CN103245753A - Mass detection method for motherwort grains - Google Patents
Mass detection method for motherwort grains Download PDFInfo
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- CN103245753A CN103245753A CN201310147385XA CN201310147385A CN103245753A CN 103245753 A CN103245753 A CN 103245753A CN 201310147385X A CN201310147385X A CN 201310147385XA CN 201310147385 A CN201310147385 A CN 201310147385A CN 103245753 A CN103245753 A CN 103245753A
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Abstract
The invention provides a mass detection method for motherwort grains. The mass detection method comprises the steps of identifying, and measuring the content of motherwort, namely (1) carrying out a chromatograph condition and system suitability test, (2) preparing a reference solution, (3) preparing a test solution, and (4) measuring to ensure that the motherwort content per bag is not less than 10.0mg based on stachydrine hydrochloride (C7H13NO2.HCl). With the adoption of the mass detection method for the motherwort grains provided by the invention, the mass control standard of the motherwort grains is improved, a content determination detection index and a detection method of a main drug, namely motherwort, in a preparation are established, and a thin-layer chromatography qualitative identification method for angelica sinensis and ligusticum wallichii is added, so that the high mass standard level of the compound preparation is guaranteed.
Description
Technical field
The present invention relates to drug quality control technology field, specifically is the quality determining method of the female particle of a kind of benefit.
Background technology
The female particle of benefit is a kind of medicine for the treatment of female diseases, and its prescription is: motherwort 480g, Radix Angelicae Sinensis 240g, Ligusticum wallichii 120g, banksia rose 45g.Motherwort is the dry aerial parts of labiate motherwort Leonurus japonicus Houtt., has promoting blood circulation for regulating menstruation, inducing diuresis to reduce edema, the effect of sore detoxifcation; When being classified as labiate Radix Angelicae Sinensis Angelica sinensis(Oliv.) the dry root of Diels., having enriches blood invigorates blood circulation, the effect of menstruction regulating and pain relieving; Ligusticum wallichii is the dry rhizome of samphire Ligusticum wallichii Ligusticum chuanxiong Hort., has blood-activating and qi-promoting, the effect of wind-expelling pain-stopping; The banksia rose is the dry root of feverfew banksia rose Aucklandia lappa Decne., has promoting qi circulation and relieving pain, the effect of reinforcing spleen to promote digestion.The female particle method for making of benefit: motherwort boiling secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and it is clear cream that filtrate is condensed into relative density; Three flavors such as all the other Radix Angelicae Sinensis extracted 2 hours with 50% alcohol reflux, filtered, and merged with above-mentioned clear cream behind the filtrate recycling ethanol, were condensed into the thick paste shape, got thick paste, and are an amount of with sucrose and ethanol, make particle, and drying is made 2478g; Or get thick paste, and add aspartame and lactose is an amount of, make particle, drying is made the 531g(no cane sugar type), namely.This product is the particle of yellowish-brown, and it is sweet to distinguish the flavor of, little hardship; Or light brown to brown granular, bitter, fiber crops, little sweet (no cane sugar type).Has promoting blood circulation for regulating menstruation, the effect of promoting qi circulation and relieving pain.Be used for the women's Qi stagnation blood stasis, irregular menstruation, dysmenorrhoea, postpartum abdominalgia with blood stasis etc.In the female granular mass control method of existing benefit, do not have thin layer to differentiate there is not the assay test item yet, be difficult to control the quality of beneficial female particle.
Summary of the invention
The objective of the invention is to overcome the deficiencies in the prior art, the quality determining method of the female particle of a kind of benefit is provided, to improve the quality control standard of beneficial female particle.
The pharmaceutical formulation of the female particle of benefit is: motherwort 480g, Radix Angelicae Sinensis 240g, Ligusticum wallichii 120g, banksia rose 45g.Make 2478g or 531g(no cane sugar type) particle.
The quality determining method of the female particle of benefit of the present invention is as follows:
1) differentiate: get beneficial female particle 40g or no cane sugar type 10g, grind, add ethyl acetate 150-250ml or 30-100ml, ultrasonic processing 15-60 minute, filter, filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Sinensis, each 0.2g of Ligusticum wallichii control medicinal material, respectively adds ethyl acetate 5-20ml, shines medicinal material solution in pairs with legal system; Test according to thin-layered chromatography, draw need testing solution 10～15 μ l, control medicinal material solution 5～10 μ l put respectively on same silica gel g thin-layer plate, with cyclohexane (or normal hexane)-ethyl acetate by volume proportioning 3-9:1 be developping agent, launch, take out, dry, put under the ultraviolet lamp 365nm and inspect, in the test sample chromatogram, showing the fluorescence spot of same color with the corresponding position of control medicinal material chromatogram;
2) assay:
(1) chromatographic condition and system suitability test: be filling agent with the propyl amides bonded silica gel, with acetonitrile-0.2%(volumetric concentration) glacial acetic acid by volume proportioning 81:19 be the phase that flows, detect with evaporative light-scattering detector, number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 3000;
(2) preparation of reference substance solution: it is an amount of to get the stachydrine hydrochloride reference substance, and accurate the title decides, and adds 70% ethanol or 70% methyl alcohol (being volumetric concentration, as follows) and makes the solution that every 1ml contains 0.3mg, namely;
(3) preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 4.5g or no cane sugar type 1g, the accurate title, decide, and puts in the tool plug conical flask, accurate 70% ethanol or the 70% methyl alcohol 25-100ml of adding, close plug claims to decide weight, ultrasonic processing 0.5-2 hour, ultrasonic processing power 100-500W, frequency 20-55kHz are put coldly, claim to decide weight again, supply the weight that subtracts mistake with 70% ethanol or 70% methyl alcohol, shake up, filter, get subsequent filtrate, namely;
(4) determination method
:Precision is drawn reference substance solution 5 μ l, 10 μ l respectively, and need testing solution 10 μ l inject liquid chromatograph, measures, with the calculating of external standard two-point method logarithmic equation, namely;
This product contains motherwort with stachydrine hydrochloride (C for every bag
7H
13NO
2HCl) meter must not be less than 10.0mg.
The quality determining method of the female particle of benefit of the present invention, improved the quality control standard of beneficial female particle, the assay of setting up main ingredient motherwort in the preparation detects index and detection method thereof, increase the qualitative discrimination method of thin-layer chromatography of Radix Angelicae Sinensis, Ligusticum wallichii, guaranteed this compound preparation higher quality standard level.
Embodiment
The quality determining method of the female particle of benefit is as follows:
1) differentiate: get beneficial female particle 40g or no cane sugar type 10g, grind, add ethyl acetate 180ml or 40ml, ultrasonic processing 30 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Sinensis, each 0.2g of Ligusticum wallichii control medicinal material, respectively adds ethyl acetate 10ml, shines medicinal material solution in pairs with legal system; Test according to thin-layered chromatography, draw need testing solution 10～15 μ l, control medicinal material solution 5～10 μ l put respectively on same silica gel g thin-layer plate, with cyclohexane-ethyl acetate by volume proportioning 9:1 be developping agent, launch, take out, dry, put under the ultraviolet lamp 365nm and inspect, in the test sample chromatogram, showing the fluorescence spot of same color with the corresponding position of control medicinal material chromatogram;
2) assay:
(1) chromatographic condition and system suitability test: be filling agent with the propyl amides bonded silica gel, with acetonitrile-0.2% glacial acetic acid by volume proportioning 81:19 be the phase that flows, detect with evaporative light-scattering detector, number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 3000;
(2) preparation of reference substance solution: it is an amount of to get the stachydrine hydrochloride reference substance, and accurate the title decides, and adds 70% ethanol and makes the solution that every 1ml contains 0.3mg, namely;
(3) preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 4.5g or no cane sugar type 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 70% ethanol 25ml that adds, close plug claims to decide weight, ultrasonic processing 1.5 hours, ultrasonic processing power 180W, frequency 35kHz are put coldly, claim to decide weight again, supply the weight that subtracts mistake with 70% ethanol, shake up, filter, get subsequent filtrate, namely;
(4) determination method
:Precision is drawn reference substance solution 5 μ l, 10 μ l respectively, and need testing solution 10 μ l inject liquid chromatograph, measures, with the calculating of external standard two-point method logarithmic equation, namely;
This product contains motherwort with C for every bag
7H
13NO
2The HCl meter must not be less than 10.0mg.
Embodiment 2:
The quality determining method of the female particle of benefit is as follows:
1) differentiate: get beneficial female particle 40g or no cane sugar type 10g, grind, add ethyl acetate 250ml or 100ml, ultrasonic processing 60 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Sinensis, each 0.2g of Ligusticum wallichii control medicinal material, respectively adds ethyl acetate 20ml, shines medicinal material solution in pairs with legal system; Test according to thin-layered chromatography, draw need testing solution 10～15 μ l, control medicinal material solution 5～10 μ l put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate by volume proportioning 3:1 be developping agent, launch, take out, dry, put under the ultraviolet lamp 365nm and inspect, in the test sample chromatogram, showing the fluorescence spot of same color with the corresponding position of control medicinal material chromatogram;
2) assay:
(1) chromatographic condition and system suitability test: be filling agent with the propyl amides bonded silica gel, with acetonitrile-0.2% glacial acetic acid by volume proportioning 81:19 be the phase that flows, detect with evaporative light-scattering detector, number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 3000;
(2) preparation of reference substance solution: it is an amount of to get the stachydrine hydrochloride reference substance, and accurate the title decides, and adds 70% methyl alcohol and makes the solution that every 1ml contains 0.3mg, namely;
(3) preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 4.5g or no cane sugar type 1g, the accurate title, decide, and puts in the tool plug conical flask, the accurate 70% methyl alcohol 50ml that adds, close plug claims to decide weight, ultrasonic processing 1.5 hours, ultrasonic processing power 350W, frequency 55kHz are put coldly, claim to decide weight again, supply the weight that subtracts mistake with 70% methyl alcohol, shake up, filter, get subsequent filtrate, namely;
(4) determination method
:Precision is drawn reference substance solution 5 μ l, 10 μ l respectively, and need testing solution 10 μ l inject liquid chromatograph, measures, with the calculating of external standard two-point method logarithmic equation, namely;
This product contains motherwort with C for every bag
7H
13NO
2The HCl meter must not be less than 10.0mg.
The quality control standard of the beneficial female particle after the improvement is as follows:
The female granular mass standard of benefit
The female particle of benefit
Yimu?Keli
[prescription] motherwort 480g Radix Angelicae Sinensis 240g Ligusticum wallichii 120g
Banksia rose 45g
[method for making] above four flavors, motherwort boiling secondary, 2 hours for the first time, 1 hour for the second time, collecting decoction filtered, and it is clear cream that filtrate is condensed into relative density; Three flavors such as all the other Radix Angelicae Sinensis extracted 2 hours with 50% alcohol reflux, filtered, and merged with above-mentioned clear cream behind the filtrate recycling ethanol, were condensed into the thick paste shape, got thick paste, and are an amount of with sucrose and ethanol, make particle, and drying is made 2478g; Or get thick paste, and add aspartame and lactose is an amount of, make particle, drying is made the 531g(no cane sugar type), namely.
[proterties] this product is the particle of yellowish-brown, and it is sweet to distinguish the flavor of, little hardship; Or light brown to brown granular, bitter, fiber crops, little sweet (no cane sugar type).
[discriminating] gets this product 45g or 10g(no cane sugar type), grind, add ethyl acetate 180ml or 40ml, ultrasonic processing 30 minutes filters, and filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Radix Angelicae Sinensis, each 0.2g of Ligusticum wallichii control medicinal material, respectively adds ethyl acetate 10ml, shines medicinal material solution in pairs with legal system.According to thin-layered chromatography (" Chinese pharmacopoeia version VI in 2010 B) test, draw need testing solution 10～15 μ l, control medicinal material solution 5～10 μ l put respectively on same silica gel g thin-layer plate, are developping agent with cyclohexane-ethyl acetate (9:1), launch, take out, dry, put under the ultraviolet lamp (365nm) and inspect, the test sample chromatogram is showing the fluorescence spot of same color with the corresponding position of control medicinal material chromatogram.
[inspection] should meet every regulation relevant under the granule item (" Chinese pharmacopoeia version appendix in 2010 I C).
[assay] photograph high performance liquid chromatography (" an appendix VI of Chinese pharmacopoeia version in 2010 D) measure.
Chromatographic condition and system suitability testBe filling agent with the propyl amides bonded silica gel; Be the phase that flows with acetonitrile-0.2% glacial acetic acid (81:19); Detect with evaporative light-scattering detector.Number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 3000.
The preparation of reference substance solutionIt is an amount of to get the stachydrine hydrochloride reference substance, and accurate the title decides, and adds 70% ethanol and makes the solution that every 1ml contains 0.3mg, namely.
The preparation of need testing solutionGet this product content under the content uniformity item, porphyrize is got about 4.5g or 1g(no cane sugar type), the accurate title, decide, and puts in the tool plug conical flask, the accurate 70% ethanol 25ml that adds, close plug claims to decide weight, ultrasonic processing (power 180W, frequency 35kHz) 1.5 hours, put coldly, claim to decide weight again, supply the weight that subtracts mistake with 70% ethanol, shake up, filter, get subsequent filtrate, namely.
Determination methodPrecision is drawn reference substance solution 5 μ l, 10 μ l respectively, and need testing solution 10 μ l inject liquid chromatograph, measures, with the calculating of external standard two-point method logarithmic equation, namely.
This product contains motherwort with stachydrine hydrochloride (C for every bag
7H
13NO
2HCl) meter must not be less than 10.0mg.
[function with cure mainly] promoting blood circulation for regulating menstruation, promoting qi circulation and relieving pain.Be used for qi depression to blood stasis, irregular menstruation, dysmenorrhoea, postpartum abdominalgia with blood stasis.
[usage and consumption] boiling water is taken after mixing it with water, one time 1 bag, 2 times on the one.
[attention] pregnant woman and menorrhalgia person avoid clothes.
The every packed 14g(in [specification] (1) is equivalent to medicine materical crude slice 5g); (2) every packed 3g(no cane sugar type is equivalent to medicine materical crude slice 5g)
[storage] sealing.
Claims (1)
1. the quality determining method of the female particle of benefit, the pharmaceutical formulation of beneficial female particle be by motherwort 480g, Radix Angelicae Sinensis 240g, and Ligusticum wallichii 120g, banksia rose 45g forms, and makes 2478g or 531g no cane sugar type particle; It is characterized in that carrying out according to the following steps:
1) differentiate: differentiate: get beneficial female particle 45g or no cane sugar type 10g, grind, add ethyl acetate 150-250ml or 30-100ml, ultrasonic processing 15-60 minute, filter, filtrate evaporate to dryness, residue add ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Radix Angelicae Sinensis, each 0.2g of Ligusticum wallichii control medicinal material, respectively adds ethyl acetate 5-20ml, shines medicinal material solution in pairs with legal system; Test according to thin-layered chromatography, draw need testing solution 10～15 μ l, control medicinal material solution 5～10 μ l put respectively on same silica gel g thin-layer plate, with cyclohexane or normal hexane-ethyl acetate by volume proportioning 3-9:1 as developping agent, launch, take out, dry, put under the ultraviolet lamp 365nm and inspect, in the test sample chromatogram, showing the fluorescence spot of same color with the corresponding position of control medicinal material chromatogram;
2) assay:
(1) chromatographic condition and system suitability test: be filling agent with the propyl amides bonded silica gel, with acetonitrile-0.2% volumetric concentration glacial acetic acid by volume proportioning 81:19 be the phase that flows, detect with evaporative light-scattering detector, number of theoretical plate calculates by the stachydrine hydrochloride peak should be not less than 3000;
(2) preparation of reference substance solution: it is an amount of to get the stachydrine hydrochloride reference substance, accurate claims surely, adds 70% ethanol or 70% methyl alcohol is made the solution that every 1ml contains 0.3mg, namely;
(3) preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 4.5g or no cane sugar type 1g, the accurate title, decide, and puts in the tool plug conical flask, accurate 70% ethanol or the 70% methyl alcohol 25-100ml of adding, close plug claims to decide weight, ultrasonic processing 0.5-2 hour, ultrasonic processing power 100-500W, frequency 20-55kHz are put coldly, claim to decide weight again, supply the weight that subtracts mistake with 70% ethanol or 70% methyl alcohol, shake up, filter, get subsequent filtrate, namely;
(4) determination method
:Precision is drawn reference substance solution 5 μ l, 10 μ l respectively, and need testing solution 10 μ l inject liquid chromatograph, measures, with the calculating of external standard two-point method logarithmic equation, namely;
This product contains motherwort with stachydrine hydrochloride (C for every bag
7H
13NO
2HCl) meter must not be less than 10.0mg.
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Cited By (8)
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| CN105548424A (en) * | 2016-01-28 | 2016-05-04 | 南京柯菲平盛辉制药有限公司 | Method for determining content of main active ingredient stachydrine hydrochloride in Naomaili granules and application of main active ingredient stachydrine hydrochloride in Naomaili granules |
| CN105911188A (en) * | 2016-04-25 | 2016-08-31 | 广西壮族自治区梧州食品药品检验所 | Method for rapid extraction-liquid chromatography-mass spectrometry tandem detection of content of stachydrine hydrochloride in Fukangning tablets |
| CN105911187A (en) * | 2016-04-25 | 2016-08-31 | 广西壮族自治区梧州食品药品检验所 | Method for liquid chromatography-mass spectrometry tandem detection of content of stachydrine hydrochloride in Fukangning tablets |
| CN105974038A (en) * | 2016-06-24 | 2016-09-28 | 广西灵峰药业有限公司 | Production quality control method of sucrose-free herba leonuri granules |
| CN107290441A (en) * | 2017-03-29 | 2017-10-24 | 广西壮族自治区梧州食品药品检验所 | A kind of method that ASE HPLC methods determine stachydrine hydrochloride content in motherwort |
| CN107561167A (en) * | 2016-07-01 | 2018-01-09 | 天津同仁堂集团股份有限公司 | A kind of detection method of musk rheumatic Dieda plaster for curing traumatic injury |
| CN110057945A (en) * | 2019-05-29 | 2019-07-26 | 南京市中西医结合医院 | The quality determining method of motherwort |
| CN113030344A (en) * | 2021-04-14 | 2021-06-25 | 山东新宝医药有限公司 | Quality control method of amber mind-tranquilizing pills |
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Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105548424A (en) * | 2016-01-28 | 2016-05-04 | 南京柯菲平盛辉制药有限公司 | Method for determining content of main active ingredient stachydrine hydrochloride in Naomaili granules and application of main active ingredient stachydrine hydrochloride in Naomaili granules |
| CN105911188A (en) * | 2016-04-25 | 2016-08-31 | 广西壮族自治区梧州食品药品检验所 | Method for rapid extraction-liquid chromatography-mass spectrometry tandem detection of content of stachydrine hydrochloride in Fukangning tablets |
| CN105911187A (en) * | 2016-04-25 | 2016-08-31 | 广西壮族自治区梧州食品药品检验所 | Method for liquid chromatography-mass spectrometry tandem detection of content of stachydrine hydrochloride in Fukangning tablets |
| CN105974038A (en) * | 2016-06-24 | 2016-09-28 | 广西灵峰药业有限公司 | Production quality control method of sucrose-free herba leonuri granules |
| CN107561167A (en) * | 2016-07-01 | 2018-01-09 | 天津同仁堂集团股份有限公司 | A kind of detection method of musk rheumatic Dieda plaster for curing traumatic injury |
| CN107290441A (en) * | 2017-03-29 | 2017-10-24 | 广西壮族自治区梧州食品药品检验所 | A kind of method that ASE HPLC methods determine stachydrine hydrochloride content in motherwort |
| CN110057945A (en) * | 2019-05-29 | 2019-07-26 | 南京市中西医结合医院 | The quality determining method of motherwort |
| CN113030344A (en) * | 2021-04-14 | 2021-06-25 | 山东新宝医药有限公司 | Quality control method of amber mind-tranquilizing pills |
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Application publication date: 20130814 |