CN100374126C - Capsule for treating myocardial strain, angina pectoris and arteriosclerosis and its preparing method - Google Patents
Capsule for treating myocardial strain, angina pectoris and arteriosclerosis and its preparing method Download PDFInfo
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- CN100374126C CN100374126C CNB2006100185427A CN200610018542A CN100374126C CN 100374126 C CN100374126 C CN 100374126C CN B2006100185427 A CNB2006100185427 A CN B2006100185427A CN 200610018542 A CN200610018542 A CN 200610018542A CN 100374126 C CN100374126 C CN 100374126C
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- 238000000034 method Methods 0.000 title claims abstract description 29
- 239000002775 capsule Substances 0.000 title claims abstract description 10
- 206010002383 Angina Pectoris Diseases 0.000 title claims abstract description 9
- 230000002107 myocardial effect Effects 0.000 title claims description 7
- 206010003210 Arteriosclerosis Diseases 0.000 title abstract description 5
- 208000011775 arteriosclerosis disease Diseases 0.000 title abstract description 5
- 239000000843 powder Substances 0.000 claims abstract description 27
- DTGKSKDOIYIVQL-WEDXCCLWSA-N (+)-borneol Chemical compound C1C[C@@]2(C)[C@@H](O)C[C@@H]1C2(C)C DTGKSKDOIYIVQL-WEDXCCLWSA-N 0.000 claims abstract description 26
- 238000002360 preparation method Methods 0.000 claims abstract description 17
- 235000003143 Panax notoginseng Nutrition 0.000 claims abstract description 16
- 241000180649 Panax notoginseng Species 0.000 claims abstract description 16
- 239000007788 liquid Substances 0.000 claims abstract description 16
- 238000003908 quality control method Methods 0.000 claims abstract description 13
- 239000008187 granular material Substances 0.000 claims abstract description 9
- 239000003814 drug Substances 0.000 claims abstract description 6
- 238000012360 testing method Methods 0.000 claims description 80
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims description 78
- RTZKZFJDLAIYFH-UHFFFAOYSA-N Diethyl ether Chemical compound CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 68
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 claims description 66
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 claims description 56
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 claims description 54
- 239000013558 reference substance Substances 0.000 claims description 42
- 239000000047 product Substances 0.000 claims description 29
- 229910000147 aluminium phosphate Inorganic materials 0.000 claims description 28
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 26
- 239000000706 filtrate Substances 0.000 claims description 25
- LRHPLDYGYMQRHN-UHFFFAOYSA-N N-Butanol Chemical compound CCCCO LRHPLDYGYMQRHN-UHFFFAOYSA-N 0.000 claims description 24
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims description 24
- 238000000605 extraction Methods 0.000 claims description 24
- IBGBGRVKPALMCQ-UHFFFAOYSA-N 3,4-dihydroxybenzaldehyde Chemical compound OC1=CC=C(C=O)C=C1O IBGBGRVKPALMCQ-UHFFFAOYSA-N 0.000 claims description 20
- 239000000463 material Substances 0.000 claims description 18
- 239000000741 silica gel Substances 0.000 claims description 18
- 229910002027 silica gel Inorganic materials 0.000 claims description 18
- 239000002904 solvent Substances 0.000 claims description 18
- 238000004809 thin layer chromatography Methods 0.000 claims description 18
- 241000628997 Flos Species 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 14
- 239000007921 spray Substances 0.000 claims description 14
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 12
- 239000011230 binding agent Substances 0.000 claims description 12
- 239000003208 petroleum Substances 0.000 claims description 12
- 238000001035 drying Methods 0.000 claims description 11
- 229960003371 protocatechualdehyde Drugs 0.000 claims description 10
- 239000000796 flavoring agent Substances 0.000 claims description 7
- 235000019634 flavors Nutrition 0.000 claims description 7
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 6
- YEZWWUMWIFKEQM-UHFFFAOYSA-N O.OC.ClC(Cl)Cl.CCOC(C)=O Chemical compound O.OC.ClC(Cl)Cl.CCOC(C)=O YEZWWUMWIFKEQM-UHFFFAOYSA-N 0.000 claims description 6
- YURJSTAIMNSZAE-UHFFFAOYSA-N UNPD89172 Natural products C1CC(C2(CC(C3C(C)(C)C(O)CCC3(C)C2CC2O)OC3C(C(O)C(O)C(CO)O3)O)C)(C)C2C1C(C)(CCC=C(C)C)OC1OC(CO)C(O)C(O)C1O YURJSTAIMNSZAE-UHFFFAOYSA-N 0.000 claims description 6
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 6
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 6
- 238000001514 detection method Methods 0.000 claims description 6
- 238000005485 electric heating Methods 0.000 claims description 6
- YURJSTAIMNSZAE-HHNZYBFYSA-N ginsenoside Rg1 Chemical compound O([C@@](C)(CCC=C(C)C)[C@@H]1[C@@H]2[C@@]([C@@]3(C[C@@H]([C@H]4C(C)(C)[C@@H](O)CC[C@]4(C)[C@H]3C[C@H]2O)O[C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)C)(C)CC1)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O YURJSTAIMNSZAE-HHNZYBFYSA-N 0.000 claims description 6
- CBEHEBUBNAGGKC-UHFFFAOYSA-N ginsenoside Rg1 Natural products CC(=CCCC(C)(OC1OC(CO)C(O)C(O)C1O)C2CCC3(C)C2C(O)CC4C5(C)CCC(O)C(C)(C)C5CC(OC6OC(CO)C(O)C(O)C6O)C34C)C CBEHEBUBNAGGKC-UHFFFAOYSA-N 0.000 claims description 6
- 239000012567 medical material Substances 0.000 claims description 6
- 238000004321 preservation Methods 0.000 claims description 6
- 229910052708 sodium Inorganic materials 0.000 claims description 6
- 239000011734 sodium Substances 0.000 claims description 6
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 6
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 6
- MWOOGOJBHIARFG-UHFFFAOYSA-N vanillin Chemical compound COC1=CC(C=O)=CC=C1O MWOOGOJBHIARFG-UHFFFAOYSA-N 0.000 claims description 6
- FGQOOHJZONJGDT-UHFFFAOYSA-N vanillin Natural products COC1=CC(O)=CC(C=O)=C1 FGQOOHJZONJGDT-UHFFFAOYSA-N 0.000 claims description 6
- 235000012141 vanillin Nutrition 0.000 claims description 6
- 239000003480 eluent Substances 0.000 claims description 4
- 238000010828 elution Methods 0.000 claims description 4
- 238000003810 ethyl acetate extraction Methods 0.000 claims description 4
- 239000000284 extract Substances 0.000 claims description 4
- 239000000945 filler Substances 0.000 claims description 4
- YTJSFYQNRXLOIC-UHFFFAOYSA-N octadecylsilane Chemical compound CCCCCCCCCCCCCCCCCC[SiH3] YTJSFYQNRXLOIC-UHFFFAOYSA-N 0.000 claims description 4
- 239000000377 silicon dioxide Substances 0.000 claims description 4
- 238000011003 system suitability test Methods 0.000 claims description 4
- 238000005303 weighing Methods 0.000 claims description 4
- SRCZQMGIVIYBBJ-UHFFFAOYSA-N ethoxyethane;ethyl acetate Chemical compound CCOCC.CCOC(C)=O SRCZQMGIVIYBBJ-UHFFFAOYSA-N 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 abstract description 8
- 238000005516 engineering process Methods 0.000 abstract description 5
- 230000000694 effects Effects 0.000 abstract description 4
- 239000002994 raw material Substances 0.000 abstract description 2
- REPVLJRCJUVQFA-UHFFFAOYSA-N (-)-isopinocampheol Natural products C1C(O)C(C)C2C(C)(C)C1C2 REPVLJRCJUVQFA-UHFFFAOYSA-N 0.000 abstract 3
- 229940116229 borneol Drugs 0.000 abstract 3
- CKDOCTFBFTVPSN-UHFFFAOYSA-N borneol Natural products C1CC2(C)C(C)CC1C2(C)C CKDOCTFBFTVPSN-UHFFFAOYSA-N 0.000 abstract 3
- DTGKSKDOIYIVQL-UHFFFAOYSA-N dl-isoborneol Natural products C1CC2(C)C(O)CC1C2(C)C DTGKSKDOIYIVQL-UHFFFAOYSA-N 0.000 abstract 3
- 244000020518 Carthamus tinctorius Species 0.000 abstract 2
- 235000003255 Carthamus tinctorius Nutrition 0.000 abstract 2
- 235000003365 Ilex pubescens Nutrition 0.000 abstract 2
- 241001100932 Ilex pubescens Species 0.000 abstract 2
- 206010050031 Muscle strain Diseases 0.000 abstract 2
- 244000086363 Pterocarpus indicus Species 0.000 abstract 2
- 235000009984 Pterocarpus indicus Nutrition 0.000 abstract 2
- 210000004165 myocardium Anatomy 0.000 abstract 2
- 240000007164 Salvia officinalis Species 0.000 abstract 1
- 238000009835 boiling Methods 0.000 abstract 1
- 235000005412 red sage Nutrition 0.000 abstract 1
- 229940126680 traditional chinese medicines Drugs 0.000 abstract 1
- 229940126672 traditional medicines Drugs 0.000 abstract 1
- 239000002552 dosage form Substances 0.000 description 2
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000000202 analgesic effect Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000005189 cardiac health Effects 0.000 description 1
- 229940126678 chinese medicines Drugs 0.000 description 1
- 239000000599 controlled substance Substances 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention discloses a capsule used for treating cardiac muscle strain, angina and arteriosclerosis and a preparing method thereof, which is mainly prepared from the raw materials of the following traditional Chinese medicines such as 300 to 500 weight parts of pubescent holly root, 10 to 30 weight parts of notoginseng, 10 to 30 weight parts of safflower, 10 to 30 weight parts of red sage root, 1 weight part of borneol, 2 to 8 weight parts of rosewood and 400 to 600 weight parts of herbasiegesbeckiae. The preparing method of the present invention comprises the following steps: the safflower, the notoginseng, the rosewood and the borneol are pulverized into fine powder and sieved; the other three traditional medicines such as the pubescent holly root, etc., are watered and boiled, and the boiling liquid is combined and filtrated; the filtrated liquid is concentrated to be uniformly mixed with the powder, dried and pulverized into fine powder to be made into granules; the granules are dried, and then the borneol is added to be uniformly mixed and encapsulated. Compared with that of the original preparation form, the capsule preparation of the present invention used for treating cardiac muscle strain, angina and arteriosclerosis has short disintegrating time, simple manufacturing technology, short production period and low production cost. The preparation of the present invention has the advantages of advanced method and technology for quality control and good repeatability, the medicine quality is excellently controlled, and the product treating effect is guaranteed.
Description
Technical field
The present invention relates to a kind of have invigorate blood circulation, the analgesic effect, be used for the treatment of the method for quality control of treatment myocardial strain, angina pectoris, arteriosclerotic capsule.The invention belongs to the field of Chinese medicines.
Background technology
Listing kind heart health sheet is evident in efficacy at treatment myocardial strain, angina pectoris, arteriosclerosis.But former dosage form manufacturing process complexity, production is long man-hour, the manufacturing cost height; And disintegration time is long, the easy moisture absorption in storage process, and method of quality control is simple, do not have quantitative approach, and quality that can not the better controlled medicine is difficult to guarantee the curative effect of medicine.
Summary of the invention
The objective of the invention is to: overcome the above-mentioned deficiency of prior art, a kind of capsule with treatment myocardial strain, angina pectoris, arteriosclerosis effect is provided, and its preparation and method of quality control are provided.
It is that component is formed by weight: Radix Ilicis Pubescentis 300-500 part, Radix Notoginseng 10-30 part, Flos Carthami 10-30 part, Radix Salviae Miltiorrhizae 10-30 part, 1 part of Borneolum Syntheticum, Lignum Dalbergiae Odoriferae 2-8 Fen, Herba Siegesbeckiae 400-600 part by following raw material of Chinese medicine mainly that the present invention is used for the treatment of myocardial strain, angina pectoris, arteriosclerotic capsule.
Preparation method of the present invention may further comprise the steps:
More than seven the flavor, Flos Carthami, Radix Notoginseng, Lignum Dalbergiae Odoriferae are ground into fine powder, sieve; Borneolum Syntheticum is ground into impalpable powder, sieves; Three flavors such as all the other Radix Ilicis Pubescentiss decoct with water 2-3 time, and each 1.5-3 hour, collecting decoction filtered, and filtrate is concentrated into the 60-80 ℃ of extractum of surveying relative density 1.15-1.35, with powder mixings such as above-mentioned Flos Carthamis, drying is ground into fine powder, makes granule, drying adds Borneolum Syntheticum again, and mixing incapsulates.Or extractum is spray dried to fine powder, with powder mixings such as above-mentioned Flos Carthamis, makes granule, and drying adds Borneolum Syntheticum again, and mixing incapsulates.
The method of quality control of Chinese medicine preparation of the present invention is:
(1) differentiates
(1) Radix Notoginseng is got this product content 1.5-2.5g, and porphyrize adds methanol 15-25ml, supersound extraction 20-40 minute, filter the filtrate evaporate to dryness, residue adds water 10-15ml makes dissolving, uses ether extraction 2-3 time, each 10-15ml, discard ether solution, reuse n-butanol extraction 2-3 time, each 5-10m, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 1-2ml makes dissolving, as need testing solution.It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ 1 of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, (12-20: 35-45: 20-30: 8-12) the lower floor's solution after the cold preservation is developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 100-105 ℃ of baking several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product content 1.5-2.5g, porphyrize, the 30-50ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, according to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 8-10 μ l, control medicinal material solution 2-4 μ l, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with petroleum ether (60-90 ℃)-ethyl acetate (3-6: 1) be developing solvent, launch, take out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃)-ethyl acetate-chloroform (8-13: 1: 2-5) be developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) content assaying method
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With mobile phase A: acetonitrile, Mobile phase B: 0.1-0.3% phosphoric acid solution, adopt the gradient elution mode, the eluent gradient order is: 0～12 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89,12-14 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89,14～21 minutes acetonitriles: 0.1-0.3% phosphoric acid solution=89: 11,21-23 minute acetonitrile: 0.1-0.3% phosphoric acid solution=89: 11,23～24 minutes acetonitriles: 0.1-0.3% phosphoric acid solution=11: 89,24-25 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89.The detection wavelength is 312nm.Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds 40-60% methanol and make the solution that every 1ml contains 5 μ g, promptly.
The preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 1-1.5g, the accurate title, decide, and precision adds entry 50-60ml, close plug, claim to decide weight, supersound process (power 120w, frequency 59KH2) 30 minutes, put coldly, claim to decide weight again, water is supplied the weight that subtracts mistake, shake up, filter, precision is measured subsequent filtrate 25ml, extract 3-5 time with the ethyl acetate jolting, each 25ml merges ethyl acetate extraction liquid, evaporate to dryness, residue adds 40-60% methanol makes dissolving in right amount, move in the 10ml measuring bottle and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Algoscopy: precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, measures, promptly.
Capsule preparations of the present invention is shorter than former dosage form disintegration time, and processing technology is simple, with short production cycle, production cost is lower; Quality of the pharmaceutical preparations control method advanced technology of the present invention, favorable reproducibility can be controlled the quality of medicine preferably, have guaranteed the curative effect of product.
The specific embodiment
The present invention is described in detail below in conjunction with the truth example.
Embodiment 1:
Get Radix Ilicis Pubescentis 300kg, Radix Notoginseng 12kg, Flos Carthami 12kg, Radix Salviae Miltiorrhizae 12kg, Borneolum Syntheticum 1kg, Lignum Dalbergiae Odoriferae 2.5kg, Herba Siegesbeckiae 400kg; Preparation method:
Flos Carthami, Radix Notoginseng, Lignum Dalbergiae Odoriferae are ground into fine powder, sieve; Borneolum Syntheticum is ground into impalpable powder, sieves; Three flavors such as all the other Radix Ilicis Pubescentiss decoct with water 2 times, and each 3 hours, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.25-1.30 (60-80 ℃ of survey), with powder mixings such as above-mentioned Flos Carthamis, drying is ground into fine powder, makes granule, drying adds Borneolum Syntheticum again, and mixing incapsulates.
Its method of quality control is:
(1) differentiates
(1) Radix Notoginseng is got this product content 1.5g, and porphyrize adds methanol 20ml, supersound extraction 30 minutes filters the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, uses ether extraction 2 times, each 10ml, discard ether solution, reuse n-butanol extraction 2 times, each 10ml, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, (12: 35: 20: 8) the lower floor's solution after the cold preservation was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 105 ℃ of bakings several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product content 1.5g, porphyrize, the 30ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, according to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 10 μ l, control medicinal material solution 2 μ l, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with petroleum ether (60-90 ℃)-ethyl acetate (3: 1) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃)-ethyl acetate-chloroform (8: 1: 2) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) content assaying method
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With mobile phase A: acetonitrile, Mobile phase B: 0.1% phosphoric acid solution, adopt the gradient elution mode, the eluent gradient order is: 0～12 minute acetonitrile: 0.1% phosphoric acid solution=11: 89,12-14 minute acetonitrile: 0.1% phosphoric acid solution=11: 89,14～21 minutes acetonitriles: 0.1% phosphoric acid solution=89: 11,21-23 minute acetonitrile: 0.1% phosphoric acid solution=89: 11,23～24 minutes acetonitriles: 0.1% phosphoric acid solution=11: 89,24-25 minute acetonitrile: 0.1% phosphoric acid solution=11: 89.The detection wavelength is 312nm.Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000.The detection wavelength is 312nm.Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds 40% methanol and make the solution that every 1ml contains 5 μ g, promptly.
The preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 1g, the accurate title, decide, and precision adds entry 50ml, close plug, claim to decide weight, supersound process (power 120w, frequency 59KH2) 30 minutes, put coldly, claim to decide weight again, water is supplied the weight that subtracts mistake, shake up, filter, precision is measured subsequent filtrate 25ml, extract 3-5 time with the ethyl acetate jolting, each 25ml merges ethyl acetate extraction liquid, evaporate to dryness, residue adds 40% methanol makes dissolving in right amount, move in the 10ml measuring bottle and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Algoscopy: precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, measures, promptly.
Embodiment 2:
Get Radix Ilicis Pubescentis 400kg, Radix Notoginseng 20kg, Flos Carthami 20kg, Radix Salviae Miltiorrhizae 20kg, Borneolum Syntheticum 1kg?, Lignum Dalbergiae Odoriferae 5kg, Herba Siegesbeckiae 500kg;
Flos Carthami, Radix Notoginseng, Lignum Dalbergiae Odoriferae are ground into fine powder, sieve; Borneolum Syntheticum is ground into impalpable powder, sieves; Three flavors such as all the other Radix Ilicis Pubescentiss decoct with water 3 times, and each 1.5 hours, collecting decoction filtered, and filtrate is concentrated into the thick paste of relative density 1.25-1.35 (60-80 ℃ of survey), with powder mixings such as above-mentioned Flos Carthamis, drying is ground into fine powder, makes granule, drying adds Borneolum Syntheticum again, and mixing incapsulates.
Its method of quality control is:
(1) differentiates
(1) Radix Notoginseng is got this product content 2g, and porphyrize adds methanol 30ml, supersound extraction 40 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, uses ether extraction 3 times, each 15ml, discard ether solution, reuse n-butanol extraction 3 times, each 10ml, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution.It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, (15: 40: 25: 10) the lower floor's solution after the cold preservation was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 105 ℃ of bakings several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get this product content 2g, porphyrize, the 40ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution.Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, according to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 8 μ l, control medicinal material solution 4 μ l, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with petroleum ether (60-90 ℃)-ethyl acetate (5: 1) is developing solvent, launches, and takes out, dry, put under the ultra-violet lamp (365nm) and inspect.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color.
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution.According to thin layer chromatography (" appendix VIB of Chinese pharmacopoeia version in 2000) test, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃)-ethyl acetate-chloroform (10: 1: 4) is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) content assaying method
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With mobile phase A: acetonitrile, Mobile phase B: 0.3% phosphoric acid solution, adopt the gradient elution mode, the eluent gradient order is: 0～12 minute acetonitrile: 0.3% phosphoric acid solution=11: 89,12-14 minute acetonitrile: 0.3% phosphoric acid solution=11: 89,14～21 minutes acetonitriles: 0.3% phosphoric acid solution=89: 11,21-23 minute acetonitrile: 0.3% phosphoric acid solution=89: 11,23～24 minutes acetonitriles: 0.3% phosphoric acid solution=11: 89,24-25 minute acetonitrile: 0.3% phosphoric acid solution=11: 89.The detection wavelength is 312nm.Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000.The detection wavelength is 312nm.Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000.
The preparation of reference substance solution: it is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds 60% methanol and make the solution that every 1ml contains 5 μ g, promptly.
The preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 1.5g, the accurate title, decide, and precision adds entry 60ml, close plug, claim to decide weight, supersound process (power 120w, frequency 59KH2) 30 minutes, put coldly, claim to decide weight again, water is supplied the weight that subtracts mistake, shake up, filter, precision is measured subsequent filtrate 25ml, extract 5 times with the ethyl acetate jolting, each 25ml merges ethyl acetate extraction liquid, evaporate to dryness, residue adds 60% methanol makes dissolving in right amount, move in the 10ml measuring bottle and be diluted to scale, shake up, filter, get subsequent filtrate, promptly.
Algoscopy: precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, measures, promptly.
Embodiment 3:
Get Radix Ilicis Pubescentis 500kg, Radix Notoginseng 30kg, Flos Carthami 30kg, Radix Salviae Miltiorrhizae 30kg, Borneolum Syntheticum 1kg, Lignum Dalbergiae Odoriferae 8kg, Herba Siegesbeckiae 600kg; Flos Carthami, Radix Notoginseng, Lignum Dalbergiae Odoriferae are ground into fine powder, sieve; Borneolum Syntheticum is ground into impalpable powder, sieves; Three flavors such as all the other Radix Ilicis Pubescentiss decoct with water 3 times, and each 1.5 hours, collecting decoction, filter, filtrate is concentrated into the extractum of relative density 1.15-1.20 (60-80 ℃ of survey), and 170-190 ℃ of spray drying gets fine powder, with powder mixings such as above-mentioned Flos Carthamis, make granule, drying adds Borneolum Syntheticum again, mixing incapsulates.
Method of quality control: with embodiment 3.
Claims (3)
1. method of quality control for the treatment of myocardial strain, angina pectoris, arteriosclerotic capsule, wherein capsule is made by weight by following crude drug: Radix Ilicis Pubescentis 300-500 part, Radix Notoginseng 10-30 part, Flos Carthami 10-30 part, Radix Salviae Miltiorrhizae 10-30 part, 1 part of Borneolum Syntheticum, Lignum Dalbergiae Odoriferae 2-8 part,
Herba Siegesbeckiae 400-600 part; Make by following preparation method: above seven flavors, Flos Carthami, Radix Notoginseng, Lignum Dalbergiae Odoriferae are ground into fine powder, sieve; Borneolum Syntheticum is ground into impalpable powder, sieves; Three flavors such as all the other Radix Ilicis Pubescentiss decoct with water 2-3 time, and each 1.5-3 hour, collecting decoction filtered, and filtrate is concentrated into the 60-80 ℃ of extractum of surveying relative density 1.15-1.35, with powder mixings such as above-mentioned Flos Carthamis, drying is ground into fine powder, makes granule, drying adds Borneolum Syntheticum again, and mixing incapsulates; Or extractum is spray dried to fine powder, with powder mixings such as above-mentioned Flos Carthamis, makes granule, and drying adds Borneolum Syntheticum again, and mixing incapsulates; It is characterized in that adopting following method to differentiate:
(1) Radix Notoginseng is got this product content 1.5-2.5g, and porphyrize adds methanol 15-25ml, supersound extraction 20-40 minute, filter the filtrate evaporate to dryness, residue adds water 10-15ml makes dissolving, uses ether extraction 2-3 time, each 10-15ml, discard ether solution, reuse n-butanol extraction 2-3 time, each 5-10ml, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 1-2ml makes dissolving, as need testing solution; It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to " appendix a VIB of Chinese pharmacopoeia version in 2000 thin layer chromatography test, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, with chloroform-ethyl acetate-methanol-water 12-20: 35-45: 20-30: the lower floor's solution after the 8-12 cold preservation is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 100-105 ℃ of baking several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get this product content 1.5-2.5g, porphyrize, the 30-50ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, according to " test of an appendix VIB of Chinese pharmacopoeia version in 2000 thin layer chromatography is drawn need testing solution 8-10 μ l, control medicinal material solution 2-4 μ l, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with 60-90 ℃ of petroleum ether-ethyl acetate 3-6: l is developing solvent, launches, and takes out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution; According to " appendix a VIB of Chinese pharmacopoeia version in 2000 thin layer chromatography test, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with 30-60 ℃ of petroleum ether-ethyl acetate-chloroform 8-13: 1: 2-5 is developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
2. method of quality control according to claim 1 is characterized in that: also comprise following content assaying method:
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; With mobile phase A: acetonitrile, Mobile phase B: 0.1-0.3% phosphoric acid solution, adopt the gradient elution mode, the eluent gradient order is: 0-12 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89,12-14 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89,14-21 minute acetonitrile: 0.1-0.3% phosphoric acid solution=89: 11,21-23 minute acetonitrile: 0.1-0.3% phosphoric acid solution=89: 11,23-24 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89,24-25 minute acetonitrile: 0.1-0.3% phosphoric acid solution=11: 89, the detection wavelength is 312nm; Number of theoretical plate calculates by the protocatechualdehyde peak should be not less than 3000;
The preparation of reference substance solution: it is an amount of that precision takes by weighing the protocatechualdehyde reference substance, adds 40-60% methanol and make the solution that every 1ml contains 5 μ g, promptly; The preparation of need testing solution: get this product content under the content uniformity item, porphyrize is got about 1-1.5g, the accurate title, decide, and precision adds entry 50-60ml, close plug, claim to decide weight, supersound process, wherein ultrasonic power is 120w, supersonic frequency is 59KHz30 minute, puts coldly, claims to decide weight again, water is supplied the weight that subtracts mistake, shakes up, and filters, precision is measured subsequent filtrate 25ml, extracts 3-5 time with the ethyl acetate jolting, each 25ml, merge ethyl acetate extraction liquid, evaporate to dryness, residue add 40-60% methanol makes dissolving in right amount, moves in the 10ml measuring bottle and is diluted to scale, shake up, filter, get subsequent filtrate, promptly; Algoscopy: precision is measured reference substance solution and each 20 μ l of need testing solution respectively, injects chromatograph of liquid, measures, promptly.
3. according to claim 1 or 2 arbitrary described method of quality control, it is characterized in that: following method is adopted in described discriminating:
(1) get this product content 1.5g, porphyrize adds methanol 20ml, supersound extraction 30 minutes filters the filtrate evaporate to dryness, residue adds water 10ml makes dissolving, uses ether extraction 2 times, each 10ml, discard ether solution, reuse n-butanol extraction 2 times, each 10ml, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to thin layer chromatography " appendix VIB test of Chinese pharmacopoeia version in 2000, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, with chloroform-ethyl acetate-methanol-water 12: 35: 20: the lower floor's solution after 8 cold preservations was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 105 ℃ of bakings several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get this product content 1.5g, porphyrize, the 30ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, " appendix VIB test of Chinese pharmacopoeia version in 2000 is drawn need testing solution 10 μ l, control medicinal material solution 2 μ l according to thin layer chromatography, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with 60-90 ℃ of petroleum ether: ethyl acetate is developing solvent at 3: 1, launches, and takes out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution; According to thin layer chromatography " appendix VIB test of Chinese pharmacopoeia version in 2000, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with 30-60 ℃ of petroleum ether-ethyl acetate-chloroform is developing solvent at 8: 1: 2, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.4. according to claim 1 or 2 arbitrary described method of quality control, it is characterized in that described discriminating adopts following method:
(1) get this product content 2g, porphyrize adds methanol 30ml, supersound extraction 40 minutes filters the filtrate evaporate to dryness, residue adds water 15ml makes dissolving, uses ether extraction 3 times, each 15ml, discard ether solution, reuse n-butanol extraction 3 times, each 10ml, merge n-butanol extracting liquid, evaporate to dryness, residue add methanol 2ml makes dissolving, as need testing solution; It is an amount of that other gets ginsenoside Rg1's reference substance, adds methanol and make the solution that every 1ml contains 2mg, in contrast product solution; According to thin layer chromatography " appendix VIB test of Chinese pharmacopoeia version in 2000, draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of binding agent with the Sodium Tvlose, with chloroform-ethyl acetate-methanol-water=15: 40: 25: the lower floor's solution after 10 cold preservations was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, in 105 ℃ of bakings several minutes, in the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get this product content 2g, porphyrize, the 40ml that adds diethyl ether, supersound extraction 20 minutes filters, and filtrate low temperature is flung to ether, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution; Other gets Lignum Dalbergiae Odoriferae control medicinal material 1g, shine medical material solution in pairs with legal system, " appendix VIB test of Chinese pharmacopoeia version in 2000 is drawn need testing solution 8 μ l, control medicinal material solution 4 μ l according to thin layer chromatography, put respectively in same be on the silica gel g thin-layer plate of binding agent with the sodium carboxymethyl cellulose, with 60-90 ℃ of petroleum ether-ethyl acetate=5: 1 was developing solvent, launched, and took out, dry, put under the 365nm ultra-violet lamp and inspect; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of same color;
(3) get need testing solution under the discriminating (2) as need testing solution; Other gets the Borneolum Syntheticum reference substance, adds ethyl acetate and makes the solution that every 1ml contains 1mg, in contrast product solution; According to thin layer chromatography " appendix VIB test of Chinese pharmacopoeia version in 2000, draw need testing solution 5 μ l and reference substance solution 2 μ l, put respectively on same silica gel g thin-layer plate, with 30-60 ℃ of petroleum ether-ethyl acetate-chloroform=10: 1: 4 was developing solvent, launch, take out, dry, spray is with 5% vanillin sulfuric acid solution, and the electric heating wind is clear to the speckle colour developing; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
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| 心宁注射液及健心丸治疗冠心病心绞痛的初步报告. 中国人民解放军广州部队总医院，广东中医学院，一七七医院，一六九医院，一九一医院，一八五医院，五○五医院.新中医，第02期. 1974 * |
| 药品标准. 卫生部药典委员会，203. 1990 * |
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Effective date of registration: 20090313 Address after: No. 399, Beijing Northeast Road, Nanchang hi tech Development Zone, Jiangxi, China Patentee after: Jiangxi shining Pharmaceutical Co., Ltd. Address before: Renhe group, Renhe South Road, Zhangshu City, Jiangxi Province, 158 Patentee before: Yang Wenlong |
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Owner name: JIANGXI SHINING PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: YANG WENLONG Effective date: 20090313 |