CN108379367B - Pure traditional Chinese medicine for drug withdrawal and preparation method thereof - Google Patents

Pure traditional Chinese medicine for drug withdrawal and preparation method thereof Download PDF

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CN108379367B
CN108379367B CN201810256613.XA CN201810256613A CN108379367B CN 108379367 B CN108379367 B CN 108379367B CN 201810256613 A CN201810256613 A CN 201810256613A CN 108379367 B CN108379367 B CN 108379367B
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王兴国
李跃辉
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    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The pure traditional Chinese medicine for drug withdrawal and the preparation method thereof are characterized in that the medicine is prepared by the following raw material medicines: radix astragali, cortex et radix Polygalae, radix Codonopsis, Ginseng radix, semen Platycladi, Poria, semen Ziziphi Spinosae, ramulus Uncariae cum uncis, rhizoma corydalis, Saviae Miltiorrhizae radix, Olibanum (preparata), Myrrha (preparata), radix Aconiti Kusnezoffii Preparata, radix Aconiti Preparata, flos Rhododendri mollis, Scorpio, Scolopendra, Succinum, radix Saposhnikoviae, Scutellariae radix, and Glycyrrhrizae radix. The raw materials are processed by the modern technology through the processes of crushing or slicing, extracting, concentrating, drying, mixing, forming and the like. The medicine has the functions of strengthening body resistance and consolidating constitution, invigorating qi and soothing the nerves, relieving spasm and pain, relieving convulsion and calming wind and regulating yin and yang, is clinically suitable for all patients who are poisoned by taking heroin and derivatives thereof or methamphetamine and derivatives thereof, and can obviously relieve and eliminate withdrawal symptoms of opioid drugs, particularly methamphetamine (methamphetamine, magaka, K powder, dancing outreach and the like) drugs and relieve drug addiction. More than 3000 cases of clinical trials show that the drug-dropping pill has obvious drug-dropping effect, is safe to apply according to recommended dose, has no toxic or side effect, and can be clinically popularized and applied.

Description

Pure traditional Chinese medicine for drug withdrawal and preparation method thereof
Technical Field
The invention relates to a pure traditional Chinese medicine for drug withdrawal and a preparation method thereof.
Background
The drug is a natural or synthetic substance which is regulated by international and domestic drug ban laws, illegally produced, processed, transported and abused, generates dependence after continuous use and can cause damage to human body functions. The types of drugs are many, and currently common drugs mainly comprise heroin, methamphetamine, morphine, ecstasy, K powder and the like. Drugs have dependence, unlawfulness and harmfulness. The harm of drug absorption is particularly great, which is shown in 1, the harm to the body and mind of the drug absorber: the drug taking dosage is too large or the drug taking time is too long, which can cause the dysfunction and the histopathological change of the organism. It is mainly manifested by lethargy, dysesthesia, dyskinesia, hallucinations, delusions, disorientation, etc. After long-term drug absorption, the body has adaptability, once the drug administration is stopped, the physiological function is disordered, a series of serious reactions occur, and people feel very painful. Many drug addicts have not purchased the drug from an economic source, have died from various complications caused by severe physical withdrawal reactions, or have suicide due to intolerable pain. Drug abuse also causes mental disorders and allergies, the most prominent manifestations of which are hallucinations and thought disorders. 2. Harm of drug absorption to society: the drugs not only damage the body and spirit of the user, but also directly induce a series of criminal activities such as drug planting, drug manufacturing, drug trafficking, drug selling, drug smuggling, drug holding, trapping, instigation, deception, other people sucking, drug injection and the like. Especially, crime groups and black social organizations formed by drug vending, and criminal activities such as violence, murder, purchase, bribery, money laundering and the like caused by the crime groups and the black social organizations become public hazards of the society, and bring great threat to the stability of the society.
The research on drug addiction at home and abroad has been in history for decades, the research and development of drugs which can relieve withdrawal symptoms and have no addiction and no toxic or side effect are urgent requirements of society and clinic, Chinese medical science accumulates a great deal of experience on the treatment, a series of traditional Chinese medicine drug rehabilitation methods and treatment schemes such as overuse first aid, withdrawal from addiction, recuperation after withdrawal and the like are created, and the curative effect of the traditional Chinese medicine is widely accepted. Modern Chinese medicine summarizes the traditional Chinese medicine drug rehabilitation treatment into two major characteristics, one is that a large number of prescriptions adopt an opiate subtraction method, the thinking is the same as that of the alternative therapy adopted by modern medicine, but the curative effects have certain differences; secondly, attention is paid to integral treatment, pathogenic factors are removed to treat the symptoms, body resistance is strengthened to consolidate the constitution, and especially attention is paid to continuous adjustment and nourishing after drug rehabilitation to reduce the relapse rate. But also the following information is obtained: at present, a few Chinese patent medicines are used for treating opioid withdrawal symptoms definitely, only chemical medicines are used for treating the psychotic state of methacrylamide (such as hallucinations, delusions, depression and the like) in the market, and no traditional Chinese medicine treatment is available; secondly, the existing medicines in the market mainly treat the symptom of opioid withdrawal, and the market of the medicines aiming at treating the symptom of methacrylamide and opioid withdrawal is almost zero.
The novel drug refers to a chemical synthesis drug which is synthesized artificially. Generally, drugs are artificially synthesized, such as amphetamine drugs. Methamphetamine (MA), a hydrochloride salt of methamphetamine (also known as methamphetamine) is a novel synthetic drug, and the methamphetamine (AMP), a main active metabolite of the Methamphetamine (MA), is a amphetamine substance with the central nerve excitation effect, and belongs to the class of drugs. The amphetamine substances are important components of novel drugs such as 'bingdu', 'ma gu', 'shui wan' and the like, and the abuse of the amphetamine substances is in a growing trend. In the eight and ninety decades of the twentieth century, holiday drugs represented by methamphetamine, ecstasy and magical drugs are popular worldwide and exceed the traditional illegal psychoactive substances such as heroin, cocaine and the like, so that the holiday drugs become a serious social problem. The disease location of methamphetamine addicts is mainly the imbalance of heart and kidney functions, and relates to the stomach and heart spirit of the disease location, and the disease nature is mainly heat and yin deficiency. Some students consider that the key influencing the social relationship of drug addicts is the dysfunction of heart or mind. Modern medical research indicates that: the drug intake can cause serious damage to organs such as heart, brain, liver, lung, stomach and intestine of people, and even many people die due to long-term large-scale drug intake. At present, no medicine with definite efficacy is clinically used for abstinence and rehabilitation, so that how to abstain drug addiction from drug addiction patients and prevent relapse is a key task of many researchers.
Referring to Chinese patent documents, patent applications 335 about drug-dropping medicines are disclosed, wherein 231 traditional Chinese medicine drug-dropping medicines account for 69%. There are 170 granted drug abstinence medicine patents. The publication number CN101417021 relates to an external traditional Chinese medicine for drug rehabilitation, which is externally applied to the projection position of an intracranial pineal body on the occipital skin of a patient, and helps the patient to abstain from addiction to drugs such as heroin, methamphetamine, marijuana or dancing outreach by utilizing the principles of combating poison with poison and dredging collaterals to draw out poison. The Chinese medicine for stopping drug addiction is a key research field and is also a feasible method. Among the medicines of the invention, Fukang tablets, drug-relief oral liquid, drug-relief electuary, drug-relief ointment, drug-relief pills and the like are not shown in the invention of traditional Chinese medicines related to drug-relief of methamphetamine (such as methamphetamine, magaka, K powder, dancing outreach and the like).
Disclosure of Invention
The invention aims to provide a pure traditional Chinese medicine for drug withdrawal, which is used for all patients who are poisoned by taking heroin and derivatives thereof or methamphetamine and derivatives thereof, relieving and eliminating withdrawal symptoms of opioid drugs, particularly methamphetamine (methamphetamine, magaka, K powder, dancing outreach and the like) drugs and relieving drug addiction. Also provides a preparation method of the traditional Chinese medicine.
In order to achieve the purpose, the invention adopts the following technical scheme:
the pure traditional Chinese medicine for drug withdrawal is prepared from the following raw materials in parts by weight: 30-45 parts of astragalus membranaceus, 30-45 parts of polygala tenuifolia, 25-40 parts of codonopsis pilosula, 30-45 parts of ginseng, 25-40 parts of platycladi seed, 25-40 parts of poria with hostwood, 30-45 parts of spina date seed, 30-45 parts of uncaria, 30-45 parts of corydalis tuber, 25-40 parts of salvia miltiorrhiza, 30-45 parts of frankincense (prepared), 30-45 parts of myrrh (prepared), 20-45 parts of prepared kusnezoff monkshood root, 20-45 parts of prepared monkshood, 1-10 parts of rhododendron molle, 20-35 parts of scorpion, 10-30 parts of centipede, 30-45 parts of amber, 30-45 parts of radix sileris, 30-45 parts of scutellaria baicalensis and 20-.
A Chinese medicine in the form of capsule, pill, tablet, powder, particle, or oral liquid for treating drug addiction is prepared from Chinese-medicinal materials through slicing or pulverizing, proportioning, extracting, concentrating, drying, pulverizing, shaping, adding auxiliary materials, and preparing different dosage forms.
The preparation method of the pure traditional Chinese medicine for drug withdrawal comprises the following steps:
(1) pretreatment of medicinal materials: processing half of Ginseng radix according to the current edition of Chinese pharmacopoeia, pulverizing, sieving with 100 mesh sieve to obtain Ginseng radix fine powder, steam sterilizing at 105 deg.C for 30 min; processing other Chinese medicinal materials according to processing standard of Chinese pharmacopoeia, and cutting into pieces;
(2) weighing: weighing the traditional Chinese medicine raw materials in parts by weight;
(3) extraction: mixing the rest 1/2 doses of Ginseng radix with radix astragali, cortex et radix Polygalae, radix Codonopsis, semen Platycladi, Poria, semen Ziziphi Spinosae, ramulus Uncariae cum uncis, rhizoma corydalis, Saviae Miltiorrhizae radix, radix Aconiti Kusnezoffii Preparata, radix Aconiti Preparata, flos Rhododendri mollis, Scorpio, Scolopendra, Olibanum, Myrrha, Succinum, radix Saposhnikoviae, Scutellariae radix, and Glycyrrhrizae radix, decocting with water twice, adding 12 times of water for the first time, decocting for 2 hr, adding 10 times of water for the second time, decocting for 1.5 hr, mixing, and filtering to obtain extractive solution;
(4) concentration: concentrating the extracting solution at 70-80 ℃ and-0.06-0.08 Mpa under reduced pressure to obtain an extract with the relative density of 1.15-1.30;
(5) and (3) drying: vacuum drying or spray drying is adopted, and the vacuum drying conditions are as follows: the relative density of the extract is 1.30-1.35, and the extract is dried for 16-24 hours at the temperature of 60-70 ℃ and the pressure of-0.06-0.08 Mpa to obtain dry extract; the spray drying conditions were: the relative density of the extract is about 1.15, an air inlet heater is started until the air inlet temperature reaches 160-;
(6) crushing dry extract: the dried extract after vacuum drying is crushed into dry extract powder and passes through a 80-mesh sieve;
(7) mixing: putting the dry extract powder and the fine ginseng powder obtained in the step (1) into a mixer, uniformly mixing, and drying at 50-60 ℃ for 4-8 hours to obtain mixed dry powder;
(8) molding: adding adjuvants required for preparing different dosage forms into the mixed dry powder, and making into different dosage forms according to Chinese medicinal preparation method.
Preferably, the mature seeds of the platycladi seeds are selected as the medicine; the Poria is selected from dry sclerotium of Wolf of Polyporaceae, Poria cocos (Poria cocos) Cocos (Schw.) Wolf, and white part of pine branch or pine root is wrapped in the middle of the dry sclerotium; the frankincense (prepared) and the myrrh (prepared) are processed by vinegar according to the vinegar processing technology of Chinese pharmacopoeia.
The traditional Chinese medicine disclosed by the invention has the following positive effects:
the Chinese herbal medicine composition is prepared by combining the Chinese herbal medicine composition, is inherited from an ancient drug rehabilitation secret recipe, is combined with clinical application, repeated research, comparison and addition and subtraction, and has no toxic or side effect.
Secondly, the traditional Chinese medicine is suitable for all patients poisoned by taking heroin and derivatives thereof or methamphetamine and derivatives thereof, and can obviously relieve and eliminate the withdrawal symptoms of opium (morphine, heroin, meperidine and the like) or methamphetamine (methamphetamine, K powder, dancing outreach and the like) drugs and relieve drug addiction.
And thirdly, completing the whole work of reporting the traditional Chinese medicine preparation, including review data, pharmaceutical data (preparation process, physicochemical property, quality standard and inspection report, stability test and the like), and pharmacological data (pharmacodynamics, pharmacological research, toxicity test, mutagenesis test, carcinogenesis test, physiological toxicity test and the like).
The clinical application of the drug of the invention in the department of forced isolation drug rehabilitation in Shaoyang city is 2587 cases of four-year drug rehabilitation treatment, wherein, heroin is 1237 times, accounting for 48 percent; 258 patients with multi-drug abuse, 1031 patients with amphetamine, 40% and 52 patients with K powder. The treatment results are as follows: 2199 cases with recovery (physiological withdrawal and complete disappearance of withdrawal symptoms) account for 85 percent, and 388 cases with improvement account for 15 percent.
Detailed Description
To illustrate the invention in more detail, the following examples are given by way of 4 examples.
Example 1
The pure traditional Chinese medicine for drug withdrawal is prepared from the following raw material medicines in parts by weight: 30-45 parts of astragalus membranaceus, 30-45 parts of polygala tenuifolia, 25-40 parts of codonopsis pilosula, 30-45 parts of ginseng, 25-40 parts of platycladi seed, 25-40 parts of poria with hostwood, 30-45 parts of spina date seed, 30-45 parts of uncaria, 30-45 parts of corydalis tuber, 25-40 parts of salvia miltiorrhiza, 30-45 parts of frankincense (prepared), 30-45 parts of myrrh (prepared), 20-45 parts of prepared kusnezoff monkshood root, 20-45 parts of prepared monkshood, 1-10 parts of rhododendron molle, 20-35 parts of scorpion, 10-30 parts of centipede, 30-45 parts of amber, 30-45 parts of radix sileris, 30-45 parts of scutellaria baicalensis and 20-.
The preparation method of the pure traditional Chinese medicine for drug withdrawal comprises the following steps:
(1) pretreatment of medicinal materials: processing 1/2 dosage of Ginseng radix according to the current edition of Chinese pharmacopoeia, pulverizing, sieving with 100 mesh sieve, sterilizing with circulating steam at 105 deg.C for 30 min to obtain Ginseng radix fine powder; the frankincense (prepared) and the myrrh (prepared) are processed by vinegar according to the vinegar processing technology of Chinese pharmacopoeia; processing other Chinese medicinal materials according to the current edition of Chinese pharmacopoeia or the processing standard of Chinese medicinal materials in Hunan province, and cutting into pieces with small volume;
(2) weighing: weighing the raw materials according to the weight part of the formula;
(3) extraction: mixing the rest 1/2 doses of Ginseng radix with radix astragali, cortex et radix Polygalae, radix Codonopsis, semen Platycladi, Poria, semen Ziziphi Spinosae, ramulus Uncariae cum uncis, rhizoma corydalis, Saviae Miltiorrhizae radix, radix Aconiti Kusnezoffii Preparata, radix Aconiti Preparata, flos Rhododendri mollis, Scorpio, Scolopendra, radix Saposhnikoviae, Scutellariae radix, Glycyrrhrizae radix, radix Aconiti Kusnezoffii Preparata, and radix Aconiti Preparata, decocting with water twice, adding 12 times of water for the first time, decocting for 2 hr, adding 10 times of water for the second time, decocting for 1.5 hr, mixing, and filtering to obtain extractive solution;
(4) concentration: concentrating the extracting solution at 70-80 ℃ and-0.06-0.08 Mpa under reduced pressure to obtain an extract with the relative density of 1.15-1.30.
(5) And (3) drying: vacuum drying or spray drying is adopted, and the vacuum drying conditions are as follows: the relative density of the extract is 1.30-1.35, and the extract is dried for 16-24 hours at the temperature of 60-70 ℃ and the pressure of-0.06-0.08 Mpa to obtain dry extract; the spray drying conditions were: and (3) starting an air inlet heater until the air inlet temperature reaches 160-.
(6) Crushing dry extract: the dried extract after vacuum drying is crushed into dry extract powder and passes through a 80-mesh sieve.
(7) Mixing: putting the dry extract powder and the fine ginseng powder obtained in the step (1) into a mixer, uniformly mixing, and drying at 50-60 ℃ for 4-8 hours to obtain mixed dry powder;
(8) and (3) taking the mixed dry powder, and filling into capsules according to dosage requirements, wherein each capsule is 0.5 g.
Example 2
The pure traditional Chinese medicine granule for drug withdrawal is prepared from the following raw materials in parts by weight:
40 parts of astragalus mongholicus, 40 parts of polygala tenuifolia, 30 parts of codonopsis pilosula, 40 parts of ginseng, 30 parts of platycladi seed, 30 parts of poria with hostwood, 30 parts of spina date seed, 30 parts of uncaria, 30 parts of rhizoma corydalis, 30 parts of salvia miltiorrhiza, 40 parts of frankincense (prepared), 40 parts of myrrh (prepared), 30 parts of prepared kusnezoff monkshood root, 30 parts of prepared monkshood, 6 parts of rhododendron molle, 25 parts of scorpion, 20 parts of centipede.
The preparation method of the pure traditional Chinese medicine for drug withdrawal comprises the following steps:
(1) steps (1) to (6) are the same as in example 1;
(7) and (3) granulating: mixing the dry extract powder and Ginseng radix fine powder in a mixer, making soft mass with 70-95% ethanol with a volume ratio of 10-30%, and granulating with 14-16 mesh sieve to obtain wet granule;
(8) and (3) drying the particles: feeding the wet granules into an oven, and drying for 4-8 hours at 50-60 ℃ to obtain dry granules;
(9) straightening: taking the dry particles, and finishing the particles through a 20-mesh sieve;
(10) total mixing: placing the dried granules after finishing the granules in a multidirectional motion mixer, and mixing until the granules have consistent color;
(11) molding: and carrying out common packaging or vacuum packaging according to dosage requirements to obtain granules.
Example 3
A pure traditional Chinese medicine for drug withdrawal is prepared into tablets and comprises the following raw materials in parts by weight:
30-45 parts of astragalus membranaceus, 30-45 parts of polygala tenuifolia, 25-40 parts of codonopsis pilosula, 30-45 parts of ginseng, 25-40 parts of platycladi seed, 25-40 parts of poria with hostwood, 30-45 parts of spina date seed, 30-45 parts of uncaria, 30-45 parts of corydalis tuber, 25-40 parts of salvia miltiorrhiza, 30-45 parts of frankincense (prepared), 30-45 parts of myrrh (prepared), 20-45 parts of prepared kusnezoff monkshood root, 20-45 parts of prepared monkshood, 1-10 parts of rhododendron molle, 20-35 parts of scorpion, 10-30 parts of centipede, 30-45 parts of amber, 30-45 parts of radix sileris, 30-45 parts of scutellaria baicalensis and 20-.
The preparation method of the pure traditional Chinese medicine for drug withdrawal comprises the following steps:
(1) steps (1) to (7) are the same as in example 1;
(8) molding: adding adjuvants into the mixed dry powder, tabletting according to dosage requirement, coating with film coat, and making into tablet.
Example 4
The pure traditional Chinese medicine for drug withdrawal is prepared into concentrated pills, and the concentrated pills comprise the following raw materials in parts by weight:
30-45 parts of astragalus membranaceus, 30-45 parts of polygala tenuifolia, 25-40 parts of codonopsis pilosula, 30-45 parts of ginseng, 25-40 parts of platycladi seed, 25-40 parts of poria with hostwood, 30-45 parts of spina date seed, 30-45 parts of uncaria, 30-45 parts of corydalis tuber, 25-40 parts of salvia miltiorrhiza, 30-45 parts of frankincense (prepared), 30-45 parts of myrrh (prepared), 20-45 parts of prepared kusnezoff monkshood root, 20-45 parts of prepared monkshood, 1-10 parts of rhododendron molle, 20-35 parts of scorpion, 10-30 parts of centipede, 30-45 parts of amber, 30-45 parts of radix sileris, 30-45 parts of scutellaria baicalensis and 20-.
The preparation method of the pure traditional Chinese medicine for drug withdrawal comprises the following steps:
(1) steps (1) to (6) are the same as in example 1;
(7) pelleting: mixing dry extract powder and Ginseng radix fine powder in a mixer, adding water or Mel, making into pill, and drying to obtain concentrated pill;
(8) packaging: and (4) packaging the concentrated pills in common or vacuum.
To illustrate the effects of the present invention, the following will now be reported about the research work
In 2007, the project commits the traditional Chinese medicine research institute of Hunan province to declare various experimental studies required by traditional Chinese medicine preparations, the medicine name is 'Nanbao drug rehabilitation Qing capsule', the studies include review data, pharmaceutical data (preparation process, physicochemical properties, quality standards and inspection reports, stability tests and the like), pharmacological data (pharmacodynamics, pharmacological studies, toxicity tests, mutagenesis tests, carcinogenic tests, physiological toxicity tests and the like), clinical tests are carried out in 2008, a summary report of the Nanbao drug rehabilitation Qing capsule for treating heroin, novel drugs and multi-drug abuse patients is written, and the report records that 2587 cases of the Nanbao drug rehabilitation Qing capsule are applied in four years, wherein the heroin accounts for 48% after 1237 people; 258 patients with multi-drug abuse, 1031 patients with amphetamine, 40% and 52 patients with K powder. The treatment results are as follows: 2199 cases with recovery (physiological withdrawal and complete disappearance of withdrawal symptoms) account for 85 percent, and 388 cases with improvement account for 15 percent. Follow-up visits, no relapse occurs within half a year, 376 cases of full one-year relapse account for 20%, and 247 cases of full two-year relapse account for 25%. The result shows that the Nanbao drug-dropping Qing capsule has obvious drug-dropping effect. Firstly, the Chinese medicinal composition has quick response, can relieve withdrawal symptoms after being taken, and obviously improves the physiological characteristics after 7 days; the drug addiction is effectively controlled; no toxic or side effect, no adverse reaction caused by taking medicine; thirdly, the drug withdrawal curative effect on the novel synthetic drugs is obvious. Is suitable for patients with withdrawal syndrome caused by taking opium narcotic drugs or deficiency of both qi and yin and accumulation of toxin and blood stasis type methamphetamine narcotic drugs.
The invention relates to a pure Chinese medicine Nanbao drug rehabilitation Qing capsule, which has the specification of 0.5 g/capsule and 50 capsules/bottle. The functional indications are as follows: has the functions of strengthening body resistance and consolidating constitution, tonifying qi and soothing the nerves, relieving spasm and pain, relieving convulsion and calming wind and regulating yin and yang, is clinically used for all patients who are poisoned by taking heroin and derivatives thereof or methamphetamine and derivatives thereof, and can obviously relieve and eliminate withdrawal symptoms of opium or methamphetamine (methamphetamine, K powder, dancing outreach and the like) drugs and relieve drug addiction. The usage and dosage are as follows: it is taken orally with boiled water, 8 granules each time, 4 times daily.
The prescription basis of the medicine of the invention
The pathogenesis of the traditional Chinese medicine is the extremely complex disease of tobacco toxin internal accumulation, viscera yin-yang imbalance, qi-blood body fluid damage, qi-blood stasis, yin-yang dual damage, finally toxic stasis mutual resistance, cold-heat mixed and deficiency-excess mutual occurrence. Guojie and other Chinese medicines have been studied historically for drug rehabilitation, and it is considered that "healthy qi deficiency and excess pathogen" and "simultaneous addiction" are the main features. Morbid behavior of morbid forest consists of the following simple pathological mechanisms: "use the smoke to eliminate the valley qi and to cause pathogen to deprive the body resistance". At present, the traditional Chinese medicine is consistent, and the pathogenesis of the drug addiction is mainly tobacco toxin accumulation, viscera yin-yang imbalance, qi-blood and body fluid damage, qi-blood stasis, yin-yang dual damage, finally toxic and fatigue mutual resistance, cold and heat mixed and deficiency-excess mutual occurrence.
The mental activities of the human body are closely related to the five zang organs, and the traditional Chinese medicine considers that the human body takes the five zang organs as the center, belongs to the viscera through the meridian system, and is externally linked to the limb joints, and only the viscera coordinate and coordinate to play the physiological functions of the human body to maintain the normal life activities of the human body. If the opium drugs are abused, the five zang-organs and six fu-organs are affected by pathogenic factors, the zang-organs malfunction, and the corresponding pathological features and manifestations will be produced. Just as jue-addict-Ben cloud: "opium refreshment hijacking disease, failure of health preservation and curing of disease, lasting absorption of hidden organ and qi and blood deficiency. The pathogenesis of qi and blood deficiency and viscera damage caused by long-time opium taking is proposed.
TCM holds that only qi, blood and body fluids normally circulate, so that the body can go up and down without any apparatus. While the opium with pungent, warm, bitter and dry taste is easy to consume yin, body fluid, qi and blood of the body, and the deficiency of both yin and yang, both qi and yin or both qi and blood will gradually develop over time.
The Chinese medicine for drug rehabilitation has application in the self-cleaning middle leaves of China and accumulates abundant experience. Forms a unique set of theory and a feasible method. In recent years, the clinical treatment principle of traditional Chinese medicine detoxification can be summarized as strengthening body resistance and eliminating pathogenic factors, the commonly used treatment methods comprise tonifying qi and blood, nourishing liver and kidney, warming and invigorating spleen and kidney, nourishing heart and soothing nerves, regulating qi to alleviate pain, promoting blood circulation and removing blood stasis, warming channels and activating yang, clearing heat and detoxicating, clearing hollow viscera and eliminating turbid urine, calming endogenous wind and relieving convulsion, and the like, and the traditional Chinese medicine detoxification is applied in clinical application or on the other side in a stepwise manner. Zhang Weifen and other products with the functions of benefiting qi and nourishing blood, tonifying liver and kidney, warming yang and relieving pain, such as rhizoma pinellinae praeparata, fructus alpiniae oxyphyllae, spina date seed, poppy shell, eucommia bark, platycladi seed, pawpaw, achyranthes root, cibotium barometz, changium smyrnioides, polygonatum, medlar, astragalus, tuckahoe, charred baked ginger, inula flower, exocarpium citri rubrum and the like, have certain curative effect on opium smoke toxicity symptoms. The Tiandispe adopts a three-step drug rehabilitation method to carry out detoxification treatment on 120 drug addicts: firstly, on the first day of detoxification treatment, the three methods of sweating, vomiting and expelling toxin are carried out by rhubarb, prepared croton, pedicellus melo and the like; taking a detoxification formula on days 2-4; the third step is taking the recipe for strengthening the body resistance and consolidating the constitution in 5 to 8 days. Wu-jin researchers at the Chinese institute of traditional Chinese medicine have summarized the treatment of drug addiction in traditional Chinese medicine into two major characteristics: firstly, a large number of prescriptions adopt an opium subtraction method, namely, opium, poppy shell, poppy flower and the like are directly added into the prescriptions, or a little opium is added during application and gradually reduced to be completely unused along with the time prolongation, so that the pain of patients in the withdrawal treatment is relieved, and the patients can quit smoking, and the method is consistent with the alternative therapy thought adopted by modern medicine, but the curative effect has certain difference; secondly, attention is paid to the overall treatment, the elimination of pathogenic factors is used for treating the symptoms, the strengthening of body resistance is used for consolidating the constitution, particularly attention is paid to the continuous adjustment and the supplementation after the drug rehabilitation so as to improve the protracted withdrawal symptoms, and the relapse rate can be effectively reduced, which is one of the characteristics superior to the western drug rehabilitation.
The invention is guided by the theory of traditional Chinese medicine, adopts the Chinese herbal medicine to form the formula, is inherited from ancient opium abstinence secret formula, combines clinical use experience, and is prepared by repeated research, comparison, addition and subtraction. The drug dependence period can be safely passed by drug dependence patients in the treatment process without drug dependence and toxic and side effects, thereby achieving the purposes of drug addiction abstinence and rapid rehabilitation. The prescription takes the astragalus and the polygala as monarch drugs, and has the effects of tonifying qi and soothing the nerves; the codonopsis pilosula and the white ginseng are used as ministerial drugs for tonifying qi; the four medicines of the platycladi seed, the poria with hostwood, the spina date seed and the uncaria are taken as ministerial medicines for soothing the nerves, and the effects of nourishing the heart and soothing the nerves are achieved; corydalis tuber, salvia miltiorrhiza, frankincense and myrrh are used as adjuvant drugs for activating blood circulation; corydalis tuber, salvia miltiorrhiza, frankincense and myrrh are used as adjuvant drugs for activating blood circulation, and prepared kusnezoff monkshood root, prepared common monkshood mother root and Chinese azalea flower are used as adjuvant drugs for relieving spasm; scorpio is used as adjuvant drug for relieving convulsion; radix Saposhnikoviae and Scutellariae radix are used to help the whole formula dispel wind and remove toxicity, and Glycyrrhrizae radix is used as a guiding drug to harmonize the properties of the drugs.
Astragalus root, radix astragali, with mild nature and sweet taste, has the effects of invigorating qi, consolidating superficial resistance, suppressing sweating, removing toxicity, promoting granulation, inducing diuresis, and relieving swelling. Ming's Bian Huang is also named … for its tonifying reason from Ben Cao gang mu. Yuan Zhi is bitter and pungent with mild warm property. It enters heart, kidney and lung meridians. Induce tranquilization and promote intelligence, dispel phlegm and resolve swelling. Can be used for treating insomnia, dreaminess, amnesia, pavor, absentmindedness, expectoration, skin and external diseases, swelling and pain of breast caused by imbalance between heart-yang and kidney-yin. Shen nong Ben Cao Jing says "treating cough and dyspnea with symptoms of deficiency, eliminating pathogenic factors, benefiting nine orifices, benefiting wisdom, hearing and eyesight, amnesia, and strengthening consciousness and power". Therefore, the two herbs are tonifying qi and soothing the nerves, and Huang Qi and Yuan Zhi are the monarch drugs.
Dangshen is sweet in nature and neutral in nature. It enters spleen and lung meridians. Tonify middle-jiao and Qi, invigorate spleen and benefit lung. Can be used for treating spleen and lung deficiency, short breath, palpitation, anorexia, loose stool, asthma, cough, internal heat, and diabetes. It is a commonly used clinical qi-tonifying medicine, and "Buzhong Yiqi, and Xiao Ding Ke ya (polydipsia) of spleen and stomach" from the book of materia medica. White ginseng, sweet and mild in nature and taste. Has the effects of invigorating qi, relieving depletion, nourishing and strengthening body constitution. The combination of the two ginseng is used as a ministerial drug for tonifying qi.
Bai Zi ren is sweet in nature and neutral in nature. It enters heart, kidney and large intestine meridians. Nourish heart and induce tranquilization, moisten intestines to relieve constipation. Can be used for treating vexation, insomnia, palpitation, constipation due to intestinal dryness, etc. In the statement of the Yaozhiyi, the Baizi ren has the fragrance of penetrating the heart and moistening the body and nourishing the blood. Fu Shen, Zi ren, Sheng Di and Mai Dong are turbid middle-clear products, and indicated for deficiency of heart-mind, palpitation, haggard color, dry and itching skin, and also for nourishing heart and blood. Fu Shen is warm in nature, sweet and mild in flavor. Enter heart and spleen meridians. Has the functions of calming heart, soothing nerves and inducing diuresis. It can be used for treating palpitation due to heart deficiency, amnesia, insomnia, fright epilepsy, and dysuria. In the chapter of Yao Hua Yi (medical science), Fu Shen is heavy in body, heavy in weight, and strong in removing toxicity, and warm in nature, tonifying and reducing weakness. Worn like a worship, heart is hot, and deficiency is cold. For example, heart-qi deficiency, uneasiness, palpitation, absentmindedness, fatigue, amnesia, and warm-keeping heart spirit, which cannot be said. Suan Zao ren is slightly warm in nature and sweet and mild in flavor. Enter heart, spleen, liver and gallbladder meridians. Has the functions of nourishing liver, calming heart, tranquilizing and arresting sweating. It is mainly used for treating vexation and insomnia, palpitation, polydipsia and sweating due to debility. There are recorded in the book of other records that the main symptoms of the cloud include restlessness, insomnia, pain in the upper and lower parts of the umbilicus, prolonged bleeding, sweating due to deficiency, polydipsia, reinforcing the middle-jiao, tonifying liver-qi, strengthening tendons and bones, assisting yin qi, and making people fertile and healthy. Uncaria rhynchophylla is cool in nature and sweet in taste. Clear heat and calm liver, extinguish wind and calm convulsion. Can be used for treating headache, vertigo, common cold, convulsion, dysentery of pregnancy, and hypertension. "Gou Teng, dispelling wind and resolving phlegm, arresting convulsions and epilepsy, and Xiao Gong , also in Ben Cao Hui Yan (materia Medica). The semen boitae, the poria with hostwood, the spina date seed and the uncaria are combined to achieve the effect of nourishing the heart and soothing the nerves, so that the semen boitae, the poria with hostwood, the spina date seed and the uncaria are used as ministerial drugs for soothing the nerves.
Corydalis tuber, pungent, bitter and warm. Has the functions of promoting qi circulation, activating blood circulation, dissipating blood stasis and relieving pain. It can be used for treating pain due to qi stagnation and blood stasis, thoracic obstruction, angina pectoris, dysmenorrhea, cold stagnation of liver-qi, arthralgia due to wind-cold evil, and traumatic injury. Dan Shen is bitter and slightly cold. It enters heart and liver meridians. Has the functions of removing blood stasis, relieving pain, promoting blood circulation, stimulating the menstrual flow, clearing away the heart-fire and relieving restlessness. Can be used for treating menoxenia, amenorrhea, dysmenorrhea, abdominal mass, thoracico-abdominal pain, arthralgia due to heat, pyocutaneous disease, swelling and pain, vexation, and insomnia; hepatosplenomegaly, angina pectoris. There is the same as Dan Shen from Ben Cao Hui Yan that is good at treating blood system, removing stagnation and promoting tissue regeneration, regulating menstruation and regulating pulse. Ru Xiang is pungent and bitter with mild flavor. Enter heart, liver and spleen meridians. Has the functions of regulating qi, promoting blood circulation, relieving pain and removing toxic substances. It can be used for treating stagnation of qi and blood, pain of heart and abdomen, carbuncle, sore, toxic swelling, traumatic injury, dysmenorrhea, and puerperal pain due to blood stasis. "Yun Ru Xiang flee, entering heart meridian, promoting blood circulation and relieving pain" from Ben Cao gang mu, it is the essential herb for carbuncle, deep-rooted carbuncle, sores and ulcers, and cardialgia and abdominal pain ". Yun from Su Wen (Su Wen) (all sores and ulcers with pain and itching) all pertain to heart fire . It is also called Gong Er for activating blood circulation in various prescriptions of obstetrics. Mo Yao, with bitter and pungent flavor and mild action. Has the functions of dissipating blood stasis, eliminating swelling and relieving pain. Can be used for treating traumatic injury, incised wound, bone and muscle pain, heart and abdominal pain, abdominal mass, amenorrhea, carbuncle, cellulitis, swelling and pain, hemorrhoid, and vision disorder. Yun Mo Yao (Yao Yan Yi) from Ben Cao Yan Yi is administered with alcohol to treat pain due to stagnation of blood. Blood stagnation causes qi stagnation, qi stagnation causes rapid and full channels and collaterals, so it is painful and swollen. This is true for the swollen muscle beard caused by meridian injury, qi and blood stagnation, and accumulation. The four herbs have the effect of promoting blood circulation, and the corydalis tuber, the salvia miltiorrhiza, the frankincense and the myrrh are used together as adjuvant drugs for promoting blood circulation.
Radix Aconiti Kusnezoffii Preparata, pungent and bitter, and hot; is toxic. It enters heart, liver, kidney and spleen meridians. Has the effects of dispelling wind and eliminating dampness, warming meridians and relieving pain. Can be used for treating arthralgia due to wind-cold-dampness, arthralgia, psychroalgia of heart and abdomen, cold hernia pain, anesthesia and pain relieving. Radix Aconiti Preparata, pungent, bitter and hot in nature; is toxic. It enters heart, liver, kidney and spleen meridians. Has the functions of dispelling wind, eliminating dampness, warming channels and relieving pain. Can be used for treating arthralgia due to wind-cold-dampness, arthralgia, psychroalgia of heart and abdomen, cold hernia, and pain due to anesthesia. The Chinese azalea flower is pungent, warm and toxic, and has the effects of dispelling wind and eliminating dampness; relieving pain; killing pests. It is mainly used for treating wind phlegm, pain and wind-damp arthralgia. The book Jing Shu Zheng Zhen Yuan Zhu, toxic drug also. But it can dispel wind, cold and dampness, so it can be indicated for malignant arthralgia. Arthralgia syndrome is also caused by wind-cold-dampness. However, it is not suitable for people with no deficiency of original qi and excessive spleen and stomach. For these toxic herbs, they are combined with stomach-pacifying and qi-regulating herbs. The three medicines have the effects of relieving dizziness and spasm and can help monarch and minister medicines nourish qi and calm nerves, so the three medicines are adjuvant medicines for relieving spasm.
Scorpio, pungent in nature and mild in nature; is toxic. It enters liver meridian. Has the effects of calming endogenous wind, relieving spasm, counteracting toxic pathogen, dissipating nodulation, dredging collaterals and relieving pain. Can be used for treating infantile convulsion, spasm, facial distortion due to apoplexy, hemiplegia, tetanus, rheumatism, headache, pyocutaneous disease, and lymphoid tuberculosis. In the word "Kaibao Ben Cao" (Chinese materia medica), it is said to treat wind-induced urticaria, hemiplegia due to wind stroke, deviation of eyes and mouth, unsmooth speech, and dragging of hands and feet. Wu Gong is salty, pungent and warm. Is toxic. It enters liver, spleen and lung meridians. Has the functions of dispelling wind and relieving spasm; dredging collaterals and relieving pain; counteract toxic pathogen and dissipate nodulation. Can be used for treating cancer, tumor, toxic accumulation, wind syndrome, spasm and pain, inflammation, swelling, and pyocutaneous disease. "Yun" from gang mu "is used to treat convulsion, trismus due to infantile convulsion, erysipelas, tinea pedis, scrofula, stool toxicity, anal fistula and snake bite. Amber, sweet, neutral. Tranquilizing, promoting urination, and promoting blood circulation. Can be used for treating infantile convulsion, epilepsy, palpitation, insomnia, dysuria, odynuria, hematuria, and amenorrhea. Therefore, the three herbs are used as the adjuvant drugs for relieving convulsion.
Fang Feng, pungent and sweet in flavor and slightly warm in nature. It enters bladder, liver and spleen meridians. Relieve exterior syndrome, dispel wind, subdue dampness and stop spasm. Can be used for treating common cold, headache, rheumatalgia, rubella, pruritus, and tetanus. "Yun Feng Fang Feng" (long sand drug solution) "has the actions of activating meridians, expelling dampness, dredging joints, relieving pain, relaxing tendons and vessels, stretching and spasm, activating limbs and joints, treating paralysis, arresting spontaneous sweating, breaking leakage and collapsing middle-jiao. Baical skullcap root is bitter in flavor and cold in nature. It enters lung, gallbladder, spleen, large intestine and small intestine meridians. Clear heat and dry dampness, purge fire and remove toxicity, stop bleeding, prevent abortion. Can be used for treating chest distress and nausea due to damp-warm and summer-warm, damp-heat distention and fullness, dysentery, jaundice, cough due to lung-heat, hyperpyrexia, polydipsia, hematemesis, carbuncle, swelling, sore, and threatened abortion. The phrase "Baikal skullcap root specially governs yang brightness steaming heat, yang brightness is in the middle, non-Baikal skullcap root can not purge and accumulate, one governs pathogenic wind and wood, one governs dampness and accumulates, can be mixed with theory". The two medicines are used for assisting the whole formula in dispelling wind and removing toxicity. It is combined with gan Cao to harmonize the properties of all herbs and is used as a guiding drug.
Clinical research report of drug p-methyl phenylpropylamine drug withdrawal test
1. Selection of study objects
The study subject is provided by the drug withdrawal administration of Shaoyang city in Hunan province, and the subject is a patient with withdrawal syndrome of deficiency of both qi and yin and accumulation of toxic stasis type taking methamphetamine (such as methamphetamine, Maguo, Boletus) or Boletus.
1.1 in the test process, screening is carried out by taking whether the subject has the withdrawal syndrome of the amphetamine drugs in Western medicine and/or the symptoms of deficiency of both qi and yin and accumulation of toxin and stasis as inclusion standards.
The specific situation is as follows:
1.1.1 amphetamine withdrawal symptoms:
(1) amphetamine or similar drugs have been taken for a long period of time and are now discontinued (or reduced).
(2) More than 2 of dysthymia and the following physiological changes occur hours or days after (l); firstly, hypodynamia is caused; lively and unpleasant dreams; ③ insomnia or lethargy; increasing the appetite; bradypsychia or hyperkinesia.
(3) Clinically significant distress, or impairment of function in social, occupational, or other important areas, occurs due to the symptoms of (2).
(4) These symptoms are not due to general physical conditions, nor are they likely to be attributable to other mental disorders.
1.1.2 the symptoms of deficiency of both qi and yin and accumulation of toxic stasis in traditional Chinese medicine:
the main symptoms are: dysphoria, stress and anxiety, general discomfort, and asthenia.
The secondary symptoms are as follows: night sweat, soreness of waist and knees, myalgia, arthralgia, hypomnesis, insomnia, anorexia, night sweat, lumbago, and chest distress.
Tongue pulse: the tongue is pale with white coating and the pulse is wiry, thready or rapid.
Diagnostic criteria: the two main symptoms are seen, while the two secondary symptoms are seen, the syndrome can be distinguished.
1.2 inclusion criteria
(1) Meets the diagnosis standard of the withdrawal syndrome caused by amphetamine, and the urine amphetamine toxicant is positive.
(2) The past drug taking history is less than 3 years, and the daily drug taking amount is less than 10 g.
(3) Male or female aged 18-55 years.
(4) Volunteer participation in clinical trials and endorsement of informed consent.
1.3 exclusion criteria
One of the following cases cannot be selected as a subject.
(1) Those under 18 years of age or over 55 years of age.
(2) Those with severe organic diseases of heart, liver and kidney and severe primary diseases of hematopoietic system.
(3) Patients with mental disease.
(4) A multidrug abuser.
(5) Pregnant or prepared pregnant women, lactating women.
(6) Allergic constitution or those allergic to various drugs.
(7) Those who used drugs known to damage major organs within 4 weeks.
(8) The patients were unable to collaborate or were participating in other drug trials.
(9) Combined with pulmonary tuberculosis, HIV infection, severe malnutrition, blood pressure lower than 90/40mmHg or heart rate lower than 60 times/min.
Design of experiments
The clinical trial is a high-efficiency clinical study by adopting a stratified block group random, placebo control and double-blind observation.
Treatment regimens
Treatment groups: the capsules in example 1 were administered 4 times daily, 8 capsules each time.
Control group: the capsule in the simulation example 1 takes starch, dextrin, edible pigment and seasoning as main raw materials, and has the same dosage form, appearance, specification and label as the tested medicament and the same name as the tested medicament. The test drug and the simulated control drug have the same batch number, 4 times a day, and 8 capsules each time.
Procedure of the test
Oral administration, with 7 days as a treatment course in both groups, observing a treatment course, and performing follow-up for 2 weeks after the administration.
Interview arrangement
Withdrawal symptoms were recorded 1 time before administration, 1 day 2, 3, 4, 5, 6, 7 days after administration, and 1 day, 7 days, 14 days after administration. Other symptoms and tongue vessel were recorded 1 time before and after administration. The observation of psychological and emotional changes during treatment period was recorded 4 times before administration, 1 day, 7 days and 14 days after the end of administration using Hamilton's anxiety scale.
Safety index
(1) General physical examination items (body temperature, respiration, heart rate, blood pressure, pulse, weight).
(2) Blood, urine and stool are tested conventionally (test for occult blood in stool).
(3) Electrocardiographic examination, liver function (ALT, AST, TP, A/G, TB, CB) and kidney function (BUN, Cr) examination.
Index of therapeutic effect
(1) Withdrawal symptoms and signs and their graded scores.
(2) Hamilton anxiety scale.
(3) The syndrome/condition scale of traditional Chinese medicine.
Standard of therapeutic effect
(1) The effect is shown: after treatment, the patients can get better in mental state and can live normally.
(2) The method has the following advantages: the patients are treated to change the mental state, but need further treatment to recover.
(3) And (4) invalidation: after treatment, there was no evidence of improvement, and the condition was even further worsened.
Statistical analysis
The measurement data of each visit of different treatment groups will be described statistically by means of the mean ± standard deviation. And comparing with the basic value of the screening period, and comparing the front difference and the back difference in the group by adopting paired t test. The changes before and after treatment in both groups were compared using analysis of variance (ANOVA) or Wilcoxon rank sum test. The counting data of each visit of different treatment groups are described by frequency (composition ratio) in statistics. The changes before and after two groups of treatment adopt X2 test or non-parameter test.
And (3) shedding analysis: the comparison of the total shedding rates of the two groups and the shedding rate due to adverse events will be performed using the χ 2 test.
Equilibrium analysis of the base values: analysis of variance or χ 2 test was used to compare demographic data with other baseline indicators to measure how well two groups are balanced.
And (3) effectiveness analysis: and evaluating the effectiveness index by adopting an analysis of variance method and an optimization test.
And (3) safety analysis: and comparing the incidence rates of two groups of adverse events by adopting a Chi 2 test, and describing the adverse events generated in the test in a parallel table. Laboratory test results relate to the test drug in normal/abnormal changes before and after the test and in the event of abnormal changes.
Test results and analysis
5.1 test case completion
The test is carried out by 108 subjects, 72 test groups and 36 control groups in total, 2 cases of the test groups are eliminated because the medicines are not taken in the test, 1 case of the control groups is eliminated because the visits are lost, the number of the actually finished cases of the test groups is 70, and the number of the actually finished cases of the control groups is 35. Comparison of the completion and drug compliance differences between groups was not statistically significant (P > 0.05).
TABLE 1 test completion
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
group n (miss) completion drop-out rejection
──────────────────────────────────
Run set 72 (0) 70 (97.22) 0 (0.00) 2 (2.78)
Control group 36 (0) 35 (97.22) 1 (2.78) 0 (0.00)
━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━
5.2 general data on subjects
The comparative differences of the demographic data of the two groups of testees in the test, such as sex, age, ethnicity, height, weight and the like, have no statistical significance (P is more than 0.05), and have better comparability.
Figure 989742DEST_PATH_IMAGE001
5.3 general vital signs of the subject
The comparison difference between the general vital signs of the two groups of subjects, such as body temperature, heart rate, respiration, pulse and blood pressure, has no statistical significance (P > 0.05) and has better comparability.
5.4 data of the disease condition
Compared differences between self-scoring of withdrawal symptoms before treatment and scoring of medical staff, anxiety scoring, traditional Chinese medicine syndrome integration, related symptom sign grading and the like of two groups of subjects have no statistical significance (P & gt 0.05), and the results have better comparability.
5.5 effectiveness analysis
5.5.1 evaluation of therapeutic efficacy
5.5.1.1 combination therapeutic effect
The significant efficiency of the comprehensive curative effect of the treatment group in the test is 60.00%, the total effective rate is 98.57%, the significant efficiency of the control group is 2.78%, and the total effective rate is 5.56%, so that the total effective rate of the comprehensive curative effect of the test group is considered to be superior to that of the 95% CI of the control group [77.15, 108.87 ].
Figure 176004DEST_PATH_IMAGE002
5.5.1.2 detection of urinary methamphetamine before and after treatment
The positive rate of the urinary methamphetamine in the test group and the control group before treatment is 100.0 percent, the positive rate of the urinary methamphetamine after treatment is 0.00 percent, the positive rate of the urinary methamphetamine after treatment is reduced, and the difference has statistical significance (P is less than 0.05).
Figure 571213DEST_PATH_IMAGE003
5.5.2 withdrawal symptom score
5.5.2.1 withdrawal symptom score before and after treatment
At the end of the treatment course, the withdrawal symptom self-score of the test group and the control group of the subjects is reduced compared with that before treatment, the difference has statistical significance (P < 0.05), and the withdrawal symptom score reduction value of the test group is greater than that of the control group (P < 0.05).
At the end of the treatment course, the withdrawal symptom self-scores of the test group subjects are all reduced compared with those before treatment, the difference is statistically significant (P < 0.05), the self-score change condition of the control group subjects is not statistically significant (P > 0.05), and the withdrawal symptom score reduction value of the test group subjects is greater than that of the control group subjects (P < 0.05).
Figure 57689DEST_PATH_IMAGE004
5.5.2.2 withdrawal symptom score before and after follow-up change
The follow-up results 14 days after the treatment course, show that the self-score of the withdrawal symptoms of the test group and the control group of the subjects is reduced compared with that of the subjects at the end of the treatment course, and the difference has statistical significance (P < 0.05).
The follow-up results 14 days after the treatment course, show that the withdrawal symptoms of the test subjects and the control subjects are lower than the withdrawal symptoms of the test subjects and the control subjects, and the scores are statistically significant (P < 0.05).
Figure 880152DEST_PATH_IMAGE005
5.5.3 anxiety score
At the end of the treatment course, the anxiety scores of the test group subjects are all reduced compared with the anxiety scores before treatment, the difference is statistically significant (P < 0.05), the self-scoring change condition of the control group subjects is not statistically significant (P > 0.05), and the reduction value of the anxiety scores of the test group subjects is greater than that of the control group subjects (P < 0.05).
The follow-up results after the treatment course is finished show that the anxiety scores of the subjects in the test group and the subjects in the control group are reduced compared with the anxiety scores at the end of the treatment course, and the difference has statistical significance (P < 0.05).
Figure 147185DEST_PATH_IMAGE006
5.5.4 curative effects on syndrome of Chinese medicine
The total significant efficiency of the traditional Chinese medicine syndrome curative effect of the treatment group is 95.72%, the total effective rate is 100.0%, the comparison difference between the control groups is 5.56% and 30.56%, the statistical significance is achieved (P is less than 0.05), and the traditional Chinese medicine syndrome curative effect of the test group is superior to that of the control group.
Figure 487031DEST_PATH_IMAGE007
5.5.5 changes before and after the integral treatment of the syndrome of traditional Chinese medicine
At the end of the treatment course, the traditional Chinese medicine syndrome integrals of the test group and the control group are reduced compared with those before treatment, the difference has statistical significance (P < 0.05), and the reduction value of the traditional Chinese medicine syndrome integrals of the test group is greater than that of the control group (P < 0.05).
Figure 624751DEST_PATH_IMAGE008
5.5.5 improvement of symptoms and signs related to Chinese medicine syndrome after administration
After the medicine is taken, the symptoms of the clinical symptoms of the two groups, such as dysphoria, tension and anxiety, general malaise, hypodynamia, night sweat, muscle pain, arthralgia, soreness and weakness of waist and knees, amnesia, insomnia, anorexia, lumbago, chest distress and the like, are all improved, the improvement condition of the test group is superior to that of the control group, and the difference has statistical significance (P is less than 0.05).
Figure 883694DEST_PATH_IMAGE009
Figure 575706DEST_PATH_IMAGE010
5.6 safety assay
5.6.1 Vital signs
The vital signs of the two groups of subjects before and after treatment were substantially stable without significant fluctuations.
Figure 447804DEST_PATH_IMAGE011
5.6.2 adverse event occurrences
No adverse event or adverse reaction occurs in the test.
5.6.3 safety index
All the cases before and after treatment or before and after treatment are tabulated and analyzed case by case, most cases are slightly increased after treatment or slightly increased compared with the normal value, the patients have no obvious clinical symptoms, and the researchers judge that the change has no clinical significance. The investigators with some subjects with obvious changes all performed the review and basically recovered to normal. It is worth mentioning that there were two subjects in the trial who had post-treatment ALT elevation (No. 7: pre-treatment 15, post-treatment 69.6; No. 19: pre-treatment 28, post-treatment 59) and the investigator rejected the review and could not determine the relationship to the drug. The investigators considered not to be related to the test drug, considering physical factors in the subjects.
It is worth pointing out that the subjects in the clinical trial are drug addicts and have constitutional abnormalities, and the subjects are all newly participated in drug abstinence patients, and the constitutional difference from the normal people is larger, so that there are more cases of before-treatment normality, after-treatment abnormality or before-treatment abnormality and after-treatment abnormality aggravation in the test. The medicine has no obvious adverse reaction report in the history of the last decade of clinical application, and the comprehensive analysis of the abnormal conditions after normal treatment before the treatment of the test or the abnormal aggravation after the abnormal treatment before the treatment is irrelevant to the test medicine.
6. Conclusion
The test result shows that the pure traditional Chinese medicine has a more positive curative effect on the withdrawal syndrome of methamphetamine drugs (such as methamphetamine, ephedra, dancing outreach and the like) with deficiency of both qi and yin and accumulation of toxin stasis. The medicine is safe to apply according to the recommended dose, has no obvious adverse reaction, and is worthy of clinical popularization and application.

Claims (3)

1. The pure traditional Chinese medicine for treating the methamphetamine drug withdrawal syndrome of deficiency of both qi and yin and accumulation of toxic stasis is characterized by being prepared from the following raw material medicines in parts by weight: 30-45 parts of astragalus membranaceus, 30-45 parts of polygala tenuifolia, 25-40 parts of codonopsis pilosula, 30-45 parts of ginseng, 25-40 parts of platycladi seeds, 25-40 parts of poria with hostwood, 30-45 parts of spina date seeds, 30-45 parts of uncaria, 30-45 parts of corydalis tuber, 25-40 parts of salvia miltiorrhiza, 30-45 parts of prepared frankincense, 30-45 parts of prepared myrrh, 20-45 parts of prepared kusnezoff monkshood root, 20-45 parts of prepared monkshood, 1-5 parts of rhododendron molle, 20-35 parts of scorpio, 10-30 parts of centipede, 30-45 parts of amber, 30-45 parts of divaricate saposhnikovia root, 30.
2. The pure traditional Chinese medicine for treating methamphetamine drug withdrawal syndrome of deficiency of both qi and yin and accumulation of toxic stasis according to claim 1, wherein the dosage form comprises any one of capsules, pills, tablets and mixtures.
3. The pure traditional Chinese medicine for treating qi-yin deficiency and toxin-stasis accumulation type methamphetamine drug withdrawal syndrome according to claim 1, wherein mature kernels of platycladi seeds are selected as the medicine; the Poria is prepared from white part of ramulus Pini Massonianae or radix Pini Massonianae wrapped in dry sclerotium of Wolf (Schw.) of Polyporaceae.
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