CN1931256A - Chinese medicine capsule for eliminating drug addiction and its prepn process - Google Patents

Abstract

The present invention discloses one kind of Chinese medicine capsule for eliminating drug addiction and its preparation process. The present invention features that the Chinese medicine capsule is prepared with 13 kinds of Chinese medicinal materials, including ginseng, angelica, decubent corvdalis, datura flower, bezoar, etc. and through extraction to obtain extract, adding supplementary material and other steps. Pharmaceutical experiment shows that the Chinese medicine capsule has excellent function of eliminating drug addiction; the toxicological experiment proves the high safety of the Chinese medicine capsule; and clinical application proves the excellent effect of eliminating drug addiction.

Description

A kind of Chinese medicinal capsule preparation that is used to quit drug abuse and preparation method thereof

Affiliated technical field

The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of Chinese medicinal capsule preparation that is used to quit drug abuse and preparation method thereof.

Background technology

Consume illegal drugs has become big public hazards of mankind nowadays society.

The drug problem just as pestilence at global rapid spread, fast, the wide any pestilence that had once taken place on the earth that involves the crowd of rate of propagation, any country, any social class all are subjected to drug problem's influence not exceptionally, and the drug problem has become one of the most serious medical problem of serious threat social security and human survival and social problem.The heroin misuser is increased sharply to about 520,000 people by tens examples in the past ten years in China, and is the gesture of quick growth; Have data to show the short 10-15 of the general crowd of average life of junkie, addicts's mortality rate is high 15 times than common people, and multiple reason can cause the junkie mortality rate to be higher than general crowd.Spreading unchecked day by day of drugs, serious threat social stability and economic development, leave a legacy of trouble to people ' s health, ruin social morals, bring out various crimes, have become the common enemy of human society.

Eliminate the social danger of drugs, the approach of saving the drug addict is exactly to give up drug addict's drug addiction.

Drug rehabilitation is present universally acknowledged difficult medical problem.In existing drug addiction treatment, the Western medicine that with the methadone is representative becomes the main flow drug-relief medicine, the medicine that methadone is actually a kind of " alternative medicine ", so-called " substituting " is exactly " replacing big poison with mild toxicity ", because methadone itself is exactly drugs,, but still has addiction though toxicity is lower, as if because the limitation of doctor trained in Western medicine, the research of drug-relief medicine just has been absorbed in predicament after methadone.So many researcheres have turned one's attention to Chinese medicine.The traditional Chinese medical science thinks, various withdrawal symptoms and since druggy all uncomfortable be mark, be that drugs cause the destruction of human internal organ, nervous system, immune system, hormonal system and cause the essence of these symptoms, this is this.Only notice that with Western medicine symptomatolytic characteristics are different, the modern Chinese medicine preparation can well replenish human body by the deficiency of both QI and blood that evil poison dissipates when rooting out toxin, recover each organ function, regulates the physiological system balance, thereby reaches the effect for the treatment of both the principal and secondary aspects of a disease.In addition, Chinese medicine against drug dependence possesses also that no dependence, toxic and side effects are low, taking convenience, meet the advantages such as condition of family's drug rehabilitation.It seems with regard to present case, Chinese medicine no matter in detoxification still the therapeutic effect in the convalescence stage all be better than Western medicine, recovering each organ function, regulate physiological system balance aspect, some Chinese prescription is better than the curative effect of Western medicine, and adding does not have addiction, and the aggregate performance of Chinese medicine against drug dependence has surpassed Western medicine.

Just owing to this, the domestic disclosed drug invention patent that is used to quit drug abuse has more than 90, but the kind that can be used for clinical treatment is also few, the domestic Chinese medicine against drug dependence that has gone on the market has the Kang Ling sheet at present, FUKANG PIAN, benefit peace HUISHENG KOUFUYE, the beneficial capsule of spirit etc., but these Chinese medicine majorities can not independent utility, the sedative hypnotic need be added and opioid drug is made auxiliary treatment, cranial nerve to the patient still has certain infringement, therefore, develop a kind of opiates ancillary drug that do not need, Chinese medicine that again can the better controlled symptom is the problem that a lot of pharmaceutical developments personnel will solve.

Application 02121578.2 " a kind of non-opium Narcotic Chinese medicine and manufacture method " discloses Chinese medicine against drug dependence with Radix Ginseng, Radix Angelicae Sinensis, Rhizoma Corydalis Decumbentis, Flos Daturae, Calculus Bovis, Scorpio, Herba Asari, Flos Albiziae, Radix Et Rhizoma Rhei, Flos Caryophylli, Semen Ziziphi Spinosae, Borneolum Syntheticum, Radix Glycyrrhizae compatibility and preparation method thereof; but this compound recipe does not take into full account the medication characteristics of Chinese medicine and the whole disease of rehabilitating addicts in some dose compatibilities; and its disclosed process is too general; can't implement industrial, thereby above-mentioned application is out of court.

Summary of the invention

For these reasons, scientific research personnel of the present invention is according to the whole disease of rehabilitating addicts, take into full account the characteristics of medicines such as Radix Angelicae Sinensis, Scorpio, Herba Asari, Flos Albiziae, Radix Et Rhizoma Rhei, Flos Caryophylli, Radix Glycyrrhizae, according to the differentiation of tcm theory, again Chinese medicine Radix Ginseng, Radix Angelicae Sinensis, Rhizoma Corydalis Decumbentis, Flos Daturae, Calculus Bovis, Scorpio, Herba Asari, Flos Albiziae, Radix Et Rhizoma Rhei, Flos Caryophylli, Semen Ziziphi Spinosae, Borneolum Syntheticum, Radix Glycyrrhizae are established prescription; Through studying for a long period of time, determined preparation technology preferably, be applicable to the suitability for industrialized production of the application's capsule preparations; Said preparation can cooperate without any need for Western medicine fully independently as anti-additive medicament; Pharmacological evaluation shows that capsule preparations of the present invention has good drug treatment function, can reach the detoxification purpose through all treatments; Toxicological experiment shows that the application's capsule preparations has very high safety.

The present invention is achieved by the following technical solutions.

One. preparation prescription

(1) prescription (crude drug is in weight portion):

Radix Ginseng 4-5, Radix Angelicae Sinensis 7-8, Calculus Bovis 0.08-0.12, Scorpio 0.5-0.7, Rhizoma Corydalis Decumbentis 10-12, Flos Daturae 0.3-0.4, Radix Et Rhizoma Rhei 4-5, Borneolum Syntheticum 0.04-0.06, Herba Asari 1.5-2.5, Flos Caryophylli 2.0-3.0, Semen Ziziphi Spinosae 3-4, Flos Albiziae 6.5-7.5, Radix Glycyrrhizae 3.5-4.5;

(2) more specifically the prescription (crude drug is in weight portion):

Radix Ginseng 4.4, Radix Angelicae Sinensis 7.2, Calculus Bovis 0.1, Scorpio 0.6, Rhizoma Corydalis Decumbentis 11, Flos Daturae 0.36, Radix Et Rhizoma Rhei 4.4, Borneolum Syntheticum 0.05, Herba Asari 1.8, Flos Caryophylli 2.2, Semen Ziziphi Spinosae 3.4, Flos Albiziae 6.8, Radix Glycyrrhizae 3.8;

In the new prescription with the Radix Ginseng strongly invigorating primordial QI, invigorating the spleen to benefit the lung, QI invigorating and blood producing, the Fructus Alpiniae Oxyphyllae of calming the nerves, reinforcing primordial QI reinforcing; Chinese angelica blood supplementing is capable to stagnate, antalgic, and two medicines share, qi and blood tonifying, removing obstruction in the collateral to relieve pain, the calmness of calming the nerves, the disease of insufficiency of vital energy and blood and pain, anxiety, insomnia is monarch drug altogether in the treatment detoxification;

The Rhizoma Corydalis Decumbentis blood-activating and qi-promoting, removing obstruction in the collateral to relieve pain, the Flos Daturae spasmolysis and analgesia has the merit of calmness, and two medicines share, and focus on pain relieving; Scorpio goes into the liver endogenous wind stopping with relieving convulsion, and current meridians are with pain relieving, and the cool liver endogenous wind stopping of Calculus Bovis is with relieving convulsion, and clearing away heart-fire and eliminating phlegm is to have one's ideas straightened out, and two medicines share, and focus on the endogenous wind stopping relieving convulsion, the refreshment of having one's ideas straightened out; More than four medicines can strengthen the effect of monarch drug removing obstruction in the collateral to relieve pain, endogenous wind stopping relieving convulsion, the Fructus Alpiniae Oxyphyllae of calming the nerves, peaceful, the convulsion of pain, the restlessness diseases such as tic of fainting are ministerial drug altogether in the treatment detoxification;

The Herba Asari refreshment of having one's ideas straightened out, numbness relieving and pain relieving; The Borneolum Syntheticum removing heat from the heart to restore the consciousness, the detoxifcation pain relieving; The Flos Albiziae dispersing the stagnated live-QI to relieve the stagnation of QI, tranquilizing the mind; The Semen Ziziphi Spinosae relieving mental strain and helping sleep, the YIN nourishing arresting sweating; The Radix Et Rhizoma Rhei clearing away heat and loosing the bowels, toxin expelling the turbid descending, blood-activating analgetic; Flos Caryophylli stomach function regulating preventing or arresting vomiting; More than six medicines share, the refreshment of having one's ideas straightened out is arranged, the pain relieving preventing or arresting vomiting is mediated the merit of tobacco poisoning, the disease that insomnia in the treatment detoxification, impatience, pain, sweating, vomiting, tobacco poisoning are delaied is adjuvant drug altogether;

Radix Glycyrrhizae can be mended, can be delayed, and can detoxify, and can increase the merit of ginseng qi-tonifying spleen invigorating, helps Radix Et Rhizoma Rhei to mediate the power of tobacco poisoning, strengthens the effect of above-mentioned all medicine pain relieving preventing or arresting vomitings simultaneously, can be in harmonious proportion the property of medicine again, and full side is attacked mend appropriateness, coordination of cold and heat, one-object-many-purposes is adjuvant.

Two. preparation technology

(1) gets the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 4-6 hour, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(2) get Radix Et Rhizoma Rhei and add the 80%-90% alcohol reflux 2 times, add 60 ℃ of reflux, extract, 0.5-1.5 of ethanol hours that 8-12 doubly measures for the first time, add 60 ℃ of reflux, extract, 0.4-0.6 of ethanol hours that ethanol 6-9 doubly measures for the second time, merge secondary raffinate, filter; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(3) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add ethanol extraction 2-3 time of 75%-85%, for the first time add alcohol reflux 2-4 hour that 8-12 doubly measures, second and third time adds ethanol 7-9 respectively and doubly measured backflow 1-3 hour, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(4) medicinal residues and Radix Glycyrrhizae, Semen Ziziphi Spinosae, the Flos Albiziae of getting step (1) medicinal residues and step (3) decocts with water secondary, adds water 10-14 for the first time and doubly measures, and extracts 1-3 hour; For the second time add water 8-12 and doubly measure, extracted 1-2 hour; Merge secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, added ethanol and made pure content reach 55%-65% (V/V), left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, and reclaims ethanol, and relative density is 1.25-1.35 when being evaporated to 60 ℃, drying under reduced pressure, pulverize, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(5) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 2-4 hour adds 0.5% magnesium stearate mixing, incapsulates, and is finished product.

Drug nomenclature of the present invention is " the Da Er recovering capsule "

Three. check and analysis

Test basis: " clinical research quality standard "

Assay: (2006.5.19 of institute provides survey report according to the check of Henan Province's food and medicine) sees Table 1:

Table 1 Da Er recovering capsule preparation assay

Inspection item	Standard code	Assay
			[proterties] [discriminating] (1) microscopic features (2) thin-layer chromatographys (3) thin-layer chromatographys (4) thin-layer chromatographys (5) thin-layer chromatographys (6) thin-layer chromatographys (7) thin-layer chromatographys (8) thin-layer chromatographys [inspection] moisture content uniformity disintegration time limited microbial limit	Should be capsule preparations, content is that pale brown color is to tan granule or powder, gas perfume (or spice), bitter in the mouth, little suffering, cold. answer the microscopic features of tool the application capsule should be consistent with ginseng control medicinal material and ginsenoside Rb1, Re, Rg1 reference substance principal spot should with cholic acid, deoxycholic aicd reference substance principal spot unanimously should with decumbent corydalis tuber control medicinal material principal spot unanimously should with rheum officinale control medicinal material and archen contrast medicine principal spot unanimously should with datura flower control medicinal material spot unanimously should with eugenol, borneol reference substance principal spot unanimously should with enoxolone reference substance principal spot unanimously must not cross 9.0% should 30 minutes planted agents are up to specification should be up to specification	Be capsule preparations, content is tan granule or powder, gas perfume (or spice), bitter in the mouth, little suffering, the microscopic features of cold. tool the application capsule and ginseng control medicinal material and ginsenoside Rb1, Re, Rg1 reference substance principal spot is consistent with cholic acid, deoxycholic aicd reference substance principal spot is consistent with decumbent corydalis tuber control medicinal material principal spot consistent and rheum officinale control medicinal material and archen contrast medicine principal spot is consistent and datura flower control medicinal material spot unanimously and eugenol, borneol reference substance principal spot unanimously and consistent 6.5% 23 minutes of enoxolone reference substance principal spot up to specification
[assay]	Every total amount that contains Radix Et Rhizoma Rhei in emodin (C15H10O6) and chrysophanol (C15H10O4) must not be less than 1.20mg	1.75mg

Conclusion: this product is checked with quality standard by clinical research, and the result is up to specification.

Four. pharmacological evaluation

(1) pharmacodynamic study data

1. urge in the withdrawal and treatment experiment rat, the Mor model group shows tangible withdrawal symptom (P＜0.01) body weight and obviously reduces (P＜0.01).Three dosage groups of Da Er recovering capsule (0.4,2.0 and 4.0g/kg), withdrawal symptom and weight loss are all shown certain therapeutical effect, and the weight loss that the weight loss of heavy dose of group withdrawal symptom score value and urgency back 30min and 60min all is starkly lower than dosage group in the Mor model group (P＜0.05 or P＜0.01) is starkly lower than Mor model group (P＜0.01).This shows that the application's capsule can significantly resist the urgency withdrawal symptom of Mor dependency rat in this model, but its therapeutical effect to withdrawal symptom is reserved not as cola.

2. in the treatment experiment of rat natural withdrawal, Mor model group body weight obviously descend (P＜0.01).Three dosage groups of the application's capsule (0.3,0.8 and 1.6g/kg) all can be controlled the decline of rat body weight to a certain extent, particularly heavy dose of group and middle dosage group are more obvious to the rat body weight control that descends, and heavy dose ofly organize after giving up the 3rd day, small dose group is starkly lower than Mor model group (P＜0.01 or P＜0.05) at the 4th day body weight decline percentage rate.Clonidine group does not have to suppress to give up the decline of back body weight.This shows that in this model the Da Er recovering capsule shows tangible detoxification treatment effect.

3. in monkey natural withdrawal treatment experiment, tangible withdrawal symptom appears in the Mor model group, and body weight and body temperature is obviously decline (p＜0.05 or p＜0.01) also; Two dosage groups of the application's capsule (0.36 and 0.72g/kg) all can controlled withdrawal symptom in varying degrees, suppress the decline of weight loss and body temperature and all be starkly lower than Mor model group (P＜0.05 or P＜0.01), the morphine withdrawal symptom is shown the obvious treatment effect.Compare with the positive control drug clonidine, the Da Er recovering capsule is aspect the control of withdrawal symptom, and is suitable with clonidine, aspect the control of weight loss, is better than clonidine, reserving not as cola aspect the control of body temperature decline.

Based on above three result of experiment, we can draw as drawing a conclusion: the withdrawal symptom that the Da Er recovering capsule is produced after morphine dependency animal is given up has tangible detoxification treatment effect, and its effect is better than clonidine in some aspects.

(2) toxicologic study data

Be subjected to the reagent thing: the Da Er recovering capsule, effluent south Jiaozuo City Yulong Chinese medicine science and technology institute provides lot number: 001006.

1. general toxicological study

To the cardiac electrical influence of rat:

Rat i.g. Da Er recovering capsule 2.0,4.0 and 8.0g/kg compare through paired data t check before each EGC parameter of different time and the administration after the administration, and its difference does not have significance (P＞0.05).Show rat i.g.2.0g/kg-8.0g/kg Da Er recovering capsule, electrocardio is not seen obvious change.

Influence to rat blood pressure:

Rat is i.g. Da Er recovering capsule 2.0,4.0 and 8.0g/kg respectively, measure the variation of each time point blood pressure behind every animals administer, check through paired data t, the result shows each time point after the Da Er recovering capsule i.g. administration, compare before systolic pressure, diastolic pressure and the mean arterial blood pressure of three dosage group rats and the administration, the equal statistically nonsignificance (P＞0.05) of its difference illustrates that Da Er recovering capsule i.g. administration 2.0g/kg-8.0g/kg does not have obvious influence to rat blood pressure.

Influence to respiratory system in rats:

Rat is i.g. Da Er recovering capsule 2.0,4.0 and 8.0g/kg respectively, measure tidal volume (VT), respiratory frequency (RE) and the minute ventilation (VE) of administration front and back rat, through paired data t check, to compare before different time measured value and the administration after the administration, its difference does not have significance (P＞0.05).This shows, gives rat i.g. Da Er recovering capsule 2.0g/kg-8.0g/kg, and (TV, RE and VE) there is no obvious influence to each respiration parameter of rat.

To the neural influence of spirit:

Behind mice difference i.g. Da Er recovering capsule 2.8,5.6 and 11.2g/kg metering and the solvent, measure each parameter of spontaneous activity of mice, irritate stomach and give behind the 2.8g/kg Da Er recovering capsule spontaneous activity in mice not to be had obvious influence.But mice 45min-60min after administration of 5.6g/kg dosage group, the spontaneous activity number of times obviously increases (P＜0.05); The spontaneous activity overall strength significantly increases (P＜0.01) when 45min, obviously increase (P＜0.05) during 60min.Above-mentioned two parameters all begin to recover behind 120min.11.2g/kg the mice of dosage group 45min spontaneous activity number of times and spontaneous activity overall strength after administration obviously increase (P＜0.05); During 60min, spontaneous activity number of times and spontaneous activity overall strength significantly increase (P＜0.01), and above-mentioned two parameters all begin to recover behind 120min.

The Da Er recovering capsule is to the influence of animal general behavior:

Rat: i.g. Da Er recovering capsule 2.8g/kg-11.2g/kg respectively, to every rat of each dosage group, after administration, begin to observe, observe 180min after the administration, the behavior of animal no abnormality seen always.

Mice: difference i.g. Da Er recovering capsule 2.8g/kg-11.2g/kg, to beginning to observe its reaction after the white mice administration, low dose group white mice no abnormality seen in the 180min after administration, middle and high dosage group 45-60min after administration, symptoms such as excited, restless appear in white mice, calm down gradually behind the 120min.

Brief summary: the Da Er recovering capsule of 2.8g/kg-11.2g/kg dosage to rat i.g. administration after, measured electrocardio, blood pressure and respiration parameter there is no significant change in the 180min; 2.8g/kg the Da Er recovering capsule of dosage group to white mice i.g. administration after, measured each parameter of white mice spontaneous activity there is no significant change in the 180min; But white mice 45min-60min after administration of 5.6g/kg dosage group, the spontaneous activity number of times obviously increases (P＜0.05); The spontaneous activity overall strength significantly increases (P＜0.01, P＜0.05) when 45min and 60min.Above-mentioned two parameters all begin to recover behind 120min.11.2g/kg the mice of dosage group 45min minute spontaneous activity number of times and spontaneous activity overall strength after administration obviously increase P＜0.05; During 60min, spontaneous activity number of times and spontaneous activity overall strength significantly increase (P＜0.01).Above-mentioned two parameters all begin to recover behind 120min; In a word, the dosage of Da Er recovering capsule in producing the drug action scope does not produce any influence to electrocardio, blood pressure and the breathing of rat, but middle and high dosage group produces obviously influence to the spontaneous activity of mice.

2. anxious poison experiment

Da Er recovering capsule mice maximum dosage-feeding experiment: give in the mice one day and to irritate stomach Da Er recovering capsules three times, maximum dosage-feeding is 24g/kg (being equivalent to 160 times of clinical plan consumptions), have behind rarely seen filling stomach under this dosage of short durationly movablely reduce, diarrhoea, none death of animal.

Experimental result: mice ig Da Er recovering capsule, dosage reaches 24.0g/kg, has transient activity to reduce behind the i.g, recovers normal after half an hour fully, and the 2nd day whole body hair of administration and anus are dirty, and the drying marks of brown liquid is arranged, and may be that row's brown toilet causes.Observe none death in 7 days.

Maximum tolerated dose and multiple calculate: this experiment maximum dosage-feeding 24.0g/kg, do not cause dead mouse, every mice can tolerate dose and is about 0.48g under this dosage, and the clinical consumption that the application's capsule is recommended is 9.0g/ day/people (60kg), with following formula computer maximum tolerated dose multiple.

$=\frac{0.48g}{20g}\×\frac{60000g}{9.0g}$

The clinical plan dosage of Da Er recovering capsule is 9.0g, and the mice maximum dosage-feeding is 160 times that 24.0g/kg (amounting to crude drug 367.2g/kg) is equivalent to clinical plan dosage.Rarely seen of short duration movable minimizing under this dosage, diarrhoea.

Da Er recovering capsule rat maximum dosage-feeding experiment: give in the rat one day and to irritate stomach (i.g) Da Er recovering capsules three times, its maximum dosage-feeding is 30g/kg (being equivalent to 200 times of clinical plan consumptions), under this dosage behind rarely seen i.g rat have that transient activity reduces, diarrhoea, none death of animal.

Experimental result: rat i.g. Da Er recovering capsule, integral dose reaches 30.0g/kg, has transient activity to reduce behind the i.g., recovers normal after half an hour fully, and the 2nd day whole body hair of administration and anus are dirty, and the drying marks of brown liquid is arranged, and may be that row's brown toilet causes.Observe none death in 7 days.

Maximum tolerated dose and multiple calculate: this experiment Da Er recovering capsule integral dose 30.0g/kg, do not cause rats death, every rat tolerance of this dosage dose 6.0g, the clinical application amount that the Da Er recovering capsule is recommended is 9.0g/ day/people 60kg, be calculated as follows maximum tolerated dose multiple (mice changes rat in the formula, and average weight is by 200g). $=\frac{6.0g}{200g}\×\frac{60000g}{9.0g}$

The clinical plan dosage of Da Er recovering capsule is 9.0g, and the rat maximum dosage-feeding is 30.0g/kg (amounting to crude drug 459g/kg), is equivalent to 200 times of clinical plan dosage.Rarely seen diarrhoea under this dosage.

3. long poison experiment

(1) Da Er recovering capsule capsule rat long term toxicity test: gavage 1.5 months continuously for the Wistar rat with 1.5g/kg, 3.75g/kg and 10g/kg dosage (being equivalent to clinical plan 10 times, 25 times and 67 times) the Da Er recovering capsule with daily dose, detect after the administration and the generally variations of indexs such as situation, hematology, blood biochemical, each organs and tissues pathology such as the weight of animals, appetite after 2 weeks of drug withdrawal, the result is as follows:

General situation: the indivedual rat appearance of high dose group activity reduces, loose stool, and off color, perpendicular hair, the back of a bow, symptom such as lose weight.Middle dosage group rat no abnormality seen in 1 week of administration changes, the 2nd all individual animal off colors, and body weight has decline but does not have significant difference, and the low dose group animal does not see drug reaction.The high dose group symptom of rats relaxes to some extent after the 5th week.

Hematological examination: after the administration and after 2 weeks of drug withdrawal, each measured value of hematology and blank group compare, difference unknown significance (P＞0.05).

Blood parameters: after the administration and after 2 weeks of drug withdrawal, each index of blood biochemical and blank group compare, difference unknown significance (P＞0.05).

Organ coefficient is checked: after the administration and after 2 weeks of drug withdrawal, organ coefficient and matched group comparing difference do not have significance (P＞0.05).

Pathological examination: each dosage group is not found drug-induced organic disease.

Conclusion: the oral Da Er recovering capsule of rat is safe being equivalent to clinical consumption below 25 times.

(2) Da Er recovering capsule dog long term toxicity test: with the Da Er recovering capsule respectively with 0.75g/kg, 2.25g/kg and 4.5g/kg dosage (being equivalent to clinical plan 5 times, 15 times and 30 times) with daily dose to Canis familiaris L. continuous irrigation stomach 1.5 months, detect after the administration and the generally variations of indexs such as situation, blood biochemical, hemogram, electrocardio, routine urinalysis, each organs and tissues pathology such as the weight of animals, appetite after 2 weeks of drug withdrawal, the result is as follows:

General situation: in the administration phase, Canis familiaris L. has sialorrhea (foam sample) after the high dose group administration, and 4/6 animal has vomiting, loose stool, 5/6 animal anorexia, and movable the minimizing, along with the prolongation of administration time, vomiting and loose stool alleviate gradually.In do not see that Canis familiaris L. has any outward appearance symptom in dosage group preceding 3 days after administration, had 1/6 animal sialorrhea and vomiting to occur on the 4th day, having 1/6 animal sialorrhea and vomiting to occur in the 3rd week in addition.Low dose group animal no abnormality seen changes.During the administration, the body weight gain of the Canis familiaris L. of high dose group is slower than matched group, and in the 6th week more obvious (P＜0.01), body weight change of the Canis familiaris L. of middle dosage group and low dose group and blank group relatively do not have significant difference (P＞0.05).

Hematological examination: after the administration and after 2 weeks of drug withdrawal, each measured value of administration group hematology and blank group compare, difference unknown significance (P＞0.05).

Blood parameters: after the administration and after 2 weeks of drug withdrawal, each index of blood biochemical and blank group compare, difference unknown significance (P＞0.05).

Electrocardioscopy: after the administration and drug withdrawal 2 week back bioassay standard II lead each ripple of ECG II, interval and heart rate, as a result each administration group and blank group relatively, difference unknown significance (P＞0.05).

Uroscopy: after the administration, adopt three urine test papers that pH value, protein, the glucose of urine are measured, the result is that each administration group and blank group compare difference unknown significance (P＞0.05).

Organ coefficient is checked: after the administration and after 2 weeks of drug withdrawal, organ coefficient and matched group comparing difference do not have significance (P＞0.05).

Pathological examination: each dosage group is not found drug-induced organic disease.

Conclusion: the oral Da Er recovering capsule of hybrid dog is safe being equivalent to clinical consumption below 15 times.

(3) drug dependence experiment

1. mice is urged and gives up experiment: number of skips of morphine group mice and urgency are given up back weight loss percentage rate and are compared with matched group, and notable difference (P＜0.05) is arranged, and show that mice has formed tangible physical dependence to morphine.3 dosage groups of Da Er recovering capsule are (no matter the accumulative total daily dose is respectively 51.9,103.8 and the 207.6g crude drug/kg) mice is a number of skips, or weight loss, compare with contrast, difference that there are no significant (P＞0.05) shows that mice does not form tangible physical dependence to the Da Er recovering capsule.

2. rat natural withdrawal experiment: body weight obviously descends (P＜0.01) after the drug withdrawal of morphine group rat, and the 7th day body weight just returns to the preceding level of drug withdrawal substantially after the drug withdrawal, shows that rat has formed tangible physical dependence to morphine.3 dosage groups of Da Er recovering capsule (after the accumulative total daily dose is respectively 17.4,69.3 and the 103.8g crude drug/kg) rat drug withdrawals, compared body weight with matched group and are not all had obvious decline (P＞0.05), show that rat does not form tangible physical dependence to the Da Er recovering capsule.

3. rat conditioned place preference experiment: morphine group rat shows that accompanying the medicine box time of staying apparently higher than matched group (P＜0.01) morphine group rat has formed tangible conditioned place preference effect.The application's capsule is little, in, heavy dose of group (dosage is respectively 5.8,23.1, the rat of 34.6g crude drug/kg) companion's medicine box time of staying with the matched group ratio, no significant difference (P＞0.05) shows that rat does not form tangible conditioned place preference effect to the application's capsule.This shows that in this model the Da Er recovering capsule does not show the potentiality that produce psychic dependence.

Experiment conclusion: the Da Er recovering capsule does not have the potentiality that produce physical dependence and psychic dependence.

Five. preparation embodiment

Embodiment 1

(1) prescription:

Radix Ginseng 400 grams, Radix Angelicae Sinensis 700 grams, Calculus Bovis 8 grams, Scorpio 50 grams, Rhizoma Corydalis Decumbentis 1000 grams, Flos Daturae 30 grams, Radix Et Rhizoma Rhei 400 grams, Borneolum Syntheticum 4 grams, Herba Asari 150 grams, Flos Caryophylli 200 grams, Semen Ziziphi Spinosae 300 grams, Flos Albiziae 650 grams, Radix Glycyrrhizae 350 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 4 hours, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 80% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1 hour of 8 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.5 hour of 6 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add the ethanol extraction 3 times that concentration is 75%--80%, the alcohol reflux 2 hours that adds for the first time 8 times of amounts, for the second time, adding 7 times of amounts of ethanol for the third time respectively refluxed 1 hour, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 10 times of amounts of water, extracted 2 hours, add for the second time 8 times of amounts of water, extracted 1 hour, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 55%--60% (V/V), left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 3 hours adds 0.5% magnesium stearate mixing, incapsulates, and is 1000 of finished products.

Embodiment 2

(1) prescription:

Radix Ginseng 500 grams, Radix Angelicae Sinensis 800 grams, Calculus Bovis 12 grams, Scorpio 70 grams, Rhizoma Corydalis Decumbentis 1200 grams, Flos Daturae 40 grams, Radix Et Rhizoma Rhei 500 grams, Borneolum Syntheticum 6 grams, Herba Asari 250 grams, Flos Caryophylli 300 grams, Semen Ziziphi Spinosae 400 grams, Flos Albiziae 750 grams, Radix Glycyrrhizae 450 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 6 hours, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 90% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1.5 hours of 12 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.6 hour of 9 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add the ethanol extraction 2 times that concentration is 80%--85%, add the alcohol reflux 3 hours of 12 times of amounts for the first time, add 9 times of amounts of ethanol for the second time respectively and reflux 2 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 14 times of amounts of water, extracted 3 hours, add for the second time 12 times of amounts of water, extracted 2 hours, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15--1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 60%--65% (V/V), left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 4 hours adds 0.5% magnesium stearate mixing, incapsulates, and gets product 1000.

Embodiment 3

(1) prescription:

Radix Ginseng 440 grams, Radix Angelicae Sinensis 720 grams, Calculus Bovis 10 grams, Scorpio 60 grams, Rhizoma Corydalis Decumbentis 1100 grams, Flos Daturae 36 grams, Radix Et Rhizoma Rhei 440 grams, Borneolum Syntheticum 5 grams, Herba Asari 180 grams, Flos Caryophylli 220 grams, Semen Ziziphi Spinosae 340 grams, Flos Albiziae 680 grams, Radix Glycyrrhizae 380 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 5 hours, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 85% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1 hour of 10 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.5 hour of 8 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) to add concentration be 80% ethanol extraction 2 times to the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion, adds the alcohol reflux 3 hours of 10 times of amounts for the first time, adds 8 times of amounts of ethanol for the second time respectively and refluxed 2 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 12 times of amounts of water, extracted 2 hours, add for the second time 10 times of amounts of water, extracted 1.5 hours, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 60%, left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 3 hours adds 0.5% magnesium stearate mixing, incapsulates, and gets product 1000.

Embodiment 4

(1) prescription:

Radix Ginseng 410 grams, Radix Angelicae Sinensis 705 grams, Calculus Bovis 9 grams, Scorpio 55 grams, Rhizoma Corydalis Decumbentis 1050 grams, Flos Daturae 32 grams, Radix Et Rhizoma Rhei 415 grams, Borneolum Syntheticum 4.5 grams, Herba Asari 165 grams, Flos Caryophylli 205 grams, Semen Ziziphi Spinosae 315 grams, Flos Albiziae 660 grams, Radix Glycyrrhizae 360 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 4.5 hours, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 85%--90% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 0.7 hour of 9 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.4 hour of 7 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add the ethanol extraction 2 times that concentration is 80%--85%, the alcohol reflux 2.5 hours that adds for the first time 9 times of amounts, adding for the second time 7 times of amounts of ethanol respectively refluxed 1.5 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 11 times of amounts of water, extracted 1.5 hours, add for the second time 9 times of amounts of water, extracted 1.5 hours, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 60%--65% (V/V), left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 4 hours adds 0.5% magnesium stearate mixing, incapsulates, and gets product 1000.

Embodiment 5

(1) prescription:

Radix Ginseng 480 grams, Radix Angelicae Sinensis 780 grams, Calculus Bovis 11 grams, Scorpio 65 grams, Rhizoma Corydalis Decumbentis 1150 grams, Flos Daturae 39 grams, Radix Et Rhizoma Rhei 435 grams, Borneolum Syntheticum 5.5 grams, Herba Asari 240 grams, Flos Caryophylli 280 grams, Semen Ziziphi Spinosae 385 grams, Flos Albiziae 740 grams, Radix Glycyrrhizae 440 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 4--5 hour with steam distillation, divide and get volatile oil, medicinal residues and steam distillation liquid are standby;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 80%--85% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1.5 hours of 11 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.6 hour of 9 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add the ethanol extraction 2 times that concentration is 80%--85%, the alcohol reflux 3.5 hours that adds for the first time 11 times of amounts, adding for the second time 9 times of amounts of ethanol respectively refluxed 2.5 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 13 times of amounts of water, extracted 2.5 hours, add for the second time 11 times of amounts of water, extracted 2 hours, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 65%, left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 2-4 hour adds 0.5% magnesium stearate mixing, incapsulates, and gets product 1000.

Embodiment 6

(1) prescription:

Radix Ginseng 460 grams, Radix Angelicae Sinensis 740 grams, Calculus Bovis 10.5 grams, Scorpio 65 grams, Rhizoma Corydalis Decumbentis 1130 grams, Flos Daturae 36 grams, Radix Et Rhizoma Rhei 450 grams, Borneolum Syntheticum 5.5 grams, Herba Asari 200 grams, Flos Caryophylli 250 grams, Semen Ziziphi Spinosae 350 grams, Flos Albiziae 700 grams, Radix Glycyrrhizae 400 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 5--6 hour, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 85% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1.5 hours of 9 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.6 hour of 8 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) to add concentration be 80% ethanol extraction 2 times to the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion, adds the alcohol reflux 3 hours of 11 times of amounts for the first time, adds 7 times of amounts of ethanol for the second time respectively and refluxed 2 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 13 times of amounts of water, extracted 2.5 hours, add for the second time 9 times of amounts of water, extracted 1 hour, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 65%, left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 2-4 hour adds 0.5% magnesium stearate mixing, incapsulates, and gets product 1000.

Embodiment 7

(1) prescription:

Radix Ginseng 4400 grams, Radix Angelicae Sinensis 7200 grams, Calculus Bovis 100 grams, Scorpio 600 grams, Rhizoma Corydalis Decumbentis 11000 grams, Flos Daturae 360 grams, Radix Et Rhizoma Rhei 4400 grams, Borneolum Syntheticum 50 grams, Herba Asari 1800 grams, Flos Caryophylli 2200 grams, Semen Ziziphi Spinosae 3400 grams, Flos Albiziae 6800 grams, Radix Glycyrrhizae 3800 grams;

(2) get the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 5 hours, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(3) getting Radix Et Rhizoma Rhei, to add concentration be 85% ethanol (V/V) reflux, extract, 2 times, adds 60 ℃ of reflux, extract, of ethanol 1 hour of 10 times of amounts for the first time, adds 60 ℃ of reflux, extract, of ethanol 0.5 hour of 8 times of amounts of ethanol for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(4) to add concentration be 80% ethanol extraction 2 times to the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion, adds the alcohol reflux 3 hours of 10 times of amounts for the first time, adds 8 times of amounts of ethanol for the second time respectively and refluxed 2 hours, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(5) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, add for the first time 12 times of amounts of water, extracted 2 hours, add for the second time 10 times of amounts of water, extracted 1.5 hours, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 60%, left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(6) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 3 hours adds 0.5% magnesium stearate mixing, incapsulates, and gets product 10000.

Claims (3)

1. a Chinese medicinal capsule preparation that is used to quit drug abuse is characterized in that it is to be prepared from by following weight portion crude drug: Radix Ginseng 4-5, Radix Angelicae Sinensis 7-8; Calculus Bovis 0.08-0.12, Scorpio 0.5-0.7, Rhizoma Corydalis Decumbentis 10-12; Flos Daturae 0.3-0.4; Radix Et Rhizoma Rhei 4-5, Borneolum Syntheticum 0.04-0.06, Herba Asari 1.5-2.5; Flos Caryophylli 2-3; Semen Ziziphi Spinosae 3-4, Flos Albiziae 6.5-7.5, Radix Glycyrrhizae 3.5-4.5.

2. a kind of Chinese medicinal capsule preparation that is used to quit drug abuse according to claim 1, it is to be prepared from by following weight portion crude drug: Radix Ginseng 4.4, Radix Angelicae Sinensis 7.2; Calculus Bovis 0.1, Scorpio 0.6, Rhizoma Corydalis Decumbentis 11; Flos Daturae 0.36; Radix Et Rhizoma Rhei 4.4, Borneolum Syntheticum 0.05, Herba Asari 1.8; Flos Caryophylli 2.2; Semen Ziziphi Spinosae 3.4, Flos Albiziae 6.8, Radix Glycyrrhizae 3.8.

3. a kind of Chinese medicinal capsule preparation that is used to quit drug abuse according to claim 1 and 2, its preparation method is:

(1) gets the water that Radix Angelicae Sinensis, Herba Asari, Flos Caryophylli add 10 times of amounts, extracted hair oil 4-6 hour, divide that to get volatile oil, medicinal residues and steam distillation liquid standby with steam distillation;

(2) getting Radix Et Rhizoma Rhei, to add concentration be 80%-90% alcohol reflux 2 times, adds 60 ℃ of reflux, extract, 0.5-1.5 of ethanol hours that 8-12 doubly measures for the first time, adds 60 ℃ of reflux, extract, 0.4-0.6 of ethanol hours that ethanol 6-9 doubly measures for the second time, merges secondary raffinate, filters; Reclaim ethanol below 60 ℃, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, crossed 80 mesh sieves, and it is standby to obtain dried cream powder A;

(3) the three flavor medical materials such as Radix Ginseng of getting Flos Daturae, Rhizoma Corydalis Decumbentis, 5/6 weight portion add ethanol extraction 2--3 time that concentration is 75%-85%, for the first time add alcohol reflux 2-4 hour that 8-12 doubly measures, second and third time adds ethanol 7-9 respectively and doubly measured backflow 1-3 hour, merge ethanol extract, filter, filtrate for later use, medicinal residues are standby;

(4) get the medicinal residues and the Radix Glycyrrhizae of step (1) medicinal residues and step (3), Semen Ziziphi Spinosae, Flos Albiziae decocts with water secondary, for the first time adding water 10-14 doubly measures, extracted 1-3 hour, for the second time adding water 8-12 doubly measures, extracted 1-2 hour, and merged secondary decoction liquor and step (1) steam distillation liquid, filter, relative density was 1.15-1.20 when filtrate decompression was concentrated into 60 ℃, add ethanol and make pure content reach 55%-65%, left standstill 24 hours, the alcohol extract of getting supernatant and above-mentioned steps (3) merges, reclaim ethanol, relative density is 1.25-1.35 when being evaporated to 60 ℃, and drying under reduced pressure is pulverized, cross 80 mesh sieves, it is standby to obtain dried cream powder B;

(5) Radix Ginseng of getting Scorpio, 1/6 weight portion is distinguished porphyrize, crosses 100 mesh sieves, with above-mentioned dried cream powder A, B mixing, obtains fine powder; Calculus Bovis, Borneolum Syntheticum are mixed thoroughly with fine powder with small amount of ethanol dissolving back, add an amount of 50% alcohol granulation again, and oven dry sprays into volatile oil, and airtight, vexed putting 2-4 hour adds 0.5% magnesium stearate mixing, incapsulates, and is finished product.