CN104127532B - The application of a kind of NAOXINTONG JIAONANG in preparation treatment oncosis medicine - Google Patents

Abstract

The present invention relates to the application of a kind of NAOXINTONG JIAONANG in the medicine of preparation treatment tumor, the crude drug composition of described NAOXINTONG JIAONANG and weight ratio thereof are the Radix Astragali 66 parts, Radix Paeoniae Rubra 27 parts, Radix Salviae Miltiorrhizae 27 parts, Radix Angelicae Sinensis 27 parts, Rhizoma Chuanxiong 27 parts, 27 parts, Semen Persicae, 13 parts, Flos Carthami, Olibanum (processed) 13 parts, Myrrha (processed) 13 parts, Caulis Spatholobi 20 parts, Radix Achyranthis Bidentatae 27 parts, Ramulus Cinnamomi 20 parts, Ramulus Mori 27 parts, Pheretima 27 parts, Scorpio 13 parts, Hirudo 27 parts composition, the object of the invention is the therapeutic use providing a kind of NAOXINTONG JIAONANG new, expand the clinical application range of this invention, avoid the waste of good drug resource.

Description

The application of a kind of NAOXINTONG JIAONANG in preparation treatment oncosis medicine

Technical field

The invention belongs to medical art, be specifically related to the application of a kind of NAOXINTONG JIAONANG in preparation treatment oncosis medicine,

Background technology

Malignant tumor is a kind of serious threat human life and healthy major disease, and sickness rate has the trend risen year by year.At present, to the treatment of this type of disease usually with X-ray therapy and chemotherapy.Wherein X-ray therapy has the effect of killing local tumor cell, but the patient shifted for cancer is just not helpless.Chemotherapy utilizes the ability of chemical substance interfere with cancer cells repetition DNA stop its increment or bring out its death, and normal tissue cell and organ have obvious damage effect simultaneously.If patient uses these class methods and medicine to treat for a long time, the side reaction such as bone marrow depression, immunologic hypofunction can be caused, and easily produce drug resistance; After cancer patient's chemicotherapy of about more than 90%, occur that leukopenic symptom is particularly common.Given this, seek good effect, medicine tool that toxic and side effects is little is of great significance.At present, clinical therapy of tumor there is no desirable treatment means, but Chinese medicine has longer history in this type of disease for the treatment of, and with its advantage that medicine source is extensive, cheap, toxic and side effects is little.

NAOXINTONG JIAONANG is produced by Shaanxi Buchang Pharmaceuticals Co., Ltd., the national drug standards performed now are numbered WS-10001 (ZD-0001)-2002-2011Z, it is used for the treatment of apoplexia disease clinically, this product is since listing, there is clinical efficacy significantly, reliably, the dark favor by consumers in general.01128760.8,200410040805.5 to this, the applicant has carried out a series of patent application to it, and wherein application number is respectively:, 200510043186.x, 200510042657.5 discloses its prescription proportioning and preparation method and different dosage forms.In a large amount of Clinical practice processes, unexpected its product of discovery has except treating except apoplexia disease, also has and has significant therapeutic effect to tumor patients in heilongjiang.

Summary of the invention

The object of the invention is the novelty teabag providing a kind of NAOXINTONG JIAONANG, is specifically related to the application of a kind of NAOXINTONG JIAONANG in preparation treatment oncosis medicine.

The crude drug composition of described NAOXINTONG JIAONANG and weight ratio thereof are the Radix Astragali 66 parts, Radix Paeoniae Rubra 27 parts, Radix Salviae Miltiorrhizae 27 parts, Radix Angelicae Sinensis 27 parts, Rhizoma Chuanxiong 27 parts, 27 parts, Semen Persicae, 13 parts, Flos Carthami, Olibanum (processed) 13 parts, Myrrha (processed) 13 parts, Caulis Spatholobi 20 parts, Radix Achyranthis Bidentatae 27 parts, Ramulus Cinnamomi 20 parts, Ramulus Mori 27 parts, Pheretima 27 parts, Scorpio 13 parts, Hirudo 27 parts.

The preparation method of described NAOXINTONG JIAONANG is:

(1) get Pheretima, scorpion powder is broken into fine powder;

(2) again all the other 14 taste medical materials are broken into fine powder;

(3) get above-mentioned steps (1) with step fine powder (2), sieve, after mixing, incapsulate, to obtain final product.

The new medicine use of scheme of the present invention is on the basis of existing NAOXINTONG JIAONANG, and find its available treatment oncosis, clinical trial effective percentage reaches 60%, the purposes that the exploitation not being only existing NAOXINTONG JIAONANG makes new advances, simultaneously also for treatment tumor opens a kind of new treatment by Chinese herbs method, not only effective percentage is high and side effect is low.

In order to more fully understand enforcement of the present invention, below by typical embodiment, the present invention is described further.Below and by pharmacodynamics and clinical trial, prove the useful therapeutic effect of NAOXINTONG JIAONANG.

One, pharmacology test

1 materials and methods

1.1 laboratory animals and tumor strain

Cleaning grade Kunming mouse, 18 ~ 22g, The Fourth Military Medical University's Experimental Animal Center provides.Euphorbia egg decoctum, the strain of ehrlich ascites tumor (EAC) tumor all draw from institute of oncology of China Medicine University.

1.2 medicines and reagent

NAOXINTONG JIAONANG: provided by Shaanxi Buchang Pharmaceuticals Co., Ltd., lot number: 20101009, the used time is diluted to desired concn with normal saline (NS); Antitumor activity in vitro medicine is made into 0.125kg crude drug/L according to a conventional method, regulates pH to 6.5 ~ 7.0, scalding 5min; Cyclophosphamide: Hengrui Medicine Co., Ltd., Jiangsu Prov. produces, lot number: 09100403; Xiaoaiping Capsules: Shaanxi Huaxi Pharmaceutical Co., Ltd., lot number: 091106.1.3 statistical procedures: experimental result with represent, adopt t inspection, measure the significance of group difference.1.4 experimental techniques and result

1.4.1 to lotus tumor S ₁₈₀the effect of mice

Get male mice in kunming 30, select the well-grown lotus tumor S of intraperitoneal inoculation 7d ₁₈₀mice, cervical dislocation is put to death, aseptic aspiration ascites, is 1 × 10 with diluting without NS ¹⁰/ L cell suspension, every Mus 0.2ml (2 × 10 ⁶individual cell) the right axillary fossa of Mice Inoculated is subcutaneous.Within 2nd day, be divided into 3 groups at random: model group (solvent) NAOXINTONG JIAONANG group (0.624/kg) and positive control drug Xiaoaiping Capsules group (0.624/kg), often organize 10.Every day gastric infusion or solvent 1 time, continuous 10d.After last administration, next day weighs, and puts to death mice, peels off tumor block and weighs.Calculate tumour inhibiting rate: tumour inhibiting rate=(model tumor weight-experimental group tumor weight)/model tumor heavy × 100%, the results are shown in Table 1.

The impact of table 1 and tumour inhibiting rate heavy on S180 sarcoma tumor ( n=10)

Compare with model group, ^{■ ■}p<0.01.

Experiment shows, NAOXINTONG JIAONANG group and Xiaoaiping Capsules group are to inoculation S ₁₈₀the tumor growth of mice has obvious inhibitory action, and tumour inhibiting rate is respectively 42.78%, and 28.14%.Compare with model group, NAOXINTONG JIAONANG group and the equal difference of positive control drug and have statistical significance (P<0.01).

1.4.2 on the impact of EAC mice

Get male mice in kunming 30, aseptic inoculation EAC mice the 7th day ascites, NS dilution is l × 10 ⁸/ L cell suspension, every Mus lumbar injection 0.2ml (2 × 10 ⁴individual cell).Within 2nd day, be divided into 3 groups at random: model group (solvent), NAOXINTONG JIAONANG group (0.624g/kg) and positive control drug Xiaoaiping Capsules group (0.624g/kg), often organize 10, successive administration or solvent, 1 time/d, continue administration until dead mouse, be limited with 30d, >30d calculates with 30d.Calculate increase in life span: increase in life span=(experimental group survival day-model group survival day)/model group survival day × 100%.The results are shown in Table 2.

Table 2 on the impact of EAC mice ( n=10)

Compare with model group, ^{■ ■}p<0.01, ^■p<0.05.

NAOXINTONG JIAONANG group can significantly improve the life span of EAC mice, and increase in life span is 46.77%, compares with model group, and difference has statistical significance (P<0.01).This illustrates, the life span of NAOXINTONG JIAONANG group to EAC mice has obvious prolongation effect.

1.4.3 to treated with cyclophosphamide pulse lotus tumor S ₁₈₀the effect of mice

Get male mice in kunming 30, aseptic inoculation S ₁₈₀mice the 7th day ascites is 1 × 10 with NS dilution ¹⁰the S of/L concentration ₁₈₀cell suspension, every Mus 0.2ml (2 × 10 ⁶individual cell), the right axillary fossa of Mice Inoculated is subcutaneous.Within 2nd day, be divided into 3 groups at random: model group (solvent), cyclophosphamide group (10mg/kg, NS dilutes), NAOXINTONG JIAONANG group+cyclophosphamide (0.624g/kg+10mg/kg), often organizes 10, every day gavage NAOXINTONG JIAONANG group group or cyclophosphamide, continuous 10d.After last administration, next day weighs, and puts to death mice, peels off tumor block and weighs, and calculates tumour inhibiting rate.The results are shown in Table 3.

The potentiation of table 3 pair cyclophosphamide ( n=10)

Compare with model group, ^{■ ■}p<0.01.

After NAOXINTONG JIAONANG group and cyclophosphamide (0.624g/kg+10mg/kg) share, cyclophosphamide is to S ₁₈₀the tumour inhibiting rate of mice brings up to 46.22% from 42.25% respectively, and result shows, NAOXINTONG JIAONANG group can improve cyclophosphamide S ₁₈₀the tumour inhibiting rate of mice, strengthens its tumor suppression curative effect.

1.4.4 to the effect of cyclophosphamide

Kunming mouse 30, male and female half and half, are divided into 3 groups at random: normal group, cyclophosphamide group (80ms/kg, lumbar injection), NAOXINTONG JIAONANG group+treated with cyclophosphamide pulse (0.624g/kg+80mg/kg), often organize 10.Daily or solvent 1 time, continuous 10d.After last administration, next day, blood was got in eyeball anticoagulant, counting leukocyte.The results are shown in Table 4.

The Attenuation of table 4 pair cyclophosphamide ( n=10)

Compare with model group, ^{■ ■}p<0.01, ^■p<0.05.

After NAOXINTONG JIAONANG group and 80mg/kg cyclophosphamide share, the toxic and side effects that cyclophosphamide suppresses murine interleukin can be improved, compare with model group, difference has statistical significance (P<0.05), this discloses, NAOXINTONG JIAONANG can improve the inhibitory action of cyclophosphamide to murine interleukin, can improve the drug side effect caused by chemotherapy preferably.

In sum, NAOXINTONG JIAONANG group is to inoculation S ₁₈₀the tumor growth of mice has obvious inhibitory action and can extend the life span of EAC mice significantly and can improve cyclophosphamide to S ₁₈₀the tumour inhibiting rate of mice and cyclophosphamide, to the inhibitory action of murine interleukin, strengthen tumor suppression curative effect.These experiment effects are pharmacological basis for the treatment of oncosis, to providing theoretical foundation for clinical treatment tumour.

Detailed description of the invention

Below in conjunction with embodiment, the present invention is further illustrated, but the present invention is not limited only to these embodiments, and under the prerequisite not departing from present inventive concept, any improvement done all drops within protection scope of the present invention.Embodiment 1

(1) get Pheretima 27g, that Scorpio 13g is ground into fine powder is for subsequent use;

(2) again the 14 taste pulverizing medicinal materials such as Radix Astragali 66g, Radix Paeoniae Rubra 27g, Radix Salviae Miltiorrhizae 27g, Radix Angelicae Sinensis 27g, Rhizoma Chuanxiong 27g, Semen Persicae 27g, Flos Carthami 13g, Olibanum (processed) 13g, Myrrha (processed) 13g, Caulis Spatholobi 20g, Radix Achyranthis Bidentatae 27g, Ramulus Cinnamomi 20g, Ramulus Mori 27g, Hirudo 27g are become fine powder;

(3) get above-mentioned steps (1) with step fine powder (2), sieve, after mixing, incapsulate, make 1000 seed lac wafers.Usage and dosage: disposablely take 4,3 times on the one.

The beneficial effect of NAOXINTONG JIAONANG is set forth further below by way of clinical observation on the therapeutic effect test and model case.

Two, clinical experiment

Pre-clinical research is carried out on zooperal basis: under the proper intensive care of doctor, instruct aspiration pill taker to try out.

1, the pre-clinical research that treatment human leukemia is preliminary, according to " WorldHealthOrganizationClassificationofTumors.Pathologya ndGeneticofTumorsofHaematopoieticandLymphoidTissue " (2008), " diagnosis of hematological diseases and criterion of therapeutical effect " (south of opening, Shen Ti edits, Science Press, 2008, the third edition), We conducted the detection of following three aspects: (1) health check-up has or is difficult lower sign: heating, mucocutaneous pale, dermatorrhagia point and ecchymosis, lymph node and hepatosplenomegaly, breastbone tenderness etc.(2) Blood cell counting and classification.(3) bone marrow examination: morphology (comprising groupization inspection).Enter to organize patient 37 example altogether, take the medicine of embodiment 1, instructions of taking is every day 3 times, each 4.One after each meal was a course for the treatment of with 28 days, and the treatment total effective rate through 3 courses for the treatment of is 64.87%, and (PD) rate of deterioration is 35.13%.Result confirms, NAOXINTONG JIAONANG is to young grain type leukemia successful morning.

2, treat the pre-clinical research of gastric cancer, according to Ministry of Public Health " gastric cancer diagnosis and treatment specification ", enter to organize patient 43 example altogether, take NAOXINTONG JIAONANG.Instructions of taking is every day 3 times, each 4.One after each meal was a course for the treatment of with 28 days, and through the treatment of 4 courses for the treatment of, total effective rate is 67.44%, and (PD) rate of deterioration is 32.56%.Result confirms that herbal mixture of the present invention has positive effect (as tumor softens atrophy, ascites disappears, and lymph node reduces, appetite increase etc.) in quality of making the life better.

3, treat the pre-clinical research of phase renal carcinoma, according to solid tumor efficacy assessment standard (RECIST), enter to organize patient 27 altogether routine, take NAOXINTONG JIAONANG, instructions of taking is every day 3 times, each 4.One after each meal was a course for the treatment of with 56 days, and through the treatment of 3 courses for the treatment of, total effective rate is 62.96%, and (PD) rate of deterioration is 37.04%.

4, the pre-clinical research of Hepatoma therapy patient, enter to organize patient 35 example altogether according to " Chinese kinds of tumor diagnosis and treatment specification ", take NAOXINTONG JIAONANG, instructions of taking is every day 3 times, each 4.One after each meal was a course for the treatment of with 56 days, and through the treatment of 3 courses for the treatment of, total effective rate is 65.71%, and (PD) rate of deterioration is 34.29%

NAOXINTONG JIAONANG passes through orally taken for curing method to the treatment of 142 many cases cancer patients, result proves, NAOXINTONG JIAONANG to the total effective rate of the patients such as leukemia, gastric cancer, renal carcinoma, hepatocarcinoma more than 60%, above experimental result shows, after tumor patient takes this medicine, significantly can improve the quality of life of cancer patient, and improve the survival rate of cancer patient, extend life span.

Chinese medicine is thought, often has that consumption impairment of QI is cloudy, taste are impaired in chemotherapy process, causes human bone marrow to suppress, hypoimmunity, affects the function of the raw and the kidney generating marrow and dominating bone of QI and bloodization.Antineoplastic Chinese medicine has QI invigorating, invigorates blood circulation, reaches QI and blood regulating, internal organs regulating YIN and YANG, and QI and blood is grown, and to correct the QI consumed the moon wound in chemotherapy process, impaired taste is repaired.In medicine of the present invention, Radix Astragali qi-supplementing, blood-engendering, Radix Paeoniae Rubra, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis, Rhizoma Chuanxiong, Semen Persicae, Caulis Spatholobi, Flos Carthami, Pheretima, Scorpio, Hirudo mutual reinforcement between are use, and the power benefit of benefiting qi and nourishing blood, blood circulation promoting and blood stasis dispelling is evident, are monarch drug altogether.Radix Achyranthis Bidentatae has bone and muscle strengthening, inducing diuresis for treating stranguria syndrome; Ramulus Mori, Ramulus Cinnamomi, the meridian dredging, row aqueous vapor, share the merit of then Dary water; Olibanum, the pain relieving of Myrrha (processed) blood-activating and qi-promoting, make all medicine tonifys without causing stagnation, make with for assistant.All medicines amount to mutually and play blood yiqi, the merit of row water of invigorating blood circulation.Thus, also for NAOXINTONG JIAONANG treatment oncosis provides theory of Chinese medical science foundation.

In addition, NAOXINTONG JIAONANG both can be used alone treatment tumor, also can use with operation, radiotherapy, chemotherapy simultaneously, effectively can alleviate the toxicity after patient's carcinosis radiotherapy and chemotherapy, for market provides a kind of active drug for the treatment of oncosis, also for Chinese medicine presses down cancer and the attenuation synergistic to chemicotherapy patient, new thinking and countermeasure is opened up.

Claims (2)

1. the application of NAOXINTONG JIAONANG in the medicine of preparation treatment oncosis, the crude drug composition of described NAOXINTONG JIAONANG and weight ratio thereof are: the Radix Astragali 66 parts, Radix Paeoniae Rubra 27 parts, Radix Salviae Miltiorrhizae 27 parts, Radix Angelicae Sinensis 27 parts, Rhizoma Chuanxiong 27 parts, 27 parts, Semen Persicae, 13 parts, Flos Carthami, Olibanum (processed) 13 parts, Myrrha (processed) 13 parts, Caulis Spatholobi 20 parts, Radix Achyranthis Bidentatae 27 parts, Ramulus Cinnamomi 20 parts, Ramulus Mori 27 parts, Pheretima 27 parts, Scorpio 13 parts, Hirudo 27 parts.

2. apply as claimed in claim 1, it is characterized in that, the preparation method of described NAOXINTONG JIAONANG is:

(1) get Pheretima, scorpion powder is broken into fine powder;

(2) again all the other 14 taste medical materials are broken into fine powder;

(3) get above-mentioned steps (1) with step fine powder (2), sieve, after mixing, incapsulate, to obtain final product.