103308645B
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Abstract
The invention relates to a detection method of a yupingfeng oral liquid. A thin layer chromatography is adopted, the same sample pretreatment method and the same chromatographic condition are used, and astragali radix and saposhnidoviae radix in a yupingfeng oral liquid prescription are simultaneously identified on the same thin layer plate. The method of identifying the astragali radix and the saposhnidoviae radix by the thin layer chromatography comprises the steps of (1) test solution preparation, (2) reference solution preparation, and (3) thin layer chromatography conditions and result. According to the detection method, the quality standard of the yupingfeng oral liquid is improved and perfected, and the identification of the saposhnidoviae radix is revised from a high performance liquid chromatography to a thin layer identification method, so that the identification time is greatly shortened, and the detection cost is lowered. Compared with a method in the prior art, the detection method is simpler, more convenient, rapider and more economical; the quality is easier to control; and the detection method is more suitable for industrial production.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, relate to the detection method of Chinese medicine, especially a kind of method of quality control of Compound Hydrochloride Phenylpropanolamine.
Background technology
Compound Hydrochloride Phenylpropanolamine is a kind of prevention and medicine that is widely used in humans and animals.Wherein people records in version " Chinese Pharmacopoeia " the 615th page in 2010 by Compound Hydrochloride Phenylpropanolamine quality standard; At pharmaceutical preparations for animals, Compound Hydrochloride Phenylpropanolamine is that Baoding Jizhong Pharmaceutical Co., Ltd. and Hebei Tianxiang Biological Pharmaceutical Co., Ltd. combine the new veterinary drug of declaring registration, new veterinary drug certificate number is: No. 03, (2010) new veterinary drug card word, its quality standard publicity is announced No. 1322 in The Ministry of Agriculture of the People's Republic of China, MOA.Compound Hydrochloride Phenylpropanolamine is made up of the Radix Astragali, the bighead atractylodes rhizome (stir-fry) and windproof three taste medicines, in quality standard to the Radix Astragali and windproof discriminating, adopt respectively thin-layered chromatography and high performance liquid chromatography to complete, and adopt high performance liquid chromatography for the qualitative discriminating of Chinese medicine preparation exist to instrument and equipment have relatively high expectations, length consuming time, consumptive material and the high problem of reagent expense, can not control quickly and easily the quality of the pharmaceutical preparations.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art part, provide a kind of can be easy, fast qualitative detects the Radix Astragali and windproof method of quality control in Compound Hydrochloride Phenylpropanolamine.
The object of the invention is to be achieved through the following technical solutions:
A method of quality control for Compound Hydrochloride Phenylpropanolamine, is characterized in that: the step of its method is:
With Astragaloside IV, 5-
0-methyl visamminol glycosides is reference substance, adopts thin-layered chromatography, with identical sample-pretreating method, and identical chromatographic condition, and on same thin layer plate, differentiate in Compound Hydrochloride Phenylpropanolamine prescription whether contain the Radix Astragali and windproof simultaneously;
The Radix Astragali in described thin-layered chromatography discriminating Compound Hydrochloride Phenylpropanolamine prescription and windproof step are:
1. the preparation of need testing solution: get Compound Hydrochloride Phenylpropanolamine 10 ml, with water saturated normal butyl alcohol jolting extraction 3 times, each 20 ml, merge normal butyl alcohol liquid, with ammonia solution washing 3 times, each 20 ml, normal butyl alcohol liquid evaporate to dryness, residue adds methyl alcohol 1 ml to be made to dissolve, as need testing solution;
2. the preparation of reference substance solution: get Astragaloside IV reference substance and 5-
0-methyl visamminol glycosides reference substance is appropriate, adds respectively methyl alcohol and makes the solution of every 1 ml containing 1 mg, product solution in contrast;
3. thin-layer chromatography condition and result: according to thin-layered chromatography test, draw above-mentioned need testing solution, each 2～4 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-water=13:7:2 at 10 DEG C of following lower floor's solution of placing layerings as developping agent, launch, take out, dry, spray is with 10 % ethanol solution of sulfuric acid, be heated to spot colour developing at 105 DEG C clear, put under ultraviolet lamp 365nm, inspect in test sample chromatogram with the corresponding position of reference substance chromatogram on the spot of aobvious same color whether, determine and in test sample, whether contain the Radix Astragali, windproof.
Advantage of the present invention and good effect are:
The present invention has carried out Improvement and perfection to Compound Hydrochloride Phenylpropanolamine quality standard, and windproof discriminating is changed to tlc identification method by high performance liquid chromatography.Prior art adopts high performance liquid chromatography to differentiate the windproof problem that length consuming time, consumptive material and reagent cost are high that exists, and adopt with the Radix Astragali merge after tlc identification method, only need with identical sample-pretreating method, and identical chromatographic condition, and the Radix Astragali and windproof discriminating just can simultaneously complete said preparation on same thin layer plate in, greatly shorten the discriminating time, reduced inspection cost, and equally also can reach the object of discriminating.Through test, the method favorable reproducibility, specificity are strong, negative noiseless, and spot colour developing is clear, easily judgement.Therefore, revised discrimination method, method compared to existing technology, more easy, quick, economical, quality is more prone to control, and is more applicable to industrialized production.
Brief description of the drawings
Accompanying drawing is the chromatogram that the Radix Astragali of the present invention and windproof thin-layer chromatography are differentiated, wherein band is followed successively by from left to right: lack Radix Astragali negative control, lack windproof negative control, Astragaloside IV reference substance, 5-
0-methyl visamminol glycosides reference substance, Compound Hydrochloride Phenylpropanolamine sample 1(lot number: 201305022), Compound Hydrochloride Phenylpropanolamine sample 2(lot number: 201305023), Compound Hydrochloride Phenylpropanolamine sample 3(lot number: 201305024).
Embodiment
Below in conjunction with embodiment, the present invention is further described, and following embodiment is illustrative, is not determinate, can not limit protection scope of the present invention with following embodiment.
A method of quality control for Compound Hydrochloride Phenylpropanolamine, the step of its method is:
The Radix Astragali and windproof thin-layer chromatography are differentiated
1. the preparation of need testing solution: get Compound Hydrochloride Phenylpropanolamine sample 10 ml, with water saturated normal butyl alcohol jolting extraction 3 times, each 20 ml, merge normal butyl alcohol liquid, with ammonia solution washing 3 times, each 20 ml, normal butyl alcohol liquid evaporate to dryness, residue adds methyl alcohol 1 ml to be made to dissolve, as need testing solution;
2. the preparation of reference substance solution: get Astragaloside IV reference substance and 5-
0-methyl visamminol glycosides reference substance is appropriate, adds respectively methyl alcohol and makes the solution of every 1 ml containing 1 mg, product solution in contrast;
3. the preparation of negative control solution: by prescription proportioning, get other taste medicinal materials except the Radix Astragali, make sample by the technique under method for making item, then make by above-mentioned need testing solution preparation method the negative control solution that lacks the Radix Astragali; By prescription proportioning, get except other windproof taste medicinal materials, make sample by the technique under method for making item, then make and lack windproof negative control solution by above-mentioned need testing solution preparation method;
4. thin-layer chromatography condition and result: according to thin-layered chromatography test, draw above-mentioned need testing solution, each 2～4 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate, taking 10 DEG C of following lower floor's solution of placing of chloroform-methanol-water (13:7:2) as developping agent, launch, take out, dry, spray, with 10 % ethanol solution of sulfuric acid, is heated to spot colour developing at 105 DEG C clear, puts under ultraviolet lamp (365nm) and inspects, in test sample chromatogram, with the corresponding position of reference substance chromatogram on, the spot of aobvious same color, is shown in accompanying drawing.
Claims (1)
1. a detection method for Compound Hydrochloride Phenylpropanolamine, is characterized in that:
With Astragaloside IV, 5-
0-methyl visamminol glycosides is reference substance, adopts thin-layered chromatography, with identical sample-pretreating method, and identical chromatographic condition, and on same thin layer plate, differentiates the Radix Astragali of Compound Hydrochloride Phenylpropanolamine in writing out a prescription and windproof simultaneously;
The Radix Astragali in described thin-layered chromatography discriminating Compound Hydrochloride Phenylpropanolamine prescription and windproof step are:
1. the preparation of need testing solution: get Compound Hydrochloride Phenylpropanolamine 10 ml, with water saturated normal butyl alcohol jolting extraction 3 times, each 20 ml, merge normal butyl alcohol liquid, with ammonia solution washing 3 times, each 20 ml, normal butyl alcohol liquid evaporate to dryness, residue adds methyl alcohol 1 ml to be made to dissolve, as need testing solution;
2. the preparation of reference substance solution: get Astragaloside IV reference substance and 5-
0-methyl visamminol glycosides reference substance is appropriate, adds respectively methyl alcohol and makes the solution of every 1 ml containing 1 mg, product solution in contrast;
3. thin-layer chromatography condition: according to thin-layered chromatography test, draw above-mentioned need testing solution, each 2～4 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate, taking chloroform-methanol-water=13:7:2 at 10 DEG C of following lower floor's solution of placing layerings as developping agent, launch, take out, dry, spray, with 10 % ethanol solution of sulfuric acid, is heated to spot colour developing at 105 DEG C clear, puts under ultraviolet lamp 365nm and inspects.
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Families Citing this family (2)
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| CN105044260B (en) * | 2015-06-30 | 2016-08-24 | 广州市香雪制药股份有限公司 | The construction method of Yupingfeng preparation finger and detection method |
| CN109464506A (en) * | 2018-12-21 | 2019-03-15 | 福建省南平市人民医院（福建省南平市中医院） | One kind plus taste Compound Hydrochloride Phenylpropanolamine and preparation method |
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| CN1857422A (en) * | 2006-03-23 | 2006-11-08 | 贵州益佰制药股份有限公司 | Quality control method for Chinese medicine preparation |
| CN102048941A (en) * | 2009-11-03 | 2011-05-11 | 天津中新药业集团股份有限公司达仁堂制药厂 | Quality control method of children-welfare tablets serving as Chinese medicinal preparation |
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Owner name: BAODING JIZHONG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: BEIJING JIUCAOTANG PHARMACEUTICAL RESEARCH INSTITUTE CO., LTD. Effective date: 20141024 |
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Effective date of registration: 20141024 Address after: 071500 Hebei Baoding Gaoyang Industrial Zone Jizhong Pharmaceutical Co., Ltd. Patentee after: Baoding Jizhong Pharmaceutical Co., Ltd. Address before: 100085, Beijing, Haidian District on the road No. 26, Zhongguancun venture building, room 1010 and 1012 Patentee before: Beijing Jiucaotang Pharmaceutical Research Institute Co., Ltd. |