CN1187079C

CN1187079C - Auxiliary medicine for cancer and preparation thereof

Info

Publication number: CN1187079C
Application number: CNB031172644A
Authority: CN
Inventors: 陈云华; 李军; 刘艳
Original assignee: LIER PHARMACEUTICAL CO Ltd CHENGDU CITY
Current assignee: LIER PHARMACEUTICAL CO Ltd CHENGDU CITY
Priority date: 2003-01-30
Filing date: 2003-01-30
Publication date: 2005-02-02
Anticipated expiration: 2023-01-30
Also published as: CN1439418A

Abstract

The present invention discloses an auxiliary medicine for treating cancer, which is prepared from Herba Scutellariae Barbatae, dahurian patrinia herb, zedoary, common prism tuber, thunberg fritillary bulb, atractylodes macrocephala, Semen Coicis, aulastomum gulo, membranous milkvetch root, ginseng, angelica, glossy privet fruit and glycyrrhiza according to a certain weight proportion. The present invention can be made into any pharmaceutical dosage form and integrates diminishing stagnation by detoxification, activating blood circulation to dissipate blood stasis and strengthening healthy qi to eliminate pathogen. Through clinical observation, the present invention has good adjuvant therapy effect on intermediate and advanced hepatoma, bronchiogenic cancer and esophagus cancer.

Description

A kind of ancillary drug for the treatment of cancer and preparation method thereof

Technical field

The present invention relates to a kind of ancillary drug for the treatment of cancer.Be the Chinese patent medicine of feedstock production specifically, the invention still further relates to the preparation method of this medicine with Chinese medicine.

Background technology

Primary hepatocarcinoma, lung bronchogenic carcinoma, esophageal carcinoma are common malignancy, have belonged to middle and advanced stage when waiting to make a definite diagnosis, lose the surgical engine meeting, and the many side effect that cause after the radiotherapy make the patient be difficult to accept and the influence treatment.The traditional Chinese medical science is thought: poison is poly-, blood stasis, weakened body resistance be the main etiology and pathology of tumor, from modern medicine, the morbidity and the prognosis of the low tumor of making decision of body's immunity, hypercoagulability helps cancer metastasis, infection is to impel one of tumor development and the factor that sb.'s illness took a turn for the worse, needs therefore to excavate that Chinese medicine is put in tumor, the auxiliary treatment effect aspect the chemotherapy.

Summary of the invention

The object of the present invention is to provide a kind of ancillary drug for the treatment of cancer, this ancillary drug is to be the medicament that feedstock production forms with Chinese medicine.

Another object of the present invention provides the preparation method of the ancillary drug of this treatment cancer.

Technical scheme of the present invention: the invention provides a kind of ancillary drug for the treatment of cancer, the weight proportion of its raw material is as follows: 30～100 parts in 100～200 portions of Radix Glycyrrhizaes of 100～200 parts of Fructus Ligustri Lucidi of 20～60 parts of Radix Angelicae Sinensis of 100～300 parts of Radix Ginsengs of 10～50 parts of Radixs Astragali of 50～120 portions of Hirudos of 60～200 parts of Semen Coiciss of 50～150 parts of Rhizoma Atractylodis Macrocephalaes of 80～200 parts of Bulbus Fritillariae Thunbergiis of 80～200 parts of rhizoma sparganic of 100～300 parts of Rhizoma Curcumae of 200～400 parts of Herba Patriniae of Herba Scutellariae Barbatae;

The consumption of drug component of the present invention is for also to have better curative effect in the following weight parts scope: 40～80 parts in 120～180 portions of Radix Glycyrrhizaes of 120～180 parts of Fructus Ligustri Lucidi of 30～50 parts of Radix Angelicae Sinensis of 120～280 parts of Radix Ginsengs of 20～40 parts of Radixs Astragali of 70～100 portions of Hirudos of 80～180 parts of Semen Coiciss of 80～130 parts of Rhizoma Atractylodis Macrocephalaes of 100～180 parts of Bulbus Fritillariae Thunbergiis of 100～180 parts of rhizoma sparganic of 140～280 parts of Rhizoma Curcumae of 240～360 parts of Herba Patriniae of Herba Scutellariae Barbatae.

The weight proportion of each raw material is preferably: 60 parts in 140 portions of Radix Glycyrrhizaes of 140 parts of Fructus Ligustri Lucidi of 40 parts of Radix Angelicae Sinensis of 160 parts of Radix Ginsengs of 30 parts of Radixs Astragali of 80 portions of Hirudos of 120 parts of Semen Coiciss of 100 parts of Rhizoma Atractylodis Macrocephalaes of 120 parts of Bulbus Fritillariae Thunbergiis of 120 parts of rhizoma sparganic of 160 parts of Rhizoma Curcumae of 280 parts of Herba Patriniae of Herba Scutellariae Barbatae.

The present invention also provides the application of described medicine in the ancillary drug of preparation treatment cancer.

The ancillary drug of this treatment cancer, its medicament are said dosage form on any pharmaceutics, preferably oral formulations, most preferably capsule.

The present invention also provides the preparation method of this medicine, and concrete steps are a, get the people participates in Hirudo powder and be broken into fine powder, sieves mixing; B, all the other Herba Scutellariae Barbataes etc. ten add the little extraction of boiling of water simply, and collecting decoction filters, and leave standstill the back and filter, and filtrate is concentrated into the extractum that relative density is 1.25～1.30 (20 ℃), and drying under reduced pressure gets dry extract, is ground into fine powder, sieves; C, with the fine powder of a step and the extractum mixing of b step, promptly.

Wherein Herba Scutellariae Barbatae etc. ten adds little the boiling of water simply and extracts three times in the b step, each 1 hour, adds 8 times of amounts of water for the first time, second and add 3 times of amounts of water for the third time.

Medicine of the present invention has detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, strengthening vital QI to eliminate pathogenic factors in one, use the clinical observation of medicine of the present invention through us to the terminal cancer immunologic function, clinical observation to the auxiliary treatment of advanced primary liver cancer, lung bronchogenic carcinoma, esophageal carcinoma has obtained effect preferably.So be used for the treatment of the ancillary drug of cancer.

The specific embodiment

Below come further to set forth the beneficial effect of medicine of the present invention by experiment.These experiments comprise pharmacodynamic experiment, clinical experiment, toxicological experiment.

Experimental example 1 medicine of the present invention is to the influence of mice spleen crust cell transformation and IL-2 generation

1, medicine and experiment material

(1) medicine of the present invention is made capsule: specification: the 0.25g/ grain, and every contains crude drug 1.55g, with 0.5%CMC-Na solution medicine is mixed with 0.22g, 0.11g, 0.056g crude drug/ml suspension, and each group is by body weight gastric infusion 0.5ml/20g body weight.

(2) ConA (German Serva company product); RPMI1640 (U.S. GIBGO product); HurIL-2 standard substance (U.S. Sigma company product); H-Tdr (Institute for Atomic Research, Chinese Academy of Sciences Beijing goods).

(3) cyclophosphamide sheet: pharmacy head factory in Nantong is produced, lot number: 910201, and specification: 50mg/ sheet.With 0.5% CMC-Na solution medicine is mixed with the 0.72mg/ml suspension, by body weight gastric infusion 0.5ml/20g body weight.

(4) ctll cell strain: Third Military Medical University's epi chamber is so kind as to give.

2, laboratory animal BALB/C mice

3, experimental technique

(1), the influence that mouse spleen lymphocyte is transformed

160 of 18～22g BALB/C mice are got in the experiment grouping, are divided into 8 groups at random, and 20 every group, male and female half and half.Grouping and gastric infusion dosage are as follows:

The 1st group: blank solvent matched group, irritate stomach by body weight and give 0.5%CMC-Na solution 0.5ml/20g (body weight);

The 2nd group: cyclophosphamide (CPA) group, give the CPA18mg/Kg body weight, 0.72mg/ml gastric infusion 0.5ml/20g body weight; (being equivalent to 3 times of clinical people's one consumption per days).

The 3rd group: medicine high dose group of the present invention, give medicine 5.6g crude drug/Kg of the present invention, 0.22g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 20 times).

The 4th group: dosage group in the medicine of the present invention, give medicine 2.8g crude drug/Kg of the present invention, 0.11g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 10 times).

The 5th group: medicine low dose group of the present invention, give medicine 1.4g crude drug/Kg of the present invention, 0.056g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 5 times).

The 6th group: cyclophosphamide adds high dose medicine group of the present invention: the dosage of CPA and medicine of the present invention is similar to the 2nd, 3 group to route of administration.

The 7th group: cyclophosphamide adds middle dosage medicine group of the present invention: the dosage of CPA and medicine of the present invention is similar to the 2nd, 4 group to route of administration.

The 8th group: cyclophosphamide adds low dosage medicine group of the present invention: the dosage of CPA and medicine of the present invention is similar to the 2nd, 5 group to route of administration.

Each experimental group equal every day of gastric infusion once, successive administration 7 days, the 8th day sacrificed by decapitation mice.

The preparation of mouse boosting cell suspension: get mouse spleen under the aseptic condition and place the plate that fills Hank`s liquid, grind to form the individual cells suspension with the hair glass rod, cross in the centrifuge tube through 200 order cell sievings, with Hahk`s liquid centrifuge washing twice, adjust cell concentration to 1 * 10 with RPMI1640 (containing 5%FcS) culture fluid ⁷Individual cell/ml promptly makes cell suspension.

The mouse spleen lymphocyte transformation experiment: get the flat culture plate in 96 holes, every hole adds above-mentioned splenocyte suspension 100ul (1 * 10 ⁶Individual cells/well); Experimental port adds ConAlug (final concentration is 5ug/ml), and control wells does not add ConA.Volume is supplied to the 200ul/ hole with the RPMI1640 culture fluid in every group of multiple two holes, puts 37 ℃ of 5%CO ₂Cultivated 72 hours in the incubator, cultivate and finish every hole adding 7.3 * 10 in preceding 16 hours ⁴Bq ³H-Tdr cultivates and to finish, with the bull cell harvestor with cell harvesting on 49 type glass fibre hole filter membranes, every hole is taken out filter membrane and is put into scintillation vial with double distilled water washing sucking filtration 5 times, with homemade counting liquid scintillation instrument mensuration Cpm, the result represents with stimulation index (SI).

(2), medicine of the present invention induces the IL-2 influence to mouse lymphocyte

IL-2 induces and determination of activity

IL-2 induces: get the above splenocyte suspension 1 * 10 of respectively organizing ⁷Individual cell/ml adds in the Kang Shi test tube, and every pipe adds ConA5ug, puts 37 ℃ of 5%CO ₂Cultivated 48 hours in the incubator, centrifugal collection supernatant is put 4 ℃ of refrigerators and is preserved activity to be measured.

IL-2 determination of activity: get well-grown ctll cell 1 * 10 ⁵Individual cell/ml uses 96 well culture plates, and every hole adds ctll cell 100ul (1 * 10 ⁶Individual cells/well) experimental port adds testing sample 100ul, and the positive control hole is with the HurIL standard substance, and negative control hole replaces with RPMI1640100ul, establishes ConA (0.5ug/ hole) simultaneously and compares, and every group of parallel hole put 37 ℃, 5%CO ₂Incubator was cultivated 24 hours, and every hole adds 3.7 * 10 ⁴Bq ³Cultivate 6 hours system filter membranes behind the H-Tdr again, (method is changeed experiment with drenching) measures Cpm with liquid scintillation instrument, and the result represents with CP.

Cp=experimental port Cpm-+ConA hole Cpm

Experimental result sees Table 1, table 2.

Table 1 medicine of the present invention is to the excretory influence of mouse spleen lymphocyte IL-2

Group animal CP

Number of elements X ± SD

The 1st group 20 26113.8 ± 4745.6

The 2nd group 20 17904.0 ± 5151.8 ^*

The 3rd group 20 3693.0 ± 2596.5 ^*

The 4th group 20 3435.8 ± 6621.5 ^*

The 5th group 20 33608.5 ± 5237.3 ^*

The 6th group of 20 28174.9 ± 4896.3##

The 7th group of 20 25761.0 ± 4747.4##

The 8th group of 20 23466.4 ± 5496.3##

Annotate: ^*With first group of comparison P＜0.05

## and second group of comparison P＜0.01

The influence that table 2 medicine of the present invention transforms mouse spleen lymphocyte

Group animal SI

Number of elements X ± SD

The 1st group 20 77.34 ± 34.53

The 2nd group 20 31.62 ± 14.33 ^*

The 3rd group 20 157.49 ± 11.72 ^*

The 4th group 20 136.32 ± 24.13 ^*

The 5th group 20 128.17 ± 54.35 ^*

The 6th group of 20 90.55 ± 27.75##

The 7th group of 20 79.85 ± 26.07##

The 8th group of 20 72.43 ± 34.63##

Annotate: ^*With first group of comparison P＜0.05

## and second group of comparison P＜0.01

Confirmed by above experimental result: medicine of the present invention can promote mice spleen lymphocytes proliferation and promote Th emiocytosis IL-2 in the splenocyte that each dosage group and blank group relatively have significant difference (P＜0.01); Medicine of the present invention can obviously resist the inhibitory action of cyclophosphamide to experiment mice lymphocyte transformation and Th cell generation IL-2, and each dosage of medicine of the present invention adds the cyclophosphamide group and the cyclophosphamide group relatively has significant difference (P＜0.01).

The anti-liver ascites experiment of experimental example 2 medicines of the present invention

1, medicine and experiment material

(2) cyclophosphamide sheet: pharmacy head factory in Nantong is produced, lot number: 910201, and specification: 50mg/ sheet.With 0.5%CMC-Na solution medicine is mixed with the 0.72mg/ml suspension, by body weight gastric infusion 0.5ml/20g body weight.

(3) hepatic ascites carcinoma strain: protecting kind of a chamber by the institute of antibiotics, Sichuan Province provides.

2, laboratory animal: ICR mice

3, experimental technique

Get 160 of 18-22gICR mices, be divided into 8 groups at random, 20 every group, grouping and dosage are as follows:

Begin to irritate stomach after the animal grouping and give medicine of the present invention, normal saline diluted at 1: 5 with sterile working's extraction hepatic ascites tumor liquid in the 5th day after the administration, and each only organizes mouse peritoneal injection tumor liquid 0.25ml/.Inoculation back begins to irritate stomach and give cyclophosphamide and medicine of the present invention next day, and up to the inoculation the last the 11st day, drug withdrawal in the 12nd day.Behind inoculation tumor liquid, begin to observe, observe each treated animal death condition every day, calculate the mean survival time (MST) in 60 days, calculate and respectively organize life-delaying rate.This tests triplicate, and three batches of experimental results are carried out statistical analysis, and experimental result sees Table 3.

Table 3 medicine of the present invention is to tumor-bearing mice (liver ascites) influence of life cycle (three batches of overall results)

The group animal natural law life-delaying rate of on average surviving

Number of elements (the % of X ± SD)

The 1st group 60 16.70 ± 2.69

The 2nd group 60 26.50 ± 3.72 ^*58.9

The 3rd group 60 23.49 ± 4.58 ^*40.7

The 4th group 60 21.49 ± 2.59 ^*28.3

The 5th group 60 19.35 ± 1.83 ^*15.9

The 6th group of 60 31.56 ± 4.02## 89.0

The 7th group of 60 30.80 ± 2.72## 84.4

The 8th group of 60 29.15 ± 3.55## 74.6

Annotate: ^*With first group of comparison P＜0.01

## and second group of comparison P＜0.01

As can be seen from Table 3, medicine of the present invention has the effect that prolongs life span to inoculation liver ascites mice, relatively there were significant differences (P＜0.01) for high, medium and low dosage group and blank group, life-delaying rate is respectively 40.7%, 28.3%, 15.9%, three dosage of medicine of the present invention add on average survive natural law and cyclophosphamide group of cyclophosphamide group mice relatively significant difference (P＜0.01), life-delaying rate obviously improves, and shows that medicine of the present invention has a synergism to cyclophosphamide is anticancer.

The anti-ehrlich carcinoma experiment of experimental example 3 medicines of the present invention

1, medicine and experiment material

(3) ehrlich carcinoma tumor strain: protecting kind of a chamber by the institute of antibiotics, Sichuan Province provides.

2, laboratory animal: ICR mice

3, experimental technique

Begin to irritate stomach after the animal grouping and give medicine of the present invention, normal saline diluted at 1: 5 with sterile working's extraction ehrlich carcinoma tumor liquid in the 5th day after the administration, and each only organizes mouse peritoneal injection tumor liquid 0.25ml/.Inoculation back begins to irritate stomach and give cyclophosphamide and medicine of the present invention next day, and up to the inoculation the last the 11st day, drug withdrawal in the 12nd day.Behind inoculation tumor liquid, begin to observe, observe each treated animal death condition every day, calculate the mean survival time (MST) in 60 days, calculate and respectively organize life-delaying rate.This tests triplicate, and three batches of experimental results are carried out statistical analysis, and experimental result sees Table 4.

Table 4 medicine of the present invention is to tumor-bearing mice (ehrlich carcinoma) influence of life cycle (three batches of overall results)

The group animal natural law life-delaying rate of on average surviving

Number of elements (the % of X ± SD)

The 1st group 60 17.55 ± 2.92

The 2nd group 60 27.50 ± 3.72 ^*56.7

The 3rd group 60 24.75 ± 3.76 ^*41.0

The 4th group 60 22.05 ± 3.92 ^*25.6

The 5th group 60 19.35 ± 2.95 ^*10.3

The 6th group of 60 31.56 ± 3.66## 79.8

The 7th group of 60 33.32 ± 3.97## 89.9

The 8th group of 60 30.25 ± 3.18## 72.4

Annotate: ^*With first group of comparison P＜0.01

## and second group of comparison P＜0.01

As can be seen from Table 4, medicine of the present invention has the effect of tangible prolongation life span to inoculation ehrlich carcinoma mice, high, in, relatively there were significant differences (P＜0.01) for low dose group and blank group, life-delaying rate is respectively 41.0%, 25.6%, 10.3%, show that medicine of the present invention has the prolongation effect to ehrlich carcinoma mice life span, three dosage of medicine of the present invention add on average survive natural law and cyclophosphamide group of cyclophosphamide group mice relatively significant difference (P＜0.01), life-delaying rate obviously improves, and shows that medicine of the present invention has a synergism to cyclophosphamide is anticancer.

Experimental example 4 medicine anti-liver-cancer solid tumor experiments of the present invention

1, medicine and experiment material

(1) medicine of the present invention is made capsule: specification: the 0.25g/ grain, and every contains crude drug 1.55g, with 0.5%CMC-Na solution medicine is mixed with 0.22g, 0.11 g, 0.056g crude drug/ml suspension, and each group is by body weight gastric infusion 0.5ml/20g body weight.

(2) cyclophosphamide sheet: pharmacy head factory in Nantong is produced, lot number: 910201, and specification: 50mg/ sheet.With 0.5% CMC-Na solution medicine is mixed with the 0.72mg/ml suspension, by body weight gastric infusion 0.5ml/20g body weight.

(3) liver-cancer solid tumor strain: protecting kind of a chamber by the institute of antibiotics, Sichuan Province provides.

2, laboratory animal: ICR mice

3, experimental technique

Get 5 of mices, the liver-cancer solid tumor strain is inoculated in mice oxter Intradermal, after 11 days, take out liver-cancer solid tumor with the sterile working, homogenizer homogenate with normal saline dilution in 1: 10, is only respectively organized mice oxter subcutaneous injection tumor liquid 0.25ml/ then.Medicine of the present invention is in inoculation beginning in preceding 4 days gastric infusion, and the ring phosphinylidyne begins gastric infusion in inoculation back next day, up to back 11 days of inoculation, mice put to death in the 12nd day, takes out the tumor body, peels off clean back and claims the tumor body weight.This tests triplicate, and three batches of experimental results are carried out statistical analysis, and experimental result sees Table 5.

Table 5 medicine of the present invention is to the influence (three batches of overall results) of liver cancer growth

Group animal tumor body average weight tumour inhibiting rate

Number of elements (g, the % of X ± SD)

The 1st group 60 5.78 ± 2.25

The 2nd group 60 2.83 ± 0.65 ^*51.0

The 3rd group 60 3.57 ± 0.93 ^*38.3

The 4th group 60 4.13 ± 1.31 ^*28.5

The 5th group 60 4.77 ± 0.77 ^*17.5

The 6th group of 60 1.52 ± 1.12## 73.7

The 7th group of 60 1.93 ± 0.79## 66.6

The 8th group of 60 2.34 ± 0.86## 59.5

Annotate: ^*With first group of comparison P＜0.01

## and second group of comparison P＜0.01

By table 5 as seen, medicine of the present invention has certain inhibitory action to the growth of liver-cancer solid tumor, high, in, relatively there were significant differences (P＜0.01) for low dose group tumor body weight and blank group, tumour inhibiting rate is respectively 38.3%, 28.5%, 17.5%, after three dosage of medicine of the present invention and cyclophosphamide share, use cyclophosphamide good more separately to the inhibitory action of tumor body, three dosage of medicine of the present invention add the average tumor of cyclophosphamide group mice heavily relatively has significant difference (P＜0.01) with the cyclophosphamide group, tumour inhibiting rate obviously improves, and shows that medicine of the present invention has synergistic function to the function of tumor inhibition of cyclophosphamide.

The anti-S of experimental example 5 medicines of the present invention ₁₈₀The sarcoma experiment

1, medicine and experiment material

2, laboratory animal: ICR mice

3, experimental technique

Get 5 of mices, with S ₁₈₀The sarcoma strain is inoculated in mice oxter Intradermal, after 11 days, takes out the tumor body with the sterile working, and homogenizer homogenate with normal saline dilution in 1: 10, is only respectively organized mice oxter subcutaneous injection tumor liquid 0.25ml/ then.Medicine of the present invention is in inoculation beginning in preceding 4 days gastric infusion, and the ring phosphinylidyne begins gastric infusion in inoculation back next day, up to back 11 days of inoculation, mice put to death in the 12nd day, takes out the tumor body, peels off clean back and claims the tumor body weight.This tests triplicate, and three batches of experimental results are carried out statistical analysis, and experimental result sees Table 6.

Table 6 medicine of the present invention is to sarcoma S ₁₈₀The influence (three batches of overall results) of growth

Group animal tumor body average weight tumour inhibiting rate

Number of elements (g, the % of X ± SD)

The 1st group 60 1.35 ± 0.53

The 2nd group 60 0.56 ± 0.32 ^*58.5

The 3rd group 60 0.84 ± 0.69 ^*37.8

The 4th group 60 0.96 ± 0.21 ^*28.9

The 5th group 60 1.19 ± 0.67 11.9

The 6th group of 60 0.32 ± 0.22## 76.3

The 7th group of 60 0.43 ± 0.79## 68.1

The 8th group of 60 0.49 ± 0.86## 63.7

Annotate: ^*With first group of comparison P＜0.01

## and second group of comparison P＜0.01

By table 6 as seen, medicine of the present invention is to S ₁₈₀The growth of sarcoma has certain inhibitory action, high, relatively there were significant differences (P＜0.01) for middle dosage group tumor body weight and blank group, low dose group and blank group be zero difference (P＞0.05) relatively, tumour inhibiting rate is respectively 37.8%, 28.9%, 11.9%, after three dosage of medicine of the present invention and cyclophosphamide share, use cyclophosphamide good more separately to the inhibitory action of tumor body, three dosage of medicine of the present invention add the average tumor of cyclophosphamide group mice heavily relatively has significant difference (P＜0.01) with the cyclophosphamide group, tumour inhibiting rate obviously improves, and shows that medicine of the present invention has synergistic function to the function of tumor inhibition of cyclophosphamide.

Experimental example 6 medicines of the present invention are to the influence of poisoning by cyclophosphamide mice

1, medicine and experiment material

2, laboratory animal: ICR mice

3, experimental technique

Get 100 of 18-22gICR mices, by body weight, male and female are divided into 5 groups, and 20 every group, male and female half and half, grouping and dosage are as follows:

The 3rd group: cyclophosphamide adds high dose medicine group of the present invention: the dosage of CPA is identical with route of administration and the 2nd group.Give medicine 5.6g crude drug/Kg of the present invention, 0.22g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 20 times).

The 4th group: cyclophosphamide adds middle dosage medicine group of the present invention: the dosage of CPA is identical with route of administration and the 2nd group.Give medicine 2.8g crude drug/Kg of the present invention, 0.11g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 10 times).

The 5th group: cyclophosphamide adds low dosage medicine group of the present invention: the dosage of CPA is identical with route of administration and the 2nd group.Give medicine 1.4g crude drug/Kg of the present invention, 0.056g crude drug/ml gastric infusion 0.5ml/20g body weight (be equivalent to clinical people's one consumption per day 5 times).

The first administration of medicine of the present invention 7 days, beginning administration in the 8th day is with cyclophosphamide, and medicine of the present invention continues administration.To the 11st day, the mice broken end was got blood 1ml anticoagulant in the 12nd day, measured quantity of leucocyte, and other gets blood 2ml, and separation of serum is measured GPT, and experimental result sees Table 7

Table 7 medicine of the present invention is to the influence of poisoning by cyclophosphamide mice

Group animal leukocyte GPT

Number of elements is (individual/mm ³, X ± and SD) (IU, X ± SD)

The 1st group 20 6732 ± 597 16.55 ± 3.27

The 2nd group 20 1905 ± 735 ^*33.51 ± 5.59 ^*

The 3rd group of 20 2406 ± 605#, 28.63 ± 6.05#

The 4th group of 20 2834 ± 766##, 24.06 ± 4.97##

The 5th group of 20 3007 ± 867##, 21.56 ± 3.18##

Annotate: ^*With first group of comparison P＜0.01

##, # and second group be P＜0.05, P＜0.01 relatively

By table 7 as seen, the leukopenia that medicine of the present invention causes cyclophosphamide, GPT raises inhibitory action, shows that medicine of the present invention has the effect of alleviating to the toxicity that cyclophosphamide produces.

Experimental example 7 medicines of the present invention are to the influence of rat blood rheological characteristic

1, medicine and experiment material are made capsule by medicine of the present invention, specification: 0.25g/ grain, every contains crude drug 1.55g, with 0.5%CMC-Na solution medicine is mixed with 0.56g, 0.28g, 0.14g crude drug/ml suspension, and each group is by body weight gastric infusion 1ml/100g body weight.

2, laboratory animal: SD rat

3, experimental technique

Get 80 of 120 ± 10gSD mices, by body weight, male and female are divided into 4 groups, and 20 every group, male and female half and half, grouping and dosage are as follows:

The 1st group: blank solvent matched group, irritate stomach by 1ml/100g (body weight) and give 0.5%CMC-Na solution;

The 2nd group: medicine high dose group of the present invention, give medicine 5.6g crude drug/Kg of the present invention, 0.56g crude drug/ml gastric infusion 1ml/100g body weight (be equivalent to clinical people's one consumption per day 20 times).

The 3rd group: dosage group in the medicine of the present invention, give medicine 2.8g crude drug/Kg of the present invention, 0.28g crude drug/ml gastric infusion 1ml/100g body weight (be equivalent to clinical people's one consumption per day 10 times).

The 4th group: medicine low dose group of the present invention, give medicine 1.4g crude drug/Kg of the present invention, 0.014g crude drug/ml gastric infusion 1ml/100g body weight (be equivalent to clinical people's one consumption per day 5 times).

The rat successive administration is after one week, pentobarbital sodium anesthesia down,, use XXE-1 type cone-plate formula viscosimetric analysis whole blood viscosity, plasma viscosity, press Wen Shi pipe method mensuration blood erythrocyte sedimentation rate and packed cell volume with sodium citrate (3.8%) anticoagulant in 1: 9 from the blood-letting of carotid artery intubate, the results are shown in Table 8

Table 8 medicine of the present invention is to the influence of rat blood rheological characteristic (X ± SD)

Group animal's whole blood viscosity plasma viscosity erythrocyte sedimentation rate packed cell volume

Number of elements is low cuts (5.755 ^-1) height cuts (192.05 ^-1) 153.605 ^-1

The 1st group 20 41.13 ± 9.32 6.88 ± 0.79 3.31 ± 0.49 0.18 ± 0.15 0.0423 ± 0.038

The 2nd group 20 25.18 ± 8.59 ^*5.07 ± 0.76 ^*2.27 ± 0.38 ^*0.17 ± 0.07 0.398 ± 0.045

The 3rd group 20 26.05 ± 9.05 ^*5.25 ± 0.85 ^*2.25 ± 0.41 ^*0.18 ± 0.07 0.397 ± 0.042

The 4th group 20 27.11 ± 8.57 ^*5.28 ± 0.70 ^*2.31 ± 0.42 ^*0.15 ± 0.07 0.404 ± 0.041

Annotate: ^*Compare P＜0.01 with the blank group

Above experimental result shows, medicine of the present invention can obviously reduce rat whole blood viscosity, plasma viscosity, the good effect that improves hemorheological property is arranged.

Show by above-mentioned experiment, medicine of the present invention has enhance immunity, suppress tumor, improve the hemorheological property effect, can strengthen its function of tumor inhibition after share with cyclophosphamide simultaneously, the minimizing that mouse spleen lymphocyte reduces and IL-2 generates that energy antagonism cyclophosphamide causes, the murine interleukin that the rising cyclophosphamide causes reduces, reduce the mice GPT rising that cyclophosphamide causes, have Synergistic and Attenuation.For clinical be used for tumor and put, the auxiliary treatment of chemotherapy, the treatment that is used for hepatocarcinoma, pulmonary carcinoma, esophageal carcinoma etc. provides pharmacodynamic experiment basis preferably.

Experimental example 8 medicines of the present invention are to the clinical observation of terminal cancer immunologic function

From over 1992, we carry out chemicotherapy to losing the operative treatment chance middle and advanced stage tumor patient divides into groups to observe, wherein 108 examples add and use medicine of the present invention, 57 examples add with Tianxian Capsule (White Cloud Mountain, Tonghua, Chinese Jilin pharmaceutical factory product, as positive control), in addition, 57 examples do not add and use medicine.Now with 222 routine middle and advanced stage Tumor Patient Before and After Treatment peripheral hemograms, it is as follows that immune globulin Pseudobulbus Bletillae (Rhizoma Bletillae) NK cytoactive detects brief summary:

One, physical data

222 examples, 205 examples are all made a definite diagnosis with pathological diagnosis, and 29 routine primary hepatocarcinoma are then checked and are made a definite diagnosis with clinical symptoms, B ultrasonic, CT, AFP.Male's 1 58 examples wherein, women's 64 examples, the oldest 78 examples, minimum 23 years old, 58 years old mean age, the course of disease the longest half a year, the shortest 26 days, average 83 days, tumor classification: pulmonary carcinoma 38 examples, primary hepatocarcinoma 29 examples, rectal cancer 27 examples, gastric cancer 31 examples, esophageal carcinoma 18 examples, colon cancer 23 examples, breast carcinoma 25 examples, uterus carcinoma 8 examples, nasopharyngeal carcinoma 15 examples, cerebral glioma 5 examples, malignant lymphoma 3 examples.

Two, Therapeutic Method

222 examples by tumor classification and prescription on individual diagnosis sequence number, are divided into 3 groups at random.

I, general treatment group adopt radiotherapy or chemotherapy and supporting treatment.

II, Tianxian Capsule group on the basis of general treatment group Therapeutic Method, add and use Tianxian Capsule, and each 2, every day 3 times.

III, medicine group of the present invention: on the basis of general treatment group Therapeutic Method, add and use medicine of the present invention, each 3, every day 3 times.

Three, treatment observed result

1, the observation to chemicotherapy toxicity preventive and therapeutic effect sees Table 9

Appetite decline nausea and vomiting leukocyte＜3 * 10 ⁹Interrupt chemicotherapy

I general treatment group 39 (68.42%) 28 (49.12%) 11 (19.30%) 11 (19.30%)

II Tianxian Capsule group 24 (42.11%) 19 (33.33%) 6 (10.30%) 6 (10.53%)

III medicine group 15 (13.8%) 20 (18.52%) 0 (0%) 0 (0%) of the present invention

I∶II?P＜0.05 I∶II?P＞0.05 I∶II?P＜0.05

I∶III?P＜0.05 I∶III?P＜0.05 I∶III?P＜0.05

II∶III?P＜0.05 II∶III?P＜0.05 II∶III?P＜0.05

Learn by statistics and handle, medicine of the present invention has preventive and therapeutic effect to digestive tract reaction and the leukopenia that chemicotherapy causes, its curative effect is better than the Tianxian Capsule group, and two groups relatively there were significant differences.

2, relatively see Table 10 before and after the peripheral blood leucocyte medication

Blood leukocytes relatively before and after three groups of medications of table 10

Group example number leukocyte count (* 109/L X * SD)

Treatment treatment in back 7 days is back 15 days before the treatment

I general treatment group 57 4.7 ± 0.32 3.8 ± 0.21 3.6 ± 0.50

The II Tianxian Capsule organizes 57 4.6 ± 0.24 3.9 ± 0.23 3.7 ± 0.43

III medicine 108 4.6 of the present invention ± 0.22 4.6 ± 0.5 4.0 ± 0.40

I∶III?P＞0.05 III∶I?P＜0.01 III∶I?P＜0.05

As can be seen from the table, treatment first three groups zero difference was treated back 7 days, and 15 days, I, II group all had decline in various degree, though the III group also has decline, but still in normal range, three groups relatively, and I, II organize zero difference, and the III group is more variant with the I group.

3, serum immune globulin relatively sees Table 11 before and after the treatment

Immunoglobulin compares (g/l) before and after three groups of medications of table 11

Before the group treatment (X ± SD) treat afterwards (X ± SD)

lgG lgA lgM lgG lgA lgM

I: general treatment group 11.93 ± 2.31 2.11 ± 0.64 1.21 ± 0.75 7.65 ± 1.63 ^*1.08 ± 0.03 ^*0.99 ± 0.07

II: Tianxian Capsule group 12.32 ± 1.97 2.42 ± 0.71 1.01 ± 0.88 9.74 ± 2.37 ^*1.68 ± 0.06 ^*1.33 ± 0.09

III: medicine group 11.77 of the present invention ± 1.78 2.58 ± 0.53 1.13 ± 0.47 14.11 ± 3.92 2.92 ± 0.24 1.18 ± 0.12

( ^*P＜0.05)

As can be seen from Table 11, I, II group lgG, lgA behind chemicotherapy all have decline in various degree, and lgG, lgA relatively have significant difference, P＜0.05 before and after the treatment of I group.Compare P＜0.05 before and after the II group lgG treatment.Zero difference before and after the treatment of III group.Relatively, treat the remarkable P of back lgGIII group and II, I group comparing difference＜0.05 between group and group.The lgAIII group compares P＜0.05 with the I group, and significant difference is arranged, and illustrates that lgG, the lgA decline that medicine of the present invention causes chemicotherapy has protective effect, can improve the immunologic function of human body.

4, NK cytoactive measured value relatively sees Table 12 before and after the treatment

The NK cytoactive relatively before and after three groups of treatments of table 12

(the treatment back of m ± SD) (the p value of m ± SD) before the group treatment

I general treatment group 0.44 ± 0.15 0.39 ± 0.18＜0.05

II Tianxian Capsule group 0.26 ± 0.10 0.36 ± 0.12＜0.01

III medicine group 0.24 of the present invention ± 0.10 0.39 ± 0.11＜0.05

As can be seen from Table 12, NK cell situation of change alive before and after three groups of treatments, simple chemicotherapy can make the NK cytoactive reduce, and significant difference P＜0.05 is arranged before and after the treatment.The Tianxian Capsule group all can make the NK cytoactive improve with medicine group of the present invention, but the more remarkable treatment effect of medicine group of the present invention.Illustrate that medicine of the present invention can improve the cell immunoreceptor of tumor.

Four, conclusion

Show with clinical observation: medicine of the present invention can strengthen the curative effect of chemicotherapy; alleviate the side effect of chemicotherapy; the appetite decline that chemicotherapy is caused, nausea and vomiting etc. have preventive and therapeutic effect; the leukopenia that chemicotherapy is caused has significant protective effect; can significantly improve the cellular immune function of tumor patient, lgG, the lgA that chemicotherapy is caused, the reduction of lgM have protective effect.Its curative effect all is better than having certainly Tianxian Capsule anticancer and the strengthening the body resistance effect.Therefore prove that the effect that medicine of the present invention has a strengthening the body resistance is effective, the safe ancillary drug of treatment malignant tumor.

Experimental example 9 medicine auxiliary treatment advanced primary liver cancer of the present invention clinical experiments

We carried out clinical observation with medicine of the present invention to the auxiliary treatment of advanced primary liver cancer from 1992 to 1993, now observed result were reported as follows:

One, case grouping

That this experiment is adopted is perspective, at random, the research method of control experiment, qualified case is by the precedence random packet of being admitted to hospital.

Two, Therapeutic Method

1, medicine of the present invention adds low dose of chemotherapy group: medicine of the present invention is made capsule, and each three, oral every day three times, MMC8mg/ time, weekly tremulous pulse pours, and 5-Fulg/ time Hepatic artery splashes into, and inferior on every Wendesdays, two weeks were a course of treatment.While in hospital regular replenishment human albumin, liver ammonia injection, Energy mixture etc., ascites person adopts anti symptom treatment.

2, chemotherapy group: adopting above-mentioned embolic chemotherapy, is a course of treatment all around, while in hospital regular replenishment human albumin, liver ammonia injection, Energy mixture etc., and ascites person adopts anti symptom treatment.

Three, result

1, physical data

The qualified patient that this research meets aforementioned condition fully is totally 164 examples, and medicine wherein of the present invention adds the treatment of low doseization difference and organizes 108 examples, chemotherapy group 56 examples.Man's 119 examples, women 45 examples at 29～66 years old age, accounted for 68% in 35～55 years old.Cardinal principle typing: massive type 94 examples, nodular type 51 examples, diffuse type 19 examples, Clinical typing: simple type 97 examples, atherosclerotic type 44 examples, inflammatory type 23 examples.Icteric 53 examples are arranged, and outer transferrer 46 examples of liver have ascites person's 44 examples, cachectic's 128 examples, and hepatalgia person's 112 examples, hepatomegaly person's 133 examples have symptom of digestive tract person's 164 examples, stool blood positive person 69 examples, AFP rising person 109 examples.

2, three groups of comparabilities detect

A, age

Table 13 liang group age ratio

Routine age several years (X ± SD)

Medicine of the present invention adds chemotherapy group 108 45.20 ± 5.34

Chemotherapy group 56 45.78 ± 5.72

Two groups of age ratios are learned by statistics and are handled there was no significant difference P＞0.05

B, sex

Table 14 liang group sex ratio

Example number sex

The men and women

Medicine of the present invention adds chemotherapy group 108 79 30

Chemotherapy group 56 40 15

Two groups of sex ratios are than there was no significant difference P＞0.05

C, cardinal principle typing

Table 15 liang group typing substantially compares

Example number massive type nodular type diffuse type

Medicine of the present invention adds chemotherapy group 108 55 31 12

Chemotherapy group 56 39 20 7

Two groups of cardinal principle typings compare there was no significant difference P＞0.05

D, Clinical typing

Table 16 liang group Clinical typing relatively

Example number simple type atherosclerotic type inflammatory type

Medicine of the present invention adds chemotherapy group 108 60 30 16

Chemotherapy group 56 37 14 7

E, cardinal symptom and sign are relatively

Table 17 liang group cardinal symptom and sign are relatively

Liver shifts outward AFP rising person hepatalgia hepatomegaly digestive tract hemorrhage ascites jaundice cachexia

Medicine of the present invention adds chemotherapy group 69 99 84 46 35 38 88 34

Chemotherapy group 40 53 49 21 9 15 48 12

Two groups of cardinal symptoms, sign, AFP rising person's the above-mentioned every comparison in comparison there was no significant difference P＞0.05, two group differences there are no significant meaning illustrates that two groups of persons have comparability.

3, efficacy analysis:

A, two groups of treatment back cardinal symptoms, sign improvement situation

Table 18 cardinal symptom, sign improvement situation are relatively

Symptom of digestive tract hepatalgia hepatomegaly digestive tract hemorrhage ascites jaundice

Medicine of the present invention adds chemotherapy group 95/,108 93,/99 69,/84 25,/46 14,/35 32/38

87.96％ 93.94％ 82.14％ 54.35％ 40.0％ 84.21％

Chemotherapy group 16,/56 38,/53 27,/49 7,/21 2/9 6/15

28.57％ 70.37％ 55.10％ 33.33％ 22.22 40.00％

B, short term effect, survival rate more than a year

Table 19 a liang group short term effect relatively reaches survival rate more than a year

Healing produce effects enabledisable effective percentage survival rate more than a year

I medicine of the present invention adds chemotherapy group-6 96 6 94.44% 64.81% (70/108)

II chemotherapy group--32 24 57.14% 10.71% (6/56)

Effective percentage is relatively: I: survival rate relatively more than II P＜0.01 one year: I: II P＜0.01

C, AFP decline situation

Table 20 liang group AFP treatment back decline situation relatively

AFP routine number stable rising that descend that raise

Medicine of the present invention adds chemotherapy group 69 34 30 5

Chemotherapy group 40 10 15 15

I∶II?P＜0.01

The relation of d, curative effect and medicine typing

Table 21 medicine of the present invention adds the relation of low dose of chemotherapy group and medicine typing

Typing example digital display is imitated the enabledisable effective percentage

Qi stagnation and blood stasis type 45 3 42-100%

Liver gallbladder damp-heat type 24 2 20 1 91.67%

Extreme noxious heat 21 2 19-100%

Liver-kidney yin deficiency 10-8 2 80.0%

Insufficiency of spleen-qi type 8-5 3 62.50%

P＜0.01

Peripheral hemogram, platelet, electrocardiogram, renal function, routine urinalysis situation before and after e, the medication

Medicine of the present invention adds the chemotherapy group peripheral hemogram, leukocyte drops to 3.9 * 10 ⁹/ L～3.5 * 10 ⁹/ L person 4 examples, the chemotherapy group leukocyte reduces to 3.0 * 10 ⁹/ L～3.9 * 10 ⁹/ L person 30 examples (53.57%), platelet reduces to 90 * 10 ⁹/ L～60 * 10 ⁹/ L person 12 examples (21.43%), urine protein positive person 11 examples (19.64%) Electrocardioscopy no abnormality seen after the medication.

Four, conclusion

Through above-mentioned clinical experiment, draw as drawing a conclusion: medicine of the present invention adds low dose of chemotherapy group treatment mid and late liver cancer curative effect preferably, can alleviate patient's misery, improves life quality, stablizes focus, prolongs life cycle.Medicine of the present invention adds low dose of chemotherapy, not only can alleviate the toxic and side effects of chemotherapy, can improve curative effect again, and medicine of the present invention is comparatively ideal adjuvant therapy medicaments.

The experiment of experimental example 10 medicine auxiliary treatment primary bronchogenic carcinoma of lungs of the present invention

We carried out clinical observation with medicine of the present invention to the auxiliary treatment of middle and advanced stage primary bronchogenic carcinoma of lung from 1991 to 1993, now observed result were reported as follows:

One, case grouping

Two, Therapeutic Method

1, chemotherapy group: scale cancer adopts the COMB scheme, and 6 weeks were a course of treatment; Adenocarcinoma adopts the FAM scheme, and 4 weeks were a course of treatment.Undifferentiated carcinoma is adopted the scheme with CAO, and 3 weeks were a course of treatment.While in hospital regular replenishment human albumin, lipomul, amino acid, Energy mixture etc. have hydrothorax person to adopt anti symptom treatment.

2, medicine of the present invention adds chemotherapy group: add the capsule made from medicine of the present invention in chemotherapy, each three, oral every day three times, one month is a course of treatment.

Three, result

(1) physical data

The qualified patient that this research meets aforementioned condition fully is totally 140 examples, and medicine wherein of the present invention adds chemotherapy group 101 examples, chemotherapy group 39 examples, and in 140 examples, male 98 examples, women 42 examples, 36～72 years old age, average 59 years old.The pathology typing, scale cancer 69 examples, adenocarcinoma 25 examples, undifferentiated carcinoma 46 types.Clinical stages: III phases 101 example, IV phases 39 example.

(2), two groups of comparabilities detect

1, the age

Table 22 liang group age ratio

Routine age several years (X ± SD)

Chemotherapy group 39 58.45 ± 3.34

Medicine of the present invention adds chemotherapy group 101 57.91 ± 2.91

Two groups of age ratios are learned processing difference by statistics and are not had significance P＞0.05

2, sex

Table 23 liang group sex ratio

Example number sex

The men and women

Chemotherapy group 39 27 12

Medicine of the present invention adds chemotherapy group 101 71 30

Two groups of sex ratios are than there was no significant difference P＞0.05

3, pathology typing

Table 24 liang group pathology typing relatively

Example number scale cancer adenocarcinoma undifferentiated carcinoma

Chemotherapy group 39 20 7 12

Medicine of the present invention adds chemotherapy group 101 49 18 34

Two groups of pathology typings relatively do not have significant difference.P＞0.05

4, clinical stages

Table 25 liang group clinical stages comparison

The example number III phase IV phase

Chemotherapy group 39 28 11

Medicine of the present invention adds chemotherapy group 101 73 28

P＞0.05

Two groups of clinical stagess, relatively do not have significant difference.

(3) efficacy analysis:

1, short term effect and survival rate more than a year

Table 26 liang group short term effect and ecological rate comparison more than a year

C.R P.R S P total effective rate survival rate more than a year

Chemotherapy group 2 (5.13%) 15 (38.46%) 18 (46.15%) 4 (10.26%) 43.59% 63.49%

Medicine group of the present invention adds chemotherapy group 8 (7.29%) 43 (42.57%) 48 (47.52%) 2 (1.98%) 50.50% 88.37%

P＜0.05

2, the relation of curative effect and medicine typing

Table 27 medicine group of the present invention adds the relation of chemotherapy group and tcm syndrome differentiation and typing

Typing example number C.R P.R S P total effective rate

Type of YIN-deficiency and interior-heat 19-9 82 47.37%

Type of deficiency of both QI and YIN 37 2 19 13 3 51.35%

Extreme noxious heat 15-7 71 46.67%

Spleen emptiness and wet sputum type 30-10 17 3 33.33%

3, peripheral hemogram, platelet, electrocardiogram, liver function, kidney merit, routine urinalysis situation before and after the medication

Chemotherapy group is SGPT rising person 6 examples after one course of treatment, hematuria person's 2 examples, and WBC is lower than 3.5 * 10 ⁹/ L person 23 examples (36.51%) are lower than 3.0 * 10 ⁹/ L person 7 examples (11.11%), platelet reduces to 90～60 * 10 ⁹(14.29%) Electrocardioscopy of/L person 9 examples and renal function no abnormality seen.

Medicine of the present invention adds chemotherapy group SGPT rising person 3 examples after one course of treatment, and WBC is lower than 3.5 * 10 ⁹/ L person 13 examples (12.9%) are lower than 3.0 * 10 ⁹/ L person 2 examples (1.98%), platelet reduces to 90～60 * 10 ⁹(6.93%) Electrocardioscopy of/L person 7 examples and renal function no abnormality seen.

The bone marrow depression of pointing out medicine of the present invention that chemotherapeutic is caused, renal function injury etc. have protective effect.

Four, conclusion

Through above-mentioned clinical experiment, draw as drawing a conclusion; Medicine of the present invention adds chemotherapeutic treatment middle and advanced stage primary lung cancer, and stable focus is arranged, the effect that prolongs life cycle, and its curative effect is reliable.Medicine of the present invention has detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, and the effect of strengthening vital QI to eliminate pathogenic factors, medicine of the present invention adds chemotherapy has curative effect preferably to dialectical middle and advanced stage primary lung cancer for type of YIN-deficiency and interior-heat, deficiency of both QI and YIN, extreme noxious heat.

Experimental example 11 medicine auxiliary treatment middle and advanced stage esophageal carcinoma clinical reports of the present invention

We carried out the auxiliary treatment clinical observation from 1992 to 1993 with medicine centering advanced esophageal cancer of the present invention, now observed result were reported as follows:

One, case grouping

Two, Therapeutic Method

1, combination radiotherapy group: put in the employing or put outward, the while in hospital gives supporting treatment, regular replenishment human albumin, lipomul, vamin N solution, Energy mixture.

2, medicine of the present invention adds combination radiotherapy group: add the capsule made from medicine of the present invention outward when putting in the employing or putting, each three, every day three times, the while in hospital gives supporting treatment, regular replenishment human albumin, lipomul, vamin N solution, Energy mixture.

Three, result

(1) physical data

The qualified patient that this research meets aforementioned condition fully is totally 144 examples, combination radiotherapy group 50 examples wherein, and medicine of the present invention adds combination radiotherapy group 94 examples, in 144 examples, male 99 examples, women 45 examples, 49～74 years old age.Be in the esophagus, epimere cancer, substantially typing: lump type 47 examples, ulcer type 63 examples, constrictive type 34 examples.Pathology typing: scale cancer 86 examples, undifferentiated carcinoma 27 examples, low branch adenocarcinoma 29 examples.Clinicopathologic stage: mid-terms 84 example, late periods 64 example.144 examples all have dysphagia in various degree, cachectic's 85 examples, metastases in local lymph node 60 examples, metastasis 18 examples.

(2) two groups of comparabilities detect

A, age

Table 28 liang group age ratio

Routine age several years (X ± SD)

Combination radiotherapy group 50 52.10 ± 3.09

Medicine of the present invention adds combination radiotherapy group 94 51.87 ± 2.77

B, sex

Table 29 liang group sex ratio

Example number men and women

Combination radiotherapy group 50 34 16

Medicine of the present invention adds combination radiotherapy group 94 65 29

Two groups of sex ratios are than there was no significant difference P＞0.05

C, cardinal principle typing

Table 30 liang group typing substantially compares

Example number lump type ulcer type constrictive type

Combination radiotherapy group 50 17 22 11

Medicine of the present invention adds combination radiotherapy group 94 30 41 23

Two groups of cardinal principle typings relatively do not have significant difference P＞0.05.

D, pathological staging

Table 31 liang group clinicopathologic stage relatively

Example number late period in mid-term

Combination radiotherapy group 50 29 21

Medicine of the present invention adds combination radiotherapy group 94 55 39

Two groups of clinical pathologies compare there was no significant difference P＞0.05

E, pathology typing

Table 32 liang group pathology typing relatively

Example number scale cancer undifferentiated carcinoma poor differentiated carcinoma

Combination radiotherapy group 50 29 10 10

Medicine of the present invention adds combination radiotherapy group 94 58 17 19

Above-mentioned every comparison, there was no significant difference between two groups illustrates between two groups to have comparability.

(3) efficacy analysis:

1, two groups of cardinal symptoms are alleviated situation

Table 33 liang group dysphagia alleviation situation relatively

It is invalid that the group produce effects effectively takes a turn for the better

Combination radiotherapy group 9 (18%) 13 (26%) 14 (28%) 14 (28%)

Medicine of the present invention adds combination radiotherapy group 19 (20.21%) 35 (37.23%) 38 (40.43%) 2 (2.31%)

P＞0.05 P＞0.05 P＜0.0?1 P＜0.01

2, short term effect and survival rate more than a year

Table 34 liang group short term effect and survival rate comparison more than a year

C.R P.R S P total effective rate coefficient of stabilization year above survival rate

Combination radiotherapy group 5 16 24 5 42.00% 48.00% 44.00%

Medicine of the present invention adds combination radiotherapy group 8 39 45 2 50.00% 47.83% 86.45%

P＞0.05 P＜0.01

3, medicine of the present invention adds the relation of radiotherapy curative effect and pathology typing

Table 35 medicine of the present invention adds the curative effect comparison of radiotherapy to the different pathological typing

Example number C.R P.R S P total effective rate coefficient of stabilization survival rate more than a year

1 scale cancer 58 6 36 14 2 72.41% 24.14% 97.38%

II poorly differentiated adenocarcinoma 17 2 10 41 70.49% 23.53% 73.52%

III undifferentiated carcinoma 19 1 11 61 63.16% 31.58% 55.62%

P＞0.05 I∶II?P＜0.05

I∶III?P＜0.01

II∶III?P＞0.05

4, the relation of curative effect and medicine typing

Table 36 medicine of the present invention adds the curative effect comparison of combination radiotherapy group to different disease types

Typing example number C.R P.R S P effective percentage

Mental disorder interlocking type 13 14 10 3 55.56%

Intermingled phlegm and blood stasis type 34 25 22 5 64.71%

Pyretic toxicity impairment of YIN type 28 18 17 2 60.71%

Both Qi and blood deficiency 14 1283 57.14%

P＞0.05

5, peripheral hemogram before and after the medication, platelet, electrocardiogram, liver function, renal function, routine urinalysis situation combination radiotherapy group are reduced to 3.9 * 10 under the WBC after course of treatment ⁹/ L person 26 examples (52%) are lower than 3.0 * 10 ⁹/ L person is 9 examples (18%), and platelet is lower than normal person's 11 examples (22%), electrocardiogram and kidney merit, liver function, routine urinalysis no abnormality seen.

Medicine of the present invention adds combination radiotherapy group and is reduced to 3.9 * 10 under the WBC after course of treatment ⁹/ L person 12 examples (13%) are lower than 3.0 * 10 ⁹/ L person is 5 examples (5.3%), and platelet is lower than normal person's 8 examples (8.5%), electrocardiogram and kidney merit, liver function, routine urinalysis no abnormality seen.

Four, conclusion

Draw as drawing a conclusion through above-mentioned clinical experiment: medicine auxiliary treatment middle and advanced stage esophageal carcinoma of the present invention, relief of symptoms is arranged, improve life quality, stablize focus, prolong life cycle, especially to the scale cancer better effects if, its curative effect is reliable.Medicine of the present invention has the effect of detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, strengthening vital QI to eliminate pathogenic factors, therefore medicine of the present invention add radiotherapy to dialectical no matter be the domination of pathogen (mental disorder interlocking type, intermingled phlegm and blood stasis type), weakened body resistance (both Qi and blood deficiency) or vital QI being weakened and pathogen being violent (pyretic toxicity impairment of YIN type) all have curative effect preferably.

Experimental example 12 animal long term toxicity tests

By using the conventional animal experimental technique, the long term toxicity test of rat shows, medicine of the present invention increases rat body weight does not have influence, and Rats Organs and Tissues coefficient, hematology, blood biochemical, histoorgan PATHOMORPHOLOGICAL OBSERVATION OF PULLORUM are not had influence, statistical result there was no significant difference (P＞0.05).28g crude drug/Kg (be equivalent to clinical dosage 100 times) is nontoxic amounts of reactants.

Experimental example 13 medicine maximum tolerance determinations of the present invention

By using the method for medicine maximum tolerance determination, the result shows medicine of the present invention, and (successive administration is three times in 12 hours for 3.1g crude drug/ml), maximum administration volume (0.8ml/20g body weight/time) with maximum administration concentration, observed seven days none death of animal after seven days after the administration continuously.Illustrate that medicine mice maximum tolerated dose of the present invention is that (the 372g crude drug/Kg), mice maximum tolerated dose multiple (multiple that is equivalent to clinical people's one consumption per day) is 1328.6 times to 7.44g crude drug/20g, and clinical adult's dosage is safe.

By above pharmacodynamic experiment, clinical experiment, toxicological experiment proves that medicine of the present invention has detoxicating and resolving stagnation of pathogens, blood circulation promoting and blood stasis dispelling, strengthening vital QI to eliminate pathogenic factors in one, for the clinical observation of the auxiliary treatment of advanced primary liver cancer, lung bronchogenic carcinoma, esophageal carcinoma, effect is better.

Further set forth medicine of the present invention and preparation method below by embodiment, but be not to be restriction claim.

Embodiment 1

Herba Scutellariae Barbatae 200g Herba Patriniae 100g Rhizoma Curcumae 80g rhizoma sparganic 80g Bulbus Fritillariae Thunbergii 50g Rhizoma Atractylodis Macrocephalae 60g Semen Coicis 50 Hirudos 10 Radix Astragali 100g Radix Ginsengs 20 Radix Angelicae Sinensis 100 Fructus Ligustri Lucidi 100g Radix Glycyrrhizae 30g

The people is participated in Hirudo powder be broken into fine powder, sieve, mixing; All the other Herba Scutellariae Barbataes etc. ten add little the boiling of water simply extracts three times, each 1 hour, adds 8 times of amounts of water for the first time, second and third time adds 3 times of amounts of water, collecting decoction filters, and leaves standstill 12 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25～1.30 (20 ℃), and drying under reduced pressure (vacuum 0.04～0.08mPa, 55～65 ℃ of temperature) gets dry extract, be ground into fine powder, sieve; With above-mentioned two kinds of fine powder mixings, incapsulate, make 1000, promptly.

Embodiment 2

Herba Scutellariae Barbatae 400g Herba Patriniae 300g Rhizoma Curcumae 200g rhizoma sparganic 200g Bulbus Fritillariae Thunbergii 150g Rhizoma Atractylodis Macrocephalae 200g Semen Coicis 120g Hirudo 50g Radix Astragali 300g Radix Ginseng 60g Radix Angelicae Sinensis 200g Fructus Ligustri Lucidi 200g Radix Glycyrrhizae 100g participates in the people in Hirudo powder and is broken into fine powder, sieves mixing; All the other Herba Scutellariae Barbataes etc. ten add little the boiling of water simply extracts three times, each 1 hour, adds 8 times of amounts of water for the first time, second and third time adds 3 times of amounts of water, collecting decoction filters, and leaves standstill 12 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25～1.30 (20 ℃), and drying under reduced pressure (vacuum 0.04～0.08mPa, 55～65 ℃ of temperature) gets dry extract, be ground into fine powder, sieve; With above-mentioned two kinds of fine powder mixings, incapsulate, make 1000, promptly.

Embodiment 3

Herba Scutellariae Barbatae 280g Herba Patriniae 160g Rhizoma Curcumae 120g rhizoma sparganic 120g Bulbus Fritillariae Thunbergii 100g Rhizoma Atractylodis Macrocephalae 120g Semen Coicis 80g Hirudo 30g Radix Astragali 160g Radix Ginseng 40g Radix Angelicae Sinensis 140g Fructus Ligustri Lucidi 140g Radix Glycyrrhizae 60g participates in the people in Hirudo powder and is broken into fine powder, sieves mixing; All the other Herba Scutellariae Barbataes etc. ten add little the boiling of water simply extracts three times, each 1 hour, adds 8 times of amounts of water for the first time, second and third time adds 3 times of amounts of water, collecting decoction filters, and leaves standstill 12 hours, filter, filtrate is concentrated into the extractum that relative density is 1.25～1.30 (20 ℃), and drying under reduced pressure (vacuum 0.04～0.08mPa, 55～65 ℃ of temperature) gets dry extract, be ground into fine powder, sieve; With above-mentioned two kinds of fine powder mixings, incapsulate, make 1000, promptly.

Claims

1, a kind of auxiliary oral drugs for the treatment of cancer is characterized in that it is the medicament of being made by the following weight proportion raw material:

30～100 parts in 100～200 portions of Radix Glycyrrhizaes of 100～200 parts of Fructus Ligustri Lucidi of 20～60 parts of Radix Angelicae Sinensis of 100～300 parts of Radix Ginsengs of 10～50 parts of Radixs Astragali of 50～120 portions of Hirudos of 60～200 parts of Semen Coiciss of 50～150 parts of Rhizoma Atractylodis Macrocephalaes of 80～200 parts of Bulbus Fritillariae Thunbergiis of 80～200 parts of rhizoma sparganic of 100～300 parts of Rhizoma Curcumae of 200～400 parts of Herba Patriniae of Herba Scutellariae Barbatae.

2, the auxiliary oral drugs of treatment cancer according to claim 1, wherein the weight proportion of each raw material is: 40～80 parts in 120～180 portions of Radix Glycyrrhizaes of 120～180 parts of Fructus Ligustri Lucidi of 30～50 parts of Radix Angelicae Sinensis of 120～280 parts of Radix Ginsengs of 20～40 parts of Radixs Astragali of 70～100 portions of Hirudos of 80～180 parts of Semen Coiciss of 80～130 parts of Rhizoma Atractylodis Macrocephalaes of 100～180 parts of Bulbus Fritillariae Thunbergiis of 100～180 parts of rhizoma sparganic of 140～280 parts of Rhizoma Curcumae of 240～360 parts of Herba Patriniae of Herba Scutellariae Barbatae.

3, the auxiliary oral drugs of treatment cancer according to claim 2, wherein the weight proportion of each raw material is: 60 parts in 140 portions of Radix Glycyrrhizaes of 140 parts of Fructus Ligustri Lucidi of 40 parts of Radix Angelicae Sinensis of 160 parts of Radix Ginsengs of 30 parts of Radixs Astragali of 80 portions of Hirudos of 120 parts of Semen Coiciss of 100 parts of Rhizoma Atractylodis Macrocephalaes of 120 parts of Bulbus Fritillariae Thunbergiis of 120 parts of rhizoma sparganic of 160 parts of Rhizoma Curcumae of 280 parts of Herba Patriniae of Herba Scutellariae Barbatae.

4,, it is characterized in that said medicament is a capsule according to the auxiliary oral drugs of each described treatment cancer of claim 1～3.

5, the application of the described medicine of claim 1 in the ancillary drug of preparation treatment cancer.

6, the preparation method of the auxiliary oral drugs of the described treatment cancer of claim 1, it is characterized in that: step is as follows: a, get the people and participate in Hirudo powder and be broken into fine powder, sieve mixing; B, all the other ten simply crude drug add the little extraction of boiling of water, collecting decoction filters, and leaves standstill the back and filters, it is 1.25～1.30 extractum that filtrate is concentrated into 20 ℃ of relative densities, drying under reduced pressure gets dry extract, is ground into fine powder; C, with the fine powder of a step and the extractum mixing of b step, promptly.

7, the preparation method of the auxiliary oral drugs of treatment cancer according to claim 6, it is characterized in that in the b step ten simply crude drug add little the boiling of water and extract three times, each 1 hour, add 8 times of amounts of water for the first time, second and add 3 times of amounts of water for the third time.