CN102100818B - Quality control method for lophanthus antifebrile tablets - Google Patents

Quality control method for lophanthus antifebrile tablets Download PDF

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CN102100818B
CN102100818B CN 200910244825 CN200910244825A CN102100818B CN 102100818 B CN102100818 B CN 102100818B CN 200910244825 CN200910244825 CN 200910244825 CN 200910244825 A CN200910244825 A CN 200910244825A CN 102100818 B CN102100818 B CN 102100818B
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thin
lophanthus
antifebrile
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CN102100818A (en
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朱晓丹
刘新元
谷翠丽
高学谦
靳学海
高松
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Jinyao Darentang Group Co ltd Longshunrong Pharmaceutical Factory
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LONGSHUNRONG PHARMACEUTICAL FACTORY TIANJIN ZHONGXIN PHARMACEUTICAL GROUP CO
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Abstract

The invention relates to a detection method for lophanthus antifebrile tablets, which comprises the following steps of: identifying whether the lophanthus antifebrile tablets in a prescription contains components such as angelica dahurica, officinal magnolia bark, swordlike atractylodes rhizome, perilla leaf oil and the like or not by thin layer chromatography, and detecting tangerine peel content in the lophanthus antifebrile tablets in the prescription by taking naringin as a reference substance through liquid chromatography. In the quality control method, specific requirements of a Chinese patent medicament variety amendment item task table in an action plan are improved according to national medicine standard. In the quality control method, the standard for the lophanthus antifebrile tablets is improved, in the original standard, officinal magnolia bark is only identified, so on the basis of the original standard, a thin layer identifying method for angelica dahurica and swordlike atractylodes rhizome is added; and a method for measuring the tangerine peel content is formulated by taking hesperidin as a reference substance, so by the amended quality standard, the quality control of medicines is improved.

Description

The detection method of lophanthus antifebrile tablet
Technical field
The invention belongs to technical field of traditional Chinese medicines, relate to the detection method of Chinese medicine, especially a kind of method of quality control of lophanthus antifebrile tablet.
Background technology
Lophanthus antifebrile tablet is made up of rhizoma atractylodis, dried orange peel, the bark of official magnolia (ginger system), the root of Dahurain angelica, Poria cocos, the shell of areca nut, prepared RHIZOMA PINELLIZE without adju-vant, extract of licorice root, patchouli oil, perilla leaf oil; Preparation method: above ten flavors; The root of Dahurain angelica and prepared RHIZOMA PINELLIZE without adju-vant are ground into fine powder respectively; Sieving for standby, dried orange peel are extracted and dissolved in right amount with ethanol after volatile oil mixes with patchouli oil, perilla leaf oil, and be subsequent use; Dried orange peel dregs of a decoction decocting boils once, and the time is 1 hour, and the shell of areca nut, Poria cocos decocting boil twice, and 2 hours for the first time, 1 hour for the second time, merge above decocting liquid, filter, filtrating merges with extract of licorice root, is concentrated into relative density 1.20~1.30 (50~60 ℃) cream; The root of Dahurain angelica, rhizoma atractylodis, the bark of official magnolia be with 60% alcohol reflux three times, and 6 hours for the first time, 4 hours for the second time, 2 hours for the third time, merge above ethanol extract, filter, filtrate recycling ethanol is condensed into cream; Water, pure condensed cream are merged, add fine powder and auxiliary materials such as prepared RHIZOMA PINELLIZE without adju-vant, the root of Dahurain angelica, mixing is processed particle, and drying is blended into the alcoholic solution of patchouli oil, perilla leaf oil, Oleum Citri Reticulatae, mixing, compacting in flakes, or bag film-coating promptly gets.
These article were " huoxiang zhengqi powder " of Song's formulary of peaceful benevolent dispensary originally; Change system into tablet in nineteen fifty-five, 1964 annual incomes " Tianjin Chinese patent drug standard " additional copy, " Tianjin Chinese patent drug standard " recorded this medicine in 1978; The 15th in 1998 annual income Ministry of Public Health Chinese traditional patent formulation preparations; Because these article are traditional Cheng Fang " huoxiang zhengqi powder " change formulation, and of the same name with the side with HuoXiangZhengQiShui, ageratum particle and HuoXiangZhengQi soft capsule etc., factory thinks that these article should not the change of title still.
Though still there is not the international standard of plant medicine at present in the world; The trend of Chinese medicine standard but the south east asia of the U.S., European Union, China and tradition outlet Chinese medicine is improved; In the case, the standard that needs to propose to be fit to China's product quality is to adapt to international standard, and it is historical that China has the Chinese medicine in thousands of years to use; Countries in the world are many Chinese medicine standards with reference to China in working out corresponding autonomic drug target level of product quality, so quality standard perfect, that improve Chinese medicine is more extremely urgent.
Summary of the invention
The objective of the invention is to overcome the weak point of prior art, a kind of method of quality control of lophanthus antifebrile tablet that can the qualitative and quantitative analysis drug ingedient is provided, this method has that detection means is simple, the testing result characteristic of accurate.
The objective of the invention is to realize through following technical scheme:
A kind of method of quality control of lophanthus antifebrile tablet, step is:
(1) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain root of Dahurain angelica composition;
(2) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain bark of official magnolia composition;
(3) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain the rhizoma atractylodis composition;
(4) liquid phase chromatography detects dried orange peel content in the lophanthus antifebrile tablet.
And the method that the thin-layer chromatography of the said root of Dahurain angelica is differentiated is following:
1. the preparation of need testing solution: get and supply examination lophanthus antifebrile tablet sample, remove dressing, porphyrize, the 30ml that adds diethyl ether flooded 1 hour, and constantly jolting is centrifugal, gets supernatant, flings to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get the Imperatorin reference substance, add ethyl acetate and process the solution that every 1ml contains 1mg, as reference substance solution;
3. thin-layer chromatography condition and result: the thin-layer chromatography test, draw need testing solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ether=3: 2 is a developping agent, launches, and takes out; Dry; Put under the 365nm ultraviolet lamp and inspect, inspect the test sample chromatogram with the corresponding position of reference substance chromatogram on whether show the fluorescence spot of same color, and then whether contain root of Dahurain angelica composition in definite sample.
And the method that the thin-layer chromatography of the said bark of official magnolia is differentiated is following:
1. the preparation of need testing solution: get the need testing solution in the root of Dahurain angelica discriminating, volatilize ethyl acetate, residue adds methyl alcohol 2ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get magnolol and honokiol reference substance and add absolute ethyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution;
3. thin-layer chromatography condition and result: the thin-layered chromatography test, draw need testing solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ethyl acetate: methyl alcohol=80: 20: 2 is developping agent, launches, and takes out; Dry, spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing; Inspect on the corresponding position of reference substance chromatogram, whether to show the spot of same color in the test sample chromatogram, and then confirm to supply whether to contain bark of official magnolia composition in the examination.
And the method that the thin-layer chromatography of said rhizoma atractylodis is differentiated is following:
1. the preparation of need testing solution: get and supply examination lophanthus antifebrile tablet sample, film-coating is removed dressing, and porphyrize adds normal hexane, and sonicated filters, the filtrating evaporate to dryness, and residue adds normal hexane 2ml makes dissolving, as need testing solution;
2. the preparation of control medicinal material solution: get rhizoma atractylodis control medicinal material 0.5g, add normal hexane 2ml, sonicated 15 minutes filters, and filtrating is as control medicinal material solution;
3. thin-layer chromatography condition and result: the thin-layered chromatography test, draw need testing solution, each 5~10 μ l of control medicinal material solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ethyl acetate=20: 1 is developping agent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid of 5% paradime thylaminobenzaldehyde; It is clear to be heated to spot colour developing, inspect in the test sample chromatogram with the corresponding position of control medicinal material chromatogram on whether show the spot of same color, and then whether contain the rhizoma atractylodis composition in definite sample.
And the method for the content of said liquid chromatography for measuring dried orange peel is:
1. chromatographic condition: use octadecylsilane chemically bonded silica to be filling agent; Acetonitrile: 0.05mol/L sodium dihydrogen phosphate=13: 70 is a moving phase; The detection wavelength is 284nm; Flow velocity: 1.0ml/min, 30 ℃ of column temperatures, number of theoretical plate should be not less than 2000 by the aurantiamarin peak;
2. the preparation of control medicinal material solution: it is an amount of that precision takes by weighing the aurantiamarin reference substance, adds methyl alcohol and process the solution that every 1ml contains aurantiamarin 60 μ g, as reference substance solution, goes into Liquid Detection;
3. the preparation of need testing solution: get 20 of these article, Film coated tablets is removed dressing, and accurate the title decides, and porphyrize is got 0.75g; The accurate title, decide, and puts in the 25ml tool plug conical flask, and the accurate methyl alcohol 25ml that adds claims to decide weight, sonicated 30 minutes; Put coldly, claim again to decide weight, supply the weight that subtracts mistake, mixing with methyl alcohol; Filter, get subsequent filtrate, promptly get, go into Liquid Detection;
4. interpretation of result: contain the quantifier regulation according to the tentative standard WS-10057 of State Food and Drug Administration (ZD-0057)-2002 lophanthus antifebrile tablet, every of these article contain dried orange peel in Determination of Hesperidin Content, must not be less than 0.35mg, wherein plain sheet: every heavy 0.3g; Film coated tablets: every heavy 0.31g.
Advantage of the present invention and good effect are:
1, improves the specific requirement that action plan Chinese patent drug kind increases revision project task table according to the national drug standards; The present invention has carried out raising, perfect to the lophanthus antifebrile tablet standard; The discriminating of having only the bark of official magnolia is arranged in primary standard, on the primary standard basis, increased the thin layer discrimination method of the root of Dahurain angelica, rhizoma atractylodis; With the aurantiamarin is reference substance, has formulated the content assaying method of dried orange peel, revised quality standard, the quality control that has improved medicine.
2, have only the thin layer of the bark of official magnolia to differentiate in the primary standard; Can not the better controlled product quality; The present invention has all carried out the thin layer discrimination test from the root of Dahurian angelica, rhizoma atractylodis, perilla leaf oil, patchouli oil in writing out a prescription on the basis of primary standard; Filtering out that favorable reproducibility, specificity are strong, the spot colour developing is clear, the bark of official magnolia, the root of Dahurain angelica, rhizoma atractylodis, perilla leaf oil method that the result is prone to judge are included in the standard, is that the discriminating of this important preparation is more accurate.
Description of drawings
Fig. 1 is a root of Dahurain angelica thin-layer chromatography identification color spectrogram of the present invention, is followed successively by from left to right: 1 lophanthus antifebrile tablet (lot number 0704001), 2 lophanthus antifebrile tablets (lot number 0704002), 3 lophanthus antifebrile tablets (lot number 0704003), Imperatorin, lophanthus antifebrile tablet root of Dahurain angelica negative sample;
Fig. 2 is a bark of official magnolia thin-layer chromatography identification color spectrogram of the present invention, is followed successively by from left to right: 1 lophanthus antifebrile tablet (lot number 0704001), 2 lophanthus antifebrile tablets (lot number 0704002); 3 lophanthus antifebrile tablets (lot number 0704003); 4 bark of official magnolia reference substances, 5 magnolia obovata reference substances, 6 lophanthus antifebrile tablet bark of official magnolia negative samples;
Fig. 3 is a rhizoma atractylodis thin-layer chromatography identification color spectrogram of the present invention, is followed successively by from left to right: 1 lophanthus antifebrile tablet (lot number 0704001), 2 lophanthus antifebrile tablets (lot number 0704002), 3 lophanthus antifebrile tablets (lot number 0704003), rhizoma atractylodis control medicinal material, 5 lophanthus antifebrile tablet rhizoma atractylodis negative samples;
Fig. 4 is a perilla leaf oil thin-layer chromatography identification color spectrogram of the present invention, is followed successively by from left to right: 1. perilla leaf oil A, 2. perilla leaf oil B, 3. perilla leaf oil C, 4. perilla leaf control medicinal material;
Fig. 5 is an aurantiamarin reference substance solution of the present invention;
Fig. 6 is negative sample spectrogram in the aurantiin detection of the present invention;
Fig. 7 is for supplying the detection chromatogram of test agent lophanthus antifebrile tablet (sample 0704001) in the aurantiin detection of the present invention.
Embodiment
Below in conjunction with embodiment, the present invention is further specified, following embodiment is illustrative, is not determinate, can not limit protection scope of the present invention with following embodiment.
The method of quality control of lophanthus antifebrile tablet, the step of its method is:
(1) thin-layer chromatography of the root of Dahurain angelica is differentiated
1. the preparation of need testing solution: get and supply 20 in examination lophanthus antifebrile tablet sample, remove dressing, porphyrize, the 30ml that adds diethyl ether flooded 1 hour, and constantly jolting is centrifugal, gets supernatant, flings to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get the Imperatorin reference substance, add ethyl acetate and process the solution that every 1ml contains 1mg, as reference substance solution;
3. the preparation of negative sample solution: by the prescription proportioning, get and remove other flavor medicinal materials of the root of Dahurain angelica, process sample, make negative sample solution by above-mentioned need testing solution preparation method again by the preparation technology of former medicine;
4. thin-layer chromatography condition and result: according to thin-layered chromatography (2005 editions appendix VIB of Chinese Pharmacopoeia) test; Draw need testing solution, negative control article solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate, with sherwood oil (60~90 ℃): ether=3: 2 is a developping agent; Launch; Take out, dry, put under the ultraviolet lamp (365nm) and inspect.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the fluorescence spot of same color, negative noiseless, testing result is seen Fig. 1.
(2) thin-layer chromatography of the bark of official magnolia is differentiated
1. the preparation of need testing solution: get the need testing solution under discriminating (1) item, volatilize ethyl acetate, residue adds methyl alcohol 2ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get magnolol and honokiol reference substance and add absolute ethyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution;
3. the preparation of negative sample solution: by the prescription proportioning, get other flavor medicinal materials of removing the bark of official magnolia, process sample, make negative sample solution by above-mentioned need testing solution preparation method again by former medicine preparation technology;
4. thin-layer chromatography condition and result: according to thin-layered chromatography (appendix VIB of Chinese Pharmacopoeia version in 2005) test, draw need testing solution, negative sample solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate; With sherwood oil (60~90 ℃): ethyl acetate: methyl alcohol=80: 20: 2 is developping agent; Launch, take out, dry; Spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the spot of same color, and negative noiseless, testing result is seen Fig. 2.
(3) thin-layer chromatography of rhizoma atractylodis is differentiated
1. the preparation of need testing solution: get and supply 6 in examination lophanthus antifebrile tablet sample, film-coating is removed dressing, and porphyrize adds normal hexane 20ml, and sonicated 15 minutes filters, the filtrating evaporate to dryness, and residue adds normal hexane 2ml makes dissolving, as need testing solution.
2. the preparation of control medicinal material solution: get rhizoma atractylodis control medicinal material 0.5g, add normal hexane 2ml, sonicated 15 minutes filters, and filtrating is as control medicinal material solution.
3. the preparation of negative sample solution: by the prescription proportioning, get other flavor medicinal materials of removing rhizoma atractylodis, process sample, make negative sample solution by above-mentioned need testing solution preparation method again by former medicine preparation technology.
4. thin-layer chromatography condition and result: according to thin-layered chromatography (2005 editions appendix VIB of Chinese Pharmacopoeia) test, draw need testing solution, each 5~10 μ l of control medicinal material solution, put respectively on same silica gel g thin-layer plate; With sherwood oil (60~90 ℃): ethyl acetate=20: 1 is developping agent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid of 5% paradime thylaminobenzaldehyde, and it is clear to be heated to the spot colour developing.In the test sample chromatogram, with the corresponding position of control medicinal material chromatogram on, show the spot of same color, and negative noiseless, see Fig. 3.
(4) thin-layer chromatography of perilla leaf oil is differentiated
1. the preparation of reference substance solution: other gets perilla leaf control medicinal material 0.7g, puts in the 500ml round-bottomed flask, adds water 250ml, mixing; Connect volatile oil determination apparatus, add water to scale from the analyzer upper end, and till overflow goes in the flask; Add sherwood oil (60 ℃~90 ℃) 1.5ml again, connect reflux condensing tube, be heated to and boil; And keep little and boiled 2 hours, put coldly, obtain petroleum ether layer as reference substance solution;
2. supply the preparation of examination solution: get and supply to try the lophanthus antifebrile tablet sample according to method method making need testing solution 1.;
3. according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2005 B) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate; With sherwood oil (60 ℃~90 ℃): ethyl acetate=19: 1 is developping agent; Launch, take out, dry; Spray is placed with the dinitrophenylhydrazine test solution.In the test sample chromatogram, with the corresponding position of control medicinal material chromatogram on, show the spot of same color.
(5) assay of liquid phase chromatography dried orange peel
Chromatographic condition: use octadecylsilane chemically bonded silica to be filling agent; Acetonitrile: 0.05mol/L sodium dihydrogen phosphate=13: 70 is a moving phase, and wherein sodium dihydrogen phosphate is with phosphoric acid adjust pH to 3; Wavelength is 284nm; Flow velocity: 1.0ml/min, 30 ℃ of column temperatures, number of theoretical plate should be not less than 2000 by the aurantiamarin peak;
1. the preparation of control medicinal material solution: it is an amount of that precision takes by weighing the aurantiamarin reference substance, adds methyl alcohol and process the solution that every 1ml contains aurantiamarin 60 μ g, as reference substance solution, goes into Liquid Detection, and testing result is as shown in Figure 5;
2. the preparation of negative sample solution: by the prescription proportioning, get other medicinal materials except that dried orange peel, process tablet by former medicine preparation technology, 1. need testing solution preparation method set by step makes negative sample solution again, goes into Liquid Detection, and testing result is as shown in Figure 6;
3. the preparation of need testing solution: get 20 of these article, Film coated tablets is removed dressing, and accurate the title decides, and porphyrize is got 0.75g; The accurate title, decide, and puts in the 25ml tool plug conical flask, and the accurate methyl alcohol 25ml that adds claims to decide weight, sonicated 30 minutes; Put coldly, claim again decide weight, supply the weight that subtracts mistake with methyl alcohol, mixing, filtration; Get subsequent filtrate, promptly get, go into liquid phase, testing result is as shown in Figure 7;
4. interpretation of result: negative need testing solution does not have the aurantiamarin Interference Peaks and exists; This detection method specificity is good; Contain the quantifier regulation according to the tentative standard WS-10057 of State Food and Drug Administration (ZD-0057)-2002 lophanthus antifebrile tablet, every (plain sheet: every heavy 0.3g of these article; Film coated tablets: every heavy 0.31g) contain dried orange peel, must not be less than 0.35mg in Determination of Hesperidin Content.

Claims (1)

1. the detection method of a lophanthus antifebrile tablet, it is characterized in that: the step of its method is:
(1) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain root of Dahurain angelica composition;
(2) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain bark of official magnolia composition;
(3) thin-layered chromatography differentiates in the lophanthus antifebrile tablet whether contain the rhizoma atractylodis composition;
(4) liquid phase chromatography detects dried orange peel content in the lophanthus antifebrile tablet;
The method that the thin-layer chromatography of the said root of Dahurain angelica is differentiated is following:
1. the preparation of need testing solution: get and supply examination lophanthus antifebrile tablet sample, remove dressing, porphyrize, the 30ml that adds diethyl ether flooded 1 hour, and constantly jolting is centrifugal, gets supernatant, flings to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get the Imperatorin reference substance, add ethyl acetate and process the solution that every 1ml contains 1mg, as reference substance solution;
3. thin-layer chromatography condition and result: the thin-layer chromatography test, draw need testing solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ether=3: 2 is a developping agent, launches, and takes out; Dry; Put under the 365nm ultraviolet lamp and inspect, inspect the test sample chromatogram with the corresponding position of reference substance chromatogram on whether show the fluorescence spot of same color, and then whether contain root of Dahurain angelica composition in definite sample;
The method that the thin-layer chromatography of the said bark of official magnolia is differentiated is following:
1. the preparation of need testing solution: get the need testing solution in the root of Dahurain angelica discriminating, volatilize ethyl acetate, residue adds methyl alcohol 2ml makes dissolving, as need testing solution;
2. the preparation of reference substance solution: get magnolol and honokiol reference substance and add absolute ethyl alcohol and process the solution that every 1ml contains 1mg, as reference substance solution;
3. thin-layer chromatography condition and result: the thin-layered chromatography test, draw need testing solution and each 5-10 μ l of reference substance solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ethyl acetate: methyl alcohol=80: 20: 2 is developping agent, launches, and takes out; Dry, spray is with 5% vanillic aldehyde sulfuric acid solution, and it is clear to be heated to the spot colour developing; Inspect on the corresponding position of reference substance chromatogram, whether to show the spot of same color in the test sample chromatogram, and then confirm to supply whether to contain bark of official magnolia composition in the examination;
The method that the thin-layer chromatography of said rhizoma atractylodis is differentiated is following:
1. the preparation of need testing solution: get and supply examination lophanthus antifebrile tablet sample, film-coating is removed dressing, and porphyrize adds normal hexane, and sonicated filters, the filtrating evaporate to dryness, and residue adds normal hexane 2ml makes dissolving, as need testing solution;
2. the preparation of control medicinal material solution: get rhizoma atractylodis control medicinal material 0.5g, add normal hexane 2ml, sonicated 15 minutes filters, and filtrating is as control medicinal material solution;
3. thin-layer chromatography condition and result: the thin-layered chromatography test, draw need testing solution, each 5~10 μ l of control medicinal material solution, put respectively on same silica gel g thin-layer plate; With sherwood oil: ethyl acetate=20: 1 is developping agent; Launch, take out, dry; Spray is with 10% ethanol solution of sulfuric acid of 5% paradime thylaminobenzaldehyde; It is clear to be heated to spot colour developing, inspect in the test sample chromatogram with the corresponding position of control medicinal material chromatogram on whether show the spot of same color, and then whether contain the rhizoma atractylodis composition in definite sample;
The method of the content of said liquid chromatography for measuring dried orange peel is:
1. chromatographic condition: use octadecylsilane chemically bonded silica to be filling agent; Acetonitrile: 0.05mol/L sodium dihydrogen phosphate=13: 70 is a moving phase; The detection wavelength is 284nm; Flow velocity: 1.0ml/min, 30 ℃ of column temperatures, number of theoretical plate should be not less than 2000 by the aurantiamarin peak;
2. the preparation of control medicinal material solution: it is an amount of that precision takes by weighing the aurantiamarin reference substance, adds methyl alcohol and process the solution that every 1ml contains aurantiamarin 60 μ g, as reference substance solution, goes into Liquid Detection;
3. the preparation of need testing solution: get 20 of these article, Film coated tablets is removed dressing, and accurate the title decides, and porphyrize is got 0.75g; The accurate title, decide, and puts in the 25ml tool plug conical flask, and the accurate methyl alcohol 25ml that adds claims to decide weight, sonicated 30 minutes; Put coldly, claim again to decide weight, supply the weight that subtracts mistake, mixing with methyl alcohol; Filter, get subsequent filtrate, promptly get, go into Liquid Detection;
4. interpretation of result: contain the quantifier regulation according to State Food and Drug Administration's tentative standard WS-10057-2002 lophanthus antifebrile tablet, every of these article contain dried orange peel in Determination of Hesperidin Content, must not be less than 0.35mg, wherein plain sheet: every heavy 0.3g; Film coated tablets: every heavy 0.31g.
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