CN1478536A - Proprietury Chinese medicine for stopping blood, analgesia, removing blood stasis and engender new and its preparation method - Google Patents
Proprietury Chinese medicine for stopping blood, analgesia, removing blood stasis and engender new and its preparation method Download PDFInfo
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Abstract
A styptic and antalgic Chinese patent medicine is prepared from 7 Chinese-medicinal materials including notoginseng, wild aconite root, yam, borneol, etc. Its preparation method is also disclosed.
Description
Technical field:
The present invention relates to the Chinese medicine of a kind of hemostatic analgesia, promoting tissue regeneration by removing blood stasis, particularly the Chinese patent medicine made from medicines such as Radix Notoginseng, Rhizoma Paridis, Radix Aconiti Kusnezoffii Preparata, Rhizoma Dioscoreae, Folium Callicarpae Macrophyllae and extract, black purple Rhizoma et radix veratri (Radix Rhizoma Veratri), Borneolum Syntheticums.
Background technology:
Hemorrhage is a kind of pilosity, common disease, and as stomach, duodenal ulcer and hemorrhage, bronchiectasis is hemorrhage, hemoptysis of pulmonary tuberculosis, dysfunctional uterine hemorrhage injures bleeding hemorrhoids outward, menoxenia, dysmenorrhoea, amenorrhea and menstrual blood loss are too much, postnatal blood stasis, stomachache, intercostal neuralgia etc.These diseases are brought big painful to the patient, need treatment in time mostly, use treatment by Chinese herbs to obtain certain effect, but belonging to a bit, existing medicine cures the symptoms, not the disease, some hemostasis but do not ease pain, some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.
The invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect, show that with pharmacological research the present invention's main feature compared with the prior art is through clinical:
1. have good functions such as promoting blood circulation to remove obstruction in the collateral, promoting tissue regeneration by removing blood stasis, expelling wind and removing dampness, hemostatic analgesia, the analgesia and the hemostasia effect of highly significant arranged, good antibiotic, antiviral, antiinflammatory are arranged, improve effects such as blood is capable, repercussive, promotion organization healing.
2. hemostasis is remarkable, applied widely.To hematemesis, hemoptysis, have blood in stool, various hemorrhages such as hematuria, dysfunctional uterine hemorrhage, vaginal hemorrhage, postnatal blood stasis, traumatic hemorrhage all have good effect, be applicable to the various hemorrhages of pattern of syndrome such as the deficiency of vital energy is lost blood, liver can not store blood, failure of the spleen to keep the blood flowing within the vessels, blood-stasis internal-depression, injury of blood collaterals by heat, and can stop blooding and not stay not blood trouble of the stasis of blood, blood stasis dispelling.
3. analgesia is remarkable, applied widely.All powerful to various pain diseases such as swelling and pain due to blood stasis, traumatic injury, acute jerk contused wound, rheumatism low pain, arthralgia, neuralgias, be applicable to the various diseases of pattern of syndrome such as the stagnation of QI, cold pain, burning pain, blood stasis.
4. outstanding to women's menopathy curative effect.Evident in efficacy to dysmenorrhes, menoxenia, menorrhagia, amenorrhea, metrorrhagia etc.
5. take stopgap measures and hold up this, treating both the principal and the secondary aspects of a disease at the same time.This product has the good effect of " seven divide and rule, three minutes support ", can promoting blood circulation to remove obstruction in the collateral, regulating the flow of QI to dissipate blood stasis, expelling wind and removing dampness, clearing heat for detumescence, have the function of replenishing QI and blood, nourishing the liver and kidney again concurrently.
Summary of the invention:
The invention provides the Chinese patent medicine of a kind of hemostatic analgesia, promoting tissue regeneration by removing blood stasis, this Chinese medicine is to make with medicine materials such as Radix Notoginseng, Rhizoma Paridis, Radix Aconiti Kusnezoffii Preparata, Rhizoma Dioscoreae, Folium Callicarpae Macrophyllae and extract, black purple Rhizoma et radix veratri (Radix Rhizoma Veratri), Borneolum Syntheticums.
Chinese medicine of the present invention is made into pharmaceutical formulation, has effects such as hemostatic analgesia, promoting tissue regeneration by removing blood stasis, can treat stomach, duodenal ulcer and hemorrhage, bronchiectasis is hemorrhage, hemoptysis of pulmonary tuberculosis, dysfunctional uterine hemorrhage, injure bleeding hemorrhoids outward, menoxenia, dysmenorrhoea, amenorrhea and menstrual blood loss are too much, postnatal blood stasis, stomachache, diseases such as intercostal neuralgia.
Its prescription of Chinese medicine preparation of the present invention consists of: the black purple black false hellebore 4-12 part borneol 1-5 part insurance prescription of pseudo-ginseng 45-79 part Paris polyphylla 108-193 part wild aconite root 56-102 part Chinese yam 14-35 part bigleafbeautyberry root or leaf and extract 42-84 part: black purple black false hellebore 20-70 part cinnabar 1-5 part is 25 parts of bigleafbeautyberry root or leafs of 80 portions of Chinese yams of 150 parts of wild aconite roots of 62 parts of Paris polyphylla of pseudo-ginseng and 3 parts of insurance of 63 parts of black 8 parts of borneols of purple black false hellebore of extract prescription preferably: 3 parts in black 45 parts of cinnabar of purple black false hellebore
In more than forming, every part of representative be weight portion, weight is calculated with crude drug, if be unit (Semen daturae fluid extract is unit with ml simultaneously) with the gram, more than form and can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, pill 1000 balls, 1000 bags of granules, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time, oral liquid can be made Different Package such as 5ml/ peace bottle, the 200ml/ bottle, 100ml/ bottle, 50ml/ bottle.
More than form, as if being unit with the gram, can be made into the preparation of 50-1000 taking dose, as capsule, make 1000 capsules, each taking dose can be the 1-20 capsules, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62.5-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the gram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
Single medicinal material, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.
Chinese medicine preparation of the present invention, can add the medicine acceptable carrier when being prepared into medicament, described medicine acceptable carrier can be: starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Chinese medicine preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, sugar coated tablet, film coated tablet, enteric coated tablet, capsule, hard capsule, soft capsule, oral liquid, suck agent, granule, electuary, pill, powder, unguentum, sublimed preparation, suspensoid, powder, solution, injection, suppository, ointment, plaster, cream, spray, drop, patch.Preparation of the present invention, peroral dosage form preferably, as: capsule, tablet, oral liquid, granule, pill, powder, sublimed preparation, unguentum etc., preferably capsule, tablet.
Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys every day three times, each 1-20 agent, as: 1-20 bag or grain or sheet.
Chinese medicine preparation of the present invention can prepare by the following method.More than seven flavors, pulverize separately becomes fine powder, sieves, mixing, makes preparation, as the capsulae vacuus of packing into, promptly.Insure sub-method for making: above black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 1000 balls, promptly.
Chinese medicine preparation of the present invention has adopted insurance as potentiation or safe composition, when packing, will insure son and preparation of the present invention by a certain percentage, as 1: 2-1: 10 ratio is packaging together jointly, can be when taking a certain amount of preparation of the present invention when taking, take a certain amount of insurance in proportion, to increase curative effect, reduce toxicity, guarantee safety, insurance of the present invention, can be made into the form of pill, also can be made into other forms such as capsule, tablet etc., its prescription is formed, black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 2-7g Cinnabaris 0.1-0.5g can be made into 100 balls or sheet or capsule, and preferred insurance prescription is: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 4.5g Cinnabaris 0.3g
The present invention also provides the method for quality control of Chinese medicine preparation of the present invention, comprising: the evaluation of product character and product are differentiated.
The evaluation content of product character comprises,
Identify the character of content in the capsule of the capsule in the Chinese medicine preparation of the present invention, Chinese medicine preparation of the present invention is capsule preferably, and content is that ecru is to brown xanchromatic powder; Gas perfume (or spice), acrid in the mouth, little hardship.Insurance son is the vermeil coating watered pill, removes behind the coating apparent pale brown to sepia; Feeble QI, bitter in the mouth.Product differentiates that content comprises 5 kinds of methods:
(1) gets the about 4g of Chinese medicine preparation content of the present invention, add water saturated n-butyl alcohol 40ml, supersound process 10 minutes, filter, filtrate adds ammonia solution washing 2 times (40,30ml), divides and gets n-butanol layer, put evaporate to dryness in the water-bath, residue adds methanol 2ml makes dissolving, as need testing solution.Other gets ginsenoside Rb1 and arasaponin R1 reference substance, adds methanol and makes the mixed solution that every 1ml contains 2.5mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with ethanol solution of sulfuric acid (1 → 10), in about 10 minutes of 105 ℃ of bakings.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(2) get the about 8g of Chinese medicine preparation content of the present invention, add 80% ethanol 60ml, reflux 2 hours filters, evaporate to dryness, residue adds 2mol/L hydrochloric acid solution 40ml gradation makes dissolving, and hydrolysis is 1 hour in the boiling water bath, cooling, filter, filtrate is extracted (40,30ml), merge extractive liquid,, evaporate to dryness 2 times with petroleum ether (60-90 ℃).Residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets Rhizoma Paridis control medicinal material 3.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with chloroform-methanol (19: 1) is 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 principal spot of 1 same color.
(3) get the about 8g of Chinese medicine preparation content of the present invention, add strong ammonia solution 2ml and make moisteningly, the 50ml merceration 24 hours of adding diethyl ether again filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Radix Aconiti Kusnezoffii Preparata control medicinal material powder 1.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 10 μ l of two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with chloroform-methanol-strong ammonia solution (8: 2: 0.2) is developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of 1 same color.
(4) get the about 1g of Chinese medicine preparation content of the present invention, add petroleum ether (60-90 ℃) 10ml, jolting constantly 10 minutes filters the filtrate evaporate to dryness.Residue adds ethyl acetate 1ml makes dissolving, 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.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 4 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with benzene-ethyl acetate (9: 1) is developing solvent, launches, and takes out, dry, spray is with 5% phosphomolybdic acid ethanol solution, in about 10 minutes of 105 ℃ of bakings, to clear spot.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color.
(5) go bail for 8 of danger sons, porphyrize adds strong ammonia solution 0.5ml and makes moisteningly, and the 30ml merceration 24 hours of adding diethyl ether again filters, and the filtrate water-bath volatilizes.Residue adds methanol 0.5ml makes dissolving, as need testing solution.Other gets black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) control medicinal material powder 0.3g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 20 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, put in the chromatography cylinder of ammonia saturated with vapor, with benzene-acetone-ethyl acetate (7: 3: 3) 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 control medicinal material chromatograph on, show the speckle of 2 above same colors.
More than can use simultaneously in use in 5 kinds of methods, also can be used in combination separately or respectively, can assert that product is qualified as long as satisfy in above-mentioned 5 kinds of methods any feature.
Below by effect experiment beneficial effect of the present invention is described.
Test the medicine that used medicine prepares for the method according to the embodiment of the invention 1, experimental result is as follows.
Pharmacodynamics: Chinese medicine preparation of the present invention, clinical have effects such as hemostatic analgesia, promoting tissue regeneration by removing blood stasis.Pharmacodynamics test shows: with medicated powder ig administration in this product, the effect of shortening mice bleeding time and clotting time, shortening rabbit prothrombin time is arranged, but whole blood platelet count and the contractility of rat in the body uterus of rat all do not had obvious influence; Mouse peritoneum acetic acid is caused pain certain analgesic activity is arranged; The effect that the subcutaneous ecchymosis of the promotion rabbit ear absorbs, the promotion rat acetic acid is burnt gastric ulcer and skin injury wound healing is arranged; The effect of increasing children's female mice uterus weight in age is seemingly arranged.
Acute toxicity test: give mice ig dispensing with medicated powder in this product, maximum tolerated dose is greater than crude drug 14.4g/kg, and this amount is 600 times of the clinical daily dose of this product.Consider from acute toxicity, can think that it is safe that Radix Notoginseng blood is hindered Yiganning capsule oral by clinical daily dose.
Long term toxicity test: the dosage by crude drug 2.4g/kg, 1.2g/kg, 0.6g/kg is given 3 weeks of medicated powder (daily dose is 100 times, 50 times, 25 times of clinical consumption) in the continuous ig this product of rat respectively, there is no to cause tangible toxic reaction; Drug withdrawal observe 2 weeks also not wind significantly delay toxic reaction.Can think that by using clinical used dosage, usage, the course of treatment be safe.
For showing the therapeutic effect of medicine of the present invention, below be to be the clinical research overview that the present invention does by attached institute of Medical Colleges Of Guilin, the People's Hospital, Guilin:
The present invention carries out clinical efficacy test case totally 330 examples, and wherein 270 examples are organized in checking, use medicine of the present invention, and matched group 60 examples are used the YUNNAN BAIYAO capsule.Clinical data statistical result shows: medicine of the present invention compares with the contrast medicine, total effective rate there was no significant difference (P＞0.05), but recovery from illness, obvious effective rate obviously are better than matched group (P＜0.05), have effects such as good hemostatic analgesia, promoting tissue regeneration by removing blood stasis, its treatment total effective rate reaches 94.07%, in clinical verification, press the security inspection interpretation of result, do not find untoward reaction and toxic and side effects, show that this product is safe.
The specific embodiment:
Further specify the present invention by the following examples
Embodiment 1: the preparation prescription of capsule: the black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 8g Borneolum Syntheticum 3g insurance prescription of Radix Notoginseng 62g Rhizoma Paridis 150g Radix Aconiti Kusnezoffii Preparata 80g Rhizoma Dioscoreae 25g Folium Callicarpae Macrophyllae and extract 63g: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 4.5g Cinnabaris 0.3g preparation method: [method for making] above seven flavors, pulverize separately becomes fine powder, sieve, mixing, incapsulate 1000, promptly.Insure sub-method for making: above black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 100, promptly.
Embodiment 2: the preparation prescription of capsule: the black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 4g Borneolum Syntheticum 1g insurance prescription of three 45g Rhizoma Paridis 108g Radix Aconiti Kusnezoffii Preparata 56g Rhizoma Dioscoreae 14g Folium Callicarpae Macrophyllaes and extract 42g: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 2g Cinnabaris 0.1g preparation method: [method for making] above seven flavors, pulverize separately becomes fine powder, sieve, mixing, incapsulate 1000, promptly.Insure sub-method for making: above black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 100, promptly.
Embodiment 3: the preparation prescription of capsule: the black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 12g Borneolum Syntheticum 5g insurance prescription of Radix Notoginseng 79g Rhizoma Paridis 193g Radix Aconiti Kusnezoffii Preparata 102g Rhizoma Dioscoreae 35g Folium Callicarpae Macrophyllae and extract 84g: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 7g Cinnabaris 0.5g preparation method: [method for making] above seven flavors, pulverize separately becomes fine powder, sieve, mixing, incapsulate 1000, promptly.Insure sub-method for making: above black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 100, promptly.
Embodiment 4: the preparation prescription of pill: the black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 8g Borneolum Syntheticum 3g insurance prescription of Radix Notoginseng 62g Rhizoma Paridis 150g Radix Aconiti Kusnezoffii Preparata 80g Rhizoma Dioscoreae 25g Folium Callicarpae Macrophyllae and extract 63g: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 4.5g Cinnabaris 0.3g preparation method: [method for making] above seven flavors, pulverize separately becomes fine powder, sieve, add Mel 50g, starch 50g mixing, pill, make 1000 pillers, oven dry, packing promptly.Insure sub-method for making: above black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 100, promptly.
Claims (10)
1. Chinese traditional compound medicine, it is characterized in that, it is made by the Chinese medicine of following component, the black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 4-12 part Borneolum Syntheticum 1-5 part insurance prescription of Radix Notoginseng 45-79 part Rhizoma Paridis 108-193 part Radix Aconiti Kusnezoffii Preparata 56-102 part Rhizoma Dioscoreae 14-35 part Folium Callicarpae Macrophyllae and extract 42-84 part: black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) 20-70 part Cinnabaris 1-5 part.
2. according to the Chinese medicine preparation of claim 1, it is characterized in that, it is made by the Chinese medicine of following component, 3 parts of insurance of 63 parts of black 8 parts of Borneolum Syntheticums of purple Rhizoma et radix veratri (Radix Rhizoma Veratri) of 25 parts of Folium Callicarpae Macrophyllaes of 80 portions of Rhizoma Dioscoreaes of 150 parts of Radix Aconiti Kusnezoffii Preparatas of 62 parts of Rhizoma Paridis of Radix Notoginseng and extract prescription: 3 parts in black 45 parts of Cinnabaris of purple Rhizoma et radix veratri (Radix Rhizoma Veratri).
3. the Chinese medicine preparation of claim 1-2 is to be fit to medicinal various dosage forms.
4. the Chinese medicine preparation of claim 3 is tablet, capsule, oral liquid, buccal tablet, granule, electuary, pill, powder, suspensoid, powder, solution, drop, drop pill.
5. the Chinese medicine preparation of claim 4 is capsules, and insurance wherein is a pill.
6. the Chinese medicine preparation of claim 1-2 prevents and/or treats application in the medicine of hemorrhage and pain disease in preparation.
7. the preparation method of the Chinese medicine preparation of claim 1-2 is characterized in that, through following steps,
A. the medical material pulverize separately with recipe quantity becomes fine powder;
B. sieve;
C. mixing;
D. be effective ingredient with c step product, mix, make pharmaceutical preparation with the medicine acceptable carrier.
8. the method for making of insurance in the Chinese medicine preparation of claim 1-2 comprises that will deceive purple Rhizoma et radix veratri (Radix Rhizoma Veratri) and Cinnabaris, pulverize separately becomes fine powder, with water pill, Cinnabar coating, makes 1000.
9. the method for quality control of the Chinese medicine preparation of claim 1-5, the evaluation and the product that comprise the product character are differentiated, the authentication method of product character comprises: the content of identifying capsule is that ecru is to brown xanchromatic powder, gas perfume (or spice), acrid in the mouth, little hardship, insurance is the vermeil coating watered pill, show pale brown, feeble QI, bitter in the mouth after removing coating to sepia; Product differentiates that content comprises 5 kinds of methods:
(1) gets the about 4g of Chinese medicine preparation content of the present invention, add water saturated n-butyl alcohol 40ml, supersound process 10 minutes, filter, filtrate adds ammonia solution washing 2 times (40,30ml), divides and gets n-butanol layer, put evaporate to dryness in the water-bath, residue adds methanol 2ml makes dissolving, as need testing solution.Other gets ginsenoside Rb1 and arasaponin R1 reference substance, adds methanol and makes the mixed solution that every 1ml contains 2.5mg, in contrast product solution.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 1 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (15: 40: 22: 10) lower floor's solution of placing below 10 ℃ was developing solvent with chloroform-ethyl acetate-methanol-water, launch, take out, dry, spray is with ethanol solution of sulfuric acid (1 → 10), in about 10 minutes of 105 ℃ of bakings.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(2) get the about 8g of Chinese medicine preparation content of the present invention, add 80% ethanol 60ml, reflux 2 hours filters, evaporate to dryness, residue adds 2mol/L hydrochloric acid solution 40ml gradation makes dissolving, and hydrolysis is 1 hour in the boiling water bath, cooling, filter, filtrate is extracted (40,30ml), merge extractive liquid,, evaporate to dryness 2 times with petroleum ether (60-90 ℃).Residue adds chloroform 1ml makes dissolving, as need testing solution.Other gets Rhizoma Paridis control medicinal material 3.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 10 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with chloroform-methanol (19: 1) is 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 principal spot of 1 same color;
(3) get the about 8g of Chinese medicine preparation content of the present invention, add strong ammonia solution 2ml and make moisteningly, the 50ml merceration 24 hours of adding diethyl ether again filters, and filtrate evaporate to dryness, residue add methanol 1ml makes dissolving, as need testing solution.Other gets Radix Aconiti Kusnezoffii Preparata control medicinal material powder 1.5g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 10 μ l of two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with chloroform-methanol-strong ammonia solution (8: 2: 0.2) is developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the principal spot of 1 same color;
(4) get the about 1g of Chinese medicine preparation content of the present invention, add petroleum ether (60-90 ℃) 10ml, jolting constantly 10 minutes filters the filtrate evaporate to dryness.Residue adds ethyl acetate 1ml makes dissolving, 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.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 4 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, with benzene-ethyl acetate (9: 1) is developing solvent, launches, and takes out, dry, spray is with 5% phosphomolybdic acid ethanol solution, in about 10 minutes of 105 ℃ of bakings, to clear spot.In the test sample chromatograph, with the corresponding position of reference substance chromatograph on, show the speckle of same color;
(5) go bail for 8 of danger sons, porphyrize adds strong ammonia solution 0.5ml and makes moisteningly, and the 30ml merceration 24 hours of adding diethyl ether again filters, and the filtrate water-bath volatilizes.Residue adds methanol 0.5ml makes dissolving, as need testing solution.Other gets black purple Rhizoma et radix veratri (Radix Rhizoma Veratri) control medicinal material powder 0.3g, shines medical material solution in pairs with legal system.Test according to thin layer chromatography (appendix VIB of Chinese Pharmacopoeia version in 2000), draw each 20 μ l of above-mentioned two kinds of solution, put respectively in same and contain on the silica gel g thin-layer plate that sodium carboxymethyl cellulose is a binding agent, put in the chromatography cylinder of ammonia saturated with vapor, with benzene-acetone-ethyl acetate (7: 3: 3) is developing solvent, launch, take out, dry, spray is with rare bismuth potassium iodide test solution, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of 2 above same colors.
10. the method for quality control of claim 9, wherein the evaluation of product character is, identify the character of content in the capsule of the capsule in the Chinese medicine preparation of the present invention, the character of this content is that ecru is to brown xanchromatic powder, gas perfume (or spice), acrid in the mouth, little hardship, insurance son is the vermeil coating watered pill, removes behind the coating apparent pale brown to sepia, feeble QI, bitter in the mouth.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103446560A (en) * | 2013-08-06 | 2013-12-18 | 贵州铜仁梵康生物科技有限责任公司 | Medicine composition for treating alopecia and preparation method thereof |
| CN104013780A (en) * | 2014-06-27 | 2014-09-03 | 三明三药兽药有限公司 | Traditional Chinese medicine composition, traditional Chinese medicine preparation process and application of traditional Chinese medicine in field of veterinary medicament |
| CN106668839A (en) * | 2017-02-24 | 2017-05-17 | 刘海宾 | Chinese and western medicine composition for stopping bleeding and alleviating pain, and preparation technology of Chinese and western medicine composition |
| CN109932469A (en) * | 2019-04-12 | 2019-06-25 | 安徽中医药大学第一附属医院 | The discrimination method of borneol in a kind of hemorrhoid complicated by anal fistula lotion |
-
2003
- 2003-07-21 CN CN 03150155 patent/CN1220513C/en not_active Expired - Lifetime
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103446560A (en) * | 2013-08-06 | 2013-12-18 | 贵州铜仁梵康生物科技有限责任公司 | Medicine composition for treating alopecia and preparation method thereof |
| CN103446560B (en) * | 2013-08-06 | 2014-12-31 | 贵州铜仁梵康生物科技有限责任公司 | Medicine composition for treating alopecia and preparation method thereof |
| CN104013780A (en) * | 2014-06-27 | 2014-09-03 | 三明三药兽药有限公司 | Traditional Chinese medicine composition, traditional Chinese medicine preparation process and application of traditional Chinese medicine in field of veterinary medicament |
| CN104013780B (en) * | 2014-06-27 | 2017-08-01 | 三明三药兽药有限公司 | The application of Chinese medicine composition, preparation technique of traditional Chinese medicine and the Chinese medicine in field of veterinary |
| CN106668839A (en) * | 2017-02-24 | 2017-05-17 | 刘海宾 | Chinese and western medicine composition for stopping bleeding and alleviating pain, and preparation technology of Chinese and western medicine composition |
| CN109932469A (en) * | 2019-04-12 | 2019-06-25 | 安徽中医药大学第一附属医院 | The discrimination method of borneol in a kind of hemorrhoid complicated by anal fistula lotion |
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| Publication number | Publication date |
|---|---|
| CN1220513C (en) | 2005-09-28 |
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