CN101264172A - Preparation of Chinese medicine composition for drug detoxification and application thereof - Google Patents
Preparation of Chinese medicine composition for drug detoxification and application thereof Download PDFInfo
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Abstract
The invention relates to a Chinese herbal medicine composition used for detoxification treatment. The material composition for preparing the effective components of the composition is listed as follows according to weight shares: rhizoma corydalis 100 to 10000 shares, greater celandine 200 to 20000 shares, radix stephaniae cepharanthae 200 to 20000 shares, radix stephaniae tetrandrae 100 to 10000 shares, hyoscyamus niger 3 to 300 shares, angelica sinensis 75 to 7500 shares, tuber fleeceflower 10 to 1000 shares, medlar 20 to 2000 shares, ginseng 8 to 800 shares, albizzia peel 100 to 10000 shares, spine data seed 40 to 4000 shares, radix glycyrrhizae 75 to 7500 shares. The invention relates to a novel preparation method of the Chinese herbal medicine composition and the application to acute withdrawal treatment of opioid addicted patients.
Description
Technical field
The present invention relates to a kind of Chinese medicine composition, particularly a kind of Chinese medicine composition that is used for drug addiction treatment and preparation method thereof and its application.
Background technology
Disclose a kind of preparation method of Chinese medicine composition of drug rehabilitation in the prior art, seen the open text of Chinese patent (application number :), the raw material of the disclosed pharmaceutical composition of the document is counted by weight:
Rhizoma Corydalis 125-8000 part, Herba Chelidonii 250-16000 part, Radix Stephaniae Cepharanthae 250-16000 part, Radix Stephaniae Tetrandrae 125-8000 part, Semen Hyoscyami 4-240 part, Radix Angelicae Sinensis 90-6000 part, Radix Polygoni Multiflori 12.5-800 part, Fructus Lycii 25-1600 part, Radix Ginseng 10-640 part, Cortex Albiziae 125-8000 part, Semen Ziziphi Spinosae 50-3200 part, Radix Glycyrrhizae 90-6000 part.
The preferred proportion of the disclosed pharmaceutical composition of the document is:
1000 parts of Rhizoma Corydalis, 2000 parts of Herba Chelidoniis, 2000 parts of Radix Stephaniae Cepharanthaes, 1000 parts of Radixs Stephaniae Tetrandrae, 30 parts of Semen Hyoscyamis, 750 parts of Radix Angelicae Sinensis, 100 parts of Radix Polygoni Multiflori, 200 parts of Fructus Lyciis, 80 parts of Radix Ginsengs, 1000 parts of Cortex Albiziaes, 400 parts of Semen Ziziphi Spinosaes, 750 parts in Radix Glycyrrhizae.
Prior art discloses this preparation of drug combination method and the application in treatment drug addiction.
Summary of the invention
The object of the present invention is to provide the new preparation method of above-mentioned Chinese medicine composition.
Further, preparation compositions raw materials of effective components composition is counted Rhizoma Corydalis 250-4000 part by weight, Herba Chelidonii 500-8000 part, Radix Stephaniae Cepharanthae 500-8000 part, Radix Stephaniae Tetrandrae 250-4000 part, Semen Hyoscyami 7.5-120 part, Radix Angelicae Sinensis 180-3000 part, Radix Polygoni Multiflori 25-400 part, Fructus Lycii 50-800 part, Radix Ginseng 20-320 part, Cortex Albiziae 250-4000 part, Semen Ziziphi Spinosae 100-1600 part, Radix Glycyrrhizae 180-3000 part.
Further, preparation compositions raw materials of effective components composition is counted Rhizoma Corydalis 500-2000 part by weight, Herba Chelidonii 1000-4000 part, Radix Stephaniae Cepharanthae 1000-4000 part, Radix Stephaniae Tetrandrae 500-2000 part, Semen Hyoscyami 15-60 part, Radix Angelicae Sinensis 375-1500 part, Radix Polygoni Multiflori 50-200 part, Fructus Lycii 100-400 part, Radix Ginseng 40-160 part, Cortex Albiziae 500-2000 part, Semen Ziziphi Spinosae 200-800 part, Radix Glycyrrhizae 375-1500 part.
Further, preparation compositions raw materials of effective components composition is counted 1000 parts of Rhizoma Corydalis by weight, 2000 parts of Herba Chelidoniis, 2000 parts of Radix Stephaniae Cepharanthaes, 1000 parts of Radixs Stephaniae Tetrandrae, 30 parts of Semen Hyoscyamis, 750 parts of Radix Angelicae Sinensis, 100 parts of Radix Polygoni Multiflori, 200 parts of Fructus Lyciis, 80 parts of Radix Ginsengs, 1000 parts of Cortex Albiziaes, 400 parts of Semen Ziziphi Spinosaes, 750 parts in Radix Glycyrrhizae.
Further, Rhizoma Corydalis of the present invention is the dry tuber of papaveraceae plant corydalis Corydalis yanhusuo W.T.Wang.
Further, preferred Rhizoma Corydalis of the present invention is the vinegar Rhizoma Corydalis.
Further, Herba Chelidonii of the present invention is the dry herb of the plant Herba Chelidonii Chelidonium majus L. of opium poppy section.
Further, Radix Stephaniae Cepharanthae of the present invention is the dried root of menispermaceous plants headdress flower Radix Stephaniae Japonicae Stephania cepharanthaHayata.
Further, Radix Stephaniae Tetrandrae of the present invention is the dry root of menispermaceous plants Radix stephaniae tetrandrae Stephania tetrandra S.Moore.
Further, Semen Hyoscyami of the present invention is the dry mature seed of plant of Solanaceae hyoscyami Hyoscyamus niger L..
Further, of the present invention when the dry root that is classified as Radix Angelicae Sinensis umbelliferae angelica Angelica sinensis (Oliv.) Diels.
Further, preferred of the present invention when being classified as Radix Angelicae Sinensis (processed with wine).
Further, Radix Polygoni Multiflori of the present invention is the dried root of polygonum multiflorum thunb Polyaonum multififlorum Thunb..
Further, preferred Radix Polygoni Multiflori of the present invention is a Radix Polygoni Multiflori Preparata.
Further, Fructus Lycii of the present invention is the dry mature fruit of plant of Solanaceae lycium barbarum Lycium barbarum L..
Further, of the present invention is the dry root of Araliaceae Radix Ginseng Panax ginseng C.A.Mey.
Further, preferred Radix Ginseng of the present invention is Radix Ginseng or sun-dried SHANSHEN.
Further, Cortex Albiziae of the present invention is the dry bark of pulse family deciduous tree plant Herba Albiziae Albizzia julibrissin Durazz..
Further, Semen Ziziphi Spinosae of the present invention is the dry mature seed of Semen Ziziphi Spinosae (parched) Rhamnaceae plant Ziziphi Spinosae Ziziphus jujube Mill.var.psinosa (Bunge) Hu ex H.F.Chou.
Further, preferred Semen Ziziphi Spinosae of the present invention is a Semen Ziziphi Spinosae (parched).
Further, Radix Glycyrrhizae of the present invention is the dry root and rhizome of glycyrrhizic legume Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. Glycyrrhiza glabra L..
Further, the effective ingredient of Rhizoma Corydalis of the present invention, Radix Stephaniae Cepharanthae, Herba Chelidonii, Radix Stephaniae Tetrandrae, Semen Hyoscyami is made by following method, gets Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, the Radix Stephaniae Tetrandrae of proportional quantity, the coarse powder of Semen Hyoscyami, puts in the percolation jar, add the dilute acid soln soaked overnight, percolation is got percolate, transfers pH, concentrate, get extractum, or dry fluid extract, extract powder got.
Further, described dilute acid soln is this area acid commonly used, and it is formulated that example hydrochloric acid, sulphuric acid, nitric acid, acetic acid, phosphoric acid, formic acid etc. add water, and preferred acid is hydrochloric acid, sulphuric acid, acetic acid, and more preferably hydrochloric acid, acetic acid most preferably are hydrochloric acid.
Further, described dilute acid soln is that concentration is the acid solution of 0.01-5%, and the concentration of preferred acidic solution is 0.05-3%, and more preferably 0.1-2% most preferably is 0.5-1%.
Further, the solvent multiple of dilute acid soln percolation extraction medical material is 4-14 a times of medical material amount, is preferably 6-12 doubly, and more excellent is 8～10 times.
Further, the soak time that the dilute acid soln percolation extracts medical material is 12-48h, is preferably 24h.
Further, the percolation speed that the dilute acid soln percolation extracts medical material is to be per kilogram medical material per minute 0.5-50ml/min the time, is preferably 1～25ml, and more excellent is 2～10ml, and optimum is 4～6ml.
Further, the percolation that the dilute acid soln percolation extracts medical material is finished and can be adopted the alkaloid reaction reagent to determine, when alkaloid reagent presents negative response, can determine that percolation finishes.
Further, described alkaloid reaction reagent is selected from Wagner's reagent, Dragendorff's reagent, improvement Dragendorff's reagent, Mayer's reagent, Bertrand's reagent, preferably improves Dragendorff's reagent.
Further, the aqueous slkali of described adjust pH is that alkali well known in the art adds the solution that water makes, be selected from sodium hydroxide, potassium hydroxide, ammonia, sodium carbonate, sodium bicarbonate, potassium carbonate, potassium bicarbonate, calcium hydroxide, calcium oxide, sodium acetate, potassium acetate, sodium phosphate, sodium hydrogen phosphate, preferred sodium hydroxide, ammonia, sodium carbonate, sodium bicarbonate.
Further, the acid solution of described adjust pH is that acid well known in the art adds the solution that water makes, and is selected from hydrochloric acid, sulphuric acid, nitric acid, acetic acid, phosphoric acid, formic acid, preferred hydrochloric acid, acetic acid, sulphuric acid.
Further, described adjust pH scope is pH5～8, preferred pH6～7.
Further, the concentrated mode that described simmer down to this area is commonly used, any or its combination of preferred vacuum concentration, concentrating under reduced pressure or thin film concentration is beneficial to keep the effective ingredient in the extract.
Further, described drying is this area drying mode commonly used, and preferred vacuum drying or spray-dired any or its combination are beneficial to keep the effective ingredient in the extract.
Further, described medical material effective ingredient is selected from it and extracts concentrated solution or extractum, the perhaps dry extract or the extract powder of dry extraction concentrated solution or extractum gained.
Further, the effective ingredient of Semen Ziziphi Spinosae of the present invention, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Cortex Albiziae, Radix Glycyrrhizae is made by following method, get Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, the Cortex Albiziae of proportional quantity, the coarse powder of Radix Glycyrrhizae, add water-alcohol solution, reflux, extract, is filtered, filtrate recycling ethanol, concentrate, get alcohol-extracted extract, standby.
Water-alcohol solution of the present invention is that alcoholic solvent well known in the art adds the solution that water makes, described alcoholic solvent is selected from any or its combination of methanol, ethanol, ethylene glycol, propylene glycol, isopropyl alcohol, ethyl acetate, acetone, dimethyl sulfoxide, ether, dimethyl formamide, is preferably ethanol.
Further, the concentration of described water-alcohol solution is 20-95%, is preferably 40-90%, and more preferably 50-80% most preferably is 60-70%.
Further, the solvent multiple of water-alcohol solution reflux, extract, medical material is 4-12 a times of medical material amount, is preferably 5-10 doubly, and more preferably 6-8 doubly.
Further, the number of times of water-alcohol solution reflux, extract, medical material is 1-5 time, is preferably 2-4 time.
Further, the time of water-alcohol solution reflux, extract, medical material is 0.5-3h, is preferably 1-2h.
The concentrated mode that simmer down to of the present invention this area is commonly used, any or its combination of preferred vacuum concentration, concentrating under reduced pressure or thin film concentration is beneficial to keep the effective ingredient in the extract.
Drying of the present invention is this area drying mode commonly used, and preferred vacuum drying or spray-dired any or its combination are beneficial to keep the effective ingredient in the extract.In case of necessity, extract obtainedly can be crushed to required particle diameter as required.
Medical material effective ingredient of the present invention is selected from it and extracts concentrated solution or extractum, the perhaps dry extract or the extract powder of dry extraction concentrated solution or extractum gained.
Compositions of the present invention can be various dosage form well known in the art, can adopt the preparation technique of this area routine to prepare.Be suitable for preparation of the present invention and be selected from oral formulations, be preferably oral formulations.
Further, described oral formulations is selected from oral liquid, syrup, granule, tablet, capsule, drop pill, effervescent, paste, suspension, soft extract, pill, mixture or Emulsion; Be preferably oral liquid, powder, suspension, granule, tablet or capsule.
Being fit to pharmaceutically acceptable carrier of the present invention is well known usual excipients or the adjuvant that is used to prepare above-mentioned preparation.Excipient that oral formulations is commonly used or adjuvant include but are not limited to filler (claim not only diluent), lubricant (but also claiming fluidizer or antitack agent), dispersant, wetting agent, binding agent, regulator, solubilizing agent, antioxidant, antibacterial, emulsifying agent, correctives, odorant etc.Binding agent, for example syrup, arabic gum, xanthan gum, cellulose and derivant thereof, gelatine size, syrup, starch slurry or polyvinylpyrrolidone, preferably syrup, starch slurry, arabic gum; Filler, for example lactose, Icing Sugar, dextrin, starch and derivant thereof, cellulose and derivant thereof, inorganic calcium salt, sorbitol or glycine, preferred starch and derivant thereof, dextrin or lactose; Lubricant, for example micropowder silica gel, magnesium stearate, Pulvis Talci, aluminium hydroxide, boric acid, hydrogenated vegetable oil or PEG; Disintegrating agent, for example starch and derivant thereof, polyvinylpyrrolidone or microcrystalline Cellulose, the preferred starch derivant is carboxymethyl starch sodium, Explotab, pregelatinized Starch, modified starch, hydroxypropyl starch or corn starch; Wetting agent, for example sodium lauryl sulphate, water or alcohol etc.
In addition, also active component can be mixed by its preparation requirement with pharmaceutically acceptable slow-released carrier or controlled release carrier, again according to the preparation method of slow releasing preparation well known in the art or controlled release preparation, prepare slow releasing preparation or its controlled release preparation, as add the blocker coating or with making micropill after the active principle microcapsulesization again, as slow-release micro-pill or controlled release micro pill; Described slow controlled release carrier includes but are not limited to oil agent, hydrophilic colloid or the coating blocker etc. of mixing, and described oil to mix agent be glyceryl monostearate, castor oil hydrogenated, Dormant oils, polysiloxanes, dimethyl siloxane; Described hydrophilic colloid is cellulose derivatives such as sodium carboxymethyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, or PVP, arabic gum, tragcanth or carbopol etc.; Described coating blocker is ethyl cellulose (EC), hydroxypropyl methylcellulose (HMPC), polyvinylpyrrolidone (PVP), cellulose acetate-phthalate (CAP), acrylic acid resinoid etc.
The unit dose of the present invention minimum dose unit that to be pharmaceutical composition use for the patient, its unit comprises, grain, sheet, ball, prop up etc.
The daily dosage of pharmaceutical composition of the present invention, day is taken number of times and the cycle of taking can decide according to patient's composite factors such as the state of an illness, age, sex, body constitution and other medicining conditions.Common daily dosage is calculated as 4.66g-167.58g/ day by prescription medical material weight, is preferably 9.31g-83.79g/ day, more preferably 18.62g-27.93g/ day.Take number of times and be 1-4 time/day or 2-3 time/day or 1 time/day or 1 time/next day.
Another object of the present invention is to provide the application of Chinese medicine composition of the present invention in preparation detoxification treatment or drug addiction treatment medicine.
The specific embodiment
Specify the present invention below with reference to embodiment, embodiments of the invention only are used to technical scheme of the present invention is described, and non-limiting essence of the present invention.
Embodiment 1The preparation of granule
1, the composition of granule
Vinegar Rhizoma Corydalis 1000g Herba Chelidonii 2000g Radix Stephaniae Cepharanthae 2000g
Radix Stephaniae Tetrandrae 1000g Semen Hyoscyami 30g Radix Angelicae Sinensis 750g
Radix Polygoni Multiflori 100g Fructus Lycii 200g Radix Ginseng 80g
Cortex Albiziae 1000g Semen Ziziphi Spinosae 400g Radix Glycyrrhizae 750g
Make 1000 bags
2, the preparation method of granule
1) get Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, Radix Stephaniae Tetrandrae, the Semen Hyoscyami coarse powder of proportional quantity, put in the percolation bucket, add to decoct with 0.1% hydrochloric acid solution and extract 2 times, 2 extraction solvent for use amounts are respectively 10 times and 9 times of medical material amount, and decocting time is followed successively by 1h, 2h; Merge 2 times filtrate, being concentrated into relative density is the extractum of 1.1～1.2 (60 ℃), gets acid extraction extractum;
2) get Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Cortex Albiziae, the Radix Glycyrrhizae coarse powder of proportional quantity,, extract the solvent for use amount for 3 times and be 8 times of medical material amount, return time 1h with 60% alcohol reflux 3 times; Merge 3 times filtrate, behind the filtrate recycling ethanol, be concentrated into 1.0～1.1 (60 ℃), get the alcohol extraction concentrated solution;
3) with 2) step gained alcohol extraction concentrated solution and 1) step gained sour water extractum mixes, and vacuum drying is ground into fine powder, and adding sucrose or dextrin are used 70% alcohol granulation, dry, granulate, promptly.
Embodiment 2The preparation of tablet
1, the composition of tablet
Vinegar Rhizoma Corydalis 200g bends dish 400g Radix Stephaniae Cepharanthae 400g
Radix Stephaniae Tetrandrae 200g Semen Hyoscyami 6g Radix Angelicae Sinensis 150g
Radix Polygoni Multiflori 20g Fructus Lycii 40g Radix Ginseng 16g
Cortex Albiziae 200g Semen Ziziphi Spinosae 80g Radix Glycyrrhizae 150g
Make 1000
2, the preparation method of granule
1) get Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, Radix Stephaniae Tetrandrae, the Semen Hyoscyami coarse powder of proportional quantity, put in the percolation bucket, add to decoct with 0.1% hydrochloric acid solution and extract 2 times, 2 extraction solvent for use amounts are respectively 10 times and 9 times of medical material amount, and decocting time is followed successively by 1h, 2h; Merge 2 times filtrate, being concentrated into relative density is the extractum of 1.1～1.2 (60 ℃), gets acid extraction extractum;
2) get Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Cortex Albiziae, the Radix Glycyrrhizae coarse powder of proportional quantity,, extract the solvent for use amount for 3 times and be 8 times of medical material amount, return time 1h with 60% alcohol reflux 3 times; Merge 3 times filtrate, behind the filtrate recycling ethanol, be concentrated into 1.0～1.1 (60 ℃), get the alcohol extraction concentrated solution;
3) with 2) step gained alcohol extraction concentrated solution and 1) step gained sour water extractum mixes, and vacuum drying is ground into fine powder, and adding starch is an amount of, uses 70% alcohol granulation, dry, granulate, promptly.
4) with 3) step gained granule, add 0.5% magnesium stearate fine powder, mix homogeneously, tabletting to the tablet machine is pressed into 1000 altogether.
5) with the slice, thin piece bag film-coat that suppresses, promptly.
Embodiment 3The preparation of oral syrup agent
1, the composition of oral syrup agent
Vinegar Rhizoma Corydalis 1000g Herba Chelidonii 2000g Radix Stephaniae Cepharanthae 2000g
Radix Stephaniae Tetrandrae 1000g Semen Hyoscyami 30g Radix Angelicae Sinensis 750g
Radix Polygoni Multiflori 100g Fructus Lycii 200g Radix Ginseng 80g
Cortex Albiziae 1000g Semen Ziziphi Spinosae 400g Radix Glycyrrhizae 750g
Make 1000 bottles
2, the preparation method of granule
1) get Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, Radix Stephaniae Tetrandrae, the Semen Hyoscyami coarse powder of proportional quantity, put in the percolation bucket, add to decoct with 0.1% hydrochloric acid solution and extract 2 times, 2 extraction solvent for use amounts are respectively 10 times and 9 times of medical material amount, and decocting time is followed successively by 1h, 2h; Merge 2 times filtrate, being concentrated into relative density is the extractum of 1.1～1.2 (60 ℃), gets acid extraction extractum;
2) get Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Cortex Albiziae, the Radix Glycyrrhizae coarse powder of proportional quantity,, extract the solvent for use amount for 3 times and be 8 times of medical material amount, return time 1h with 60% alcohol reflux 3 times; Merge 3 times filtrate, behind the filtrate recycling ethanol, be concentrated into 1.0～1.1 (60 ℃), get the alcohol extraction concentrated solution;
3) get 2) with 1) step gained concentrated solution and extractum mixes, adds sucrose 1300g, heating for dissolving filters, and is cooled to 60 ℃, adds deionized water to 2000ml, mixing, and packing is in 105 ℃ of 30min that sterilize, promptly.
Below verify the pharmacological action of Chinese medicine composition of the present invention by the test example.The dosage of test example except as otherwise noted, is all in the crude drug amount.
Test example 1 Chinese medicine composition of the present invention is to the effect of the giving up research of opium dependent patient
Patient's choice criteria: 1. age 18-50 year; 2. body weight 45-80 kilogram; 3. meet DSM-IV opiates dependency diagnostic criteria person, withdrawal symptom is arranged, and meet the diagnostic criteria of opiates withdrawal symptom; 4. the urine trace morphine detects positive; 5. suck opium drug before this treatment always; 6. a nearest every day in week is on average below the amount of sucking 2.0 grams; 7. last is admitted to hospital with malicious time interval and is no more than 36 hours; 8. before the treatment withdrawal symptom is arranged, withdrawal symptom scoring total points is at the 65-140 branch; 9. the consume illegal drugs mode is not limit (totally control intravenous injection person and account for the test total number of persons more than 20%).
Patient's 240 examples are divided into test group and matched group.Test group 120 examples, oral Chinese medicine oral liquid of the present invention (10ml/ props up) and Lofexidine Hydrochloride simulation medicine (for the placebo of Lofexidine Hydrochloride sheet); Matched group 120 examples, oral hydrochloride lofexidine sheet (trade name Kai Erding, 0.2mg/ sheet) and Chinese medicine oral liquid of the present invention simulation medicine (being the placebo of oral liquid).Two groups drug dose and outward appearances are identical.Dosage regimen is:
The 1st day: granule 1 bag (20 milliliters of oral liquids, 5 in tablet)/time, q8h; 2 in tablet, q12h;
2-5 day: granule 1 bag (20 milliliters of oral liquids, 5 in tablet)/time, q8h; 3 in tablet, q8h;
6-7 day: granule 1 bag (20 milliliters of oral liquids, 5 in tablet)/time, q12h; 2 in tablet, q8h;
8-9 day: granule 1 bag (20 milliliters of oral liquids, 5 in tablet)/time, q12h; Tablet 1-2 sheet, q12h;
The 10th day: granule 1 bag (20 milliliters of oral liquids, 5 in tablet), take before sleeping evening; 1 in tablet is taken before sleeping evening.
During the medication plus-minus follow during dosage following some:
(1) experimenter's drug usage individuation.According to weight in patients, body constitution, nutriture, previously take drugs the drug rehabilitation history, in the recent period suck dosage, the last amount of sucking, suck definite dosage regimen such as mode.Especially tightly observe initial 1-3 day of medication.
(2) withdrawal symptom control is undesirable, have no adverse reaction or untoward reaction slight, suitably raise dosage.
(3) during the medication, particularly initial 1-2 day, that the experimenter occurs is obviously drowsiness, blurred vision, dysarthria, instability of gait, photis, auditory hallucination, agitation, delirium, blood pressure drops and decreased heart rate etc., suitably reduces the single dosage of oral liquid and tablet or reduces medication every day number of times.
(4) untoward reaction severe patient can be taken off blindly, and carries out corresponding emergency case and handles, and important mornitoring.
(5) in time fill in every experimenter's concrete medication dose, administration number of times and untoward reaction etc.
The drug combination regulation: duration of test does not use paramedicines as far as possible.But obvious intake deficiency, health are excessively weak or dehydration tendency person is arranged, and give Supporting Therapy.To the serious insomnia or the person of fermenting, give the estazolam or the clonazepam of routine dose in case of necessity.To the person that the disturbance of consciousness occurs (as delirium etc.), judge and the dependency that is subjected to the reagent thing, can give anti-psychotropic drugs symptomatic treatments such as Benzodiazepines.Poor effect is tended to and the trial drug person of being closely related, but drug withdrawal is observed.
The narcoticness drug-breaking medicine is used in nonjoinder.
Observe the experimenter and treat situation every day, the timely desired content of record on case report form, and as administration time, the scoring of withdrawal symptom isodose chart, drug combination situation, untoward reaction, and every day blood pressure, pulse, breathing etc.
Experimenter's check: after finishing test, the experimenter checks on time, urinates opiates sample detection, hematuria routine, hepatic and renal function and electrocardiogram check.Experimental result is as follows:
1, main curative effect index-withdrawal symptom subtracts the situation of change comparison day by day of branch rate
FAS crowd, withdrawal symptom subtracts the branch rate and rises day by day obviously after test group and the treatment of control group, have statistical significance (P＜0.01), preceding 5 days withdrawal symptoms subtract the branch rate and rise rapidly, and medication the 1st is per day about 30%, the 2nd per dayly rises to nearly 50%, test group on average reached 66% on 1, matched group average out to 63%, and test group the 5th day is on average 84%, matched group the 5th per day nearly 80%, two group to the 10th per day reaching more than 90%.Compare between group during test group and the treatment of control group, difference has statistical significance (P＜0.05), and test group subtracts the branch rate and rises fast than matched group.See Table 1.
Table 1 test group and matched group detoxification treatment withdrawal symptom subtract the branch rate and change comparison (FAS collection) day by day
* withdrawal symptom subtracts total points before branch rate=(total points-every day total points before the treatment)/treatment
PP crowd, two groups of results are similar to FAS crowd result.Withdrawal symptom subtracts the branch rate and rises day by day obviously after test group and the treatment of control group, has statistical significance (P＜0.01), preceding 5 days withdrawal symptoms subtract the branch rate and rise rapidly, and medication the 1st is per day about 30%, and test group on average reached 54% on 1, matched group average out to 47%, test group on average reached 68% on 1, matched group average out to 62%, and test group the 5th day is on average 84%, matched group the 6th is per day more than 84%, and two groups to the 10th per day reaching about 95%.Compare between group during test group and the treatment of control group, difference has statistical significance (P＜0.05), and test group subtracts the branch rate and rises fast than matched group.See Table 2.
Table 2 test group and matched group detoxification treatment withdrawal symptom subtract the branch rate and change comparison (PP collection) day by day
* withdrawal symptom subtracts total points before branch rate=(total points-every day total points before the treatment)/treatment.
2, secondary efficacy index situation of change (withdrawal symptom total points situation of change day by day compares)
FAS crowd, on average about 100 minutes, no difference of science of statistics between group has comparability for test group and matched group withdrawal symptom total points before the medication.Before and after test group and the treatment of control group, two groups of withdrawal symptom total points descend obviously day by day, relatively have statistical significance (P＜0.01) in the group.Test group and matched group medication the 1st per day decline are about 30 minutes, and the 2nd per day decline is about 50 minutes, and test group on average descended nearly 70 minutes on 1, and matched group on average descended about 60 minutes, and two groups to the 10th day withdrawal symptom total points average out to are about 5 minutes.Compare between group during test group and the treatment of control group, difference has statistical significance (P＜0.05).See Table 3.
PP crowd, on average about 100 minutes, no difference of science of statistics between group has comparability for test group and matched group withdrawal symptom total points before the medication.Before and after test group and the treatment of control group, two groups of withdrawal symptom total points descend obviously day by day, relatively have statistical significance (P＜0.01) in the group.Test group and matched group medication the 1st per day decline are about 30 minutes, the 2nd per day decline is about 50 minutes, test group on average descended nearly 70 minutes on 1, matched group on average descended about 60 minutes, test group was on average below 10 minutes on 1, matched group on average dropped to below 10 minutes on 1, and two groups to the 10th day withdrawal symptom total points average out to are about 5 minutes.Compare between group during test group and the treatment of control group, difference has statistical significance (P＜0.05).See Table 5-1.Test group and matched group withdrawal symptom total points are respectively 108.73 ± 13.93 and 107.87 ± 15.05 before the medication, and no difference of science of statistics between group has comparability.Compare in the group before and after test group and the treatment of control group, the withdrawal symptom total points descends obviously day by day, has statistical significance (P＜0.01).
PP crowd and FAS crowd all show, compare between the withdrawal symptom total packet during test group and the treatment of control group, and difference has statistical significance (P＜0.05).Prompting test group control withdrawal symptom usefulness is obvious than matched group.See Table 4.
Table 3 test group and matched group detoxification treatment withdrawal symptom total points change comparison (FAS collection) day by day
Table 4 test group and matched group detoxification treatment withdrawal symptom total points change comparison (PP collection) day by day
Conclusion: this test has been investigated Chinese medicine composition of the present invention and has been used for the effectiveness that opiates relies on detoxification treatment.Chinese medicine composition of the present invention control withdrawal symptom overall efficiency is obvious, control main withdrawal symptom (as crave for, anxiety, shed tears, bone myalgia, abdominal pain diarrhea, insomnia etc.) usefulness is obvious, and with matched group (lofexidine) therapeutic equivalence.
In addition, the main adverse reaction of Chinese medicine composition of the present invention has, dizziness, xerostomia, instability of gait, confusion, blurred vision, dysarthria, weak, hallucination, drowsiness, faint, delirium, postural hypotension, to murmur to oneself, anxiety, vomiting etc., but not obvious to hematuria routine, hepatic and renal function and Electrocardiographic influence.
Claims (10)
1, a kind of Chinese medicine composition that is used for detoxification treatment, preparation compositions raw materials of effective components composition is counted Rhizoma Corydalis 125-8000 part by weight, Herba Chelidonii 250-16000 part, Radix Stephaniae Cepharanthae 250-16000 part, Radix Stephaniae Tetrandrae 125-8000 part, Semen Hyoscyami 4-240 part, Radix Angelicae Sinensis 90-6000 part, Radix Polygoni Multiflori 12.5-800 part, Fructus Lycii 25-1600 part, Radix Ginseng 10-640 part, Cortex Albiziae 125-8000 part, Semen Ziziphi Spinosae 50-3200 part, Radix Glycyrrhizae 90-6000 part.
2, Chinese medicine composition according to claim 1, preparation compositions raw materials of effective components composition is counted Rhizoma Corydalis 250-4000 part by weight, Herba Chelidonii 500-8000 part, Radix Stephaniae Cepharanthae 500-8000 part, Radix Stephaniae Tetrandrae 250-4000 part, Semen Hyoscyami 7.5-120 part, Radix Angelicae Sinensis 180-3000 part, Radix Polygoni Multiflori 25-400 part, Fructus Lycii 50-800 part, Radix Ginseng 20-320 part, Cortex Albiziae 250-4000 part, Semen Ziziphi Spinosae 100-1600 part, Radix Glycyrrhizae 180-3000 part.
3, Chinese medicine composition according to claim 2, preparation compositions raw materials of effective components composition is counted Rhizoma Corydalis 500-2000 part by weight, Herba Chelidonii 1000-4000 part, Radix Stephaniae Cepharanthae 1000-4000 part, Radix Stephaniae Tetrandrae 500-2000 part, Semen Hyoscyami 15-60 part, Radix Angelicae Sinensis 375-1500 part, Radix Polygoni Multiflori 50-200 part, Fructus Lycii 100-400 part, Radix Ginseng 40-160 part, Cortex Albiziae 500-2000 part, Semen Ziziphi Spinosae 200-800 part, Radix Glycyrrhizae 375-1500 part.
4, Chinese medicine composition according to claim 3, preparation compositions raw materials of effective components composition is counted 1000 parts of Rhizoma Corydalis by weight, 2000 parts of Herba Chelidoniis, 2000 parts of Radix Stephaniae Cepharanthaes, 1000 parts of Radixs Stephaniae Tetrandrae, 30 parts of Semen Hyoscyamis, 750 parts of Radix Angelicae Sinensis, 100 parts of Radix Polygoni Multiflori, 200 parts of Fructus Lyciis, 80 parts of Radix Ginsengs, 1000 parts of Cortex Albiziaes, 400 parts of Semen Ziziphi Spinosaes, 750 parts in Radix Glycyrrhizae.
5. according to each described Chinese medicine composition of claim 1-4, the effective ingredient of described Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, Radix Stephaniae Tetrandrae, Semen Hyoscyami is made by following method, gets Rhizoma Corydalis, Radix Stephaniae Cepharanthae, Herba Chelidonii, the Radix Stephaniae Tetrandrae of proportional quantity, the coarse powder of Semen Hyoscyami, puts in the percolation jar, add the dilute acid soln soaked overnight, percolation is got percolate, transfers pH, concentrate, get extractum, or dry fluid extract, extract powder got.
6. according to each described Chinese medicine composition of claim 1-4, the effective ingredient of described Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, Cortex Albiziae, Radix Glycyrrhizae is made by following method, get Semen Ziziphi Spinosae, Radix Polygoni Multiflori, Radix Ginseng, Fructus Lycii, Radix Angelicae Sinensis, the Cortex Albiziae of proportional quantity, the coarse powder of Radix Glycyrrhizae, add water-alcohol solution, reflux, extract, is filtered filtrate recycling ethanol, concentrate, get alcohol-extracted extract.
7. according to each described Chinese medicine composition of claim 1-6, the preparation of described compositions is selected from oral formulations, injection, external preparation or its sustained-release preparation.
8. Chinese medicine composition according to claim 5, described oral formulations is selected from oral liquid, pill, powder, granule, tablet, soft extract, capsule, drop pill, oral cavity disintegration tablet, effervescent, paste, medicinal tea, suspension, syrup, mixture or Emulsion.
9, a kind of method for preparing each described Chinese medicine composition of claim 1-8 comprises effective ingredient and pharmaceutically acceptable carrier uniform mixing with Rhizoma Corydalis, Herba Chelidonii, Radix Stephaniae Cepharanthae, Radix Stephaniae Tetrandrae, Semen Hyoscyami, Radix Angelicae Sinensis, Radix Polygoni Multiflori, Fructus Lycii, Radix Ginseng, Cortex Albiziae, Semen Ziziphi Spinosae, Radix Glycyrrhizae.
10, the application of each described Chinese medicine composition of claim 1-8 in preparation detoxification treatment or drug addiction treatment medicine.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726779A (en) * | 2016-04-01 | 2016-07-06 | 吴蓓莉 | Traditional Chinese medicine composition for rehabilitation and preparation method thereof |
| CN112402517A (en) * | 2020-12-12 | 2021-02-26 | 高洪士 | A Chinese medicinal oral liquid for treating drug addiction |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105726779A (en) * | 2016-04-01 | 2016-07-06 | 吴蓓莉 | Traditional Chinese medicine composition for rehabilitation and preparation method thereof |
| CN112402517A (en) * | 2020-12-12 | 2021-02-26 | 高洪士 | A Chinese medicinal oral liquid for treating drug addiction |
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