CN100543470C - A kind of quality determining method of compound pyrrosia leaf particle - Google Patents
A kind of quality determining method of compound pyrrosia leaf particle Download PDFInfo
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- CN100543470C CN100543470C CNB2005100390520A CN200510039052A CN100543470C CN 100543470 C CN100543470 C CN 100543470C CN B2005100390520 A CNB2005100390520 A CN B2005100390520A CN 200510039052 A CN200510039052 A CN 200510039052A CN 100543470 C CN100543470 C CN 100543470C
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Abstract
The present invention openly provides a kind of Preparation method and its quality control technique of compound pyrrosia leaf particle, raw material holds four flavor Chinese medicines by pyrrosia lingua, the Radix Astragali, kuh-seng, pivot and forms, on the basis of composite shi-wei tablet, making tablet into granule makes, consider that the former formulation disintegration of tablet time is long, bioavilability is low, takes shortcomings such as inconvenience, the present invention carries out secondary development research to this kind, and dosage changing form is a granule.It has advantages such as absorption is fast, and produce effects is rapid.Owing to select natural sweeteners such as stevioside low in calories for use aborning, diabetic also can be taken.
Description
Technical field
The present invention relates to a kind of Preparation method and its quality control technique of compound pyrrosia leaf particle.
Technical background
Composite shi-wei tablet records kind for office of National Drug Administration issues the 15 in standard Chinese traditional patent formulation preparation (the 15 in former Ministry of Public Health drug standards Chinese traditional patent formulation promulgated by the ministries or commissions of the Central Government preparation), hold four traditional Chinese medicine and form by pyrrosia lingua, kuh-seng, Radix Astragali, pivot, has heat-clearing and damp-drying drug, the effect of inducing diuresis for treating strangurtia.There are following deficiency in former formulation tablet and preparation technology thereof: 1. the disintegration of tablet process is slower, is not easy to absorb; 2. pyrrosia lingua, the Radix Astragali, a piece of writing hold part crude drug powder; 3. kuh-seng, pyrrosia lingua, the retaining of Radix Astragali, pivot extract preparation, are not inconsistent with the contained effective constituent character that mainly contains of its each medicine, and extraction efficiency is not high and contain a large amount of invalid components.
Summary of the invention
The invention provides a kind of Preparation method and its quality control technique of compound pyrrosia leaf particle, issue the 15 in standard Chinese traditional patent formulation preparation (the 15 in former Ministry of Public Health ministerial standard Chinese traditional patent formulation preparation) in office of State Food and Drug Administration and record kind " composite shi-wei tablet (WS
3-B-2940-98) " the basis on, make tablet into granule and make, consider that the former formulation disintegration of tablet time is long, bioavilability is low, takes shortcomings such as inconvenience, and this kind is carried out secondary development research, dosage changing form is a granule.It has advantages such as absorption is fast, and produce effects is rapid.Owing to select natural sweeteners such as stevioside low in calories for use aborning, diabetic also can be taken
Technical scheme
A kind of preparation method of compound pyrrosia leaf particle, its bulk drug is that pyrrosia lingua, the Radix Astragali, kuh-seng, pivot hold, and it is characterized in that:
(1), the weight proportion of each material component is
Pyrrosia lingua 740 Radixs Astragali 740 kuh-sengs 740 pivots hold 740
(2), get kuh-seng, 715～720 parts of pyrrosia linguas, 680～690 parts of the Radixs Astragali and piece hold 715～720 parts, adding 6～8 times of water gagings decocts, filter, it is 1.30～1.35 clear cream (60 ℃ of heat are surveyed) that filtrate decompression is condensed into relative density, other gets 20～25 parts of pyrrosia linguas, the Radix Astragali 40～50 Fen, pivots hold 20～25 parts and are ground into fine powder, add 500～525 parts in dextrin, 3040～50 parts of 30 POVIDONE K 30 BP/USPs, 20～25 parts of steviosides again, make softwood, make particle with above-mentioned clear cream mixing;
Above-mentioned steps (2) can be optimized for: get kuh-seng, 715 parts of pyrrosia linguas, the Radix Astragali 690 Fen Ji pivot holds 715 parts, add 6 ~ 8 times of water gagings and decoct secondary, 1 ~ 2 hour for the first time, 0.5 ~ 1 hour for the second time, filter, it is 1.30 ~ 1.35 clear cream (60 ℃ of heat are surveyed) that filtrate decompression is condensed into relative density, other gets 25 parts of pyrrosia linguas, the Radix Astragali 50 part, pieces hold 25 parts and are ground into fine powder, add 525 parts in dextrin, 3050 parts of 30 POVIDONE K 30 BP/USPs, 25 parts of steviosides again, make softwood, make particle with above-mentioned clear cream mixing.
The Quality Control Technology of compound pyrrosia leaf particle is characterized in that:
(1), qualitative identification
A, to get this product Chinese medicine content an amount of, adds an amount of refluxing extraction of methyl alcohol, filters merging filtrate, put evaporate to dryness in the water-bath, residue adds several sodium hydroxide solution of 0.05～0.2mol makes dissolving in right amount, is transferred in the separating funnel, the extraction that adds diethyl ether is left standstill, and the alkali lye layer is retained; Divide and get ether solution, merge, put evaporate to dryness in the water-bath, residue adds methyl alcohol makes dissolving in right amount, as need testing solution; Other gets the matrine reference substance, adds methyl alcohol and makes the matrine reference substance solution; Draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, the benzene-acetone-ethyl acetate-strong ammonia solution that with the volume ratio is 2:3:4:0.2 launches as developping agent, takes out, and dries, and spray is with rare bismuth potassium iodide test solution; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the spot of same color;
B, get and differentiate a item alkali lye layer down, add water-saturated n-butanol and extract, leave standstill the retention of alkali lye layer; Divide and get normal butyl alcohol liquid, merge, put evaporate to dryness in the water-bath, residue adds water makes dissolving in right amount, passes through D
101The type macroporous adsorptive resins (50ml,
1.8cm * 40cm), add an amount of wash-out of water, discard water lotion, continuous with an amount of wash-out of 30～50% ethanol, discard ethanol eluate, add an amount of wash-out of 50～80% ethanol again, collect ethanol eluate, put evaporate to dryness in the water-bath, residue adds methyl alcohol makes dissolving in right amount, as need testing solution; Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes the Astragaloside IV reference substance solution; Drawing need testing solution, each 5 μ l of Astragaloside IV reference substance solution, put respectively on same silica gel g thin-layer plate, is that chloroform-methyl alcohol-glacial acetic acid-water of 12:3:1:0.5 is developping agent with the volume ratio, launch, take out, dry, spray is with sulfuric acid ethanol liquid, and it is clear to be heated to the spot colour developing at high temperature; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, should show the spot of same color;
(2), quantitative measurement
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filling agent; Methyl alcohol-acetonitrile-phosphate buffer (pH 7.6)-triethylamine (15:25:65:0.1 transfers pH=7.8 with phosphoric acid) is a moving phase, detects wavelength 220nm; Number of theoretical plate calculates by the matrine peak should be not less than 9000; The preparation of reference substance solution: precision takes by weighing puts phosphorus pentoxide desiccator to be dried to the matrine reference substance of constant weight an amount of, adds methyl alcohol and makes the solution that every 1ml contains 0.2mg, shakes up, promptly; The preparation of need testing solution: get this product Chinese medicine content 1g, the accurate title, decide, and puts in the round-bottomed flask, add strong ammonia solution, chloroform is an amount of, heating and refluxing extraction filters, filter residue, filter add chloroform and wash in right amount, merging filtrate is transferred in the separating funnel, and the sodium hydroxide solution that adds 0.1mol/L washs 1～3 time, each 5～20ml, leave standstill, divide and get the alkali lye layer, discard; Chloroform layer adds water again and washs in right amount, divides and gets chloroform solution, puts evaporate to dryness in the water-bath, and residue adds an amount of gradation of methyl alcohol makes dissolving, and quantitatively moves in the 10ml measuring bottle, adds methyl alcohol again and is diluted to scale, and close plug shakes up, promptly; Determination method: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject liquid chromatograph, measure, promptly get the every 5g of this product Chinese medicine and contain kuh-seng with matrine (C
15H
24N
2O) meter must not be less than 5.0mg.
Description of drawings
Fig. 1 making schematic flow sheet of the present invention.
Embodiment
Referring to Fig. 1.
[prescription] pyrrosia lingua 740g piece of writing holds 740g kuh-seng 740g Radix Astragali 740g
[method for making] above four flavors are got kuh-seng, pyrrosia lingua 715g, Radix Astragali 690g Ji pivot holds 715g, add 8 times of water gagings and decoct secondary, 2 hours for the first time, 1 hour for the second time, filter, it is 1.30 ~ 1.35 clear cream (60 ℃ of heat are surveyed) that filtrate decompression is condensed into relative density, other gets pyrrosia lingua 25g, Radix Astragali 50g, a piece of writing holds 25g and is ground into fine powder, adds dextrin 575g, stevioside 25g again, makes softwood with above-mentioned clear cream mixing, make particle, drying is made 1000g, promptly.
[proterties] this product is that yellowish-brown is to tan particle; Little sweet, little hardship of distinguishing the flavor of.
This product 10g is got in [discriminating] (1), and porphyrize adds methyl alcohol 50ml refluxing extraction 2 times, each 1 hour, filter, merging filtrate is put evaporate to dryness in the water-bath, the sodium hydroxide solution 30ml that residue adds 0.1mol/L makes dissolving, be transferred in the separating funnel, add diethyl ether and extract 3 times, each 15ml, leave standstill, the alkali lye layer is retained.Divide and get ether solution, merge, put evaporate to dryness in the water-bath, residue adds methyl alcohol 5ml makes dissolving, as need testing solution.Other gets the matrine reference substance, adds methyl alcohol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin-layered chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with benzene-acetone-ethyl acetate-strong ammonia solution (2:3:4:0.2) is developping agent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the spot of same color.
(2) get discriminating (1) alkali lye layer down, add water-saturated n-butanol and extract 3 times, each 15ml leaves standstill, the retention of alkali lye layer.Divide and get normal butyl alcohol liquid, merge, put evaporate to dryness in the water-bath, residue adds water 5ml heating makes dissolving, is cooled to room temperature, passes through D
101The type macroporous adsorptive resins (50ml,
1.8cm * 40cm), add water 100ml wash-out, discard water lotion, continuous with 40% ethanol 50ml wash-out, discard 40% ethanol eluate, add 70% ethanol 100ml wash-out again, collect 70% ethanol eluate, put evaporate to dryness in the water-bath, residue adds methyl alcohol 1ml makes dissolving, as need testing solution.Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin-layered chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with chloroform-methyl alcohol-glacial acetic acid-water (12:3:1:0.5) is developping agent, launch, take out, dry, spray is with 10% sulfuric acid ethanol liquid, and it is clear to be heated to the spot colour developing at 105 ℃.In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, should show the spot of same color.
[inspection] should meet every regulation relevant under the granule item (appendix IC of Chinese Pharmacopoeia version in 2000).
[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).
Chromatographic condition and system suitability test are filling agent with octadecylsilane chemically bonded silica; Methyl alcohol-acetonitrile-phosphate buffer (pH 7.6)-triethylamine (15:25:65:0.1 transfers pH=7.8 with phosphoric acid) is a moving phase, detects wavelength 220nm.Number of theoretical plate calculates by the matrine peak should be not less than 9000.
The preparation precision of reference substance solution takes by weighing puts phosphorus pentoxide desiccator to be dried to the matrine reference substance of constant weight an amount of, adds methyl alcohol and makes the solution that every 1ml contains 0.2mg, shakes up, promptly.
The content under this product content uniformity is got in the preparation of need testing solution, and porphyrize is got about 1g, the accurate title, decide, and puts in the round-bottomed flask, adds strong ammonia solution 1ml, chloroform 50ml, heating and refluxing extraction 2 hours filters, and filter residue, filter add chloroform 10ml washing, merging filtrate is transferred in the separating funnel, and the sodium hydroxide solution that adds 0.1mol/L washs 2 times, each 15ml, leave standstill, divide and get the alkali lye layer, discard.Chloroform layer adds water 15ml washing again, divides and gets chloroform solution, puts evaporate to dryness in the water-bath, and residue adds methyl alcohol 10ml gradation makes dissolving, and quantitatively moves in the l0ml measuring bottle, adds methyl alcohol again and is diluted to scale, and close plug shakes up, promptly.
Accurate respectively reference substance solution and each the 20 μ l of need testing solution of drawing of determination method inject liquid chromatograph, measure, promptly.
This product contains kuh-seng with matrine (C for every bag
15H
24N
2O) meter must not be less than 5.0mg.
[function with cure mainly] heat-clearing and damp-drying drug, inducing diuresis for treating strangurtia.Be used for difficult urination, frequent micturition, urgent urination, odynuria, edema of lower extremity;
Also can be used for acute and chronic glomerulonephritis, pyelonephritis, cystitis, see the person that has the above-mentioned symptom.
[usage and consumption] boiling water is taken after mixing it with water, one time 1 bag, 3 times on the one, 15 days is a course of treatment, can serve on two courses of treatment.
[specification] every packed 5g
[storage] sealing.
Claims (1)
1, a kind of quality determining method of compound pyrrosia leaf particle is characterized in that: compound pyrrosia leaf particulate material medicine is that pyrrosia lingua, the Radix Astragali, kuh-seng, pivot hold, and the weight proportion of each material component is: pyrrosia lingua 740, the Radix Astragali 740, kuh-seng 740, pivots hold 740; Preparation by the following method: get kuh-seng, pyrrosia lingua 715-720 part, Radix Astragali 680-690 Fen Ji pivot holds 715-720 part, add 6-8 times of water gaging and decoct, filter, it is the clear cream of 1.30-1.35 that filtrate decompression is condensed into 60 ℃ of heat surveys, relative densities; Other gets pyrrosia lingua 20-25 part, Radix Astragali 40-50 part, a piece of writing holds 20-25 part and is ground into fine powder, adds dextrin 500-525 part, 30 POVIDONE K 30 BP/USP 3040-50 part, stevioside 20-25 part again, makes softwood with above-mentioned clear cream mixing, makes particle;
Resulting granules is carried out following discriminating and mensuration:
(1), qualitative identification
A, to get this product Chinese medicine content an amount of, adds an amount of refluxing extraction of methyl alcohol, filters merging filtrate, put evaporate to dryness in the water-bath, the sodium hydroxide solution that residue adds 0.05～0.2mol/L makes dissolving in right amount, is transferred in the separating funnel, the extraction that adds diethyl ether is left standstill, and the alkali lye layer is retained; Divide and get ether solution, merge, put evaporate to dryness in the water-bath, residue adds methyl alcohol makes dissolving in right amount, as need testing solution; Other gets the matrine reference substance, adds methyl alcohol and makes the matrine reference substance solution; Draw each 5 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, the benzene-acetone-ethyl acetate-strong ammonia solution that with the volume ratio is 2:3:4:0.2 launches as developping agent, takes out, and dries, and spray is with rare bismuth potassium iodide test solution; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, show the spot of same color;
B, get and differentiate a item alkali lye layer down, add water-saturated n-butanol and extract, leave standstill the retention of alkali lye layer; Divide and get normal butyl alcohol liquid, merge, put evaporate to dryness in the water-bath, residue adds water makes dissolving in right amount, passes through D
101Type, 50ml,
1.8cm the macroporous adsorptive resins of * 40cm, add an amount of wash-out of water, discard water lotion, continue with an amount of wash-out of 30～50% ethanol, discard ethanol eluate, add an amount of wash-out of 50～80% ethanol again, collect ethanol eluate, put evaporate to dryness in the water-bath, residue adds methyl alcohol makes dissolving in right amount, as need testing solution; Other gets the Astragaloside IV reference substance, adds methyl alcohol and makes the Astragaloside IV reference substance solution; Drawing need testing solution, each 5 μ l of Astragaloside IV reference substance solution, put respectively on same-silica gel g thin-layer plate, is that chloroform-methyl alcohol-glacial acetic acid-water of 12:3:1:0.5 is developping agent with the volume ratio, launch, take out, dry, spray is with sulfuric acid ethanol liquid, and it is clear to be heated to the spot colour developing at high temperature; In the test sample chromatogram, with the corresponding position of reference substance chromatogram on, should show the spot of same color;
(2), quantitative measurement
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filling agent; 15:25:65:0.1 methyl alcohol-acetonitrile-phosphate buffer-triethylamine be moving phase, transfer pH=7.8 with phosphoric acid, methyl alcohol-acetonitrile-phosphate buffer pH7.6 detects wavelength 220nm; Number of theoretical plate calculates by the matrine peak should be not less than 9000; The preparation of reference substance solution: precision takes by weighing puts phosphorus pentoxide desiccator to be dried to the matrine reference substance of constant weight an amount of, adds methyl alcohol and makes the solution that every 1ml contains 0.2mg, shakes up, promptly; The preparation of need testing solution: get this product Chinese medicine content 1g, the accurate title, decide, and puts in the round-bottomed flask, add strong ammonia solution, chloroform is an amount of, heating and refluxing extraction filters, filter residue, filter add chloroform and wash in right amount, merging filtrate is transferred in the separating funnel, and the sodium hydroxide solution that adds 0.1mol/L washs 1～3 time, each 5～20ml, leave standstill, divide and get the alkali lye layer, discard; Chloroform layer adds water again and washs in right amount, divides and gets chloroform solution, puts evaporate to dryness in the water-bath, and residue adds an amount of gradation of methyl alcohol makes dissolving, and quantitatively moves in the 10ml measuring bottle, adds methyl alcohol again and is diluted to scale, and close plug shakes up, promptly; Determination method: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject liquid chromatograph, measure, promptly get the every 5g of this product Chinese medicine and contain kuh-seng with matrine C
15H
24N
2The O meter must not be less than 5.0mg.
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| CNB2005100390520A CN100543470C (en) | 2005-04-22 | 2005-04-22 | A kind of quality determining method of compound pyrrosia leaf particle |
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| CNB2005100390520A CN100543470C (en) | 2005-04-22 | 2005-04-22 | A kind of quality determining method of compound pyrrosia leaf particle |
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| CN103055140A (en) * | 2013-02-04 | 2013-04-24 | 贵阳德昌祥药业有限公司 | Granules for nourishing liver and kidney and tranquilizing mind by nourishing heart and preparation method thereof |
| CN105403654B (en) * | 2015-12-11 | 2017-04-05 | 陇西保和堂药业有限责任公司 | A kind of method for improving the identification of Radix Astragali thin-layer chromatography |
| CN105943898A (en) * | 2016-03-22 | 2016-09-21 | 季晓斌 | Traditional Chinese medicine composition for treating dysuria |
| CN110441443B (en) * | 2019-09-20 | 2022-06-24 | 广东一方制药有限公司 | UPLC characteristic spectrum construction method and identification method of pyrrosia peduncularis, pyrrosia lingua, pyrrosia cottonii and pyrrosia huabeiensis |
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2005
- 2005-04-22 CN CNB2005100390520A patent/CN100543470C/en not_active Expired - Fee Related
Non-Patent Citations (3)
| Title |
|---|
| 中药药剂学. 范碧亭，392，上海科学技术出版社. 1997 * |
| ***药品标准. 国家药典委员会，134. 1997 中药药剂学. 范碧亭，392，上海科学技术出版社. 1997 |
| ***药品标准. 国家药典委员会，134. 1997 * |
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