CN1323696C - Chinese traditional medicine capsule for treating apoplexy, its preparation process and quality control method - Google Patents
Chinese traditional medicine capsule for treating apoplexy, its preparation process and quality control method Download PDFInfo
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Abstract
The present invention relates to a traditional Chinese medicine capsule preparation for treating apoplexy, a preparation process and a quality control method thereof. The traditional Chinese medicine capsule is prepared from 225g of astragalus root, 100g of leeches, 90g of Chuanxiong rhizome, 90g of Chinese angelica root, 90g of safflower, 113g of peach kernels, 90g of red peony root, 90g of aucklandia root, 90g of grassleaved sweetflag rhizome, 60g of earthworms, 90g of mistletoe and 35g of acanthopanax root extract. The quality control method of the traditional Chinese medicine capsule preparation for treating apoplexy comprises traditional Chinese medicines including the leeches, acanthopanax root, the red peony root and the earthworm are identified by a thin layer chromatography; the content of the astragalus root in the traditional Chinese medicine capsule preparation is measured by a thin layer scanning method.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation, particularly a kind of Chinese medicinal capsule agent and method for making and method of quality control that is used for the treatment of apoplexy.
Background technology
Apoplexy belongs to cerebrovascular disease, have that morbidity is anxious, the state of an illness heavy, it is fast to change, can repeatedly fall ill and characteristics such as case fatality rate height, particularly old people healthy of human body health in serious harm, brings very white elephant per capita for society, family and patient.Chinese patent gazette disclosed the name of being declared by the applicant and was called " a kind of Chinese patent medicine that is used for the treatment of apoplexy " on November 5th, 2003, publication number is 1453000 patent application, and the weight proportion of forming each herbal medicine raw material of the described Chinese patent medicine of invention is: 40～1000 unit of weights of the Radix Astragali, 10～500 unit of weights of Hirudo, 10～450 unit of weights of Rhizoma Chuanxiong, 9～500 unit of weights of Radix Angelicae Sinensis, 45～400 unit of weights of Flos Carthami, 20～600 unit of weights of Semen Persicae, 50～300 unit of weights of Radix Paeoniae Rubra, 30～300 unit of weights of the Radix Aucklandiae, 20～400 unit of weights of Rhizoma Acori Graminei, 10～600 unit of weights of Pheretima, 20～500 unit of weights of Herba Taxilli, 7～500 unit of weights of Radix Et Caulis Acanthopanacis Senticosi extractum.But we find that the effect of this Chinese patent medicine is desirable not enough in actual application.In nearly 2 years time, we grope by a large amount of experiments on original basis, have found best set of dispense ratio and have made capsule, scientifically carry out quality control, and clinical pharmacodynamic experiment effect is remarkable.
Summary of the invention
The objective of the invention is to: Chinese medicinal capsule agent and method for making and method of quality control that a kind of treatment apoplexy evident in efficacy is provided.
The present invention is achieved in that
One, prescription:
Radix Astragali 225g, Hirudo 100g, Rhizoma Chuanxiong 90g, Radix Angelicae Sinensis 90g, Flos Carthami 90g, Semen Persicae 113g, Radix Paeoniae Rubra 90g, Radix Aucklandiae 90g, Rhizoma Acori Graminei 90g, Pheretima 60g, Herba Taxilli 90g, Radix Et Caulis Acanthopanacis Senticosi extractum 35g.
Two, method for making:
More than 12 the flavor, except that Hirudo, Pheretima, Radix Et Caulis Acanthopanacis Senticosi dried cream powder are broken into the fine powder; Nine flavors such as all the other Radixs Astragali decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, it is 1.1-1.2 (60 ℃) that collecting decoction, filtrate are concentrated into relative density, and spraying drying powder-forming adds Pheretima, Hirudo, Radix Et Caulis Acanthopanacis Senticosi powder mix homogeneously, incapsulate, make 1000, promptly.
Three, character:
This product is a capsule, and content is that yellowish-brown is to chocolate brown powder; The feeble QI raw meat, mildly bitter flavor.
Four, differentiate:
(1) gets this product content 2g, put in the conical flask, add 70% ethanol 30ml, reflux 30 minutes is put coldly, and evaporate to dryness in the evaporating dish is gone in filter, residue adds water 10ml, stirs to make dissolving, filters, filtrate is by strongly acidic cation-exchange (1.5g) post (long 15cm, internal diameter 1cm), and the water flushing is to colourless, use 1mol/L sodium hydroxide 10ml eluant solution then, collect eluent, transfer to neutrality with dilute hydrochloric acid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other trematodiasis control medicinal material 0.5g that fetches water shines medical material solution in pairs with legal system.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 5 μ l, reference substance solution 10 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, be developing solvent with n-butyl alcohol-glacial acetic acid-water (4: 1: 1), launch, take out, dry, spray is with 0.2% ethanol solution of ninhydrin, about 5 minutes of 105 ℃ of bakings.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show the speckle of same color.
(2) get this product content 1g, add chloroform 10ml, water-bath refluxed 30 minutes, filtered, and filtrate evaporate to dryness, residue add chloroform 0.5ml makes dissolving, as need testing solution.Other gets the isofraxidin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer 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 in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, be developing solvent with chloroform-methanol (95: 5), launch, taking-up is dried, and puts under the ultra-violet lamp (365nm) and inspects.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
(3) get this product content 3g, add 80% ethanol 30ml, heating in water bath refluxed 30 minutes, filter, filtrate evaporate to dryness, residue add water 15ml and heat and make dissolving, absorbent cotton filters, and collects filtrate, extracts 2 times with water-saturated n-butanol, each 10ml merges n-butanol extracting liquid, adds water 5ml washing, discard aqueous solution, n-butyl alcohol liquid evaporate to dryness, residue add that water 15ml is warm to make dissolving, and absorbent cotton filters, filtrate is transferred to D101 type macroporous adsorptive resins (long 3cm, internal diameter 1cm), the water flushing adds 70% ethanol 30ml eluting again to colourless, collect ethanol elution, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution.Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer 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 in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with chloroform-methanol (5: 1) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 110 ℃ dry by the fire to the speckle colour developing clear.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the speckle of same color.
(4) get this product content 5g, add ethyl acetate-formic acid (9.5: 0.5) mixed liquor 20ml.Supersound process 25 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution.Other gets Pheretima control medicinal material 0.5g, shines medical material solution in pairs with legal system.According to thin layer 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 in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with toluene-ethyl acetate-formic acid (9: 1: 0.5) is developing solvent, saturated 30 minutes, 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.
Five, check:
Should meet every regulation relevant under the capsule item (an appendix I of Chinese Pharmacopoeia version in 2000 L).
Six, assay:
Get this product content 6g, the accurate title, decide, and puts in the conical flask, the accurate 2% potassium hydroxide methanol solution 50ml that adds claims to decide weight, heating and refluxing extraction 1 hour, put coldly, claim to decide weight, supply the weight that subtracts mistake with 2% potassium hydroxide methanol solution, shake up, filter, precision is measured subsequent filtrate 30ml, put in the evaporating dish, evaporate to dryness, residue add water 20ml makes dissolving, add chloroform-n-butyl alcohol (2: 1) mixed solution and extract 5 times, each 10ml, merge extractive liquid,, with ammonia solution washing 2 times, each 20ml discards ammoniacal liquor, chloroform-n-butyl alcohol liquid evaporate to dryness, the residue dissolve with methanol, and be transferred in the 2ml measuring bottle, add methanol and be diluted to scale, shake up, as need testing solution.It is an amount of that other gets the astragaloside reference substance, accurate claims surely, adds methanol and make solution that every 1ml contains 0.5mg product solution in contrast.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw need testing solution 4 μ l and 6 μ l, reference substance solution 3 μ l and 5 μ l, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, lower floor's solution with chloroform-methanol-water (65: 35: 10) (placing layering below 10 ℃) is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, it is clear to dry by the fire to the speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B thin layer chromatography scanning), wavelength X S=530nm, λ R=650nm measures test sample trap integrated value and reference substance trap integrated value, calculate, promptly.
Every of this product contains the Radix Astragali with astragaloside (C
41H
68O
14) meter should be no less than 56 μ g.
Seven, function and curing mainly:
Inrigorating qi and promoting blood circulation, the removing blood stasis collateral dredging.Being used for the arteriosclerotic cerebral infarction convalescent period differential diagnosis in tcm is Qi deficiency blood stasis type apoplexy apoplex involving the channels and collaterals person, and disease is seen hemiplegia, hemianesthesia, distortion of commissure, dysphonia etc.
Eight, usage and dosage:
Oral, every 0.4g, one time 5,3 times on the one.
Results of pharmacodynamic test: observe the rheol influence of rabbit blood, can make hematocrit (%), blood plasma viscosity (ratio), whole blood height are cut viscosity (ratio), and whole blood is low cuts the remarkable decline of viscosity (ratio), make erythrocyte electrophoresis accelerate (P equal＜0.05); To the influence of rat platelet aggregation function, but the inductive platelet aggregation of inhibition ADP (P＜0.01) of highly significant: and the rabbit antithrombotic forms experiment, but the formation of the inhibition thrombosis of highly significant (P＜0.01); To the influence of experimental anesthetized dog cerebral blood flow (ml/min) and cerebral vascular resistance (mmHg/ml/min), but the cerebral blood flow increasing amount of highly significant (P＜0.01), and the highly significant low cerebral vascular resistance (P＜0.001) of falling.
Claims (4)
1, a kind of Chinese medicinal capsule agent that is used for the treatment of apoplexy is characterized in that it is to be prepared from by following method: Hirudo 100g, Pheretima 60g, the dried cream 35g of Radix Et Caulis Acanthopanacis Senticosi are ground into fine powder; Radix Astragali 225g, Rhizoma Chuanxiong 90g, Radix Angelicae Sinensis 90g, Flos Carthami 90g, Semen Persicae 113g, Radix Paeoniae Rubra 90g, Radix Aucklandiae 90g, Rhizoma Acori Graminei 90g, Herba Taxilli 90g decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter collecting decoction, relative density was 1.1-1.2 when filtrate was concentrated into 60 ℃, spraying drying powder-forming adds Pheretima, Hirudo, Radix Et Caulis Acanthopanacis Senticosi powder mix homogeneously, incapsulates, make 1000, promptly.
2, the method for making of the Chinese medicinal capsule agent of treatment apoplexy as claimed in claim 1 is characterized in that: Hirudo 100g, Pheretima 60g, the dried cream 35g of Radix Et Caulis Acanthopanacis Senticosi are ground into fine powder; Radix Astragali 225g, Rhizoma Chuanxiong 90g, Radix Angelicae Sinensis 90g, Flos Carthami 90g, Semen Persicae 113g, Radix Paeoniae Rubra 90g, Radix Aucklandiae 90g, Rhizoma Acori Graminei 90g, Herba Taxilli 90g decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter collecting decoction, relative density was 1.1-1.2 when filtrate was concentrated into 60 ℃, spraying drying powder-forming adds Pheretima, Hirudo, Radix Et Caulis Acanthopanacis Senticosi powder mix homogeneously, incapsulates, make 1000, promptly.
3, the discrimination method of the Chinese medicinal capsule agent of treatment apoplexy as claimed in claim 1 is characterized in that this method comprises one or more in the following discrimination method:
(1) thin layer of Hirudo is differentiated: get this product content 2g, put in the conical flask, add 70% ethanol 30ml, reflux 30 minutes is put coldly, and evaporate to dryness in the evaporating dish is gone in filter, residue adds water 10ml, stirs to make dissolving, filters, filtrate is by the long 15cm of 1.5g, and internal diameter 1cm strongly acidic cation-exchange post, water wash to colourless, use 1mol/L sodium hydroxide 10ml eluant solution then, collect eluent, transfer to neutrality with dilute hydrochloric acid, evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution; Other trematodiasis control medicinal material 0.5g that fetches water shines medical material solution in pairs with legal system; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 5 μ l, reference substance solution 10 μ l, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, be developing solvent with n-butyl alcohol-glacial acetic acid of 4: 1: 1-water, launch, take out, dry, spray is with 0.2% ethanol solution of ninhydrin, about 5 minutes of 105 ℃ of bakings; In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show the speckle of same color;
(2) thin layer of Radix Et Caulis Acanthopanacis Senticosi is differentiated: get content 1g of the present invention, add chloroform 10ml, water-bath refluxed 30 minutes, filtered, and filtrate evaporate to dryness, residue add chloroform 0.5ml makes dissolving, as need testing solution; Other gets the isofraxidin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; According to Chinese Pharmacopoeia thin layer chromatography test, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with 95: 5 chloroform-methanols was developing solvent, launched, and took out, dry, put under the ultra-violet lamp of 365nm and inspect; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
(3) thin layer of Radix Paeoniae Rubra is differentiated: get content 3g of the present invention, add 80% ethanol 30ml, heating in water bath refluxed 30 minutes, filter, filtrate evaporate to dryness, residue add water 15ml and heat and make dissolving, absorbent cotton filters, and collects filtrate, extracts 2 times with water-saturated n-butanol, each 10ml merges n-butanol extracting liquid, adds water 5ml washing, discard aqueous solution, n-butyl alcohol liquid evaporate to dryness, residue add that water 15ml is warm to make dissolving, and absorbent cotton filters, filtrate is transferred to long 3cm, the D101 type macroporous adsorptive resins of internal diameter 1cm, the water flushing adds 70% ethanol 30ml eluting again to colourless, collect ethanol elution, evaporate to dryness, residue add methanol 0.5ml makes dissolving, as need testing solution; Other gets the peoniflorin reference substance, adds methanol and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with 5: 1 chloroform-methanols was developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, 110 ℃ dry by the fire to the speckle colour developing clear; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on show the speckle of same color;
(4) thin layer of Pheretima is differentiated: get content 5g of the present invention, add ethyl acetate-formic acid mixed liquor 20ml of 9.5: 0.5, supersound process 25 minutes filters, and filtrate evaporate to dryness, residue add methanol 5ml makes dissolving, as need testing solution; Other gets Pheretima control medicinal material 0.5g, shines medical material solution in pairs with legal system; According to the Chinese Pharmacopoeia thin layer chromatography, draw each 5 μ l of above-mentioned two kinds of solution, put respectively in same be on the silica gel g thin-layer plate of adhesive with the sodium carboxymethyl cellulose, with toluene-ethyl acetate-formic acid of 9: 1: 0.5 was developing solvent, saturated 30 minutes, launch, take out, dry, put under the ultra-violet lamp of 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.
4, the content assaying method of the Chinese medicinal capsule agent of treatment apoplexy as claimed in claim 1 is characterized in that: get content 6g of the present invention, the accurate title, decide, put in the conical flask, the accurate 2% potassium hydroxide methanol solution 50ml that adds claims to decide weight, heating and refluxing extraction 1 hour is put coldly, claims to decide weight, supply the weight that subtracts mistake with 2% potassium hydroxide methanol solution, shake up, filter, precision is measured subsequent filtrate 30ml, put in the evaporating dish, evaporate to dryness, residue add water 20ml makes dissolving, chloroform-n-butyl alcohol the mixed solution that adds 2: 1 extracts 5 times, each 10ml, merge extractive liquid, is with ammonia solution washing 2 times, each 20ml, discard ammoniacal liquor, chloroform-n-butyl alcohol liquid evaporate to dryness, residue dissolve with methanol, and be transferred in the 2ml measuring bottle, add methanol and be diluted to scale, shake up, as need testing solution; It is an amount of that other gets the astragaloside reference substance, accurate claims surely, adds methanol and make solution that every 1ml contains 0.5mg product solution in contrast; Test according to the Chinese Pharmacopoeia thin layer chromatography, draw need testing solution 4 μ l and 6 μ l, reference substance solution 3 μ l and 5 μ l, respectively the cross point in same be on the silica gel g thin-layer plate of adhesive with 0.3% sodium carboxymethyl cellulose, with 65: 35: 10, lower floor's solution of placing stratified chloroform-methanol-water below 10 ℃ is developing solvent, launch, take out, dry, spray is with 10% ethanol solution of sulfuric acid, it is clear to dry by the fire to the speckle colour developing at 100 ℃, take out, on lamellae, cover onesize glass plate, use immobilization with adhesive tape on every side, scan according to the Chinese Pharmacopoeia thin layer chromatography, wavelength X S=530nm, λ R=650nm measures test sample trap integrated value and reference substance trap integrated value, calculate, it is C with the molecular formula that every of the present invention contains the Radix Astragali
41H
68O
14The astragaloside meter should be no less than 56 μ g.
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Families Citing this family (8)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101028354B (en) * | 2006-03-01 | 2011-05-25 | 河北长天药业有限公司 | Detection method of siegesbeckia orientalis tablets |
| CN102309632B (en) * | 2010-06-29 | 2013-06-12 | 陕西步长制药有限公司 | Application of pharmaceutical composition in preparation of pharmaceuticals for treating complications of diabetes |
| CN102441080A (en) * | 2010-10-09 | 2012-05-09 | 浙江大学医学院附属第二医院 | Traditional Chinese medicinal composition (compound safflower drink) for treating cerebral trauma and preparation method thereof |
| CN102236006A (en) * | 2011-06-24 | 2011-11-09 | 大连美罗中药厂有限公司 | Method for detecting earthworm in infantile lung-heat clearing granules |
| CN103550702A (en) * | 2013-11-07 | 2014-02-05 | 吴鑫 | Traditional Chinese medicine composition for cerebral arterial thrombosis |
| CN104524278A (en) * | 2014-12-19 | 2015-04-22 | 刘鹏捷 | Traditional Chinese medicine composition for treating cerebral infarction |
| CN111366680B (en) * | 2020-02-29 | 2022-09-23 | 陕西步长制药有限公司 | Substance content determination method and application thereof |
| WO2021168855A1 (en) * | 2020-02-29 | 2021-09-02 | 陕西步长制药有限公司 | Content determination method for material and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1453000A (en) * | 2002-04-28 | 2003-11-05 | 咸阳步长医药科技发展有限公司 | Chinese patent medicine for treating apoplexy |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1453000A (en) * | 2002-04-28 | 2003-11-05 | 咸阳步长医药科技发展有限公司 | Chinese patent medicine for treating apoplexy |
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| 急性缺血性脑血管病中药治疗近况 邹世昌，实用中医内科杂志，第13卷第3期 1999 * |
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