CN102552662A - Quality detection method for Chinese herbal preparation of fritillary bulb extract oral liquid - Google Patents
Quality detection method for Chinese herbal preparation of fritillary bulb extract oral liquid Download PDFInfo
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- CN102552662A CN102552662A CN2010106101313A CN201010610131A CN102552662A CN 102552662 A CN102552662 A CN 102552662A CN 2010106101313 A CN2010106101313 A CN 2010106101313A CN 201010610131 A CN201010610131 A CN 201010610131A CN 102552662 A CN102552662 A CN 102552662A
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Abstract
The invention belongs to the field of pharmacy and relates to a detection method for Chinese herbal preparation of fritillary bulb extract oral liquid, in particular to a detection method for the fritillary bulb extract oral liquid. The detection method comprises an identification method of medicine constituents and a content measurement method of hydrocyanic acid. The detection method is quick in speed and high in accuracy.
Description
Technical field
The present invention relates to shake bile-fritillary Chinese medicine preparation quality determining method, particularly the quality determining method of Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus.
Background technology
Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus is made up of flavour of a drug such as Fel Serpentis, Bulbus Fritillariae Ussuriensiss, is used for the cough due to pathogenic wind-heat, abundant expectoration asthma, and uncomfortable in chest, expectoration is not well or chronic cough is more than.Has curative effect preferably clinically.
The Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus prescription:
Fel Serpentis 10g, Bulbus Fritillariae Ussuriensis 75g, aqua armeniacae 30ml
Method for making: above two flavors, the Bulbus Fritillariae Uninbracteatae of making even is extracted with 80% alcohol heating reflux, and extracting solution filters, and filtrating is condensed into fluid extract; Other gets sucrose 560g and Mel 80g, processes syrup, adds Fel Serpentis, Bulbus Fritillariae Ussuriensis fluid extract and aqua armeniacae 30ml and an amount of Mentholum and antiseptic, and mixing adds water and makes into 1000ml, promptly gets.Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus standard state pencil is annotated in [2000] No. 168 appended standards of literary composition has method of quality control; Respectively to differentiating and assay about flavour of a drug carry out thin layer in the prescription; But assay adopts the titrimetry method that the effective ingredient hydrocyanic acid of aqua armeniacae is carried out content control in this method, and the influence factor is more for this control method, and repeatability is relatively poor as a result; Can not the better controlled drug quality, thus the stable uniform of product quality can not be guaranteed well.
The present invention adopts potentiometric titration that the hydrocyanic acid in the Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus is carried out assay; Add and cooperate thin layer to differentiate; The titration measuring that adopts with primary standard has more accurately, the characteristics of favorable reproducibility, and more former method precision, sensitivity, stability are all higher.Thereby can accurately strictly control the quality and the homogeneity of product.
Summary of the invention
[0003] defective that exists to existing detection method, the present invention uses the content of hydrocyanic acid in the potentiometric determination Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus instead in the proper mass detection method, has solved quality Control in the process of producing product effectively.
The present invention realizes through following method:
(1) adopting thin layer chromatography, is control medicinal material with the Bulbus Fritillariae Ussuriensis, differentiates the Bulbus Fritillariae Ussuriensis medical material in the Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus;
(2) adopting thin layer chromatography, is control medicinal material with the Fel Serpentis, differentiates Fel Serpentis composition in the Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus;
(3) content of hydrocyanic acid in the employing potentiometric determination Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus.
The detection method of Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus of the present invention, wherein discrimination method may further comprise the steps:
(1) get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 40ml, the sodium hydroxide solution with 10% is regulated more than the pH value to 12, divides the secondary jolting to extract with chloroform 50ml, and the combined chloroform extracting solution is put evaporate to dryness in the water-bath, and residue adds dehydrated alcohol 0.5ml makes dissolving, as need testing solution; Other Bulbus Fritillariae Uninbracteatae control medicinal material 2g that makes even with 80% alcohol heating reflux 2 hours, filters; Filtrating is put when steaming near doing in the water-bath and is moved into separatory funnel, transfers to alkalescence with ammonia, and 20ml divides second extraction with chloroform; Merge extractive liquid; Put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 0.5ml makes dissolving, as control medicinal material solution; According to thin layer chromatography (version pharmacopeia appendix VI B in 2010) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-acetic acid-ethyl ester-diethylamine (5:4:0.5) is developing solvent, launches, and takes out; Dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph; With the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 20ml, add water 10ml and stir, add n-butyl alcohol 50ml and divide three (20,20,10ml) joltings to extract; Merge n-butanol extracting liquid; Water 35ml divide secondary washing, obtains n-butyl alcohol liquid, puts evaporate to dryness in the water-bath; Residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; It is an amount of that other gets Fel Serpentis, adds ethanol and process the solution that every 1ml contains 5mg, as control medicinal material solution; According to thin layer chromatography (version pharmacopeia appendix VI B in 2010) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-isopropyl alcohol-glacial acetic acid-methanol-water (8:4:2:3:1) is developing solvent, launches, and takes out; Dry, spray is with 30% ethanol solution of sulfuric acid, about 3 minutes of 105 ℃ of bakings; Put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
The detection method of Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus of the present invention, wherein assay may further comprise the steps:
Precision is measured Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 150ml, puts in the 500ml kjeldahl flask, adds water 100ml; Attach condensing tube, water flowing steam distillation, distillate imports in the alcoholic acid absorption liquid of 10ml90%; Receiving bottle is put in the ice bath and is cooled off, and when the distillate full dose reaches 150ml, stops distillation, in distillate, adds each 2ml of potassium iodide test solution and ammonia solution; According to potentiometric titration (an appendix VIII of Chinese Pharmacopoeia version in 2010 A first method),, titration results is proofreaied and correct with blank assay with slowly titration of silver nitrate solution (0.01mo1/L); Promptly get; Every 1ml silver nitrate solution (0.01mo1/L) is equivalent to the HCN of 0.5405mg, and every of these article contain mandelonitrile in hydrocyanic acid (HCN), should be 0.1～0.3mg.
Monitoring method of the present invention is obtaining of process experiment sieving, with experimental example the present invention is further specified below.
Test Example 1
1, experiment condition: potentiometric titrimeter, used reagent are analytical pure, and water is purified water
2, methodological study
2.1 replica test: precision is measured 5 parts in the sample of same lot number (090201), measures by method under the text assay item, and the result sees Fig. 1.The result shows the mensuration relative standard deviation, and < 2.0%, this method repeatability is good.
2.2 negative control test: get prescription medical material (removal aqua armeniacae) and prepare the negative control sample by standard technology. the sample of preparation is pressed [assay] operation down, and the result shows: other components do not have interference to this method hydrocyanic acid hydrocyanic acid content in the sample.
2.3 stability test: get same lot sample article (lot number, 090201), by [assay] operation down, 0,4, sample introduction was measured in 6,8,24 hours.The volume of the volumetric solution of hydrocyanic acid mean consumption as a result does,
RSDBe 1.56%, this method is good at 24 hours internal stabilities.Measure the result and see Fig. 2.The result shows that hydrocyanic acid content is basicly stable in 24 hours.
2.4 the assay of ten lot sample article: by [assay] method ten lot sample article have been carried out assay, the result sees
The assay result of Fig. 3 ten lot sample article
The specific embodiment
Prescription: Fel Serpentis 10g, Bulbus Fritillariae Ussuriensis 75g, aqua armeniacae 30ml
Method for making: above two flavors, the Bulbus Fritillariae Uninbracteatae of making even is extracted with 80% alcohol heating reflux, and extracting solution filters, and filtrating is condensed into fluid extract; Other gets sucrose 560g and Mel 80g, processes syrup, adds Fel Serpentis, Bulbus Fritillariae Ussuriensis fluid extract and aqua armeniacae 30ml and an amount of Mentholum and antiseptic, and mixing adds water and makes into 1000ml, promptly gets.The quality determining method of Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus is:
Differentiate:
(1) get these article 40ml, the sodium hydroxide solution with 10% is regulated more than the pH value to 12, divides the secondary jolting to extract with chloroform 50ml, and the combined chloroform extracting solution is put evaporate to dryness in the water-bath, and residue adds dehydrated alcohol 0.5ml makes dissolving, as need testing solution; Other Bulbus Fritillariae Uninbracteatae control medicinal material 2g that makes even with 80% alcohol heating reflux 2 hours, filters; Filtrating is put when steaming near doing in the water-bath and is moved into separatory funnel, transfers to alkalescence with ammonia, and 20ml divides second extraction with chloroform; Merge extractive liquid; Put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 0.5ml makes dissolving, as control medicinal material solution; According to thin layer chromatography (version pharmacopeia appendix VI B in 2010) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-acetic acid-ethyl ester-diethylamine (5:4:0.5) is developing solvent, launches, and takes out; Dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph; With the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(2) get these article 20ml, add water 10ml and stir, add n-butyl alcohol 50ml and divide three (20,20,10ml) joltings to extract; Merge n-butanol extracting liquid, water 35ml divide secondary washing, obtains n-butyl alcohol liquid; Put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; It is an amount of that other gets Fel Serpentis, adds ethanol and process the solution that every 1ml contains 5mg, as control medicinal material solution; According to thin layer chromatography (version pharmacopeia appendix VI B in 2010) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-isopropyl alcohol-glacial acetic acid-methanol-water (8:4:2:3:1) is developing solvent, launches, and takes out; Dry, spray is with 30% ethanol solution of sulfuric acid, about 3 minutes of 105 ℃ of bakings; Put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.Assay:
Measure according to potentiometric titration (an appendix VIII of Chinese Pharmacopoeia version in 2010 A first method), precision is measured these article 150ml, puts in the 500ml kjeldahl flask; Add water 100ml, attach condensing tube, water flowing steam distillation; Distillate imports in the alcoholic acid absorption liquid of 10ml90%, and receiving bottle is put in the ice bath and cooled off, and when the distillate full dose reaches 150ml, stops distillation; In distillate, add each 2ml of potassium iodide test solution and ammonia solution, according to potentiometric titration, with slowly titration of silver nitrate solution (0.01mo1/L); Titration results is proofreaied and correct with blank assay, promptly get, every 1ml silver nitrate solution (0.01mo1/L) is equivalent to the HCN of 0.5405mg; Every of these article contain mandelonitrile in hydrocyanic acid (HCN), should be 0.1～0.3mg.
Claims (6)
1. the detection method of a Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus is characterized in that, comprises the discriminating and the assay of product active ingredient.
2. the detection method of claim 1 is characterized in that, adopts thin layer chromatography to differentiate the Bulbus Fritillariae Uninbracteatae in the product, Fel Serpentis composition, the content of hydrocyanic acid in the employing potentiometric determination Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus.
3. detection method according to claim 2 is characterized in that discrimination method may further comprise the steps: get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 40ml; Sodium hydroxide solution with 10% is regulated more than the pH value to 12; Divide the secondary jolting to extract with chloroform 50ml, the combined chloroform extracting solution is put evaporate to dryness in the water-bath; Residue adds dehydrated alcohol 0.5ml makes dissolving, as need testing solution; Other Bulbus Fritillariae Uninbracteatae control medicinal material 2g that makes even with 80% alcohol heating reflux 2 hours, filters; Filtrating is put when steaming near doing in the water-bath and is moved into separatory funnel, transfers to alkalescence with ammonia, and 20ml divides second extraction with chloroform; Merge extractive liquid; Put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 0.5ml makes dissolving, as control medicinal material solution; According to thin layer chromatography (2010 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-acetic acid-ethyl ester-diethylamine (5:4:0.5) is developing solvent, launches, and takes out; Dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph; With the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
4. according to the detection method of claim 2, it is characterized in that discrimination method may further comprise the steps: get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 20ml; Add water 10ml and stir, add n-butyl alcohol 50ml and divide three (20,20,10ml) joltings to extract, merge n-butanol extracting liquid; Water 35ml divide secondary washing, obtains n-butyl alcohol liquid, puts evaporate to dryness in the water-bath; Residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; It is an amount of that other gets Fel Serpentis, adds ethanol and process the solution that every 1ml contains 5mg, as control medicinal material solution; According to thin layer chromatography (2010 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-isopropyl alcohol-glacial acetic acid-methanol-water (8:4:2:3:1) is developing solvent, launches, and takes out; Dry, spray is with 30% ethanol solution of sulfuric acid, about 3 minutes of 105 ℃ of bakings; Put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
5. detection method according to claim 2, wherein assay may further comprise the steps:
According to potentiometric determination, precision is measured these article 150ml, puts in the 500ml kjeldahl flask, adds water 100ml; Attach condensing tube, water flowing steam distillation, distillate imports in the alcoholic acid absorption liquid of 10ml90%; Receiving bottle is put in the ice bath and is cooled off, and when the distillate full dose reaches 150ml, stops distillation, in distillate, adds each 2ml of potassium iodide test solution and ammonia solution; With slowly titration of silver nitrate solution (0.01mo1/L), titration results is proofreaied and correct with blank assay, promptly get; Every 1ml silver nitrate solution (0.01mo1/L) is equivalent to the HCN of 0.5405mg, and every of these article contain mandelonitrile in hydrocyanic acid (HCN), should be 0.1～0.3mg.
6. detection method according to claim 2 comprises following steps:
(1) get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 40ml, the sodium hydroxide solution with 10% is regulated more than the pH value to 12, divides the secondary jolting to extract with chloroform 50ml, and the combined chloroform extracting solution is put evaporate to dryness in the water-bath, and residue adds dehydrated alcohol 0.5ml makes dissolving, as need testing solution; Other Bulbus Fritillariae Uninbracteatae control medicinal material 2g that makes even with 80% alcohol heating reflux 2 hours, filters; Filtrating is put when steaming near doing in the water-bath and is moved into separatory funnel, transfers to alkalescence with ammonia, and 20ml divides second extraction with chloroform; Merge extractive liquid; Put evaporate to dryness in the water-bath, residue adds dehydrated alcohol 0.5ml makes dissolving, as control medicinal material solution; According to thin layer chromatography (2010 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 6 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-acetic acid-ethyl ester-diethylamine (5:4:0.5) is developing solvent, launches, and takes out; Dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph; With the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(2) get Fel Serpentis et Bulbus Fritillariae Cirrhosae Liquidus 20ml, add water 10ml and stir, add n-butyl alcohol 50ml and divide three (20,20,10ml) joltings to extract; Merge n-butanol extracting liquid; Water 35ml divide secondary washing, obtains n-butyl alcohol liquid, puts evaporate to dryness in the water-bath; Residue adds dehydrated alcohol 1ml makes dissolving, as need testing solution; It is an amount of that other gets Fel Serpentis, adds ethanol and process the solution that every 1ml contains 5mg, as control medicinal material solution; According to thin layer chromatography (2010 editions one appendix VI B of Chinese Pharmacopoeia) test, draw each 3 μ l of above-mentioned two kinds of solution, put respectively in same and use on the silica gel g thin-layer plate of sodium carboxymethyl cellulose as binding agent; With toluene-isopropyl alcohol-glacial acetic acid-methanol-water (8:4:2:3:1) is developing solvent, launches, and takes out; Dry, spray is with 30% ethanol solution of sulfuric acid, about 3 minutes of 105 ℃ of bakings; Put under the ultra-violet lamp (365nm) and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) according to potentiometric determination, precision is measured these article 150ml, puts in the 500ml kjeldahl flask, adds water 100ml; Attach condensing tube, water flowing steam distillation, distillate imports in the alcoholic acid absorption liquid of 10ml90%; Receiving bottle is put in the ice bath and is cooled off, and when the distillate full dose reaches 150ml, stops distillation, in distillate, adds each 2ml of potassium iodide test solution and ammonia solution; With slowly titration of silver nitrate solution (0.01mo1/L), titration results is proofreaied and correct with blank assay, promptly get; Every 1ml silver nitrate solution (0.01mo1/L) is equivalent to the HCN of 0.5405mg, and every of these article contain mandelonitrile in hydrocyanic acid (HCN), should be 0.1～0.3mg.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103149288A (en) * | 2013-02-04 | 2013-06-12 | 合肥今越制药有限公司 | Quality control method for snake bile in bezoar snake gall bulbus fritilariae capsules by means of feature maps |
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2010
- 2010-12-29 CN CN2010106101313A patent/CN102552662A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103149288A (en) * | 2013-02-04 | 2013-06-12 | 合肥今越制药有限公司 | Quality control method for snake bile in bezoar snake gall bulbus fritilariae capsules by means of feature maps |
| CN103149288B (en) * | 2013-02-04 | 2015-09-30 | 合肥今越制药有限公司 | A kind of method utilizing characteristic spectrum to control snake gall juice quality in bezoar-shake bile-fritillary capsule |
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Application publication date: 20120711 |