CN1069056C - Pure Chinese herb medicine for stopping drugs - Google Patents

Pure Chinese herb medicine for stopping drugs Download PDF

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Publication number
CN1069056C
CN1069056C CN99103255A CN99103255A CN1069056C CN 1069056 C CN1069056 C CN 1069056C CN 99103255 A CN99103255 A CN 99103255A CN 99103255 A CN99103255 A CN 99103255A CN 1069056 C CN1069056 C CN 1069056C
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drug
medicine
radix
withdrawal
present
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CN1268361A (en
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苏月秋
俞永信
方良珍
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Abstract

The present invention relates to pure traditional medicine for drug abstinence, which belongs to the technical field of traditional Chinese medicine and the processing thereof. The pure traditional medicine for the drug abstinence is prepared from more than ten kinds of traditional Chinese medicine such as corydalis rhizome, rhizoma corydalis, forsythia, gastrodia tuber, etc. Experiments prove that the pure traditional medicine perfectly eliminates abstinence syndromes in bodies of drug addicts and has the advantages of conspicuous addiction elimination effect and no toxic or side effect.

Description

Pure Narcotic Chinese medicine
The invention belongs to Chinese medicine and processing technique field thereof.
Drug rehabilitation has become the important subject of the world today.This is the target that research drug-breaking medicine of new generation is pursued for " withdrawal and a non-addiction, withdrawal and withdrawal symptom do not occur repeatedly ", estimates the standard of withdrawal clinically, at first considers safety, the 2nd, and whether effectiveness and addiction promptly form new dependence to this medicine.Also do not have a kind of ideal medicament comparatively reliably and Therapeutic Method can help junkie to eradicate drug addiction at present both at home and abroad, withdrawal method comparatively commonly used mainly contains replacement therapy, opiates blocker clonidine and similar treatment etc.The alternative medicine common drug is methadone, buprenorphine etc., though this law can be alleviated withdrawal symptom, itself also can form psychology and drug dependence, is unfavorable for body recovery; Opiates blocker Lip river is received ketone and naltrexone and all can be brought out withdrawal symptom, can not be used for early stage withdrawal treatment, though effectively prevention of recurrence seldom has the patient can adhere to using this medicine, the clonidine medicine is the a-2 receptor stimulating agent, can alleviate partial abstinence symtoms, do not have an addiction, but be difficult to suppress drug abstainer to the craving for of drugs, side effect own is more, patient can be to accept, at present only as auxiliary treatment.
Chinese medicine is the mature culture rarity of the Chinese nation, seeking ideal anti-additive medicament from Chinese medicine has become when working as objectively needs, think according to the differential diagnosis in tcm theory: the addiction of drugs, the mind is badly damaged, the dominant force of becoming homeless, the body many-side gets muddled, cause disharmony of nutrient QI with defensive QI, gastrointestinal, liver-spleen disharmony, extreme misery is not handed over, deficiency of both QI and blood, lack of preservation of spirit.The present invention is in whole research process, and removing drug addiction and conditioning viscera, the tonify deficiency QI and blood is recovered body according to theory of Chinese medical science, and treating both the principal and secondary aspects of a disease makes the prescription of solution for giving up addiction of drug addict effect as the drug rehabilitation main points.
Below narrate main contents of the present invention:
Chinese medicine preparation of the present invention (percentage by weight):
Rhizoma Corydalis Decumbentis 12-15%, Rhizoma Corydalis 12-15%, Fructus Forsythiae 8-12%, Rhizoma Gastrodiae 6-8%, Cortex Albiziae 6--8%, Radix Ginseng 8-12%, Radix Morindae Officinalis 8-12%, Cordyceps 2-3%, Radix Bupleuri 8-12%, Rhizoma Chuanxiong 6-8%, Radix Saposhnikoviae 4-6%, Radix Aconiti Kusnezoffii Preparata 6-8%, Radix Glycyrrhizae 4-6%
Production technology of the present invention
Medicine among the above-mentioned prescription is carried out fragmentation, soaked at normal temperatures 8-12 hour with 2 times tap waters, the extraction of heating again, for the first time with 6 times water extraction, with 4 times water extraction, use 60% ethanol extraction for the third time for the second time, merge three extracting solution and be condensed into extractum, the drying room powdered extract, water content is pulverized after being reduced to 5%, crosses 80 mesh sieves, and the capsule charge workshop that at cleanliness factor is 1000 grades is with No. 1 capsule charge, with comparing delicate balance adjusting device difference, the capsule polishing is carried out quality inspection by company standard, and capsule is aluminum-plastic packaged, the dress box dispatches from the factory.
The present invention is best, and production technology is
Medicine among the above-mentioned prescription is carried out fragmentation, soaked at normal temperatures 12 hours, heat again with 2 times tap waters.To 100 ℃ of extractions, for the first time with 6 times water extraction 6 hours, the second time was with 4 times water extraction 4 hours, used 60% ethanol extraction for the third time 3 hours, and merged three extracting solution and be condensed into extractum, the drying room powdered extract, water content is pulverized after being reduced to 5%, crosses 80 mesh sieves, and the capsule charge workshop that at cleanliness factor is 1000 grades is with No. 1 capsule charge, regulate content uniformity with comparing delicate balance, the capsule polishing is carried out quality inspection by company standard, and capsule is aluminum-plastic packaged, the dress box dispatches from the factory.
This product prescription is made up of natural Chinese medicines, divides detoxicating withdrawal and the body resistance strengthening and constitution consolidating two class Chinese medicines to form compound recipe, does not contain the addiction feature Chinese medicine ingredients, has the detoxicating withdrawal, the effect of the body resistance strengthening and constitution consolidating; Can control rapidly suck with quiet notes opium drug addiction after the various withdrawal symptoms that occur, suppress drug craving, and have appetite stimulator, improve sleep, the diuresis relieving constipation promotes the effect of each systemic-function rehabilitation of health.
Clinical trial shows, this product has rapid-action (15 minutes), withdrawal fast (3 days), short treating period (10 days), characteristics repeatedly not, effect stability.
Toxicity test shows that this product is safe and reliable, and is without any side effects, patient's acceptance is good, in the therapeutic process withdrawal smooth, withdrawal symptom does not have bounce-back, all be better than buprenorphine at aspects such as control withdrawal symptom and inhibition drug cravings, Hai Feixi waits drug-breaking medicine commonly used surely, and non-evident effect can be in safety, help junkie to finish withdrawal treatment in the no pain, eliminate the purpose of disconnected symptom and drug craving that is situated between, thereby make junkie thoroughly break away from drug addiction, recover physically and mentally healthy comprehensively.
Embodiment 1:
Toxicity test report of the present invention
Get Rhizoma Corydalis Decumbentis 250g, Rhizoma Corydalis 250g, Fructus Forsythiae 200g, Rhizoma Gastrodiae 150g, Cortex Albiziae 150g, Radix Ginseng 200g, Radix Morindae Officinalis 200g, Cordyceps 50g, Radix Bupleuri 200g, Rhizoma Chuanxiong 150g, Radix Saposhnikoviae 100g, Radix Aconiti Kusnezoffii Preparata 150g, Radix Glycyrrhizae 150g by aforementioned formula; By aforementioned technology lixiviate, concentrate, dry, pulverize, sieve, capsule charge, quality inspection, packing promptly make product of the present invention.
One, acute toxicity test and long term toxicity test
Be subjected to the reagent thing: product of the present invention
Test unit: Hunan Province's institute of Pharmaceutical Industry
This test is undertaken by the design of toxicological test code requirement
1, acute toxicity test: mouse stomach gives product capsule of the present invention, successive administration 10 days, and every day, maximum consumption was equivalent to crude drug 600g/kg, was 100 times of clinical dosage, result of the test, none death of mice.
2, long term toxicity test: rat is 50 times of clinical dosage by being equivalent to crude drug 200g/kg every day, successive administration 30 days, animal appetite, body weight, all are movable normal for defecation etc., routine blood test and hepatic and renal function are normal, heart, stomach, spleen, adrenal gland, incubate major organs pathological sections such as nest, testis, lung and all do not have the observability pathological change, and this result shows that it is safe that the present invention uses with dosage by clinical plan.
Two, morphine is relied on the influence of rat blood laboratory indexes
Be subjected to the reagent thing: product of the present invention (concrete component is the same)
Test unit: Beijing Medical University's mental health institute
Test method and result: make the rat morphine and rely on, give respectively to organize rat product of the present invention respectively, clonidine hydrochloride, FUKANG PIAN, placebo, and the normal rat matched group is set, after one week of administration, blood is got in the rat heart puncture, and blind method is made albumin (AIB), blood urea nitrogen (BUN), phosphokinase (CPK), glutamic oxaloacetic transaminase, GOT (GOT), glutamate pyruvate transaminase (GPT), hemoglobin (HGB), lactic acid dehydrogenase (LDH), red blood cell count(RBC) (RBC) is checked.The result shows: the experiment medicine is compared with every result of laboratory test of normal control and other Therapeutic Method at different levels, and except that normal dose product treatment of the present invention group GOT raise, all the other differences had significance statistically.
Embodiment 2:
Product pharmacology pharmacodynamic test of the present invention
Beijing Medical University's mental health institute has carried out the pharmacology pharmacy test to product of the present invention, and control drug is a clonidine.
Enforcement shows: the present invention has good inhibitory effect to the various withdrawal symptoms that morphine relies on rat, and effect is better than clonidine, has clinical value.
Embodiment 3:
Morphine-like substance of the present invention and heavy metal examining report
One, morphine-like substance detects
Beijing Medical University's mental health institute is tested to morphine-like substance of the present invention.
Conclusion: sample does not detect morphine-like substance through using the thin layer chromatography check.
Two, heavy metal check
Instrument room, HSPH of Beijing Medical University center testing result is as follows:
This product contains Pb 13ug/100g As 18mg/100g, and Hg does not detect, and meets national Specification.
Embodiment 4:
Clinical research report of the present invention
Get Rhizoma Corydalis Decumbentis 120g, Rhizoma Corydalis 150g, Fructus Forsythiae 120g, Rhizoma Gastrodiae 60g, Cortex Albiziae 80g, Radix Ginseng 120g, Radix Morindae Officinalis 120g, Cordyceps 30g, Radix Bupleuri 80g, Rhizoma Chuanxiong 60g, Radix Saposhnikoviae 40g, Radix Aconiti Kusnezoffii Preparata 60g, Radix Glycyrrhizae 60g by aforementioned formula; By aforementioned technology lixiviate, concentrate, dry, pulverize, sieve, capsule charge, quality inspection, packing promptly make product of the present invention.
One, by this prescription product 11 routine test report of the present invention
Be subjected to the reagent thing: product of the present invention
Control drug: buprenorphin hydrochloride (intramuscular injection)
Test unit: Hunan Medical University's mental health institute
1, object: the volunteer addict who selects Hunan Province narcotic house to be admitted to hospital continuously in August, 96 to November is an object of study, is pressed into the group standard, random packet, every group 10 people.
2, judge standard: press the various withdrawal symptoms of heroin addict, utilize withdrawal symptom self-appraisal scale, show 23 sample orders, wherein measure the health withdrawal symptom for 19, with " nothing ", " slightly ", " severe " expression, corresponding note 0-3 branch, wherein 4 is that degree is craved in evaluation: the degree of craving in (1) 24 hour, the number of times of craving in (2) 24 hours, the persistent period that crave at every turn (3), the change that crave for (4).It is every score sum that health is given up total points, craves for total points: crave for X+ several X+ persistent period of degree
3, test method: single blind method
4, result
Show that general effect of the present invention is better than buprenorphine after using 10 days courses of treatment, patient's withdrawal symptom and to crave for total points all low than buprenorphine group in therapeutic process shows that this medicine is rapid-action, and the course of treatment is shorter, and the disconnected symptom that is situated between when the treatment withdrawal does not have characteristics such as bounce-back.Side effect: from clinical observation, safety is all compared in two groups of treatments, and during the treatment, vital sign is steady, no serious side reaction, and the buprenorphine group has weak, and is fidgety, the insomnia phenomenon, but two groups do not have an example to withdraw from treatment because of side reaction in therapeutic process.
Embodiment 5:31 example clinical experiment report
Product of the present invention is got Rhizoma Corydalis Decumbentis 120g, Rhizoma Corydalis 120g, Fructus Forsythiae 80g, Rhizoma Gastrodiae 60g, Cortex Albiziae 80g, Radix Ginseng 120g, Radix Morindae Officinalis 90g, Cordyceps 20g, Radix Bupleuri 80g, Rhizoma Chuanxiong 80g, Radix Saposhnikoviae 40g, Radix Aconiti Kusnezoffii Preparata 60g, Radix Glycyrrhizae 50g by following prescription; By aforementioned technology lixiviate, concentrate, dry, pulverize, sieve, capsule charge, quality inspection, packing promptly make product of the present invention.
Be subjected to the reagent thing: product of the present invention
Control drug: lofexidine (a receptor agonist)
Test unit: the Hunan Province State Administration of Traditional Chinese Medicines, Changsha narcotic house (pressure), stopping narcotic taking center, the Southern Mountain, Hengyang City (anti-drug institution voluntarily)
1, object: for meeting pressure into the group standard, the volunteer addict is divided into experimental group and matched group at random, experimental group 31 people, matched group 33 people, two groups of there was no significant differences on sex, age, occupation, schooling, the drug abuse mode before the treatment, drug abuse frequency, the average drug abuse time, average using dosage, indexs such as the number of times of on average quitting drug abuse there are no significant difference, two groups have comparability.
2, test method:
Route of administration and dosage are all by the description of each medicine
Observation index:
(1) self-editing drug abuse application form, understanding patient's drug abuse reason, drug abuse mode, time, dosage etc.
(2) withdrawal symptom self-appraisal scale, 23 clauses and subclauses are respectively: crave for, anxiety ferments, headache, cardiopalmus, fear of cold or alternation of chills and fever, watery nasal discharge is shed tears, the muscle osteodynia, stomachache etc., every according to light and heavy degree meter 0-3 branch.
(3) the uremic product detect: with immunochromatographic method quantitative assay uremic product, reach treatment before the treatment and finish each once.
(4) side effect scale: 19 clauses and subclauses are arranged, be divided into: the whole body is unable, instability of gait, and blurred vision, vomiting is felt sick, and is dizzy, and nervous, every clauses and subclauses are according to light and heavy degree meter 0-3 branch.
3, conclusion
Ordinary circumstance between (1) two group, the drug abuse situation, index such as withdrawal symptom there are no significant difference illustrates that two groups have comparability preferably before the treatment.
(2) the treatment back is 1-2 days, the fairly obvious matched group that is better than of experimental group withdrawal symptom, and difference has significance, and the illustrative experiment medicine has the effect of better withdrawal opiates withdrawal symptom.
(3) the branch rate that subtracts of the 1st, the 2nd day experiment medicine withdrawal symptom total points is higher than matched group after treatment, and difference has significance.
(4) the experiment medicine ferments in the control anxiety, and is convenient, and fear of cold is perspired, and is sleepy, goose pimples, and insomnia, xerostomia, there is curative effect preferably aspects such as anorexia.
(5) experimental drug group patient body weight amplification is bigger, and control drug amplification is less, and significant difference is arranged.
(6) two groups of remarkable significant differences no before treatment of side effect total points, the experiment medicine side reaction less, the contrast medicine side reaction, in 1-3 after the treatment days, two groups of differences have significance, the side reaction of contrast medicine mainly shows dizzy, xerostomia, tinnitus, nervous, aspects such as string is dizzy are compared with the experiment medicine, and significant difference is obvious.
(7) two groups of blood pressures before treatment, the difference not statistically significant of heart rate rose in treatment on the 3rd day, the control drug systolic pressure, diastole descends to some extent, with experimental group difference significance is arranged.
Embodiment 6
Product 103 routine clinical experiment reports of the present invention
Get Rhizoma Corydalis Decumbentis 250g, Rhizoma Corydalis 250g, Fructus Forsythiae 200g, Rhizoma Gastrodiae 150g, Cortex Albiziae 150g, Radix Ginseng 200g, Radix Morindae Officinalis 200g, Cordyceps 50g, Radix Bupleuri 200g, Rhizoma Chuanxiong 150g, Radix Saposhnikoviae 100g, Radix Aconiti Kusnezoffii Preparata 150g, Radix Glycyrrhizae 150g by following prescription; By aforementioned technology lixiviate, concentrate, dry, pulverize, sieve, capsule charge, quality inspection, packing promptly make product of the present invention.
Trial drug: product of the present invention
Clinical unit: Guangzhou Zhu Cun stopping narcotic taking institute
Narcotic house of Guangzhou Sanatorium, P.L.A.
The voluntary narcotic house in Qinzhou City, Guangxi
Ordinary circumstance:
1, case: case sum 103 examples, male 91 examples, woman's 12 examples, age 20-33 year
2, history of drug abuse: 1-3,42 examples, 4-5,36 examples, 8-10,26 examples, drug abuse mode are the heroin suction, quiet notes after quiet notes or the suction earlier.
3, patient all is pressed into the group standard, and exclusion standard and premature termination Standard Selection enter test, all heroin are had intensive body and psychological dependence, interrupts using in 4 hours to 2 days, obvious withdrawal symptom all occurs.
Therapeutic Method:
Be 10 days the course of treatment, the oral product of the present invention of patient, first three day dosage be 10/time, suppress withdrawal symptom every day six times, remove drug dependence to drugs, dosage was 8 in 4-7 days, every day 4 times, 8-10 days, each 6, every day 4 times.
According to patient's medical history, first three light poison amount of receiving treatment is used malicious approach, and body weight is taken all factors into consideration, take medicine and subtracted in 10 days, the decrement principle is for first quick and back slow, only subtracts not add, and drug withdrawal is firm, as insomnia appears, and fidgety person can add with stable class anxiolytic drugs, and dosage is looked concrete condition.
Observation of curative effect
The giving-up taking drugs and removing drug addiction criterion of therapeutical effect is decided to be: took medicine seven days in, and do not send out drug addiction, withdrawal symptom disappears, and drug addiction is observed after 10 days in drug withdrawal, and not send out the person be effective; There have the symptom of discovery to be decided to be in seven days to be invalid.
The patient produces effect of drugs in 15-30 minute taking medicine, and obviously alleviates withdrawal symptom, and xerostomia occurs, characteristics such as whole body has hotness, wants to drink water, and urine is many, and is drowsy.
Use in 103 examples of the present invention, 3 days addiction person's 35 examples that disappear, 5 days addiction person 49 people that disappear, 7 days addiction person 19 people that disappear, the addiction that disappears effective percentage 100%, and 52 routine patients are followed the tracks of a year and a half, none example is reverted to take drugs.
Side reaction: use during the present invention's treatment, patient's vital sign is steady, and no toxicity wherein has 7 examples that nauseating phenomenon is arranged, and slight insomnia fidgetyly waits reaction, all treats none example of case and seriously withdraws from treatment because of side reaction or withdrawal symptom.
From the situation of clinical practice, the present invention is safely and effectively, can eliminate the physical withdrawal symptom of junkie preferably, suppresses drug craving, withdrawal is smooth in the course of treatment, gives up shape and do not have bounce-back, and the addiction that disappears is respond well, toxicity is light, is a kind of ideal Chinese medicine drug rehabilitation medication, is worth further promoting.
Embodiment 7: model case
Example one, Wang Zhijun, the man is 27 years old, unmarried, Feng Yuan people from village, Conghua City sucked heroin for 10 years, chasing dragon 6 years, quiet notes 4 years, and 2 use methamphetamine hydrochlorides (per injection 0.01g), past attempts 10 an ancient unit of weight equal to 20 or 24 *taels of silver Jie poison are all failed, because shoot up, right hand nerve is downright bad, the right finesse distortion can not be stretched, and the complexion ash is blue or green, amyotrophy, through 15 days detoxicating body-strengthening extract for treating, patient's drug addiction was eliminated, have rosy cheeks, right finesse can stretch, functional rehabilitation.
Example two, Xu Chengyan, man, 23 years old, unmarried, people from Qinzhou City, the patient sucked heroin 5 years, and wherein chasing dragon is 2 years, quiet notes 3 years, every day 2-3 time, consumption per day 1.5g, once 5 drug rehabilitations, tried all not successes of multiple drug rehabilitation method, drug addiction increases the weight of day by day, and in October, 97, voluntary accepting was quit drug abuse with this product, through 10 days system's withdrawal treatments, eliminate drug addiction fully.

Claims (1)

1, a kind of pure Narcotic Chinese medicine, by Chinese medicine fragmentation, lixiviate, concentrate, dry, pulverize, sieve, filling, check, packaging and other steps process, and it is characterized in that the raw material of Chinese medicine of this drug-breaking medicine and percentage by weight thereof are:
Rhizoma Corydalis Decumbentis 12-15% Rhizoma Corydalis 12-15% Fructus Forsythiae 8-12% Rhizoma Gastrodiae 6-8%
Cortex Albiziae 6-8% Radix Ginseng 8-12% Radix Morindae Officinalis 8-12% Cordyceps 2-3%
Radix Bupleuri 8-12% Rhizoma Chuanxiong 6-8% Radix Saposhnikoviae 4-6% Radix Aconiti Kusnezoffii Preparata 6-8%
Radix Glycyrrhizae 4-6%
CN99103255A 1999-03-29 1999-03-29 Pure Chinese herb medicine for stopping drugs Expired - Fee Related CN1069056C (en)

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CN1069056C true CN1069056C (en) 2001-08-01

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN100345582C (en) * 2005-09-20 2007-10-31 马仁宝 Medicine for abstaining from drug
CN113546149A (en) * 2020-04-26 2021-10-26 福州辰星药业有限公司 Traditional Chinese medicine formula preparation for relieving withdrawal symptoms and preparation method thereof

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1146900A (en) * 1995-05-13 1997-04-09 郭恒盛 Narcotic capsule and its preparing process
CN1207300A (en) * 1997-07-31 1999-02-10 尹大良 Medicine for giving up drug

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1146900A (en) * 1995-05-13 1997-04-09 郭恒盛 Narcotic capsule and its preparing process
CN1207300A (en) * 1997-07-31 1999-02-10 尹大良 Medicine for giving up drug

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