CN1085796A - The oral Chinese medicine compositions of treatment cancer - Google Patents

Abstract

The invention provides and a kind ofly form the solid oral agent type Chinese medicine composition that is used for the treatment of cancer by 15 kinds of natural drug raw materials such as Mylabris, show that through a large amount of experiments and Preliminary Clinical Observation its effect aspect dispersing pathogen accumulation and strengthening the body resistance is remarkable, have multiple treatment for cancer, alleviate the side effect of radiotherapy or chemotherapy, improve actively many-sided and effect reliably such as the resistance, immunologic function of body and prolongation life cycle.

Description

The oral Chinese medicine compositions of treatment cancer

What the present invention relates to is a kind of solid-state oral medicine that is used for the treatment of cancer of being made up of Chinese medicine ingredients.

Natural drugs such as utilization Chinese herbal medicine are treated or auxiliary for treating cancer is the work of studying always and exploring, and the documents and materials of having reported are also very many.According to " Guangdong medical science " 1989, the 10(2) report of 31-33, filtered out 3000 at least at present surplus kind of Chinese medicine and compound recipe.Controlling way and effect by these medicines can be divided into four big classes.One class is that cancerous cell is had direct inhibitory or killing effect and through the Chinese medicine of clinical verification, as medicine or its extracts such as indirubin, harringtonine, Rhizoma Curcumae, Mylabris, Rabdosia rubescens, camptothecine, bruceas.Another kind of is that certain antitumaous effect is arranged, and the medicine that can alleviate the patient suffering and prolong life cycle is as crane toad sheet, Flos Nelumbinis tablet, LIUSHEN WAN, plum blossom tongue pellet, Xi Huan Wan etc.A class is to improve immunologic function again, the medicine of enhancing body body constitution as Radix Ginseng commonly used, the Radix Astragali, Fructus Ligustri Lucidi, Cordyceps and as Mycophytas such as Polyporus, Ganoderma, Lentinus Edodess, can alleviate and radiate or the toxic and side effects of chemotherapy, improve immune status, prolong life cycle.Last class is the Chinese medicine of treatment precancerous lesion, and as Rabdosia rubescens, LIUWEI DIHUANG WAN, for oral administration or medicine for external use such as Xiao Jianzhong Tang, Mylabris tincture is mainly and prevents that cell mutation from being the reverse variation of cancerous cell.

Be not difficult to find out from these classification, uncharm and tonification is set upright two aspects and carried out from breaking through so that natural drug treatment cancer is outer.Though it is of a great variety to screen the Pharmaceutical composition that combines according to different guidelines and therapeutic purposes in above-mentioned a large amount of natural medicinal materials of animals and plants, usage is different, as the Chinese patent publication number is 1040506A, 1071335A, 1049973A, tens of pieces of documents such as 1066189A are report to some extent all, and they all have separately characteristics and curative effect, but further the more effective task with the wideer thereby also even more ideal pharmaceutical composition of subject range of screening is still being carried out.

The object of the present invention is to provide a kind of new treatment cancer Chinese medicine composition of solid oral agent form, confirm satisfactory for result through a series of zooperies and clinical observation.

Medicine provided by the invention consists of (in weight portion):

Mylabris 0.1, Scolopendra 1.5, Hirudo 1.5,

Scorpio 1, Radix Ginseng 1, Butyrum Carapax Trionycis 1,

Squama Manis 1, rhizoma sparganic 7.5, Rhizoma Curcumae 7.5,

Herba Patriniae 7.5, the Radix Astragali 7.5, Radix Notoginseng powder 0.75,

Pulvis Cornus Bubali Concentratus 0.8, Cornu Saigae Tataricae 1.25 Calculus Boviss 1.25.

Though the Calculus Bovis in wherein forming can have natural Calculus Bovis and artificial Calculus Bovis's branch, its effect scope is identical, and from resource and raw material sources and cost consideration, suggestion is to select for use the artificial Calculus Bovis for well.

Aforementioned pharmaceutical compositions through screening combines combines the counteracting toxic substances in the theory of Chinese medical science with eliminating stagnation, melt eliminating evil and set upright to be one.Mylabris in the composition has the effect of counteracting toxic substances removing blood stasis, is the counteracting toxic substances principal agent.Scolopendra can be aided with dispersing pathogen accumulation, and Scorpio can the collateral dredging detoxifcation.It cooperatively interacts and can bring into play the effect for the treatment of the poisonous disease with poisonous drugs.Rhizoma sparganic, Rhizoma Curcumae are equipped with Hirudo, Radix Notoginseng and Herba Patriniae again and are used for eliminating mass.Squama Manis is good at promoting blood circulation to remove obstruction in the collateral.These medicines cooperatively interact and can strengthen the broken mass-dissipating efficacy of eliminating mass.Calculus Bovis, Cornu Saigae Tataricae are longer than the cool liver of heat clearing away, Cornu Bubali is longer than removing pathogenic heat from blood and toxic substance from the body, suppress some composition with it and use heat-transformation for a long time, and make the dissipation of heat of changing.The use of a large amount of holagogue removing mass medicines must damage to some extent to human body self vigour, and Radix Ginseng, the Radix Astragali can strongly invigorating primordial QI, the Carapax Trionycis nourishing YIN for suppressing the hyperactive YANG, and hard masses softening and resolving plays supplementing QI and nourishing YIN, the strengthening the body resistance effect.In forming, the Carapax Trionycis yin nourishing is arranged, medicine clearing away heat and cooling blood such as Cornu Saigae Tataricae, Calculus Bovis, the Mylabris detoxifcation is so be suitable for interior-heat caused by deficiency of YIN or extreme noxious heat disease.Again because of promoting flow of QI and blood compositions such as rhizoma sparganic, Rhizoma Curcumae are arranged, so also be suitable for the qi stagnation and blood stasis type disease.Owing to adopted the broken knot for the treatment of the poisonous disease with poisonous drugs and eliminating mass medicine, can prevent tumor recurrence, transfer so the patient after surgical resection and radiotherapy, the chemotherapy used; Liquid is grown in yin nourishing, and the strengthening the body resistance composition can improve body's immunological function, to the healthy energy after operation, radiotherapy, the chemotherapy is deficient good restitution is arranged.

After said medicine raw material of the present invention is concocted or is handled by the Pharmacopoeia of the People's Republic of China (1990 editions) earlier before use, to boil for several times based on the conventional decocting of rhizoma sparganic, Rhizoma Curcumae, the Radix Astragali and the Herba Patriniae of aqueous soluble active constituent earlier, get decoction liquor and concentrate, be prepared into extract powder by the pharmacopeia regulation.All the other each material compositions then directly are broken into powder, with the abundant mix homogeneously of the extract powder that has prepared.This pharmaceutical powder blend can incapsulate, or adds the excipient adjuvant routinely and make tablet or pill, can become operational solid-state oral formulations.In these preparations, the most convenient with capsule form especially.

Aforementioned pharmaceutical compositions of the present invention is mixed with suspension with 0.7% carboxymethyl cellulose, with body weight is that acute toxicity test is done in the ICR mouse stomach administrations of 19～21 grams, with body weight be the SD rat oral gavage administrations of 120～130 grams make long term toxicity test the results are shown in Table 1.The result animal acute poisoning phenomenon do not occur with the dosage that is equivalent to 266.7 times of clinical dosages as can be seen thus, with the dosage administration that is equivalent to 100 times of clinical dosages 90 days, only the weight of animals is had certain influence yet, shows that medicine of the present invention is safe.

In the general pharmacology research experiment, Beagle Canis familiaris L. with 5～7 kilograms of body weight is a laboratory animal, press 0.225g(crude drug amount, below all with)/kg and the administration of 0.45g/kg oral dose observed in 24 hours, to its behavior, diet, stool, and all there are not influence, statistical result P＞0.05 with the blood pressure of four road physiology monitors record, electrocardiogram, breathing etc.ICR mice with 18～22 grammes per square metres, with righting reflex loss to recover the normal time as the sleep index, carry out reciprocal action test with pentobarbital sodium, dosage is that the test group of 0.225g/kg and 0.45g/kg all shows not have synergism therebetween, illustrates that medicine of the present invention does not have influence to nervous system.

Some situations of medicine of the present invention being carried out relevant pharmacodynamics test are as follows:

1. with the BALB/C mice influence of laboratory animal test to splenocyte conversion and IL-2 generation.The suspension that is mixed with 0.7% carboxymethyl cellulose is respectively with 0.18g/kg and 1.8g/kg two dosage group gastric infusions, the result shows that small dose group can obviously promote mouse lymphocyte propagation and promote TH emiocytosis IL-2 in the splenocyte, and can obviously resist cyclophosphamide to this two inhibitory action; Heavy dose of group then can suppress the breeder reaction of splenocyte, and inducing of IL-2 also had slight inhibition.This shows that medicine of the present invention has the amphicheirality to influence to the cell epidemic disease function of body and the generation of IL-2, and has the dose-effect regularity.

2. antagonism radiological detriment test

With the ICR mice of body weight 20～23 gram, press 4 times of 0.18g/kg(clinical dosages) and 10 times of 0.41g/kg(clinical dosages) oral administration, the matched group oral normal saline.Draw the survival rate after 7 days: test group 63.3%, matched group 36.6% with cobalt 60 irradiation 800; Animals survived number of elements test group is greater than 1.2 times of matched groups (P＜0.005); Spleen, thymus regulating liver-QI to dead animal are weighed, and test group all overweights matched group.Shown that medicine of the present invention can play the protection human body in radiotherapy, improved body autoprotection ability, radiotherapy has been had the auxiliary treatment effect.

3. mice carbon clearance test

The ICR mice of body weight 18～21 grams is divided into two groups by inoculation S180 sarcoma and nonvaccinated intact animal, with medicine 0.045g/kg of the present invention, 0.45g/kg and 0.9g/kg various dose gastric infusion.The result shows the phagocytic function that remarkable increase mononuclear phagocyte is all arranged, and becomes dose-effect relationship, and wherein the immunological enhancement to tumor animal is more obvious.

4. measure with serum hemolysin and carry out immunological testing, be divided into two groups by inoculating the S180 sarcoma and not inoculating the intact animal equally.The result shows that medicine of the present invention all has significant immunological enhancement to two treated animals, and is then more obvious to tumor animal.To the intact animal, low dosage (0.045g/kg) effect is the most obvious; Then the difference between the effects between the dosage size is little to tumor animal.

5. mice emergency function test

ICR mice to body weight 18～20 grams, did swimming continuance time and 50 ± 1 ℃ of high temperature resistant time-to-live and measures after 15 days with medicine gastric infusion of the present invention after hungry 12 hours, matched group is irritated stomach with 0.7% carboxymethyl cellulose.The result shows, compare swimming continuance time with matched group and in the high temperature resistant time-to-live the highest rate elongation of test group can reach 77.69% and 109.49% respectively.Under same test conditions, adopt at present and test in the Chinese medicine medicine for preventing FUFANG TIANXIAN JIAONANG of using, the highest rate elongation of swimming continuance time and high temperature resistant time-to-live only is respectively 22.75% and 12.05%.Illustrate that medicine of the present invention has strong body of body-building preferably and antifatigue effect.

6. anti-ehrlich carcinoma and the test of anti-liver ascites

Be that 18～21 ICR mices that restrain are that laboratory animal is with irritating the administration of stomach mode all with body weight.Result of the test to the animal that inoculated the tumor strain respectively shows that significant antagonism is all arranged, and the effect of obvious prolongation time-to-live is arranged, but do not become dose-effect relationship, and is wherein best with 0.45g/kg * 15d dose effect.

On the basis of above animal test results, medicine of the present invention has been made the preliminary art effect observation that faces again.

To advanced primary liver cancer, middle and advanced stage primary bronchogenic carcinoma of lung and advanced esophageal cancer adopt use Drug therapy of the present invention (a), medicine of the present invention to combine (b) separately with low dose of chemotherapy, chemotherapy (c) and independent radiotherapy (d) the distinct methods results of comparison for the treatment of sees Table 2 separately, be oral capsule when wherein using medicine of the present invention, each 0.5 gram (crude drug), every day three times.Can find out obviously that by table 2 medicine of the present invention has significant superior curative effect on the various cancers of tabular.Though wherein not little to back two kinds of recent heterodynes of each therapy of cancer, survival rate then has marked difference more than 1 year.

To patient with advanced cancer 172 examples (comprising the cancer of different parts such as liver, lung, rectum, stomach, esophagus, colon, mammary gland, uterus, nasopharynx, and cerebral glioma and malignant lymphoma disease) with general conventional therapy (radiotherapy, chemotherapy and supporting treatment) (A), FUFANG TIANXIAN JIAONANG (productions of Tonghua, the Chinese Jilin Bai Shan pharmaceutical factory) treatment (B) and the medicament capsule of the present invention treatment (C) of existing anticancer function certainly, the patient immune function influenced does to contrast observation.The result shows that medicine of the present invention can strengthen the curative effect of radiation and chemotherapy, alleviates its side effect.The appetite decline that radiotherapy, chemotherapy are caused, nausea and vomiting etc. have preventive and therapeutic effect (seeing Table 3); Its leukopenia that causes there is significant protective effect; Can obviously improve the cellular immune function of tumor patient, IgG, the IgA that radiotherapy, chemotherapy are caused, the reduction of IgM have protective effect, and improve the NK cytoactive.The curative effect that also demonstrates medicine of the present invention with the controlled trial result who has the FUFANG TIANXIAN JIAONANG of affirming anticancer and strengthening the body resistance effect all is better than this medicine (seeing Table 4).

Claims (2)

1, a kind ofly forms the solid-state oral medicine that is used for the treatment of cancer, it is characterized in that consisting of (weight portion) by Chinese medicine ingredients

Mylabris 0.1

Scolopendra 1.5

Hirudo 1.5

Scorpio 1

Radix Ginseng 1

Butyrum Carapax Trionycis 1

Squama Manis 1

Rhizoma sparganic 7.5

Rhizoma Curcumae 7.5

Herba Patriniae 7.5

The Radix Astragali 7.5

Radix Notoginseng powder 0.75

Pulvis Cornus Bubali Concentratus 0.8

Cornu Saigae Tataricae 1.25

Calculus Bovis 1.25.

2, medicine as claimed in claim 1 is characterized in that said Calculus Bovis is the artificial Calculus Bovis.