CN1137405A - Chinese herbal medicine composition for preparing non-dependence anti-cancer pain-alleviating drug and preparation thereof - Google Patents
Chinese herbal medicine composition for preparing non-dependence anti-cancer pain-alleviating drug and preparation thereof Download PDFInfo
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Abstract
The present invention relates to a Chinese herbal medicine composite for alleviating pain and its preparation. Its composition includes 16 Chinese medicines such as epimedium, asarum herb, eucommia bark, poria, pilose asiabell root, stir-fried spiny jujube kernel, Chinese yam, cinnamon bark, white peony root, blast-fried ginger and cyperus root, etc. Its optimum preparation is decoction. It possesses the functions of strengthening the body resistance to eliminate pathogenic factors, dredging the channel, raising immunity, and can quickly alleviate pain, has no side effect and doesn't produce dependence, mainly used for alleviating pain of intermediate and late cancer patients.
Description
The present invention relates to a kind of Chinese herbal medicine pain relieving of cancers medicine for oral administration, more particularly, relate to a kind of herbal composite and preparation thereof that is used to prepare the no dependence analgesic.
As everyone knows, the reason that causes pain is varied, and particularly cancer pain is a global common problem, because the incidence rate of tumor all has the trend that rises appreciably all over the world, become one of major reason of various countries resident death, the serious threat mankind's life and health.Statistics in 1993 show that the number that China dies from cancer every year rises to about 1,300,000 by 700,000.The World Health Organization (WHO) and China's Ministry of Public Health have all been classified pain relieving of cancers as one of the emphasis problem that solves of being badly in need of.Effectively the pain management pain management of patients with advanced cancer (especially for) has been listed one of four emphasis problems in World Health Organization's cancer unified plan in.World Health Organization (WHO) proposes to remove the misery of cancer patient, improves cancer patient quality of life, and has proposed the pain of cancer patient is carried out three grades of rescue by stages.China's Ministry of Public Health was also sent out (1993) No. 22 literary composition propositions in 1993 to defend medicine: " three grades of pain relieving staircase methods of cancer patient guideline ", proposition will be eliminated cancer pain in 2000.According to this article the principle of " oral, on time, press ladder " administration is proposed, give gently, in, severe cancer pain patient's representative drugs is respectively: a series of analgesic such as oral of aspirin, codeine, dolantin, buprenorphine, dihydroetorphine, morphine.This class analgesic mostly is narcotics, generally is after character, the reason of cancer pain are made correct assessment, suitably selects corresponding analgesics according to patient's the pain degree and the cause of disease, and dosage is ascending, analgesic activity grow from weak to strong ground administration.Use three grades of rescue by stages of this class medicine to play analgesic effect within a certain period of time to the cancer pain patient.Yet this class medicine all has than important disadvantages, just has bigger side effect, particularly has dependency and toleration.Along with the deterioration of patient status, dosage is increasing, thereby makes the rapid toleration that produces this class narcosis analgesic of patient, impels conversely again and constantly increases clinical using dosage, thereby formed a kind of vicious cycle.As everyone knows, use the opium analgesics thing must cause the change of patient physiological function, for example degradation under the appetite in a large number.Also can cause immune function to reduce simultaneously, very unfavorable to further treatment.And because patient's body constitution decline is more and more obvious to the dependency of this class narcoticness medicine.So the life-time service of this class narcoticness medicine more and more causes people's worry.Therefore, at present in the world All Countries all urgently wish to work out a kind of no dependence and pain relieving analgesic drug product rapidly.
The objective of the invention is shortcoming at existing various analgesic drug products, provide a kind of and can make all kinds of patients (particularly cancer pain patient and drug dependence patient) with pain symptom pain relievings rapidly, side effect is little and do not have the compositions and the preparation thereof of dependent full medicinal herb components fully.
The inventor furthers investigate relevant theory of Chinese medical science based on above-mentioned purpose, has obtained following understanding.Theory of Chinese medical science thinks that the process of disease is the process that healthy energy and pathogen contradiction both sides struggle against mutually, and pathogen preponderating over vital QI then disease advances, vital QI preponderating over pathogen is then retired due to illness, thereby the treatment disease is wanted reinforcing body resistance, eliminating pathogens exactly, change evil positive both sides' balance of force, make it to help disease and transform to the recovery from illness aspect.Theory of Chinese medical science thinks, cancerous pain be because accumulate in the evil poison, the malicious stasis of blood ties mutually, causes stagnation of QI-blood, the phlegm-damp gluing forms crux.Cause compressing owing to evil poison contamination, tumor increase again, thereby cause the blood clots absorbing stagnant, meridians are jammed.Very important a kind of viewpoint is " stagnation of QI and blood may bring about pain " in the theory of Chinese medical science, because the stagnation of QI, blood stasis, cold coagulation, blood deficiency that cancer itself forms body cause the patient to produce violent pain.And the drug dependence patient because function decline causes the whole machine body deterioration, thereby makes and produces violent pain in the time spent of doing that breaks away from the narcoticness medicine.Therefore the traditional Chinese medical science is thought, cancer middle and advanced stage patient and drug dependence patient's pain symptom all is because healthy energy loss and pathogen are better than the cause of healthy energy.And from people's complicated body itself, the spleen being the foundation of acquired constitution, source of generating QI and blood.Weakness of the spleen and stomach, then no resource of generating and transforming QI and blood causes deficiency of qi and blood.The then unable promotion blood operation of the deficiency of vital energy, thus pathological changes such as qi depression to blood stasis caused.Blood stasis causes that then venation is obstructed, and general rule does not produce pain.As seen the source of pain is positive weakness of QI and pathogen victory.Therefore,, must note the body resistance strengthening and constitution consolidating being used for the analgesic prescription, reach in healthy energy deposits that taking stopgap measures consolidates, thereby pain is eliminated, and can not produce drug dependence again for eliminate pain fundamentally.The inventor has carried out further investigation and for many years animal experiment and clinical trial based on above-mentioned to the understanding of theory of Chinese medical science and in conjunction with conventional formulation, finally found and a kind ofly can make all kinds of pain patients, particularly cancer pain patient and the rapid pain relieving of drug dependence patient, side effect is little and do not have the compositions and the optimal formulation of dependent full medicinal herb components fully.Because this result of study has so far just been finished the present invention.
Thereby, the invention provides a kind of herbal composite that is used to prepare the no dependence analgesic, it is characterized in that it contains following ingredients:
Medicine name weight portion
(general quantity) (preferred amounts) barrenwort 8-12 10 root of Chinese wild ginger 4-7 5 bark of eucommia 8-12 10 Poria cocos 16-24 20 Radix Codonopsis 12-18 15 stir-baked SEMEN ZIZIPHI SPINOSAE 16-24 20 Chinese yam 8-12 10 Chinese cassia tree 4-8 6 root of herbaceous peony 12-18 15 baked ginger 8-12 10 rhizoma cyperi 6-10 8 dried orange peel 8-12 10 bighead atractylodes rhizome 12-18 15 hawthorn 8-12 10 charred FRUCTUS CRATAEGI 8-12 10 fleece-flower root 12-18 15
The present invention is used to prepare the herbal composite of no dependence analgesic can make various dosage forms, and for example: decoction, powder, pill, unguentum or the like, all various dosage forms all within the scope of the present invention.Wherein be preferably decoction, the speed that takes effect of decoction is more faster than other various dosage forms.Making under the situation of decoction, the water yield that adds when boiling contains the dried medicine composition of 220-300mg with the every ml of final medicinal liquid and is as the criterion, and preferably every ml contains the dried medicine composition of 260mg and is as the criterion.
Thereby, the invention provides a kind of no dependence Chinese herbal medicine pain relieving decoction, it is characterized in that, it is to boil with above-mentioned Chinese medicine ingredients and water to form, the water yield that adds when boiling contains the dried medicine composition of 220-300mg with the every ml of final medicinal liquid and is as the criterion, and preferably every ml contains the dried medicine composition of 260mg and is as the criterion.
Pharmacology below in conjunction with various main components in the compositions of the present invention is further explained the present invention.
In prescription of the present invention, Cortex Cinnamomi warming middle-JIAO YANG invigorating, dispersing cold for relieving pain has the effect of central and tip blood vessel dilating, can strengthen blood circulation.Herba Asari has the effect of dispersing cold for relieving pain, and low dose of Oleum Asari has sedation, and the Herba Asari water decoction also has analgesic activity, and the kakuol extracting solution can be used for local anesthesia.Cortex Eucommiae invigorating the liver and kidney, bone and muscle strengthening, and certain analgesic activity is arranged.The Radix Paeoniae Alba yin fluid astringing that nourishes blood, easing the affected liver to relieve pain.The pain relieving of Rhizoma Cyperi depressed liver-energy dispersing and QI regulating.The Fructus Crataegi promoting blood circulation, removing blood stasis and relieving pain.Be equipped with Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, the Poria of replenishing QI to invigorate the spleen among the we again; The Herba Epimedii of invigorating heart and kidney, Semen Ziziphi Spinosae (parched) etc.Therefore, originally can be when reaching analgesic effect, note the body resistance strengthening and constitution consolidating, thereby reach in healthy energy deposits that taking stopgap measures consolidates, and pain is eliminated, and helps the recovery of body simultaneously.Because compositions of the present invention is not to come pain relieving and mainly be to be used for pain relieving by relaxing muscles and tendons to promote blood circulation, the blood stasis dispelling of stimulating the menstrual flow, depressed liver-energy dispersing and QI regulating, replenishing QI to invigorate the spleen etc. by the narcoticness medicine, thereby can accelerate the recovery of body significantly, the enhancing body vigor, fundamentally therefore the root of eliminate pain can overcome the dependency of patient to medicine.
Compare with the similar medicine of prior art, compositions of the present invention has following advantage:
From the theory of Chinese medicine, compositions of the present invention has the effect of strengthening vital QI to eliminate pathogenic factors, dredging the meridian, benefiting QI and nourishing blood, thereby the medicine dependent patient is returned to one's perfect health and no longer needs to rely on medicine, and does not produce any sequela.Also can reach the pain relieving of long period for the intermediary and later stages cancer patient, improve patient's quality of life significantly, play the obviously effect of auxiliary curative effect.Viewpoint from modern medicine and pharmacology, compositions of the present invention can be improved the blood circulation of patient in the heart, lung, cerebrovascular system, improve the immunity of health, each organ of the interior evil in damaged condition of dummy also recovers their normal function, improve intravital metabolism, adjust the physiological equilibrium of hormonal system.Thereby the medicine dependent patient is strengthened to the absorption of nutrition with to the eliminating of long-pending poison, finally not only can make the medicine dependent patient overcome dependence fully, and its health is returned to one's perfect health medicine., can also strengthen its body constitution significantly, thereby play the effect of obvious auxiliary curative effect reaching the long period analgesic simultaneously for the intermediary and later stages cancer patient.
Below enumerate embodiment and contrast test and further explain the present invention.The embodiment that enumerates below belongs to the decoction of optimum implementation of the present invention.Therefore, the present invention is not subjected to the qualification of this embodiment.In addition, for for simplicity, among below the embodiment and contrast test, optimum implementation-decoction of the present invention is called Kang Saide pain relieving soup.
Implement the preparation of 1.-Kang Saide pain relieving soup
Take by weighing the dried quick-fried Chinese medicine that various processes are cleaned and shredded by following prescription:
Composition weight (g)
Herba Epimedii 10
Herba Asari 5
The Cortex Eucommiae 10
Poria 20
Radix Codonopsis 15
Semen Ziziphi Spinosae (parched) 20
Rhizoma Dioscoreae 10
Cortex Cinnamomi 6
The Radix Paeoniae Alba 15
Rhizoma Zingiberis Preparatum 10
Rhizoma Cyperi 8
Pericarpium Citri Reticulatae 10
The Rhizoma Atractylodis Macrocephalae 15
Fructus Crataegi 10
Fructus Crataegi (parched to brown) 10
Radix Polygoni Multiflori 15 is with these Chinese medicine ingredients mixings, place a medicine pot, add 2100ml water, promptly transferring little fire after boiling with vigorous fire to decocts, be as the criterion can keep fluidized state, little fire like this decocted 30 minutes, filtered with crosus cloth then, obtain medicinal liquid 727ml, be equivalent to every ml medicinal liquid and contain the dried medicine composition of 260mg.This is no dependence pain relieving decoction of the present invention.Be designated hereinafter simply as Kang Saide pain relieving soup.In addition,, prepared relatively large Kang Saide pain relieving soup according to the above ratio, still contained the dried medicine of 260mg approximately during preparation and become to assign to grasp by every ml medicinal liquid in order to carry out fairly large clinical trial.
Enumerate two zooperal Comparative Examples below effect of the present invention is described.The inventor adopts classical way-writhing method and the liner-plate method aspect analgesic experiment to test, and selects for use Kunming kind white mice to detect and is used for the analgesic effect contrast that drugs are given up method syndrome severe analgesic medicine methadone and Kang Saide pain relieving soup of the present invention in the prior art.
(totally 60 of white mice, male and female half and half on average weigh 20 ± 2g) to animal experiment Comparative Examples 1-writhing method
In the writhing method analgesic experiment, the methadone dosage that is used for mice is 18mg/kg.Average weight in patient is 50kg, and then above-mentioned dosage is equivalent to people's clinical dosage 900mg, and people's clinical administration limiting quantity is each 10mg, so above-mentioned methadone dosage is 90 times of human clinical's consumption.The consumption of Kang Saide pain relieving soup then only is equivalent to 5 times of its clinical consumption.The result shows that the analgesia rate of methadone group is 100%, and the analgesia rate of Kang Saide pain relieving soup group is 92%.This explanation methadone is compared with Kang Saide pain relieving soup high dose group, and P＞0.05 that is to say, does not see statistical significant difference.Be that the analgesic effect of Kang Saide is compared with methadone and do not had significant difference.
Animal experiment Comparative Examples 2-hot plate method
In mice hot plate method analgesic experiment, select 60 of Kunming mouses for use, weight 20 ± 2g.If normal saline and methadone matched group improve at 30,60,120,180 minutes pain thresholds after the administration of methadone group, there is highly significant difference P＜0.01.The Kang Saide high dose group improves at 30,60,120,180 minutes pain thresholds of administration equally, and statistical result P＜0.01 has highly significant difference too.The German-Chinese dosage group of Kang Sai improves at 30,60 minutes pain thresholds of administration, and statistical result P＜0.01 has highly significant difference; 120, pain threshold improves after 180 minutes, and statistical result P＜0.05 has significant difference.This explanation Kang Saide of the present invention can significantly improve pain threshold.
Comprehensive above two experimental results illustrate that Kang Saide of the present invention has tangible analgesic effect.Should be noted that, consumption in the experiment METHADONE IN is 90 times of a maximum dose 10mg of human body, and the consumption of Kang Saide only is equivalent to once 5 times of the highest consumption of human bodies, and the analgesic effect of the two is similar, this shows that Kang Saide pain relieving soup of the present invention has significant outstanding effect.
For the toxicity of understanding Kang Saide pain relieving soup and the safety of clinical practice, the inventor has done following animal acute toxicity experiment.
Animal toxicity experiment 1
Carry out acute toxicity testing with white mice, select 40 of Kunming kind white mice for use, male and female half and half, body weight 20 ± 2g.Owing in trial test, surveys to go out LD50, thus use instead mensuration dosage on the one when being equivalent to intend with 83.2 times of clinical dosage and 166.4 times the health status of animal judge the maximum tolerated dose (MTD) of animal.Through totally seven days twice of every day, divide two groups to irritate stomaches and observed 7 days by above-mentioned concentration, toxic reaction is not seen in the healthy survival of all animals.In addition, in the rat long term toxicity test, with 40 of rat, male and female half and half, body weight 160 ± 4g, if two dosage groups of height, promptly 52g/kg and 26g/kg reach the normal saline matched group, the difference gastric infusion, once a day, any undue toxicity's reaction is not seen in the healthy survival of all animals after the administration in continuous 45 days.The body weight of each treated animal all in time passing and increase, the body weight change of each administration group and normal saline group is not seen notable difference, p＞0.05.Hematology and blood biochemical are learned index inspection: ALB (albumin), GP (globulin), A/G (Archon albumen ratio), ALT (GPT glutamate pyruvate transaminase), AST (GOT glutamic oxaloacetic transaminase, GOT), A/A (paddy third, millet straw ratio), TB (total bilirubin), DB (the directly red matter of gallbladder), BUN (blood urea nitrogen), CRE (flesh liver), UA every indexs such as (uric acid), there is no significant difference (P＞0.05) between each administration group and the normal saline group.The toxicity of this explanation Kang Saide is low, and functions such as liver, kidney are not seen obvious damage.The result of pathological examination shows that to the weight of the heart, liver, spleen, lung, 5 organs of kidney, each administration group and normal saline group relatively there is no significant difference, P＞0.05.The result of histopathologic examination: organs and tissues such as (1) liver,spleen,kidney, adrenal gland, thymus, thyroid, hypophysis, testis, epididymis, prostate, uterus, ovary, each treated animal shows no obvious abnormalities.(2) heart: the equal Non Apparent Abnormality of matched group and low dose group, high dose group are seen congested 1 example of matter between cardiac muscle, but compare unknown significance difference, P＞0.05 with matched group.(3) lung: the lung of each treated animal is all seen the blood stasis (matched group 1 example, low dose group 3 examples, high dose group 1 example) that has in various degree, but each experimental group is compared unknown significance difference (P＞0.05) with matched group.In sum, can think that administration Kang Saide did not all have influence to organizing of each major organs of rat after 45 days, prompting Kang Saide does not have toxicity.
In order to guarantee drug safety, the inventor has carried out the animal dependency with rat and has produced test.Method is that rat is irritated stomach with Kang Saide pain relieving soup, and each consumption 26g/kg once a day, after continuous 45 days, carries out intramuscular injection with naloxone 4mg/kg and urges addiction, withdrawal symptom whether occurs to observe animal in one hour.The result shows that experimental animal does not have any abnormal response and occurs, and this explanation Kang Saide does not produce dependency in administration after heavy dose of continuous 45 days yet.
In order to prove the therapeutic effect of Kang Saide to heroin dependence monkey withdrawal symptom, the inventor selects for use Rhesus Macacus to set up heroin and relies on monkey model.Heroin is relied on monkey be divided into two groups, do not take Kang Saide for one group behind the heroin of stopping using, another group is then taken Kang Saide by clinical dosage behind the heroin of stopping using, observe the withdrawal symptom that these two groups of heroin rely on monkey.The result shows, one group of heroin not taking Kang Saide relies on monkey and withdrawal symptom occurred in about 10 hours behind the heroin of stopping using, and withdrawal symptom peaked in 2-4 days, and the 5th day begins to alleviate, and disappears in the 8th day.And one group of heroin dependence monkey performance always behind the heroin of stopping using of taking Kang Saide is very quiet.Peak at withdrawal symptom the 3rd day, can suppress the withdrawal symptom more than 80%, this explanation Kang Saide can suppress withdrawal symptom effectively.
In addition, behind the 3rd day behind the heroin withdrawal, the body weight of control animals begins obvious decline, and administration treated animal body weight does not only reduce, and slightly increases on the contrary.As seen Kang Saide not only can ease pain, and can really be used for the withdrawal and treatment of drug dependence effectively.
From top animal experiment as can be seen, health Saden pain relieving soup of the present invention has reliable safety, avirulence, effectiveness, no dependence, pain relieving rapidity.So the inventor is used for clinical experiment with Kang Saide pain relieving soup.
Totally 142 examples use Kang Saide pain relieving soup treatment heroin to rely in patients' the clinical observation on Anshun, Guizhou rehabilitation center, Dali, Yunnan Province first narcotic house, Dali rehabilitation center, Affiliated Hospital of Inst. of Traditional Chinese Medicine and Pharmacology of Yunnan Prov. and other places, and urine qualitative detection strong positive when being admitted to hospital transfers weak positive or negative to.The withdrawal symptom extent of reaction reaches I and II person all transfers to below the one-level after taking Kang Saide pain relieving soup.Along with the prolongation of medicine time, all patients all recover normal viability basically.In addition, Kang Saide has obvious effect to the increase of body weight before and after the patient treatment.
In addition, in cancer pain patient's clinical treatment, patient is respectively gastric cancer, colon cancer, carcinoma vulvae, breast carcinoma, ovarian cancer, hepatocarcinoma, malignant lymphoma, totally 35 examples, is the middle and terminal cancer patient.Male's 21 examples wherein, women's 14 examples, 40.16 years old mean age, pain is the I-III level.These patients are at ordinary times by dolantin, the pain relieving of morphine class medicine.The inventor stops the administration of opioid drugs such as dolantin, morphine, and they is divided into two groups in order to carry out effect contrast to these patients, only throw for one group and give placebo (being mainly brown sugar water), with as a comparison.Another group is thrown and is given health Saden pain relieving soup of the present invention.The result shows that these two groups of patients' analgesic effect has very marked difference.One group that takes placebo does not have analgesic effect basically, takes one group of Kang Saide pain relieving soup then relieving pain, and the pain relieving effective time is 3 minutes the soonest, is 15 minutes the most slowly, and average effective time is 5.8 minutes.Side reaction 1 example, this is because the patient to the Chinese medicine discomfort, vomits when taking medicine first.Subsequently with 1 times of Kang Saide pain relieving soup dilution, take after adding an amount of brown sugar, vomiting, the transference cure of feeling sick, pain symptom also obviously alleviates.Above-mentioned clinical experiment result shows that it is rapid-action that Kang Saide pain relieving soup has analgesic activity, and analgesia time is long, use repeatedly and do not produce drug resistance and addiction, nontoxic, there are not advantages such as bad side effect, be a kind ofly can really improve pain-suffered patient effective analgesic of quality of life.
In addition, health Saden pain relieving soup of the present invention is for the irrelevant pain of some and cancer, and for example postoperative pain, biliary colic, headache, toothache, stomachache, rheumatalgia etc. also all have better curative effect.
Claims (6)
1, a kind of herbal composite for the preparation of the no dependence anodyne; It is characterized in that it contains following ingredients: medicine name weight portion barrenwort 8-12 root of Chinese wild ginger 4-7 bark of eucommia 8-12 Poria cocos 16-24 Radix Codonopsis 12-18 stir-baked SEMEN ZIZIPHI SPINOSAE 16-24 Chinese yam 8-12 Chinese cassia tree 4-8 root of herbaceous peony 12-18 baked ginger 8-12 rhizoma cyperi 6-10 dried orange peel 8-12 bighead atractylodes rhizome 12-18 hawthorn 8-12 charred FRUCTUS CRATAEGI 8-12 fleece-flower root 12-18
2, the herbal composite that is used to prepare the no dependence analgesic as claimed in claim 1 is characterized in that it contains following ingredients:
Medicine name weight portion
Herba Epimedii 10
Herba Asari 5
The Cortex Eucommiae 10
Poria 20
Radix Codonopsis 15
Semen Ziziphi Spinosae (parched) 20
Rhizoma Dioscoreae 10
Cortex Cinnamomi 6
The Radix Paeoniae Alba 15
Rhizoma Zingiberis Preparatum 10
Rhizoma Cyperi 8
Pericarpium Citri Reticulatae 10
The Rhizoma Atractylodis Macrocephalae 15
Fructus Crataegi 10
Fructus Crataegi (parched to brown) 10
Radix Polygoni Multiflori 15
3, a kind of no dependence Chinese herbal medicine pain relieving decoction is characterized in that, it is to boil with described Chinese medicine ingredients of claim 1 and water to form, and the water yield that adds when boiling contains the dried medicine composition of 220-300mg with the every ml of final medicinal liquid and is as the criterion.
4, no dependence Chinese herbal medicine pain relieving decoction as claimed in claim 3 is characterized in that, the water yield that adds during wherein said boiling contains the dried medicine composition of 260mg with the every ml of final medicinal liquid and is as the criterion.
5, no dependence Chinese herbal medicine pain relieving decoction as claimed in claim 3 is characterized in that, it is to boil with described Chinese medicine ingredients of claim 2 and water to form, and the water yield that adds when boiling contains the dried medicine composition of 220-300mg with the every ml of final medicinal liquid and is as the criterion.
6, no dependence Chinese herbal medicine pain relieving decoction as claimed in claim 5 is characterized in that, the water yield that adds during wherein said boiling contains the dried medicine composition of 260mg with the every ml of final medicinal liquid and is as the criterion.
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| CN 96103376 CN1050297C (en) | 1996-04-05 | 1996-04-05 | Chinese herbal medicine composition for preparing non-dependence anti-cancer pain-alleviating drug and preparation thereof |
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| CN 96103376 CN1050297C (en) | 1996-04-05 | 1996-04-05 | Chinese herbal medicine composition for preparing non-dependence anti-cancer pain-alleviating drug and preparation thereof |
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