CN1823935A - Preparation medicine of wind dispelling pain eliminating tablet and its preparation methid, quality control method - Google Patents
Preparation medicine of wind dispelling pain eliminating tablet and its preparation methid, quality control method Download PDFInfo
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Abstract
A Chinese medicine in the form of tablet for dispelling wind and alleviating pain is prepared from 7 Chinese-medicinal materials including clematis root, wild aconite root, pubescent angelica root, safflower, etc. Its preparing process and quality control method are also disclosed.
Description
Technical field
The present invention relates to the manufacture method of Chinese patent medicine, specifically is a kind of preparation method of Chinese patent medicine, prescription and Quality Control Technology.
Background technology
Existing treatment anemofrigid-damp arthralgia disease drug on the market, its effect is not ideal.QUFENG ZHITONG PIAN mainly contains antiinflammatory, analgesia, effects such as immunomodulating.Have dispel the wind cold, invigorating the liver and kidney, the effect of strengthening bone and muscle.Be used for the numbness disease due to wind-cold damp pathogen impatency, the caused by liver and kidney deficiency, disease is seen arthroncus, lumbocrural pain, numb limbs and tense tendons.QUFENG ZHITONG PIAN prescription science, compatibility is rigorous, through pharmacology, toxicity, and clinical research, shows this medicine safety and stability, and determined curative effect is obtained comparatively ideal effect.
The prescription of QUFENG ZHITONG PIAN is:
Herba Erodii 500g Radix Clematidis 125g Radix Aconiti Kusnezoffii Preparata 125g Radix Angelicae Pubescentis 125g
Flos Carthami 125g Herba Visci 250g Radix Dipsaci 250g.
Summary of the invention
Purpose of the present invention is optimized research to prescription, production technology, the detection method of QUFENG ZHITONG PIAN, has formulated quality control standard, improves content of effective in the QUFENG ZHITONG PIAN, and the detection science is quality controllable, makes medicine more safe and effective.Technical scheme of the present invention is as follows:
1, prescription: Herba Erodii 500g Radix Clematidis 125g Radix Aconiti Kusnezoffii Preparata 125g Radix Angelicae Pubescentis 125g
Flos Carthami 125g Herba Visci 250g Radix Dipsaci 250g
2, preparation method: Radix Clematidis, Radix Angelicae Pubescentis are ground into fine powder, sieve fine powder 180g; Chinese medicine of the five flavours materials such as Herba Visci decoct with water being 3 hours, and filtering residue adds CHENGLINGXIAN again, Radix Angelicae Pubescentis coarse powder decocting time is 3 hours, and merging filtrate is condensed into the extractum that relative density is 1.26～1.28 (80 ℃).
After above-mentioned extractum and fine powder mixing, drying, the pulverizing, make granule with 65% ethanol, dry, be pressed into 1000, sugar coating.
3, pharmacological action:
Analgesic activity: this product stimulates chemical stimulation and hot plate brings out mice pain obvious analgesic activity is all arranged.
Antiinflammatory action: the swelling of rat toes has obvious inhibitory action due to this product on Carrageenan, and the rat granuloma hypertrophy is had obvious inhibitory action, and rat assist agent arthritis is had the obvious suppression effect.
Immune suppression function: nonspecific immunity and humoral immune function are had obvious inhibitory action: this product has obvious inhibitory action to immune organ (thymus, spleen), peritoneal macrophage phagocytic function, serum hemolysin generation.
4, toxicologic study:
In 27 weeks of high, normal, basic three the dosage successive administration mices of QUFENG ZHITONG PIAN (ig), no overt toxicity reaction does not have the time delay toxic reaction yet.
5, clinical research:
QUFENG ZHITONG PIAN have dispel the wind cold, invigorating the liver and kidney, the effect of strengthening bone and muscle.Be used for the numbness disease due to wind-cold damp pathogen impatency, the caused by liver and kidney deficiency, disease is seen diseases such as arthroncus, lumbocrural pain, numb limbs and tense tendons.Through Henan Province institute of traditional Chinese medicine 310 routine clinical experimental studies, obvious effective rate is 51.3%, and total effective rate is 92.6%.
The QUFENG ZHITONG PIAN of explained hereafter of the present invention, the prescription science, compatibility is rigorous, through pharmacology, toxicity and clinical research, shows that this medical instrument has higher clinical efficacy, does not find tangible untoward reaction, safety and stability, technology advanced person, the detection means science, quality controllable.
The specific embodiment
1, prescription
Herba Erodii 500g Radix Clematidis 125g Radix Aconiti Kusnezoffii Preparata 125g Radix Angelicae Pubescentis 125g
Flos Carthami 125g Herba Visci 250g Radix Dipsaci 250g.
2, manufacture method: above seven the flavor, Radix Clematidis, Radix Angelicae Pubescentis are ground into fine powder, sieve fine powder 180g; The five tastes such as all the other Herba Viscis decoct with water secondary, decoct 3 hours for the first time, add CHENGLINGXIAN, Radix Angelicae Pubescentis coarse powder for the second time, decocted 3 hours, gradation filters, merging filtrate, being condensed into relative density is the extractum of 1.26～1.28 (80 ℃), with above-mentioned fine powder mixing, drying, pulverize, make granule with 65% ethanol, drying gets granule 300g, be pressed into 1000, sugar coating promptly.
The above-mentioned QUFENG ZHITONG PIAN of making is carried out following character, discriminating, inspection and assay:
3, character: this product is a coated tablet, removes to show brownish black behind the sugar-coat; Bitter in the mouth, puckery.
4, differentiate
(1), gets 4 of this product, porphyrize, 10ml adds diethyl ether, supersound process 15 minutes filters, and filtrate volatilizes, residue adds ethyl acetate 1ml makes dissolving, as need testing solution, other gets Radix Angelicae Pubescentis control medicinal material 0.2g, shines medical material solution in pairs with legal system, test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), drawing above-mentioned two kinds of each 5ul of solution, put respectively on same silica gel g thin-layer plate, is developing solvent with normal hexane-benzene-ethyl acetate (2: 1: 1), 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.
(2), get 10 of this product, remove sugar-coat, porphyrize is put in the flask, 70% ethanol 100ml in addition, reflux, extract, 1 hour is put coldly, filters, container and filter wash with 70% ethanol 20ml, washing liquid and filtrate merging, water-bath boils off ethanol.Add water 20ml again, move in the separatory funnel, use ether extraction 4 times, each 40ml.Discard ether solution, water liquid is with water saturated n-butanol extraction 3 times, each 40ml, merge n-butyl alcohol liquid,, discard water lotion with the saturated water 30ml washing of n-butyl alcohol, n-butyl alcohol liquid water bath method, residue add water 30ml heating makes dissolving, moves in the 100ml flask, add dilute sulfuric acid 1.5ml again, shake up, boiling reflux 1 hour, put cold, move in the separatory funnel, use ethyl acetate extraction 3 times, each 30ml, merge ethyl acetate liquid, water 30ml washing discards water lotion, and ethyl acetate liquid filters with dry filter paper, the filtrate water bath method, residue adds methanol 2ml makes dissolving, centrifugal, gets supernatant and holds liquid as test sample.Other gets the Quercetin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution.Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw need testing solution 3-6ul, reference substance solution 2ul, putting respectively on same silica gel g thin-layer plate, is developing solvent with toluene-Ethyl formate-formic acid (5: 4: 1), launches, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 5% aluminum chloride alcoholic solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color.
5, check: aconitine limit is got 40 of this product, removes sugar-coat, porphyrize, put in the tool plug conical flask 200ml that adds diethyl ether, jolting 10 minutes, add ammonia solution 5ml again, supersound process 10 minutes was placed 2 hours, filter, filtrate is put in the separatory funnel, extracts 3 times with the hydrochloric acid solution jolting of 0.05mol/L, each 20ml, merge acid liquid, transfer pH value to 12, extract 3 times with the ether jolting with liquor ammoniae fortis, each 30mL, merge ether solution, low temperature evaporate to dryness, residue add dehydrated alcohol makes dissolving, and quantitatively be transferred in the 1mL measuring bottle, add dehydrated alcohol to scale, shake up, as need testing solution.Other gets the aconitine reference substance, adds dehydrated alcohol and makes the solution that every 1ml contains 1mg, solution in contrast.Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw need testing solution 6ul, reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate-diethylamine (6: 4: 1) is developing solvent, launches, and takes out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of appearance should or speckle not occur less than the speckle of reference substance.
Other should meet regulation relevant under the tablet item (appendix of Chinese Pharmacopoeia version in 2005).
6, assay: the preparation precision of reference substance solution takes by weighing 105 ℃ of aconitine reference substance 10mg that are dried to constant weight, puts in the 100ml measuring bottle, adds the chloroform dissolving and is diluted to scale, shakes up, and promptly gets (containing aconitine 0.1mg among every 1ml).
The accurate reference substance solution 0 of drawing of the preparation of standard curve, 1,2,3,4,5ml, put respectively in the separatory funnel, accurate successively adding chloroform is to 20ml, and accurate again adding PH3.0 buffer solution (takes by weighing anhydrous sodium acetate 0.15g, add and make dissolving, add glacial acetic acid 5.6mL, be diluted with water to 500ml, shake up, and correction on the PH meter) 10ml and 0.1% bromocresol green solution (are got bromocresol green 0.2g, add 0.05mol/L sodium hydroxide solution 3.2ml and make dissolving, be diluted with water to 200ml, shake up) 2ml, powerful jolting, left standstill 20 minutes, and divided and get chloroform layer, filter with dry filter paper, filtrate is measured trap at the wavelength place of 421nm respectively according to spectrophotography (appendix of Chinese Pharmacopoeia version in 2005).With the trap is vertical coordinate, and concentration is abscissa, the drawing standard curve.
Algoscopy is with 15 of this product, and accurate the title decided porphyrize, get about 1.2g, the accurate title, decide, and puts in the tool plug conical flask, add the mixed solution 25ml and the ammonia solution 2ml of E-C-dehydrated alcohol (16: 8: 1), shake up, excusing from death was handled 10 minutes, placement is spent the night, and jolting is put only, filter, residue adds the mixed solvent jolting again and extracts 2 times, and each 10ml filters, container and filter be with mixed solvent 10ml washing, washing liquid and filtrate entirely also, evaporate to dryness.Add diethyl ether 10ml gradation dissolving of residue is transferred in the separatory funnel, with 0.05mol/L sulphuric acid solution extraction four times, each 10ml divides and gets sulphuric acid liquid, puts in another separatory funnel, adding liquor ammoniae fortis 5ml shakes up, with chloroform extraction four times, each 10ml divides and gets chloroform solution, filter, filter washs with minimum of chloroform, washing liquid and filtrate entirely also, evaporate to dryness, residue adds chloroform gradation dissolving, quantitatively be transferred in the 25ml measuring bottle, add chloroform and be diluted to scale, shake up, precision is measured 20ml, put in the separatory funnel, the method under the sighting target directrix curve preparation is from " fine scale adds PH3.0 buffer 10ml ", measure trap in accordance with the law, from the amount (ug/ml) that standard curve is read the need testing solution mesaconitine, calculate, promptly.
Every of this product contains the Aconitum carmichjaelii Debx. total alkaloids with aconitine (C
34H
47NO
11) meter, should be 0.060-0.24mg.
7, function and curing mainly: it is cold to dispel the wind, invigorating the liver and kidney, strengthening bone and muscle.Be used for the numbness disease due to wind-cold damp pathogen impatency, the caused by liver and kidney deficiency, disease is seen arthroncus, lumbocrural pain, numb limbs and tense tendons.
8, usage and consumption: oral, one time 4,2 times on the one.
9, note: contraindication in pregnancy.
10, storage: sealing.
Claims (4)
1, a kind of preparation medicine of QUFENG ZHITONG PIAN is characterized in that, raw material is made up of by following proportionate relationship following seven flavor medicine thing:
Herba Erodii 500g; Radix Clematidis 125g; Radix Aconiti Kusnezoffii Preparata 125g; Radix Angelicae Pubescentis 125g; Flos Carthami 125g; Herba Visci 250g; Radix Dipsaci 250g.
2, the preparation method of the preparation medicine of QUFENG ZHITONG PIAN according to claim 1 is characterized in that may further comprise the steps:
(1), Radix Clematidis, Radix Angelicae Pubescentis be ground into fine powder, sieve fine powder;
(2), after Chinese medicine of the five flavours material such as all the other Herba Viscis decocts with water, filtering liquid medicine, filtering residue add Radix Clematidis again, the Radix Angelicae Pubescentis coarse powder decocts, and filter; Merging filtrate is condensed into extractum,
(3), above-mentioned extractum and fine powder mixing, drying is pulverized, and makes granule with 65% ethanol, drying is pressed into 1000, sugar coating promptly.
3, preparation method according to claim 2 is characterized in that:
Radix Clematidis, Radix Angelicae Pubescentis are ground into fine powder, sieve fine powder 180g; It is 3 hours that Chinese medicine of the five flavours materials such as Herba Visci decoct with water the time, and filtering residue adds Radix Clematidis again, Radix Angelicae Pubescentis coarse powder decocting time is 3 hours, and merging filtrate is condensed into the extractum that relative density is 1.26～1.28 (80 ℃);
After above-mentioned extractum and fine powder mixing, drying, the pulverizing, make granule with 65% ethanol, dry, be pressed into 1000, sugar coating.
4, the method for quality control of QUFENG ZHITONG PIAN is characterized in that carrying out following character, discriminating, inspection and assay:
Character: this product is a coated tablet, removes to show brownish black behind the sugar-coat; Bitter in the mouth, puckery;
Differentiate:
(1), gets 4 of this product, every contains medical material 1.5g, porphyrize, the 10ml that adds diethyl ether, supersound process 15 minutes, filter, filtrate volatilizes, and residue adds ethyl acetate 1ml makes dissolving, as need testing solution, other gets Radix Angelicae Pubescentis control medicinal material 0.2g, shine medical material solution in pairs with legal system,, draw above-mentioned two kinds of each 5ul of solution according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005) test, put respectively on same silica gel g thin-layer plate, with normal hexane-benzene-ethyl acetate (2: 1: 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;
(2), get 10 of this product, remove sugar-coat, porphyrize is put in the flask, 70% ethanol 100ml in addition, reflux, extract, 1 hour is put coldly, filters, container and filter wash with 70% ethanol 20ml, washing liquid and filtrate merging, water-bath boils off ethanol; Add water 20ml again, move in the separatory funnel, use ether extraction 4 times, each 40ml; Discard ether solution, water liquid is with water saturated n-butanol extraction 3 times, each 40ml, merge n-butyl alcohol liquid,, discard water lotion with the saturated water 30ml washing of n-butyl alcohol, n-butyl alcohol liquid water bath method, residue add water 30ml heating makes dissolving, moves in the 100ml flask, add dilute sulfuric acid 1.5ml again, shake up, boiling reflux 1 hour, put cold, move in the separatory funnel, use ethyl acetate extraction 3 times, each 30ml, merge ethyl acetate liquid, water 30ml washing discards water lotion, and ethyl acetate liquid filters with dry filter paper, the filtrate water bath method, residue adds methanol 2ml makes dissolving, centrifugal, gets supernatant and holds liquid as test sample; Other gets the Quercetin reference substance, adds methanol and makes the solution that every 1ml contains 0.5mg, in contrast product solution; Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw need testing solution 3-6ul, reference substance solution 2ul, putting respectively on same silica gel g thin-layer plate, is developing solvent with toluene-Ethyl formate-formic acid (5: 4: 1), launches, take out, dry, spray is put under the ultra-violet lamp (365nm) and is inspected with 5% aluminum chloride alcoholic solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the fluorescence speckle of same color;
Check: aconitine limit is got 40 of this product, removes sugar-coat, porphyrize, put in the tool plug conical flask 200ml that adds diethyl ether, jolting 10 minutes, add ammonia solution 5ml again, supersound process 10 minutes was placed 2 hours, filter, filtrate is put in the separatory funnel, extracts 3 times with the hydrochloric acid solution jolting of 0.05mol/L, each 20ml, merge acid liquid, transfer pH value to 12, extract 3 times with the ether jolting with liquor ammoniae fortis, each 30mL, merge ether solution, low temperature evaporate to dryness, residue add dehydrated alcohol makes dissolving, and quantitatively be transferred in the 1mL measuring bottle, add dehydrated alcohol to scale, shake up, as need testing solution; Other gets the aconitine reference substance, adds dehydrated alcohol and makes the solution that every 1ml contains 1mg, in contrast product solution; Test according to thin layer chromatography (appendix of Chinese Pharmacopoeia version in 2005), draw need testing solution 6ul, reference substance solution 5ul, put respectively on same silica gel g thin-layer plate, with normal hexane-ethyl acetate-diethylamine (6: 4: 1) is developing solvent, launches, and takes out, dry, spray is with rare bismuth potassium iodide test solution; In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, the speckle of appearance should or speckle not occur less than the speckle of reference substance;
Other should meet regulation relevant under the tablet item (appendix of Chinese Pharmacopoeia version in 2005);
Assay: the preparation precision of reference substance solution takes by weighing 105 ℃ of aconitine reference substance 10mg that are dried to constant weight, puts in the 100ml measuring bottle, adds the chloroform dissolving and is diluted to scale, shakes up, and promptly gets (containing aconitine 0.1mg among every 1ml);
The accurate reference substance solution 0 of drawing of the preparation of standard curve, 1,2,3,4,5ml, put respectively in the separatory funnel, accurate successively adding chloroform is to 20ml, and accurate again adding PH3.0 buffer solution (takes by weighing anhydrous sodium acetate 0.15g, add and make dissolving, add glacial acetic acid 5.6mL, be diluted with water to 500ml, shake up, and correction on the PH meter) 10ml and 0.1% bromocresol green solution (are got bromocresol green 0.2g, add 0.05mol/L sodium hydroxide solution 3.2ml and make dissolving, be diluted with water to 200ml, shake up) 2ml, powerful jolting, left standstill 20 minutes, and divided and get chloroform layer, filter with dry filter paper, filtrate is measured trap at the wavelength place of 421nm respectively according to spectrophotography (appendix of Chinese Pharmacopoeia version in 2005); With the trap is vertical coordinate, and concentration is abscissa, the drawing standard curve;
Algoscopy is with 15 of this product, and accurate the title decided porphyrize, get about 1.2g, the accurate title, decide, and puts in the tool plug conical flask, add the mixed solution 25ml and the ammonia solution 2ml of E-C-dehydrated alcohol (16: 8: 1), shake up, excusing from death was handled 10 minutes, placement is spent the night, and jolting is put only, filter, residue adds the mixed solvent jolting again and extracts 2 times, and each 10ml filters, container and filter be with mixed solvent 10ml washing, washing liquid and filtrate entirely also, evaporate to dryness; Add diethyl ether 10ml gradation dissolving of residue is transferred in the separatory funnel, with 0.05mol/L sulphuric acid solution extraction four times, each 10ml divides and gets sulphuric acid liquid, puts in another separatory funnel, adding liquor ammoniae fortis 5ml shakes up, with chloroform extraction four times, each 10ml divides and gets chloroform solution, filter, filter washs with minimum of chloroform, washing liquid and filtrate entirely also, evaporate to dryness, residue adds chloroform gradation dissolving, quantitatively be transferred in the 25ml measuring bottle, add chloroform and be diluted to scale, shake up, precision is measured 20ml, put in the separatory funnel, the method under the sighting target directrix curve preparation is from " fine scale adds PH3.0 buffer 10ml ", measure trap in accordance with the law, from the amount (ug/ml) that standard curve is read the need testing solution mesaconitine, calculate, promptly; Every of this product contains the Aconitum carmichjaelii Debx. total alkaloids with aconitine (C
34H
47NO
11) meter, should be 0.060-0.24mg.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104312887A (en) * | 2014-10-08 | 2015-01-28 | 登封市绿之源农副产品开发有限公司 | Wind dispelling and pain relieving persimmon vinegar and preparation method thereof |
| CN104547818A (en) * | 2013-10-25 | 2015-04-29 | 王波 | Production technology of Hantongle Yunji and quality control method thereof |
| CN108096246A (en) * | 2017-03-08 | 2018-06-01 | 中国农业科学院饲料研究所 | Quercetin and aconitine combine the application for being used to prepare treatment uterine neck cancer drug and treatment uterine neck cancer drug |
| CN114028458A (en) * | 2021-12-27 | 2022-02-11 | 吉林吉春制药股份有限公司 | Traditional Chinese medicine composition and pill for dispelling wind and relieving pain and preparation method thereof |
-
2005
- 2005-12-31 CN CNB200510097337XA patent/CN100487450C/en active Active
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104547818A (en) * | 2013-10-25 | 2015-04-29 | 王波 | Production technology of Hantongle Yunji and quality control method thereof |
| CN104312887A (en) * | 2014-10-08 | 2015-01-28 | 登封市绿之源农副产品开发有限公司 | Wind dispelling and pain relieving persimmon vinegar and preparation method thereof |
| CN108096246A (en) * | 2017-03-08 | 2018-06-01 | 中国农业科学院饲料研究所 | Quercetin and aconitine combine the application for being used to prepare treatment uterine neck cancer drug and treatment uterine neck cancer drug |
| CN114028458A (en) * | 2021-12-27 | 2022-02-11 | 吉林吉春制药股份有限公司 | Traditional Chinese medicine composition and pill for dispelling wind and relieving pain and preparation method thereof |
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| Publication number | Publication date |
|---|---|
| CN100487450C (en) | 2009-05-13 |
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