CN101390984A - Quality control method of Lanhuayao - Google Patents
Quality control method of Lanhuayao Download PDFInfo
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- CN101390984A CN101390984A CN200810013418.0A CN200810013418A CN101390984A CN 101390984 A CN101390984 A CN 101390984A CN 200810013418 A CN200810013418 A CN 200810013418A CN 101390984 A CN101390984 A CN 101390984A
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Abstract
The invention discloses a quality control method for a Lanhuayao which is composed of 10 kinds of Chinese herbs of borax, borneol, natural indigo, weathered sodium sulfate, talcum powder, amber, calcined alum, gesso, catechu and figwortflower picrorhiza rhizome; the invention is the quality control method for the Lanhuayao, which measures the natural indigo content by utilizing the high-effective liquid chromatography method, measures the borneol content by gas phase chromatography method and performs qualitative identification for the borneol and catechu by thin-layer chromatography method; the quality control method can make up shortcomings in prior art; the perfect quality control standard can ensure the reliability and uniformity of medicine quality, and is simple and practicable with operability.
Description
Technical field:
The present invention relates to a kind of method of quality control of the Lanhuayao of making by Borax, Borneolum Syntheticum, Indigo Naturalis, Matrii Sulfas Exsiccatus, Pulvis Talci, succinum, dried Alumen, Gypsum Fibrosum, catechu, Rhizoma Picrorhizae 10 flavor Chinese crude drugs, especially a kind of with high effective liquid chromatography for measuring Indigo Naturalis content, with gas chromatography determination content of bornyl alcohol and the method for quality control that Borneolum Syntheticum, catechu carried out the Lanhuayao of qualitative identification with thin layer chromatography.
Background technology:
Lanhuayao is a kind ofly to be used for the treatment of acute and chronic tonsillitis, gums redness, to have sore throat and the Chinese patent medicine of infantile malnutrition, and this product records in the 3rd (WS of ministry standard Chinese traditional patent formulation preparation
3-B-0647-91), make by Borax, Borneolum Syntheticum, Indigo Naturalis, Matrii Sulfas Exsiccatus, Pulvis Talci, succinum, dried Alumen, Gypsum Fibrosum, catechu and Rhizoma Picrorhizae ten flavor medical materials.In its quality standard, concrete regulation the prescription of Lanhuayao, method for making, character and discrimination method, but the chemical differential method that Indigo Naturalis, Borax, Borneolum Syntheticum are only arranged, specificity is not strong, still not having the thin layer of contained flavour of a drug differentiates and content assaying method, limitation is very big, is difficult to control more all sidedly the quality of this medicine.To this, " time precious traditional Chinese medical science traditional Chinese medicines " the 5th phase of the 2006th the 17th volume disclosed " quality standard research of Lanhuayao " has been done to replenish to the method for quality control of this medicine, but also has only the microscopical identification of employing method that Gypsum Fibrosum in the Lanhuayao (polarisation), Indigo Naturalis, catechu, succinum, Talcum, Borneolum Syntheticum (flores) are carried out microscopical identification; Adopt thin layer chromatography that Indigo Naturalis, Borneolum Syntheticum in the prescription are carried out qualitative identification; Adopt Na in the titration measuring Borax
2B
4O
7Content, still do not measure the content of Indigo Naturalis, Borneolum Syntheticum, it is described that Borneolum Syntheticum is carried out qualitative identification is to use the ether supersound extraction.Ether belongs to low boiling point solvent, and highly volatile when supersound extraction is difficult to operation in actual applications.
Summary of the invention:
The present invention is in order to overcome the deficiencies in the prior art, provide a kind of with high effective liquid chromatography for measuring Indigo Naturalis content, Borneolum Syntheticum, catechu are carried out qualitative identification with the gas chromatography determination content of bornyl alcohol and with thin layer chromatography, simple, have the method for quality control of the Lanhuayao of operability.
Technical solution of the present invention is: a kind of method of quality control of Lanhuayao, it is characterized in that it being Indigo Naturalis content to be measured with high performance liquid chromatography, and operating procedure is as follows:
Chromatographic condition: with the octadecylsilane chemically bonded silica is filler;
Methanol-water with volume ratio 73:27 is mobile phase;
The detection wavelength is 289nm;
Number of theoretical plate calculates by the indirubin peak should be not less than 7000;
The preparation of reference substance solution: precision takes by weighing indirubin reference substance 5mg, puts in the 25ml measuring bottle, adds chloroform and makes the indirubin dissolving and be diluted to scale, shake up, precision is measured 1ml and is put in the 10ml measuring bottle and be diluted to scale with methanol, shakes up, and promptly gets the reference substance solution that contains indirubin 20 μ g among every 1ml;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.25g, puts in the tool plug conical flask, the accurate chloroform 25ml that adds, close plug claims to decide weight, supersound process 30 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with chloroform, shake up, filter, get subsequent filtrate, promptly get need testing solution;
Algoscopy: accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing, inject chromatograph of liquid, to measure, every 1g Lanhuayao contains Indigo Naturalis in indirubin, must not be less than 80 μ g.
Feature of the present invention is with gas chromatography content of bornyl alcohol to be measured, and operating procedure is as follows:
Chromatographic condition: Polyethylene Glycol (PEG)-20M capillary column (column length 30m, internal diameter 0.32mm, film thickness 0.5 μ m), column temperature is 140 ℃; Number of theoretical plate calculates by the Borneolum Syntheticum peak should be not less than 30000;
Correction factor is measured: precision takes by weighing the methyl salicylate reference substance and adds dehydrated alcohol and make the solution that every 1ml contains 2mg, as inner mark solution; Precision takes by weighing the Borneolum Syntheticum reference substance, adds inner mark solution and makes the solution that every 1ml contains 2mg, in contrast product solution; Draw reference substance solution 0.5 μ l, inject gas chromatograph, the calculation correction factor;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.5g and puts in the conical flask, the accurate inner mark solution 5ml that adds claims to decide weight, supersound process 5 minutes, claim to decide weight again, replenish the weight that subtracts mistake with dehydrated alcohol, filter, accurately draw subsequent filtrate 0.5ml, precision adds the 0.5ml inner mark solution again, and mixing is as need testing solution;
Algoscopy: accurate reference substance solution and each 0.5 μ l of need testing solution of drawing, inject gas chromatograph is measured, and calculates with Borneolum Syntheticum, isoborneol peak area sum, promptly gets content of bornyl alcohol, and every 1g Lanhuayao contains Borneolum Syntheticum (C
10H
18O) must not be less than 15mg.
Feature of the present invention is with thin layer chromatography Borneolum Syntheticum to be carried out qualitative identification, and operating procedure is as follows:
Get Lanhuayao 1.5g porphyrize, add chloroform 15ml and shake up, flooded 2 hours, filter, filtrate is as need testing solution; Get the Borneolum Syntheticum reference substance, add chloroform and make the solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography, draw each 4 μ l of above-mentioned two kinds of solution, to put respectively on same silica gel g thin-layer plate, the benzene-acetone that with the volume ratio is 9:1 is that developing solvent launches, and takes out, and dries, and spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the principal spot of same color.
Feature of the present invention is with thin layer chromatography catechu to be carried out qualitative identification, and operating procedure is as follows:
Get Lanhuayao 8g porphyrize, add ethyl acetate 40ml, supersound process 10 minutes filters, and the residue behind the filtrate evaporate to dryness adds methanol 3ml makes its dissolving, as need testing solution; Other gets catechu control medicinal material 50mg, adds methanol 10ml, floods 20 minutes, filters, and filtrate is medical material solution in contrast.According to thin layer chromatography, draw need testing solution 6 μ l, reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, chloroform-methanol-the formic acid that with the volume ratio is 20:5:2 is that developing solvent launches, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
The present invention has remedied the deficiencies in the prior art, reliability that perfect quality control standard can be ensured drug quality and homogeneity.
1. increase the method for quantitatively determining of Indigo Naturalis, indirubin is a kind of main effective ingredient in the Indigo Naturalis, has good antibacterial activity, and the present invention utilizes the content of indirubin in this medicine of high effective liquid chromatography for measuring, and the result is accurate, favorable reproducibility;
2. increase the method for quantitatively determining of Borneolum Syntheticum, the present invention utilizes the high resolution gas chromatography method to measure the content of Borneolum Syntheticum in this medicine, and method is easy, and the result is accurate, favorable reproducibility;
3. change the thin layer chromatography qualitative identification method of Borneolum Syntheticum, be with chloroform as extracting solvent, its volatility is far below ether, has easy operating, safe advantage.And it is exclusive, feasible, negative noiseless through methodology test confirmation method;
4. increase the thin layer chromatography qualitative identification method of catechu, and exclusive, feasible, negative noiseless through methodology test confirmation method.
The specific embodiment:
Embodiment 1:
According to the standard method for making, make Lanhuayao and (provide lot number by Pan Shoude: 20070502).
Reference substance and control medicinal material provide by Nat'l Pharmaceutical ﹠ Biological Products Control Institute.
According to an appendix VID of Chinese Pharmacopoeia version in 2005 high performance liquid chromatography Indigo Naturalis content is measured, operating procedure is as follows:
Chromatographic condition: with the octadecylsilane chemically bonded silica is filler;
Methanol-water with volume ratio 73:27 is mobile phase;
The detection wavelength is 289nm;
Number of theoretical plate calculates by the indirubin peak should be not less than 7000;
The preparation of reference substance solution: precision takes by weighing indirubin reference substance 5mg, puts in the 25ml measuring bottle, adds chloroform and makes the indirubin dissolving and be diluted to scale, shakes up; Precision is measured 1ml and is put in the 10ml measuring bottle and be diluted to scale with methanol, shakes up, and promptly gets the reference substance solution that contains indirubin 20 μ g among every 1ml;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.25g, puts in the tool plug conical flask, the accurate chloroform 25ml that adds, close plug claims to decide weight, supersound process 30 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with chloroform, shake up, filter, get subsequent filtrate, promptly get need testing solution;
Algoscopy: accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing, inject chromatograph of liquid, to measure, every 1g Lanhuayao contains Indigo Naturalis in indirubin, is 110 μ g.
Embodiment 2:
On the basis of embodiment 1, according to an appendix VIE of Chinese Pharmacopoeia version in 2005 gas chromatography content of bornyl alcohol to be measured, operating procedure is as follows:
Chromatographic condition: Polyethylene Glycol (PEG)-20M capillary column (column length 30m, internal diameter 0.32mm, film thickness 0.5 μ m), column temperature is 140 ℃; Number of theoretical plate calculates by the Borneolum Syntheticum peak should be not less than 30000;
Correction factor is measured: precision takes by weighing the methyl salicylate reference substance and adds dehydrated alcohol and make the solution that every 1ml contains 2mg, as inner mark solution; Precision takes by weighing the Borneolum Syntheticum reference substance, adds inner mark solution and makes the solution that every 1ml contains 2mg, in contrast product solution; Draw reference substance solution 0.5 μ l, inject gas chromatograph, the calculation correction factor;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.5g and puts in the conical flask, the accurate inner mark solution 5ml that adds claims to decide weight, supersound process 5 minutes, claim to decide weight again, replenish the weight that subtracts mistake with dehydrated alcohol, filter, accurately draw subsequent filtrate 0.5ml, precision adds the 0.5ml inner mark solution again, and mixing is as need testing solution;
Algoscopy: accurate reference substance solution and each 0.5 μ l of need testing solution of drawing, inject gas chromatograph is measured, and calculates with Borneolum Syntheticum, isoborneol peak area sum, promptly gets content of bornyl alcohol, and every 1g Lanhuayao contains Borneolum Syntheticum (C
10H
18O) be 21.7mg.
Embodiment 3:
On the basis of embodiment 1 or embodiment 2, according to thin layer chromatography among 2005 editions appendix VIB of Chinese Pharmacopoeia Borneolum Syntheticum is carried out qualitative identification, operating procedure is as follows:
Get Lanhuayao 1.5g porphyrize, add chloroform 15ml and shake up, flooded 2 hours, filter, filtrate is as need testing solution; Get the Borneolum Syntheticum reference substance, add chloroform and make the solution that every 1ml contains 2mg, in contrast product solution; Draw each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, the benzene-acetone that with the volume ratio is 9:1 is that developing solvent launches, and takes out, and dries, and spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the principal spot of same color.
Embodiment 4:
On the basis of embodiment 3, according to thin layer chromatography among 2005 editions appendix VIB of Chinese Pharmacopoeia catechu is carried out qualitative identification, operating procedure is as follows:
Get Lanhuayao 8g porphyrize, add ethyl acetate 40ml, supersound process 10 minutes filters, and the residue behind the filtrate evaporate to dryness adds methanol 3ml makes its dissolving, as need testing solution; Other gets catechu control medicinal material 50mg, adds methanol 10ml, floods 20 minutes, filters, and filtrate is medical material solution in contrast.Draw need testing solution 6 μ l, reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, the chloroform-methanol-formic acid that with the volume ratio is 20:5:2 is that developing solvent launches, take out, dry, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to speckle colour developing at 105 ℃.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
Claims (4)
1. the method for quality control of a Lanhuayao is characterized in that it being with high performance liquid chromatography Indigo Naturalis content to be measured, and operating procedure is as follows:
Chromatographic condition: with the octadecylsilane chemically bonded silica is filler;
Methanol one water with volume ratio 73:27 is mobile phase;
The detection wavelength is 289nm;
Number of theoretical plate calculates by the indirubin peak should be not less than 7000;
The preparation of reference substance solution: precision takes by weighing indirubin reference substance 5mg, puts in the 25ml measuring bottle, adds chloroform and makes the indirubin dissolving and be diluted to scale, shake up, precision is measured 1ml and is put in the 10ml measuring bottle and be diluted to scale with methanol, shakes up, and promptly gets the reference substance solution that contains indirubin 20 μ g among every 1ml;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.25g, puts in the tool plug conical flask, the accurate chloroform 25ml that adds, close plug claims to decide weight, supersound process 30 minutes, put coldly, claim again to decide weight, supply the weight that subtracts mistake with chloroform, shake up, filter, get subsequent filtrate, promptly get need testing solution;
Algoscopy: accurate respectively reference substance solution and each 5 μ l of need testing solution of drawing, inject chromatograph of liquid, to measure, every 1g Lanhuayao contains Indigo Naturalis in indirubin, must not be less than 80 μ g.
2. the method for quality control of Lanhuayao according to claim 1 is characterized in that it being with gas chromatography content of bornyl alcohol to be measured, and operating procedure is as follows:
Chromatographic condition: Polyethylene Glycol (PEG)-20M capillary column (column length 30m, internal diameter 0.32mm, film thickness 0.5 μ m), column temperature is 140 ℃; Number of theoretical plate calculates by the Borneolum Syntheticum peak should be not less than 30000;
Correction factor is measured: precision takes by weighing the methyl salicylate reference substance and adds dehydrated alcohol and make the solution that every 1ml contains 2mg, as inner mark solution; Precision takes by weighing the Borneolum Syntheticum reference substance, adds inner mark solution and makes the solution that every 1ml contains 2mg, in contrast product solution; Draw reference substance solution 0.5 μ l, inject gas chromatograph, the calculation correction factor;
The preparation of need testing solution: get the Lanhuayao porphyrize, precision takes by weighing 0.5g and puts in the conical flask, the accurate inner mark solution 5ml that adds claims to decide weight, supersound process 5 minutes, claim to decide weight again, replenish the weight that subtracts mistake with dehydrated alcohol, filter, accurately draw subsequent filtrate 0.5ml, precision adds the 0.5ml inner mark solution again, and mixing is as need testing solution;
Algoscopy: accurate reference substance solution and each 0.5 μ l of need testing solution of drawing, inject gas chromatograph is measured, and calculates with Borneolum Syntheticum, isoborneol peak area sum, promptly gets content of bornyl alcohol, and every 1g Lanhuayao contains Borneolum Syntheticum (C
10H
18O) must not be less than 15mg.
3. the method for quality control of Lanhuayao according to claim 1 and 2 is characterized in that it being with thin layer chromatography Borneolum Syntheticum to be carried out qualitative identification, and operating procedure is as follows:
Get Lanhuayao 1.5g porphyrize, add chloroform 15ml and shake up, flooded 2 hours, filter, filtrate is as need testing solution; Get the Borneolum Syntheticum reference substance, add chloroform and make the solution that every 1ml contains 2mg, in contrast product solution; Draw each 4 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, the benzene-acetone that with the volume ratio is 9:1 is that developing solvent launches, and takes out, and dries, and spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing in 105 ℃; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the principal spot of same color.
4. the method for quality control of Lanhuayao according to claim 3 is characterized in that it being with thin layer chromatography catechu to be carried out qualitative identification, and operating procedure is as follows:
Get Lanhuayao 8g porphyrize, add ethyl acetate 40ml, supersound process 10 minutes filters, and the residue behind the filtrate evaporate to dryness adds methanol 3ml makes its dissolving, as need testing solution; Other gets catechu control medicinal material 50mg, adds methanol 10ml, floods 20 minutes, filters, and filtrate is medical material solution in contrast; Draw need testing solution 6 μ l, reference substance solution 5 μ l, put respectively on same silica gel g thin-layer plate, the chloroform-methanol-formic acid that with the volume ratio is 20:5:2 is that developing solvent launches, and takes out, dries, spray is with 5% vanillin sulfuric acid solution, and it is clear to be heated to the speckle colour developing at 105 ℃; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.
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| CN200810013418.0A CN101390984B (en) | 2008-09-27 | 2008-09-27 | Detection method of Lanhuayao |
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| CN200810013418.0A CN101390984B (en) | 2008-09-27 | 2008-09-27 | Detection method of Lanhuayao |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102743568A (en) * | 2012-06-28 | 2012-10-24 | 蒋月芳 | Traditional Chinese medicine composite for treating acute gangrenous stomatitis |
| CN102788863A (en) * | 2012-05-18 | 2012-11-21 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
| CN106979987A (en) * | 2017-05-11 | 2017-07-25 | 吉林师范大学 | The HPLC detection methods of main active in Lanhuayao |
| CN113876820A (en) * | 2021-10-07 | 2022-01-04 | 湖南兴蒙制药有限公司 | Processing technology of medicinal fragrant ink |
-
2008
- 2008-09-27 CN CN200810013418.0A patent/CN101390984B/en not_active Expired - Fee Related
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102788863A (en) * | 2012-05-18 | 2012-11-21 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
| CN102788863B (en) * | 2012-05-18 | 2014-04-23 | 贵州神奇药业股份有限公司 | Detection method of compound preparation containing compound Zingiber corallinum Hance solution and urea miconazole ointment |
| CN102743568A (en) * | 2012-06-28 | 2012-10-24 | 蒋月芳 | Traditional Chinese medicine composite for treating acute gangrenous stomatitis |
| CN102743568B (en) * | 2012-06-28 | 2013-07-17 | 杜振莲 | Traditional Chinese medicine composite for treating acute gangrenous stomatitis |
| CN106979987A (en) * | 2017-05-11 | 2017-07-25 | 吉林师范大学 | The HPLC detection methods of main active in Lanhuayao |
| CN106979987B (en) * | 2017-05-11 | 2019-06-25 | 吉林师范大学 | The HPLC detection method of main active in Lanhuayao |
| CN113876820A (en) * | 2021-10-07 | 2022-01-04 | 湖南兴蒙制药有限公司 | Processing technology of medicinal fragrant ink |
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|---|---|
| CN101390984B (en) | 2011-04-20 |
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