CN102590430A - Method for detecting liuwei caragana preparation - Google Patents
Method for detecting liuwei caragana preparation Download PDFInfo
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- CN102590430A CN102590430A CN2012100150033A CN201210015003A CN102590430A CN 102590430 A CN102590430 A CN 102590430A CN 2012100150033 A CN2012100150033 A CN 2012100150033A CN 201210015003 A CN201210015003 A CN 201210015003A CN 102590430 A CN102590430 A CN 102590430A
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Abstract
The invention relates to a method for detecting a liuwei caragana preparation, which comprises the following identification method of qualitatively identifying phyllanthus emblica and/or lagotisglauca in the preparation through thin layer chromatography. The detecting method has the characteristics of good sensitivity and reproducibility and strong specificity. The liuwei caragana preparation can be effectively detected through the detecting method.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicines, be specifically related to a kind of detection method of Chinese medicine preparation.
Background technology
Six-element caragana soup looses for Tibetan medicine, records in " the Sanitation Ministry medicine standard " Tibetan medicine fascicle, and standard is numbered WS3-BC-0292-95, is made up of shagspine peashrub bark stem and leaf, Tibet inula root, tsaoko, cardamom, betel nut, galangal Six-element medicine.Be mainly used in blending blood, dragon, cough is short of breath, kidney Low Back Pain pain, seminal emission, private parts fistula that internal lesion caused by overexertion causes, and " ridge crust " is sick, ascites.
The Six-element caragana soup random notes of using at present are stated from first of " Drug Standard of Ministry of Public Health of the Peoples Republic of China " nineteen ninety-five version Tibetan medicine:
Phonetic name: Liuwei Jinjier Tangsan
Book page number: C1-295 standard numbering: WS3-BC-0292-95
[prescription] shagspine peashrub bark stem and leaf 200g, Tibet inula root 200g, tsaoko 100g, cardamom 100g, betel nut 100g, galangal 100g.
[method for making] above Six-element is ground into meal, sieves, and mixing promptly gets.
[proterties] these article are the light brown meal; The little perfume (or spice) of gas, bitter, little peppery.
[inspection] should meet each item regulation relevant under the powder item.
[function with cure mainly] kidney tonifying, eliminating dampness.Be used to concoct blood, dragon, cough is short of breath, kidney Low Back Pain pain, seminal emission, private parts fistula that internal lesion caused by overexertion causes, and " ridge crust " is sick, ascites.
[usage and consumption] 2g, 2 times on the one.Use the milk tea decoction.
[specification] every packed 20g.
[storage] is airtight, puts shady and cool dry place.
The present invention adjusts this prescription Chinese crude drug and dosage according to the requirement that the Tibetan medicine quality standard improves, and is specially: cream 100g such as ZANGJINJIER 150g, BAXIAGA 100g, emblic 130g, Herba Corydalis 100g, Song Sheng, flood connect 100g.
ZANGJINJIER: record " the Sanitation Ministry medicine standard " (first of Tibetan medicine), these article are the woody part heartwood of legume shagspine peashrub bark stem and leaf Caraganajubata (pall.) Poir. and Changdu caragana Caraganachangduensis fiauf.Cut and get the maroon woody part, cut off, dry in the shade.
BAXIAGA: record in " Tibet Autonomous Region local quality of medicinal material standard ", standard No. is XZ-BC-0001-2003, is the dry aerial parts of the little brightly yellowish violet Corydalis racemosa of bloodroot (Thunb.) pers, dry or cut off dry subsequent use.
Emblic: record that " one one of Chinese pharmacopoeia version in 2010, the 167th page, this strain Tibetan conventional crude drugs is the dry mature fruit of euphorbia plant emblic Phyllanthus emblica L..Winter to time spring gathers during fruit maturation, removes impurity, drying.
Herba Corydalis: record in " the Sanitation Ministry medicine standard " (first of Tibetan medicine); Standard numbering: WS3-BC-0114-95; These article are the dry herb of bloodroot Herba Corydalis Corydalis hendersonii Hemsl. (C.nepaiesis kitamura) and the yellow violet C.mucionifera of flat handle Maxim.; Grubbed out summer, cleans, and dries in the shade.
Hong Lian: record " one one of Chinese pharmacopoeia version in 2010, the 249th page, this strain Tibetan conventional crude drugs.Dry herb for the short tube of goatweed Lagotis glauca Lagotis brevituba Maxim.Summer, autumn gathered when two seasons, the flowers are in blossom, removed impurity, cleaned, and dried in the shade.
Cream such as Song Sheng: these article are the desiccated wood of the Fructus Rhamni parvifoliae Rhamnus parvifolia Bunge of Rhamnaceae plant Rhamnella gilgitica Rhamnella gilgitica Mansf.et Melch..All can gather the whole year, removes and debark, and the section of being sawn into is dried after riving.The material sheet of getting it filled adds 2 times in water, simmers bubble 3～4 days with the Wenshui, boils 4 hours, filters, and residue adds 1.5 times in water again, boils, filters secondary, and merging filtrate is condensed into cream with slow fire.
Tsaoko: record that " one one of Chinese pharmacopoeia version in 2010, the 222nd page, these article are the dry mature fruit of zingiberaceous plant tsaoko Amomum tsao-ko Crevost et Lemaire.Gather during fruit maturation autumn, removes impurity, dries or low temperature drying.
Cardamom: record that " one one of Chinese pharmacopoeia version in 2010, the 156th page, these article are the dry mature fruit of zingiberaceous plant Amomum cardamomum Amomum Kravanh Pierre exGagnep. or amomum compactum Soland ex Maton Amomum compactum Soland ex Maton.Be divided into " former cardamom " and " the white bandit of Indonesia " by place of production difference.
Betel nut: record that " one one of Chinese pharmacopoeia version in 2010, the 342nd page, these article are the dry mature seed of babassu betel nut Rreca catechu L..The ripening fruits of gathering at the beginning of spring end to autumn, behind poach, drying is removed pericarp, takes out seed, drying.
Galangal: record that " one one of Chinese pharmacopoeia version in 2010, the 270th page, these article are the dry rhizome of zingiberaceous plant galangal Alpinia officinarum Hance.Excavate at the beginning of autumn late summer, remove fibrous root and residual scale, clean, cut off, dry.
The detection method that Six-element caragana preparation is not arranged at present as yet.
Summary of the invention
The object of the present invention is to provide a kind of detection method of Six-element caragana preparation, said method favorable reproducibility, specificity are strong, can detect the quality of Six-element caragana preparation effectively, thereby make the steady quality, safe, controlled of Six-element caragana preparation.
For realizing above-mentioned purpose, technical scheme of the present invention is:
A kind of detection method of Six-element caragana preparation, the bulk drug of said preparation consists of: cream 80-120 weight portions such as ZANGJINJIER/shagspine peashrub bark stem and leaf 120-180 weight portion, BAXIAGA 80-120 weight portion, emblic 100-150 weight portion, Herba Corydalis 80-120 weight portion, Song Sheng, flood connect the 80-120 weight portion;
Said detection method comprises:
Through thin-layer chromatography emblic in the preparation and/or flood are repeatedly kicked into capable qualitative identification.
Particularly, the qualitative identification of emblic comprises:
1a) preparation emblic need testing solution, emblic control medicinal material solution, do not contain the negative sample solution of emblic;
2a) according to thin-layered chromatography " step 1a is drawn in 2010 editions appendix VIB of Chinese pharmacopoeia test respectively) need testing solution, control medicinal material solution, the negative sample solution that are obtained, and point sample is on same silica gel g thin-layer plate;
Be that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent 3a), with step 2a with boiling point) thin layer plate that obtained be placed on saturated in the expansion cylinder, launch, take out, dry, spray is with liquor ferri trichloridi, the colour developing of wind to spot is clear; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
The qualitative identification of Hong Lian comprises:
1b) the preparation flood connects need testing solution, flood connects control medicinal material solution, do not contain the negative sample solution that flood connects;
2b) according to thin-layered chromatography " step 1b is drawn in 2010 editions appendix VIB of Chinese pharmacopoeia test respectively) need testing solution, control medicinal material solution, the negative sample solution that are obtained, and point sample is on same silica gel g thin-layer plate;
Be developping agent 3b), with step 2b with methyl alcohol-acetate-water) thin layer plate that obtained be placed on saturated in the expansion cylinder, launch, take out, dry, put under the ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
Particularly, the preparation method of said emblic, the big vast need testing solution that connects, control medicinal material solution, negative sample solution comprises:
(1) need testing solution of emblic, control medicinal material solution, negative sample solution
Get said Six-element caragana preparation, porphyrize adds methyl alcohol, and sonicated filters, and filtrating concentrates, as the emblic need testing solution; Other gets the emblic control medicinal material, processes emblic control medicinal material solution according to the preparation method of said emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution;
(2) flood need testing solution, control medicinal material solution, negative sample solution even
Get said Six-element caragana preparation, porphyrize adds methyl alcohol, and sonicated filters, and filtrating concentrates, and connects need testing solution as flood; Other gets flood and connects control medicinal material, and the preparation method who connects need testing solution according to said flood processes the big vast control medicinal material solution that connects; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution.
More specifically, said detection method may further comprise the steps:
A) qualitative identification of emblic
Get said Six-element caragana preparation 0.5～5 weight portion, porphyrize adds methyl alcohol 5～40 parts by volume, and sonicated 10～60 minutes filters, and filtrating is concentrated into 0.5～8 parts by volume, as the emblic need testing solution; Other gets emblic control medicinal material 0.1～2.5 weight portion, processes emblic control medicinal material solution according to the preparation method of said emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution.According to " the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010; Draw each 0.001～0.02 parts by volume of above-mentioned three kinds of solution, point sample is that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent with boiling point on same silica gel g thin-layer plate respectively; The volume ratio of developping agent is petroleum ether-ethyl acetate-formic acid (1～15: 1～9: 0.05～0.5); Thin layer plate was put in the expansion cylinder saturated 0～40 minute, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
B) flood qualitative identification even
Get said Six-element caragana preparation 0.5～5 weight portion, porphyrize adds acetone 5～40 parts by volume, and sonicated 10～60 minutes filters, and filtrating is concentrated into 0.5～8 parts by volume, connects need testing solution as flood; Other gets flood and connects control medicinal material 0.1～2.5 weight portion, and the preparation method who connects need testing solution according to said flood processes the big vast control medicinal material solution that connects; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution; According to " each 0.001～0.02 parts by volume of above-mentioned three kinds of solution is drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, puts respectively on same polyamide film; With volume ratio is 0.1～10: 0.05～5: methyl alcohol-acetate of 1～20-water is developping agent; Thin layer plate was put in the expansion cylinder saturated 0～40 minute, launched, and took out; Dry, put under the 365nm ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
More specifically, said detection method may further comprise the steps:
I) qualitative identification of emblic:
Get said Six-element caragana preparation 2g, porphyrize adds methyl alcohol 20ml, and sonicated 30 minutes filters, and filtrating is concentrated into 4ml, as the emblic need testing solution; Other gets emblic control medicinal material 0.5g, processes emblic control medicinal material solution according to the preparation method of said emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution; According to " each 5 μ L of above-mentioned three kinds of solution are drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, and point sample is on same silica gel g thin-layer plate respectively; With boiling point is that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent, and the volume ratio of developping agent is petroleum ether-ethyl acetate-formic acid (6: 4: 0.25), and thin layer plate was put in the expansion cylinder saturated 30 minutes; Launch; Take out, dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
The ii) big vast qualitative identification that connects
Get said Six-element caragana preparation 2g, porphyrize adds acetone 20ml, and sonicated 30 minutes filters, and filtrating is concentrated into 4ml, connects need testing solution as flood; Other gets flood and connects control medicinal material 0.5g, and the preparation method who connects need testing solution according to said flood processes the big vast control medicinal material solution that connects; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution; According to " each 5 μ L of above-mentioned three kinds of solution are drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film; With volume ratio is that methyl alcohol-acetate-water of 2: 1: 7 is developping agent; Thin layer plate was put in the expansion cylinder saturated 30 minutes, launched, and took out; Dry, put under the 365nm ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
The formulation of Six-element caragana preparation of the present invention can be tablet, capsule, granule, pill or powder.The preparation method is: get said Six-element caragana preparation, be ground into fine powder, sieve, mixing adds the suitable quantity of water pill, and drying in the shade promptly gets; Or get said Six-element caragana preparation, and be ground into fine powder, sieve, mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the oral formulations of accepting clinically: granule, pill, capsule, tablet or powder.
The present invention is directed to the constituent of Six-element caragana preparation, index property composition emblic, flood are repeatedly kicked into capable qualitative detection, to reach the purpose that the quality of preparation is controlled.The invention provides the detection method of good Six-element caragana preparation, this detection method has the strong characteristics of sensitivity, favorable reproducibility and specificity.
Description of drawings
Fig. 1 is that the emblic thin-layer chromatography is differentiated figure in the Six-element caragana preparation;
Wherein sample is in proper order from left to right: need testing solution 1, need testing solution 2, need testing solution 3, emblic control medicinal material solution, emblic control medicinal material solution, emblic negative sample solution;
Wherein developping agent is sherwood oil (60 ℃～90 ℃)-ethyl acetate-formic acid (6: 4: 0.25).
Fig. 2 is that flood connects thin-layer chromatography discriminating figure in the Six-element caragana preparation;
Wherein sample is in proper order from left to right: need testing solution 1, need testing solution 2, need testing solution 3, flood connect control medicinal material solution, flood connects control medicinal material solution, the big vast negative sample solution that connects;
Wherein developping agent is methyl alcohol-acetate-water (2: 1: 7).
Embodiment
Following experimental example and embodiment further specify but are not limited to the present invention.
Followingly be used for preparation that each composition differentiates, under each discrimination method, all abbreviate " test sample " as; Being interpreted as it is the test sample according to each discrimination method requirement preparation, is " test sample of emblic qualitative identification " at the test sample described in the emblic qualitative identification method for example.
Experimental example 1: the screening experiment of the thin-layer chromatography condition of emblic
(1) instrument
Electronic scales, tool plug conical flask, transfer pipet, Extraction by Ultrasound appearance, funnel, filter paper, evaporating dish, sample applicator, silica G plate, chromatography cylinder, spray bottle, hair dryer.
(2) control medicinal material
The emblic control medicinal material (lot number: 121289-200301), available from Nat'l Pharmaceutical & Biological Products Control Institute.
(3) reagent
Methyl alcohol, ether, acetone, sherwood oil (60～90 ℃), ethyl acetate, formic acid, ferric trichloride.
(4) method of inspection
Extract choice of Solvent: adopt solution such as ether, acetone, methyl alcohol respectively for extracting solvent;
The selection of method for distilling: adopt ultrasonic Extraction and cold soaking to extract respectively;
The selection of developping agent: adopting sherwood oil (60～90 ℃)-ethyl acetate (3: 8), sherwood oil (60～90 ℃)-ethyl acetate (6: 4), sherwood oil (60～90 ℃)-ethyl acetate-formic acid (6: 4: 0.25) respectively is developping agent;
Select above solvent, method for distilling and the developping agent of extracting to make an experiment respectively, the result is following:
Repetition test under above condition, confirmed that finally the specificity thin layer discrimination method of emblic is following:
Prepare first group of sample solution, get said Six-element caragana preparation 2g, porphyrize adds methyl alcohol 20mL, and sonicated 30 minutes filters, and filtrating is concentrated into 4mL, as the emblic need testing solution; Other gets emblic control medicinal material 0.5g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in an appendix VI of Chinese pharmacopoeia version in 2010 B test, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (6: 4: 0.25) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.As shown in Figure 1, in the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
Experimental example 2: the screening experiment of the thin-layer chromatography condition that flood connects
(1) instrument
Electronic scales, tool plug conical flask, transfer pipet, Extraction by Ultrasound appearance, funnel, filter paper, evaporating dish, sample applicator, polyamide film, chromatography cylinder.
(2) control medicinal material
Big vast even control medicinal material (lot number: 121242-200401), available from Nat'l Pharmaceutical & Biological Products Control Institute.
(3) reagent
Methyl alcohol, ethyl acetate, ether, acetate, water.
(4) method of inspection:
Extract choice of Solvent: adopt solution such as methyl alcohol, ethyl acetate, ether respectively for extracting solvent;
The selection of method for distilling: adopt ultrasonic Extraction and cold soaking to extract respectively;
The selection of developping agent: adopting methanol-water (2: 7), methyl alcohol-acetate-water (2: 1: 7) respectively is developping agent;
Select above solvent, method for distilling and the developping agent of extracting to make an experiment respectively, the result is following:
Repetition test under above condition, confirmed that finally the specificity thin layer discrimination method of big vast company is following:
Prepare second group of sample solution, get said Six-element caragana preparation 2g, porphyrize adds methyl alcohol 20mL, and sonicated 30 minutes filters, and filtrating is concentrated into 4mL, connects need testing solution as flood; Other gets flood and connects control medicinal material 0.5g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (2: 1: 7) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.As shown in Figure 2, in the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
Following embodiment all can realize the effect of above-mentioned experimental example.
The preparation of [embodiment 1] Six-element caragana preparation
Cream 100g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 150g, BAXIAGA 100g, emblic 130g, Herba Corydalis 100g, Song Sheng, flood are connected 100g, be ground into fine powder, sieve, mixing adds the suitable quantity of water pill, dries in the shade promptly to get; Or get above Six-element, and be ground into fine powder, sieve, mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the oral formulations of accepting clinically: granule, pill, capsule, tablet or powder.
The usage and the consumption of said Six-element caragana preparation: a day dose is a 2g crude drug amount, 2 times on the one.
The discriminating that [embodiment 2] Six-element caragana soup looses
Cream 100g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 150g, BAXIAGA 100g, emblic 130g, Herba Corydalis 100g, Song Sheng, flood connect 100g;
Above Six-element is ground into fine powder, sieves, and mixing promptly gets.
A. the thin layer of emblic is differentiated
Get the diffusing 2g of said Six-element caragana soup, add methyl alcohol 20mL, sonicated 30 minutes filters, and filtrating is concentrated into 4mL, as the emblic need testing solution.Other gets emblic control medicinal material 0.5g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (6: 4: 0.25) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get the diffusing 2g of said Six-element caragana soup, add methyl alcohol 20mL, sonicated 30 minutes filters, and filtrating is concentrated into 4mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 0.5g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in an appendix VI of Chinese pharmacopoeia version in 2010 B test, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (2: 1: 7) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
The discriminating of [embodiment 3] Six-element caragana particle
Cream 80g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 120g, BAXIAGA 80g, emblic 100g, Herba Corydalis 80g, Song Sheng, flood connect 80g;
Above Six-element is ground into fine powder, sieves, and mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the Six-element caragana particle of accepting clinically.
A. the thin layer of emblic is differentiated
Get said Six-element caragana particle 0.5g, porphyrize adds methyl alcohol 5mL, and sonicated 15 minutes filters, and filtrating is concentrated into 1mL, as the emblic need testing solution.Other gets emblic control medicinal material 0.2g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 10 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (2: 1.6: 0.1) is developping agent; Thin layer plate was put in the expansion cylinder saturated 30 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get said Six-element caragana particle 0.5g, porphyrize adds methyl alcohol 5mL, and sonicated 15 minutes filters, and filtrating is concentrated into 1mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 0.2g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 10 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (0.5: 0.3: 1.8) is developping agent; Thin layer plate was put in the expansion cylinder saturated 30 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
The discriminating of [embodiment 4] Six-element caragana ball
Cream 120g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 180g, BAXIAGA 120g, emblic 150g, Herba Corydalis 120g, Song Sheng, flood connect 120g;
Above Six-element is ground into fine powder, sieves, and mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the Six-element caragana ball of accepting clinically.
A. the thin layer of emblic is differentiated
Get said Six-element caragana ball 4.5g, porphyrize adds methyl alcohol 40mL, and sonicated 45 minutes filters, and filtrating is concentrated into 2mL, as the emblic need testing solution.Other gets emblic control medicinal material 1g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; According to thin-layered chromatography " appendix VIB test of Chinese pharmacopoeia version in 2010; Drawing each 5 μ l of above-mentioned three kinds of solution, put respectively on same silica gel g thin-layer plate, is developping agent with sherwood oil (60～90 ℃)-ethyl acetate-formic acid (10: 6: 0.2); Launch; Take out, dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get said Six-element caragana ball 4.5g, porphyrize adds methyl alcohol 40mL, and sonicated 45 minutes filters, and filtrating is concentrated into 2mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 1g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (4: 3: 10) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
The discriminating of [embodiment 5] Six-element caragana hard shell capsules
Cream 100g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 150g, BAXIAGA 100g, emblic 130g, Herba Corydalis 100g, Song Sheng, flood connect 100g;
Above Six-element is ground into fine powder, sieves, and mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the Six-element caragana hard shell capsules of accepting clinically.
A. the thin layer of emblic is differentiated
Get said Six-element caragana hard shell capsules 2g, porphyrize adds methyl alcohol 20mL, and sonicated 30 minutes filters, and filtrating is concentrated into 4mL, as the emblic need testing solution.Other gets emblic control medicinal material 0.5g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (6: 4: 0.25) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get said Six-element caragana hard shell capsules 1g, porphyrize adds methyl alcohol 10mL, and sonicated 20 minutes filters, and filtrating is concentrated into 5mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 1.5g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 15 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (6: 4.6: 12) is developping agent, launches, and takes out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
The discriminating of [embodiment 6] Six-element caragana sheet
Cream 80g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 120g, BAXIAGA 120g, emblic 100g, Herba Corydalis 120g, Song Sheng, flood connect 120g;
Above Six-element is ground into fine powder, sieves, and mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the Six-element caragana sheet of accepting clinically.
A. the thin layer of emblic is differentiated
Get said Six-element caragana sheet 1g, porphyrize adds methyl alcohol 10mL, and sonicated 20 minutes filters, and filtrating is concentrated into 5mL, as the emblic need testing solution.Other gets emblic control medicinal material 1.5g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 15 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (12: 6.5: 0.3) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get said Six-element caragana sheet 2g, porphyrize adds methyl alcohol 20mL, and sonicated 30 minutes filters, and filtrating is concentrated into 4mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 0.5g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 5 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (2: 1: 7) is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
The discriminating of [embodiment 7] Six-element caragana soft capsule
Cream 120g such as ZANGJINJIER/shagspine peashrub bark stem and leaf 180g, BAXIAGA 80g, emblic 150g, Herba Corydalis 80g, Song Sheng, flood connect 80g;
Above Six-element is ground into fine powder, sieves, and mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the Six-element caragana soft capsule of accepting clinically.
A. the thin layer of emblic is differentiated
Get said Six-element caragana soft capsule 3.5g, add methyl alcohol 30mL, sonicated 60 minutes filters, and filtrating is concentrated into 6mL, as the emblic need testing solution.Other gets emblic control medicinal material 2g, processes emblic control medicinal material solution according to the preparation method of emblic need testing solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of above-mentioned emblic need testing solution; " each 10 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same silica gel g thin-layer plate according to thin-layered chromatography; With sherwood oil (60～90 ℃)-ethyl acetate-formic acid (14: 8: 0.4) is developping agent; Thin layer plate was put in the expansion cylinder saturated 40 minutes, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast.In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color, and negative noiseless.
B. flood thin layer is even differentiated
Get said Six-element caragana soft capsule 3.5g, add methyl alcohol 30mL, sonicated 60 minutes filters, and filtrating is concentrated into 6mL, connects need testing solution as flood.Other gets flood and connects control medicinal material 2g, and the preparation method who connects need testing solution according to flood processes even control medicinal material solution of flood; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that above-mentioned flood connects need testing solution; " each 10 μ l of above-mentioned three kinds of solution are drawn in appendix VIB test of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film according to thin-layered chromatography; With methyl alcohol-acetate-water (8.4: 3.8: 6.5) is developping agent; Thin layer plate was put in the expansion cylinder saturated 40 minutes, launched, and took out; Dry, put under the ultraviolet lamp (365nm) and inspect.In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color, and negative noiseless.
Claims (8)
1. the detection method of a Six-element caragana preparation, the bulk drug of said preparation consists of: cream 80-120 weight portions such as ZANGJINJIER/shagspine peashrub bark stem and leaf 120-180 weight portion, BAXIAGA 80-120 weight portion, emblic 100-150 weight portion, Herba Corydalis 80-120 weight portion, Song Sheng, flood connect the 80-120 weight portion;
Said detection method comprises:
Through thin-layer chromatography emblic in the preparation and/or flood are repeatedly kicked into capable qualitative identification.
2. detection method as claimed in claim 1, wherein, described emblic qualitative identification comprises:
1a) preparation emblic need testing solution, emblic control medicinal material solution, do not contain the negative sample solution of emblic;
2a) according to thin-layered chromatography " step 1a is drawn in 2010 editions appendix VIB of Chinese pharmacopoeia test respectively) need testing solution, control medicinal material solution, the negative sample solution that are obtained, and point sample is on same silica gel g thin-layer plate;
Be that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent 3a), with step 2a with boiling point) thin layer plate that obtained be placed on saturated in the expansion cylinder, launch, take out, dry, spray is with liquor ferri trichloridi, the colour developing of wind to spot is clear; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
The qualitative identification of Hong Lian comprises:
1b) the preparation flood connects need testing solution, flood connects control medicinal material solution, do not contain the negative sample solution that flood connects;
2b) according to thin-layered chromatography " step 1b is drawn in 2010 editions appendix VIB of Chinese pharmacopoeia test respectively) need testing solution, control medicinal material solution, the negative sample solution that are obtained, and point sample is on same silica gel g thin-layer plate;
Be developping agent 3b), with step 2b with methyl alcohol-acetate-water) thin layer plate that obtained be placed on saturated in the expansion cylinder, launch, take out, dry, put under the ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
3. detection method as claimed in claim 2, the preparation method of the need testing solution that wherein said emblic, flood connect, control medicinal material solution, negative sample solution comprises:
(1) need testing solution of emblic, control medicinal material solution, negative sample solution
Get said Six-element caragana preparation, porphyrize adds methyl alcohol, and sonicated filters, and filtrating concentrates, as the emblic need testing solution; Other gets the emblic control medicinal material, according to the preparation method of said emblic need testing solution, processes emblic control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution;
(2) flood need testing solution, control medicinal material solution, negative sample solution even
Get said Six-element caragana preparation, porphyrize adds methyl alcohol, and sonicated filters, and filtrating concentrates, and connects need testing solution as flood; Other gets flood and connects control medicinal material, according to the said flood even preparation method of need testing solution, processes flood and connects control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution.
4. like each described detection method of claim 1 to 3, comprise the steps:
A) qualitative identification of emblic
Get said Six-element caragana preparation 0.5～5 weight portion, porphyrize adds methyl alcohol 5～40 parts by volume, and sonicated 10～60 minutes filters, and filtrating is concentrated into 0.5～8 parts by volume, as the emblic need testing solution; Other gets emblic control medicinal material 0.1～2.5 weight portion, according to the preparation method of said emblic need testing solution, processes emblic control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution; According to " the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010; Draw each 0.001～0.02 parts by volume of above-mentioned three kinds of solution, point sample is that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent with boiling point on same silica gel g thin-layer plate respectively; The volume ratio of developping agent is petroleum ether-ethyl acetate-formic acid=1～15: 1～9: 0.05～0.5; Thin layer plate was put in the expansion cylinder saturated 0～40 minute, launched, and took out; Dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
B) flood qualitative identification even
Get said Six-element caragana preparation 0.5～5 weight portion, porphyrize adds acetone 5～40 parts by volume, and sonicated 10～60 minutes filters, and filtrating is concentrated into 0.5～8 parts by volume, connects need testing solution as flood; Other gets flood and connects control medicinal material 0.1～2.5 weight portion, according to the said flood even preparation method of need testing solution, processes flood and connects control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution; According to " each 0.001～0.02 parts by volume of above-mentioned three kinds of solution is drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, puts respectively on same polyamide film; With volume ratio is 0.1～10: 0.05～5: methyl alcohol-acetate of 1～20-water is developping agent; Thin layer plate was put in the expansion cylinder saturated 0～40 minute, launched, and took out; Dry, put under the 365nm ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
5. detection method as claimed in claim 4 is characterized in that, may further comprise the steps:
I) qualitative identification of emblic:
Get said Six-element caragana preparation 2g, porphyrize adds methyl alcohol 20ml, and sonicated 30 minutes filters, and filtrating is concentrated into 4ml, as the emblic need testing solution; Other gets emblic control medicinal material 0.5g, according to the preparation method of said emblic need testing solution, processes emblic control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the negative sample of emblic, and processes emblic negative sample solution by the compound method of said emblic need testing solution; According to " each 5 μ L of above-mentioned three kinds of solution are drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, and point sample is on same silica gel g thin-layer plate respectively; With boiling point is that petroleum ether-ethyl acetate-formic acid of 60～90 ℃ is developping agent, and the volume ratio of developping agent is petroleum ether-ethyl acetate-formic acid=6: 4: 0.25, and thin layer plate was put in the expansion cylinder saturated 20 minutes; Launch; Take out, dry, it is clear that spray is blown to the spot colour developing with 10% liquor ferri trichloridi hot blast; In the thin-layer chromatography, with the corresponding position of emblic control medicinal material chromatogram on, the test sample chromatogram shows the spot of same color;
The ii) big vast qualitative identification that connects
Get said Six-element caragana preparation 2g, porphyrize adds acetone 20ml, and sonicated 30 minutes filters, and filtrating is concentrated into 4ml, connects need testing solution as flood; Other gets flood and connects control medicinal material 0.5g, according to the said flood even preparation method of need testing solution, processes flood and connects control medicinal material solution; In prescription ratio and preparation technology, configuration does not contain the big vast negative sample that connects, and processes even negative sample solution of flood by the compound method that said flood connects need testing solution; According to " each 5 μ L of above-mentioned three kinds of solution are drawn in the said thin-layered chromatography test of appendix VIB of Chinese pharmacopoeia version in 2010, put respectively on same polyamide film; With volume ratio is that methyl alcohol-acetate-water of 2: 1: 7 is developping agent; Thin layer plate was put in the expansion cylinder saturated 20 minutes, launched, and took out; Dry, put under the 365nm ultraviolet lamp and inspect; In the thin-layer chromatography, connecting on the corresponding position of control medicinal material chromatogram with flood, the test sample chromatogram shows the spot of same color.
6. detection method as claimed in claim 1; It is characterized in that said preparation raw material medicine consists of: cream 100 weight portions such as ZANGJINJIER/shagspine peashrub bark stem and leaf 150 weight portions, BAXIAGA 100 weight portions, emblic 130 weight portions, Herba Corydalis 100 weight portions, Song Sheng, flood connect 100 weight portions.
7. detection method as claimed in claim 1 is characterized in that, the formulation of said Six-element caragana preparation is tablet, capsule, granule, pill or powder.
8. detection method as claimed in claim 1 is characterized in that, gets said Six-element caragana preparation, is ground into fine powder, sieves, and mixing adds the suitable quantity of water pill, and drying in the shade promptly gets; Or get said Six-element caragana preparation, and be ground into fine powder, sieve, mixing, mixing by the pharmacy conventional method, adds conventional auxiliary material, processes the oral formulations of accepting clinically.
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| CN104274583A (en) * | 2012-08-15 | 2015-01-14 | 西藏奇正藏药股份有限公司 | Tibetan medicinal preparation for treating essential hypertension and preparation method thereof |
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