CN105535437A

CN105535437A - Traditional Chinese medicine composition for treating malignant tumors of upper gastrointestinal tract and preparing method

Info

Publication number: CN105535437A
Application number: CN201610010216.5A
Authority: CN
Inventors: 郭海; 龚婕宁; 郭士祺; 吉福志; 董丽霞; 赵晓峰
Original assignee: Huaian No 1 Peoples Hospital
Current assignee: Huaian No 1 Peoples Hospital
Priority date: 2016-01-07
Filing date: 2016-01-07
Publication date: 2016-05-04

Abstract

The invention discloses a traditional Chinese medicine composition for treating malignant tumors of an upper gastrointestinal tract and a preparing method. The traditional Chinese medicine composition is prepared from, by weight, 5.50% of unprocessed rhizoma pinelliae, 5.50% of ginger processed pinellia, 5.50% of honey-fried licorice root, 16.48% of honey, 16.48% of scutellariae barbatae herba, 8.24% of oldenlandia diffusa, 8.24% of stiff silkworm, 8.24% of fiveleaf akebia fruit, 8.24% of radix pseudostellariae, 8.24% of radix ophiopogonis, 6.59% of radix rhapontici and 2.75% of centipede. The traditional Chinese medicine composition relieves the illness states of malignant tumors of the upper gastrointestinal tract, accelerates apoptosis of the tumor tissue, improves the emesis symptom and the life quality of patients and prolongs the life time of patients with tumors, no obvious toxic or side effect exists, and no adverse reaction exists.

Description

The Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors and preparation method

Technical field

The present invention relates to Chinese medicine composition and preparation method thereof, be specifically related to Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors and preparation method thereof.

Background technology

Upper-digestive-tract malignant tumors comprises esophagocardial carcinoma, gastric cancer, accounts for about 65% of whole malignant tumor, and wherein gastric cancer and the esophageal carcinoma are respectively and are positioned at digestive system tumor the 1st, the 4th.The sickness rate of northern territory, Jiangsu Province upper-digestive-tract malignant tumors increases year by year, and the sickness rate of the existing only esophageal carcinoma just reaches 69.47/10 ten thousand.When most upper-digestive-tract malignant tumors patient obtains clarifying a diagnosis, be middle and advanced stage, cannot row radical surgery.The patient of early metaphase upper-digestive-tract malignant tumors, while operation and chemicotherapy treatment, also can destroy body's immunity further.Part gerontal patient cardio-pulmonary function is poor, cannot accept chemicotherapy with one or more chronic systemic disease, and therefore the treatment of upper-digestive-tract malignant tumors exists the problems such as weak curative effect, easily recurrence, life cycle be shorter.Therefore in conjunction with Chinese medicine, patient's Perinatal Therapy, the immunologic function of chemicotherapy phase need be improved, alleviate the toxicity of chemicotherapy, Tumor suppression grows, improve life in patients, elongated strap tumor survival period, therefore Chinese medicine becomes one of important method for the treatment of upper-digestive-tract malignant tumors.

Upper-digestive-tract malignant tumors belongs to the category such as Chinese medicine " dysphagic ", " stomachache ", " regurgitation ", clinical with retrosternal pain, stomach pain, vomiting food and sputum for feature, very then " eating in the morning but vomiting out in the evening, vomiting out in the morning what eaten at last night " or " eat and namely tell ", most scholar thinks that primary disease pathogenesis is cancer poison and phlegm and blood stasis.As traditional Chinese medical science great master Professor Zhou Zhongying just thinks that this cause of disease cancer poison stays outstanding esophagus, stomach, hinder meridians mechanism of qi to run, cause body fluid can not become expectorant by normal defeated Bu Zeliu, vim and vigour normally can not be run and then stop as the stasis of blood, and cancer poison is fought with the expectorant stasis of blood and tied, then form lump, or soft or hard as rock, what push away does not move.Cancerous protuberance not only consumes human righteousness, damage function, and easily flees that it is dirty, forms primary tumor and metastasis.

Summary of the invention

The object of the invention is to: provide a kind of Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors and preparation method thereof, draw materials extensively, with low cost, Be very effective, without obvious toxic-side effects.

Technical solution of the present invention is: the Chinese medicine composition of this treatment upper-digestive-tract malignant tumors is made up of following raw material components percentage by weight: Rhizoma Pinelliae, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Glycyrrhizae Preparata each 5.50%, Mel, Herba Scutellariae Barbatae each 16.48%, Herba Hedyotidis Diffusae, Bombyx Batryticatus, Fructus Akebiae, Radix Pseudostellariae, Radix Ophiopogonis each 8.24%, Radix Rhapontici 6.59%, Scolopendra 2.75%.

Wherein, the preparation method of the Chinese medicine composition of this treatment upper-digestive-tract malignant tumors comprises the following steps:

(1) screening of raw material components: screening Rhizoma Pinelliae 100g, clear water is cleaned, for subsequent use; Screening Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Mel 300g are for subsequent use; Screening Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Bombyx Batryticatus 150g, Scolopendra 50g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g is for subsequent use;

(2) ultrasonic mixing: Rhizoma Pinelliae and Mel, adding distil water 500ml, boils 40 minutes, boil rear little wood spoon not stop to stir, and repetition 200 times of kicking up, then put into container, put into ultrasonic machine together with container, ultrasonic mixing 20min, obtain the cancer antidote semi-finished product 1 that disappear;

(3) extract: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Rhapontici, Fructus Akebiae, Radix Pseudostellariae, Radix Ophiopogonis, Radix Glycyrrhizae Preparata eight herbal medicine are added water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum;

(4) pulverize: Bombyx Batryticatus, Scolopendra two herbal medicine are pulverized through pulverizer, and 100 eye mesh screens sieve, and sterilizing obtains mixed powder;

(5) mix: the mixed powder of the thick extractum of step (3) and step (4) is moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains the cancer antidote semi-finished product 2 that disappear; The cancer that disappears antidote semi-finished product 2 and the cancer antidote semi-finished product 1 that disappear are the Chinese medicine composition of control upper-digestive-tract malignant tumors altogether.

Wherein, the method that the Chinese medicine composition of this treatment upper-digestive-tract malignant tumors makes oral liquid is: by Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boil 40 minutes, stir, kick up 200 times, ultrasonic mixing 20min, precipitation, filters, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, 100 eye mesh screens sieve, and sterilizing obtains mixed powder; Thick extractum and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product adding distil water 1200ml, boils 20 minutes, precipitation, and filter, get filtrate, vacuum concentration is 600ml, sub-bottle fill, 200 milliliters every bottle, and sterilizing seals, and is No. two oral liquids.

Wherein, the method that the Chinese medicine composition of this treatment upper-digestive-tract malignant tumors makes capsule is: by Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boil 40 minutes, stir, kick up 200 times, ultrasonic mixing 20min, precipitation, filters, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, sterilizing seals, and is an oral liquid;

By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; By Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, sieve with 100 eye mesh screens, sterilizing, obtains mixed powder; Thick extractum obtained above and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product move into container, are paved into thin layer, put into vacuum drying oven drying, temperature is set as 60-70 degree Celsius, dry 24 hours, and the cancer antidote semi-finished product that disappear of drying are moved into pulverizer, pulverize with 80 eye mesh screens, sterilizing, obtain with capsule filler is encapsulated the cancer detoxicating capsule that disappears, rotary speed is 30-40 rev/min, vacuum pressure pump 0.016MPa, the filled capsule polisher of capsule carries out polishing, every capsules 0.25g, packaging.

Wherein, the instructions of taking of the Chinese medicine composition of this treatment upper-digestive-tract malignant tumors is: oral liquid 10ml every day 3 times, adds No. two oral liquid 20ml every days 3 times, 15 minutes, the two interval, and two kinds of oral liquids are sequential to be taken; Or oral liquid 10ml every day 3 times, add capsule 3 every days 3 times, 15 minutes, the two interval, an oral liquid and capsule is sequential takes.

Advantage of the present invention is: 1, upper-digestive-tract malignant tumors treatment is basic rule for the treatment of with anticancer removing toxic substances, pungent temperature eliminating stagnation, select Rhizoma Pinelliae and Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) equivalent, get raw ripe half and half, to promote the normal differentiation of tumor cell, be converted into fully-developed normal cell by heterocyst; 2, Rhizoma Pinelliae thought that this medicine was poisonous modern age more, multiplex Rhizoma Pinelliae Preparata, but Toxicity of Rhizoma Pinelliae reduces after concocting, the therapeutical effect of its pungent temperature eliminating stagnation also reduces, toxic component through observing Rhizoma Pinelliae is mainly malicious needle, main manifestations is the zest toxicity to throat, the present invention selects Rhizoma Pinelliae, adopt decoct same with Mel, constantly stir in decoction process and kick up, and further through ultrasonic mixing, to destroy malicious needle, Mel holds malicious needle, alleviates the zest toxic action of Rhizoma Pinelliae, retains its antitumor action; 3, select Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), both Rhizoma Zingiberis Recens and the Rhizoma Pinelliae are pungent using warming therapy product, alleviate stimulation of raw Rhizoma Pinellia toxicity, add the function of the pungent temperature eliminating stagnation of the Rhizoma Pinelliae simultaneously; 4, all the other medicines are as Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Rhapontici, Bombyx Batryticatus, Scolopendra, Fructus Akebiae heat-clearing and toxic substances removing, dissipating phlegm and resolving masses, blood circulation promoting and blood stasis dispelling; 5, Radix Pseudostellariae, Radix Ophiopogonis supplementing QI and nourishing YIN, Radix Glycyrrhizae Preparata coordinating the actions of various ingredients in a prescription, eliminating pathogenic factor for supporting vital QI, reinforcement and elimination in combination; 6, the present invention adopts that two kinds of oral liquids are sequential to be taken, or oral liquid and the sequential administrated method taken of capsule, has both alleviated the zest of medicine, and has too increased therapeutical effect; 7, at Clinical practice, obtain good clinical effectiveness, through zooperal research, certain understanding has been had to the mechanism of its control upper-digestive-tract malignant tumors, part illustrate its mechanism of action, be expected to be developed as a kind of new drug preventing and treating upper-digestive-tract malignant tumors, without obvious toxic-side effects, without obvious adverse reaction.

Accompanying drawing explanation

Fig. 1 is tumor tissues morphological change (HE × 200) after each group of administration.

Fig. 2 is tumor tissues morphological change (2 μm) after each group of mice administration.

Fig. 3 is the impact of cancer antidote on Survivin protein expression in H22 mice-transplanted tumor that disappear.

Fig. 4 is the impact of cancer antidote on Survivin protein expression in H22 mice-transplanted tumor that disappear.

Detailed description of the invention

Further illustrate technical solution of the present invention below in conjunction with specific embodiment, these embodiments can not be interpreted as it is restriction to technical scheme.

Embodiment 1: according to following methods oral liquid

By Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boils 40 minutes, stirs, kicks up 200 times, ultrasonic mixing 20min, precipitation, and filter, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, and sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, 100 eye mesh screens sieve, and sterilizing obtains mixed powder; Thick extractum and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product adding distil water 1200ml, boils 20 minutes, precipitation, and filter, get filtrate, vacuum concentration is 600ml, sub-bottle fill, 200 milliliters every bottle, and sterilizing seals, and is No. two oral liquids.

Embodiment 2: according to following methods oral liquid

By Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boils 40 minutes, stirs, kicks up 200 times, ultrasonic mixing 20min, precipitation, and filter, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, and sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 82.5 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, 100 eye mesh screens sieve, and sterilizing obtains mixed powder; Thick extractum and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product adding distil water 1200ml, boils 20 minutes, precipitation, and filter, get filtrate, vacuum concentration is 600ml, sub-bottle fill, 200 milliliters every bottle, and sterilizing seals, and is No. two oral liquids.

Embodiment 3: according to following methods oral liquid

By Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boils 40 minutes, stirs, kicks up 200 times, ultrasonic mixing 20min, precipitation, and filter, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, and sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 85 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, 100 eye mesh screens sieve, and sterilizing obtains mixed powder; Thick extractum and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product adding distil water 1200ml, boils 20 minutes, precipitation, and filter, get filtrate, vacuum concentration is 600ml, sub-bottle fill, 200 milliliters every bottle, and sterilizing seals, and is No. two oral liquids.

Embodiment 4: according to following methods glue capsule

By Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boils 40 minutes, stirs, kicks up 200 times, ultrasonic mixing 20min, precipitation, and filter, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, and sterilizing seals, and is an oral liquid;

By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; By Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, sieve with 100 eye mesh screens, sterilizing, obtains mixed powder; Thick extractum obtained above and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product move into container, are paved into thin layer, put into vacuum drying oven drying, temperature is set as 60 degrees Celsius, dry 24 hours, and the cancer antidote semi-finished product that disappear of drying are moved into pulverizer, pulverize with 80 eye mesh screens, sterilizing, obtain with capsule filler is encapsulated the cancer detoxicating capsule that disappears, rotary speed is 30 revs/min, vacuum pressure pump 0.016MPa, the filled capsule polisher of capsule carries out polishing, every capsules 0.25g, packaging.

Embodiment 5: according to following methods glue capsule

By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 82.5 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; By Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, sieve with 100 eye mesh screens, sterilizing, obtains mixed powder; Thick extractum obtained above and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product move into container, are paved into thin layer, put into vacuum drying oven drying, temperature is set as 65 degrees Celsius, dry 24 hours, and the cancer antidote semi-finished product that disappear of drying are moved into pulverizer, pulverize with 80 eye mesh screens, sterilizing, obtain with capsule filler is encapsulated the cancer detoxicating capsule that disappears, rotary speed is 35 revs/min, vacuum pressure pump 0.016MPa, the filled capsule polisher of capsule carries out polishing, every capsules 0.25g, packaging.

Embodiment 6: according to following methods glue capsule

By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 85 degrees Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; By Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, sieve with 100 eye mesh screens, sterilizing, obtains mixed powder; Thick extractum obtained above and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product move into container, are paved into thin layer, put into vacuum drying oven drying, temperature is set as 70 degrees Celsius, dry 24 hours, and the cancer antidote semi-finished product that disappear of drying are moved into pulverizer, pulverize with 80 eye mesh screens, sterilizing, capsule filler is encapsulated obtains the cancer detoxicating capsule that disappears, rotary speed 40 revs/min, vacuum pressure pump 0.016MPa, the filled capsule polisher of capsule carries out polishing, every capsules 0.25g, packaging.

Experimental example 1: the cancer that disappears antidote in vivo antitumor effect mechanism

1 material

1.1 animals: cleaning grade ICR mice, male, body weight (18 ± 2) g, totally 72, purchased from Shanghai Si Laike laboratory animal responsibility company limited, laboratory animal production licence SCXK (Shanghai) 2007-0005, laboratory animal occupancy permit SYXK (Soviet Union) 2007-0030; Feedstuff is all purchased from Qinglongshan animal reproduction field, Jiangning county.

1.2 cell strains: the strain of H22 tumor is inoculated in mouse peritoneal, and well-grown, animal provides by Nanjing drum tower hospital Animal House in inoculation, and goes down to posterity in the inoculation of this laboratory, goes down to posterity once, for long run test every about 7d.

1.3 medicines: the cancer that disappears antidote by Herba Hedyotidis Diffusae, Bombyx Batryticatus, Scolopendra, Fructus Akebiae etc. according to dosage ratio form, Chinese medicine preparation is purchased from Chinese medicine and western medicine company limited of Haozhou city of Anhui Province; Fried by pharmacology teaching and research room of Nanjing University of Traditional Chinese Medicine, being condensed into crude drug amount is 2g/mL filtrate, saves backup; Cisplatin injections (Nanjing Pharmaceutical Factory Co., Ltd., lot number 20091118); Injection normal saline (Nanjing Xiaoying Medicine Group Co., Ltd, lot number 2009090403).

1.4 reagent and instrument: CS-15R type tabletop refrigerated centrifuge (Beckman company of the U.S.); OL-901 type suspendible instrument (its woods Bel instrument manufacturing company limited of Haimen City); BT323S type electronics sky (d=0.001g, German Sai Duolisi); MMP2-ELISA test kit (Pierce company of the U.S., lot number E0900225).

2 methods

2.1 animal models and grouping: cervical dislocation puts to death kind of a Mus, with iodine tincture, ethanol disinfection abdominal part, extract kind of a mouse ascites fluid 5mL, add the normal saline dilution of lOmL; Get 60 mices, the right axil skin of 75% ethanol disinfection mice, is inoculated in the right axil of mice by every Mus 0.2mL subcutaneous; Complete in the whole 60min of operating in, weigh after inoculation 24h; Be divided into 5 groups at random, often organize 12, i.e. model control group (normal saline gavage), positive controls (Intraperitoneal Cisplatin injection), the high, medium and low dosage group of Chinese medicine (cancer that disappears antidote Chinese medicine gavage); Separately getting 12 mices is blank group, and method is the same, every Mus inoculation 0.2mL normal saline; After inoculation the 2nd day starts administration, and dosage, with reference to clinical application amount, converts by people and mice (1:0.0026).

2.2 medications: blank group, model group gavage (ig) normal saline 0.9mL, qd; Cisplatin group lumbar injection (ip) cisplatin 0.001g/kgd, high, medium and low dose of Chinese medicine more group respectively gavage (ig) to disappear cancer Jiedu Fang, low dosage 10g/kgd, middle dosage 30g/kgd, high dose 90g/kgd; Except cisplatin group only administration 1d, all the other respectively organize equal successive administration 10d; Abdominal aortic blood after 10d, puts to death mice, peels off tumor block.

2.3 common light microscopic tissue slices: often organize and get 2 mices at random, peel off tumor body, draw materials, fix, conventional film-making, HE dyes.

The making of 2.4 electron microscope specimens: often organize and get 2 mices at random, cuts 0.5mm after peeling off tumor body ³the tumor soma of volume, 2.5% glutaraldehyde is fixed, conventional dehydration, infiltration, embedding, section, dyeing; Ready-made electron microscopic section is observed under transmission electron microscope.

2.5MMP-2 assay: peripheral blood sample, operates by MMP2-ELISA test kit description normal process.

2.6 statistical method: all defeated people's computer of all data, adopt SPSSl20 statistical software to analyze, data are with mean ± standard deviation represent, adopt t inspection, P<O.05 is for there being significant difference.

3 results

3.1 tumor tissues morphological change under light microscopic, Fig. 1.

3.2 tumor cell morphology change under Electronic Speculum, Fig. 2.

The unrestrained distribution of model group tumor cell bullet, visible a little apoptotic cell therebetween, the cell shrinkage of apoptosis, plasma membrane is complete, and endochylema is fine and close, and organelle is regression in various degree, nuclear chromatin is fine and close, form that shape differs, too little agglomerate limit not etc. combines in nuclear membrane place, part cell cytosol bud is prominent to come off rapidly, forms many apoptotic bodies; The cancer that disappears antidote low dose group: tumor cell fills the air distribution, visible apoptotic cell therebetween, apoptotic cell quantity more than model group, the cell shrinkage of apoptosis, plasma membrane is complete, the regression in various degree of endochylema inner cell organ, gulp down drink cavity in a large number as seen, nuclear chromatin is fine and close, forms that shape differs, the agglomerate limit that differs in size combines in nuclear membrane place, part cell cytosol bud is prominent to come off rapidly, forms many apoptotic bodies; Dosage group in the cancer that disappears antidote: swollen lame cell fills the air distribution, visible apoptotic cell therebetween, apoptotic cell quantity more than Chinese medicine low dose group, the cell shrinkage of apoptosis, plasma membrane is complete, the regression in various degree of endochylema inner cell organ, gulp down drink cavity in a large number as seen, nuclear chromatin is fine and close, forms that shape differs, the agglomerate limit that differs in size combines in nuclear membrane place, part cell cytosol bud is prominent to come off rapidly, forms many apoptotic bodies; The cancer that disappears antidote high dose: tumor cell fills the air distribution, the cancer that disappears Jiedu Fang apoptotic cell quantity is similar to Chinese medicine low dose group, the cell shrinkage of apoptosis, plasma membrane is complete, and the regression in various degree of endochylema inner cell organ, gulps down drink cavity as seen in a large number, nuclear chromatin is fine and close, the agglomerate limit that formation shape differs, differ in size combines in nuclear membrane place, and part cell cytosol bud is prominent to come off rapidly, and part core is chipping; Cisplatin group tumor cell fills the air distribution, apoptotic cell quantity is similar to Chinese medicine low dose group, the cell shrinkage of apoptosis, plasma membrane is complete, the regression in various degree of endochylema inner cell organ, and nuclear chromatin is fine and close, form that shape differs, too little agglomerate limit not etc. combines in nuclear membrane place, part karyorrhexis, part cell cytosol bud is prominent to come off rapidly, forms many apoptotic bodies.

3.3 peripheral blood MMP-2 content: compare with model group, blank group, the cancer that disappears antidote low dose group peripheral blood MMP-2 level significantly reduces (P<0.05, P<0.01); Cisplatin group and Chinese drug-treated group high dose group peripheral blood MMP-2 level reduce, but there was no significant difference; In Chinese medicine, dosage group MMP-2 level rises.

Table 1 disappears the impact of cancer antidote on mice with tumor peripheral blood MMP-2 content

Note: compare * P<0.05**P<0.01 with model group

Experimental example 2: the experiment of the cancer that disappears antidote antitumor action

1 material and instrument

1.1 instruments: CO2 gas incubator (ThermoForma company of the U.S.); DLF560 type superclean bench (Dutch ClearAirTechniekbv company); Tissue Culture Flask (Canadian BIOFIL company); Inverted microscope (German LeicaBMIRB company); The automatic microplate reader of SUNRISE (Austrian TECAN company); 100000/electronic balance (German Sai Duolisi).

1.2 cell lines: S180 tumor cell line and H22 tumor cell line are purchased from Nanjing Medical University's cell bank.

1.3 animals: Kunming mouse (regular grade), by Nanjing University of Traditional Chinese Medicine's Experimental Animal Center purchased from Shanghai Si Laike laboratory animal responsibility company limited, laboratory animal production licence: SCXK (Shanghai) 2003-0003; Laboratory animal occupancy permit: SYXK (Soviet Union) 2002-0123.

1.4 medicines and reagent

The cancer that disappears antidote: the routines such as Herba Hedyotidis Diffusae, Radix Rhapontici, Herba Scutellariae Barbatae are boiled medicine, merging filtrate, concentrated, save backup; New-born calf serum (Hangzhou Ilex purpurea Hassk.[I.chinensis Sims company, lot number 031801); Tetramethyl ribavirin indigo plant (MTT, Beijing Baeyer enlightening biotech firm, Amresco0993); Dimethyl sulfoxide (DMSO, vast Imtech); 0.25% HycloneLab company of the trypsin U.S.); Cyclophosphamide (Hualian Pharmaceutical Co., Ltd., Shanghai, lot number 050936); Injection normal saline (Xuzhou Lai Si Pharma Inc., lot number 051922).

2 methods

The 2.1 cancer antidote that disappear act in euphorbia egg decoctum cyton

Get Kunming mouse 60, male, weight 18 ~ 22g, be divided into 5 groups, often organize 12, i.e. model control group (normal saline gavage), positive controls (cyclophosphamide), the high, medium and low dosage group of medicine (cancer that disappears detoxification Chinese traditional medicine gavage); Administration 1 time/d, successive administration 14d, after administration the 4th day, every Mus right oxter inoculation S180 cell suspension 0.2mL; Within 15th day, strip solid tumor and weigh, calculating the heavy coefficient of tumor and tumour inhibiting rate as follows, and t inspection between organizing.

Heavy coefficient=tumor weight/the body weight of tumor

Tumour inhibiting rate (%)=(the heavy coefficient mean of the heavy coefficient mean-medicine group tumor of model group tumor) heavy coefficient mean × 100% of/model group tumor

The 2.2 cancer antidote that disappear act in Murine Hepatoma22 cyton

Get Kunming mouse 60, male, weight 18 ~ 22g, is divided into 5 groups, often organizes 12, i.e. model control group (igNS), positive controls (ip cyclophosphamide), the high, medium and low dosage group of medicine (ig disappear cancer antidote); Administration 1 time/d, successive administration 14d, after administration the 4th day, every Mus intraperitoneal inoculation H22 cell suspension 0.2ml; The H22 cell suspension of inoculation is 1: 3 dilution by volume of the transferred species H22 tumor source animal ascites normal saline of the 8th day; The tumor-bearing mice time-to-live after observation medication, calculate survival prolongation rate as follows, and t inspection between organizing.

Survival prolongation rate (%)=(medication group survival natural law mean-model group survival natural law mean)/model group survival natural law mean × 100%

2.3 statistical methods: all data all input computer, adopt SPSS12.0 statistical software, experimental data with represent, adopt t inspection.

3 results

3.1 disappear the inhibitory action of cancer antidote to S180 sarcoma

Result shows: the suppression ratio of the cancer that disappears Jiedu Fang high dose group reaches more than 40%, points out the cancer Jiedu Fang gavage that disappears to give to have certain inhibitory action, in table 2 to transplantability S180 sarcoma.

Table 2 disappears cancer antidote to the impact heavily of S180 sarcoma mouse entity tumor

Note: compare with model group, ^{★ ★}p < 0.01, ^★p < 0.05; N=12

3.2 disappear the inhibitory action of cancer antidote to H22 ehrlich ascites carcinoma

Result shows, all there is certain prolongation the time-to-live of the cancer that disappears Jiedu Fang high, medium and low dosage group tumor-bearing mice, and wherein, the increase in life span of high, middle dosage group reaches more than 30%, in table 3.

Table 3 disappears the impact of cancer antidote on the H22 ehrlich ascites carcinoma mouse survival time

Note: compare with model group, ^{★ ★}p < 0.01, ^★p < 0.05; N=12

Experimental example 3: the cancer that disappears antidote is on the impact of H22 tumor-bearing mice Peripheral Blood transforming growth factor-beta 1

1 materials and methods

1.1 main agents and medicine: the strain of H22 tumor is inoculated in mouse peritoneal, and grows vigorous, more than inoculating animal provides by Nanjing drum tower hospital Animal House, and goes down to posterity in the inoculation of this laboratory, goes down to posterity once, for long run test every about 7 days; The cancer that disappears antidote is made up of in given dose ratio Herba Hedyotidis Diffusae, Bombyx Batryticatus, Scolopendra, Fructus Akebiae etc., the prepared slices of Chinese crude drugs are purchased from Bozhou City Chinese medicine and western medicine company limited of Anhui Province, fried by pharmacology teaching and research room of Nanjing University of Traditional Chinese Medicine, being condensed into crude drug amount is 2g/mL filtrate, saves backup; Cisplatin injections (Nanjing Pharmaceutical Factory Co., Ltd., lot number 20091118); Injection normal saline (Nanjing Xiaoying Medicine Group Co., Ltd, lot number 2009090403).

1.2 instruments: tabletop refrigerated centrifuge GS-15R (BECKMAN company of the U.S.); Suspendible instrument OL-901 (its woods Bel instrument manufacturing company limited of Haimen City); Electronic balance BT323S (d=0.001g, German Sai Duolisi); TGF-β 1ELISA test kit (Pierce company of the U.S.).

1.3 laboratory animals: cleaning grade ICR mice, male, body weight (18 ± 2) g, totally 60; By Nanjing University of Traditional Chinese Medicine's Experimental Animal Center purchased from Shanghai Si Laike laboratory animal responsibility company limited, laboratory animal production licence: SCXK (Shanghai) 2007-0005; Laboratory animal occupancy permit: SYXK (Soviet Union) 2007-0030; Feedstuff is all purchased from Qinglongshan animal reproduction field, Jiangning county.

1.4 methods: ICR mice is divided into blank group at random, model group (normal saline gavage), the basic, normal, high dosage group (gavage) of the cancer that disappears antidote, cisplatin group (lumbar injection), often organizes 10; Cervical dislocation puts to death kind of a Mus, with 75% alcohol disinfecting abdominal part, extracts kind of a mouse ascites fluid 5mL, adds the normal saline dilution of 10mL.Except blank group, all the other the 5 groups right armpit skins of sterilization mice, are inoculated in the right axil of mice by every Mus 0.2mL subcutaneous, complete in the whole 60min of operating in; The cancer that will disappear antidote Chinese medicine water boiling concentration becomes 2g/mL; Take therapeutic dose as experiment low dosage, the appearance gavages such as the basic, normal, high dosage group of cancer antidote that disappears by 1: 3: 9 concentration, consumption all converts by people and Mice Body surface area dose,equivalent; Convert according to concentrated medicine, low dose group is 10g/ (kgd), and middle dosage group is 30g/ (kgd), and high dose group is 90g/ (kgd); Cisplatin group lumbar injection presses 0.001g/ (kgd) administration; Mice administration every day in 2nd day 1 time after modeling, continuous 10 days; Within 11st day, get blood through mouse orbit, blood sample centrifugal (rotating speed 3000r/min, centrifugal 10min), get serum (-70 ~-20 DEG C of preservations); Detect TGF-β 1 content in serum by ELISA kit, operating procedure completes by test kit description.

1.5 statistical methods: adopt SPSS12.0 statistical software process, experimental data with represent, group difference compares employing t inspection, with P < 0.05 for difference has statistical significance.

2 results: as shown in the table, compare with model group, blank group, the middle and high dosage group of Chinese medicine, cisplatin group Peripheral Blood TGF-β 1 level all decreases, Chinese medicine high dose group and cisplatin group and the blank group Peripheral Blood horizontal no difference of science of statistics of TGF-β 1 (P > 0.05), prompting disappear cancer antidote high dose in reduction Peripheral Blood TGF-β 1 is horizontal and cisplatin there is suitable effect.

Table 4 disappears the impact of cancer antidote on experiment mice Peripheral Blood TGF-β 1

Note: compare with model group ^★p < 0.05 ^{★ ★}p < 0.01

Experimental example 4: the impact that the cancer that disappears antidote is expressed H22 cell strain apoptosis and Survivin

1 materials and methods

1.1 material

1.1.1 the cancer that disappears antidote by the Chinese medicines such as Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Rhapontici, Bombyx Batryticatus, Scolopendra, Fructus Akebiae, Radix Pseudostellariae, Radix Ophiopogonis, Radix Glycyrrhizae Preparata according to dosage ratio form, fried by pharmacology teaching and research room of Nanjing University of Traditional Chinese Medicine, being condensed into crude drug amount is 2g/ml filtrate, saves backup; Cisplatin injections is purchased from Nanjing Pharmaceutical Factory Co., Ltd. (lot number is 20100218), and Westernblotting, test kit is purchased from Nanjing Sai Yan biotech firm.

1.1.2 animal: cleaning grade ICR mice, male, body weight (18 ± 2) g, totally 62, purchased from Shanghai Si Laike laboratory animal responsibility company limited, animal credit number: SCXK (Shanghai) 2007-0005, occupancy permit number is SYXK (Soviet Union) 2007-0030, and feedstuff is all purchased from Qinglongshan animal reproduction field, Jiangning county; Mus is provided by Nanjing drum tower hospital Animal House H22 hepatocarcinoma kind; Extraction kind of a mouse ascites fluid 0.4ml is inoculated in 2 ICR mouse peritoneals and carries out go down to posterity (ascites does not only dilute 0.2ml/), again goes down to posterity 1 time, for continuous experiment every about 7d.

1.2 method

1.2.1 laboratory animal grouping, modeling and administration

ICR mice is divided into blank group at random, model group (normal saline gavage), the basic, normal, high dosage group (gavage) of the cancer that disappears Jiedu Fang, cisplatin group (lumbar injection), often organizes 10; Cervical dislocation puts to death kind of a Mus, with 75% alcohol disinfecting abdominal part, extracts kind of a mouse ascites fluid 5ml, adds the normal saline dilution of 10ml; Except blank group, all the other the 5 groups right armpit skins of sterilization mice, are inoculated in the right axil of mice by every Mus 0.2ml subcutaneous, complete in the whole 60min of operating in; The cancer that will disappear antidote Chinese medicine water boiling concentration becomes 2g/ml; Take therapeutic dose as experiment low dosage, to disappear cancer antidote basic, normal, high dosage group isometric(al) gavage by 1:3:9 concentration, consumption all converts by people and Mice Body surface area dose,equivalent.Convert according to concentrated medicine, low dose group is 10g/kg/d, and middle dosage group is 30g/kg/d, and high dose group is 90g/kg/d.Cisplatin group lumbar injection presses 0.001g/kg/d administration.Mice administration every day in 2nd day 1 time after modeling, continuous 10 days, puts to death mice on the 11st day.

1.2.2 Flow cytometry H22 transplanted tumor cell cycle and apoptotic peak (hypodiploid peak)

Get the mice H22 transplanted tumor tissue of execution and shred grinding, 400 order nylon net filters become single cell suspension, the centrifugal 5min of 1000r/min, quick abandoning supernatant, adds PBS0.5ml, suspendible instrument slowly injects 2ml4 DEG C, the cold ethanol of 75%, 20 DEG C of preservations after cell is fixing, 1800r/min is centrifugal, and 10min removes ethanol, adds PBS2ml, 1000r/min is centrifugal abandons supernatant, adds PBS and adjusts cell density to be 1 × 10 ⁶individual/ml, makes final volume be 0.5ml, adds the mixing of PI dye liquor, and after 30min, upper machine testing, analyzes each group of H22 transplanted tumor cell hypodiploid apoptotic peak, study tumour cell cycle and apoptotic impact.

1.2.3Westernblot method detects H22 transplanted tumor cell Survivin protein expression

Terminate to put to death mice in after administration the 2nd day, get the transplanted tumor tissue of putting to death mice, tumor sample body lysis buffer is diluted same concentrations, gets equivalent sample-loading buffer in test tube, protein content is 70 μ g, and after 95 ~ 100 DEG C of 5min cooled on ice loading; Deposition condition: concentrated glue constant voltage 60V is about 20min, and separation gel 80V is about 80min; Take out gel, be placed in transfering buffering liquid and balance 15min; Prepare filter paper and pvdf membrane, insert in transfering buffering liquid and deionized water respectively; Keep flat bottom electrode (anode), place filter paper, NC film, gel and filter paper above respectively, after getting rid of each layer bubble, upper electrode (negative electrode) is put in sandwich; Be energized by constant current 200mA, electrotransfer 1h; Pvdf membrane closes (room temperature, 2h) in 5% defatted milk powder confining liquid, discards confining liquid, does not wash.By about 0.1ml/cm ²amount add confining liquid and appropriate primary antibodie is all 1: 500; Shaking table sways hatches (4 DEG C, spend the night).PBST rinsing filter membrane 4 times, each 10min; Sway under film is combined with HRP two anti-(horseradish peroxidase labelling goat-anti rabbit, two anti-confining liquids dilute) (1: 5000) room temperatures and hatch 2h, then fully wash film with PBST, rinsing 4 times, each 10min; ECL colour developing is taken pictures, and β-actin is as internal reference; Application EADS290 gel imaging system analysis result.Survivin relative expression quantity=Survivin gray value/β-actin gray value.

1.3 statistical methods: experimental data with represent, adopt SPSS17.0 statistical software, adopt one factor analysis of variance and q to check more each group difference, with P < 0.05 or P < 0.01 for difference has statistical significance according to difference homogeneous.

2 results

2.1 disappear the impact (table 5) of cancer Jiedu Fang on H22 transplanted tumor cell cycle and apoptosis

Table 5 result shows, and each dosage group of the cancer that disappears antidote and cisplatin group apoptosis can occur, and after drug effect, the apoptosis rate of cell does not raise in dose dependent; The mice mean apoptotic rate of each dosage group of the cancer that disappears antidote and cisplatin positive controls is all higher than model group mice mean apoptotic rate.The two compares, and difference all has statistical significance (P < 0.01, P < 0.05).The cancer that disappears antidote dosage be 30mg/kg with cisplatin group apoptosis rate compared with model group, P < 0.01, difference have height statistical significance; The cancer that disappears antidote dosage is 10mg/kg with 90mg/kg apoptosis rate P < 0.05 compared with model group, and difference has statistical significance; FCM Cell cycles showed, compare with model group, in the cancer that disappears antidote, dosage group is relative with cisplatin positive controls cell G0/G1 phase ratio increases, P < 0.05, difference has statistical significance, and S phase and G2 decline relatively from phase ratio, and cell cycle blocked in the G0/G1 phase, P < 0.05, difference has statistical significance; Low dose of the cancer that disappears antidote compares with high agent group cell and model group, and the cell S phase, G2/M phase ratio declines to some extent, but P > 0.05, G0/G1 phase ratio rises, but P > 0.05.

Table 6 respectively the cell cycle of group mouse tissue cell and apoptosis rate compare (n=10, %)

Note: compare with model group, ^{★ ★}p < 0.01, ^★p < 0.05

2.2 disappear the impact (Fig. 3, Fig. 4) of cancer antidote on H22 transplanted tumor cell Survivin protein expression

Westernblot method detects each group of Survivin protein expression result compared with model group, each group of survivin protein expression all has downward trend, wherein DDP positive controls Survivin protein expression reduces the most obvious, and in the cancer that disappears antidote 10mg/kg low dose of group, 90mg/kg height agent group and 30mg/kg, agent group Survivin protein expression also reduces successively.

Result shows the mice mean apoptotic rate of the disappear each dosage group of cancer antidote and cisplatin positive controls all higher than model group mice mean apoptotic rate; The two compares, and difference all has statistical significance (P < 0.01, P < 0.05); The cancer that disappears antidote dosage be 30mg/kg with cisplatin group apoptosis rate compared with model group, P < 0.01, difference have height statistical significance; FCM Cell cycles showed, compare with model group, in the cancer that disappears antidote, dosage group is relative with cisplatin positive controls cell G0/G1 phase ratio increases, P < 0.05, difference has statistical significance, and S phase and G2 decline relatively from phase ratio, and cell cycle blocked in the G0/G1 phase, P < 0.05, difference has statistical significance; Westernblot method detects each group of Survivin protein expression result compared with model group, each group of survivin protein expression all has downward trend, wherein DDP positive controls Survivin protein expression reduces the most obvious, and in the cancer that disappears antidote 10mg/kg low dose of group, 90mg/kg height agent group and 30mg/kg, agent group Survivin protein expression also reduces successively; This experiment cancer antidote that shows to disappear can promote apoptosis of tumor cells, and suppressing Survivin protein expression, is one of its mechanism of anticancer action.

Experimental example 5: the cancer that disappears antidote treatment esophageal carcinoma clinical observation on the therapeutic effect

1 data and method

1.1 data

1.1.1 Disease Diagnosis Standard: discomfort, burn feeling, vexed swollen sense, esophagus pain, foreign body sensation, dysphagia after patient exists breastbone, the clinical symptoms such as sense, food entrapment sense, vomiting, hoarseness and anorexia of slightly choking with sobs when swallowing, and make a definite diagnosis, through TNM classification through imaging examination and histology or cytolgical examination.

1.1.2 Chinese medical disease diagnostic criteria: the visible dysphagia of patient, blocks, eats lattice and refuse down, emaciated physique, shortness of breath and fatigue, dry mouth and throat, pharyngalgia, constipation with dry stool, dysphoria with feverish sensation in the chest palms and soles, is doublely shown in distending pain in the chest and hypochondrium, has a dizzy spell, and generally tells saliva clearly, sticky saliva is more, chest and diaphragm pain, and skin is shrivelled, pale or sallow complexion, or cold physique is breathed hard, body of the tongue light HongShaoJin(SIC), thready and rapid pulse or stringy and rapid pulse, dialectical is functional activities of the body fluid virtual loss, knot card in pyretic toxicity.

1.1.3 case inclusive criteria: pathology or cytolgical examination are clearly the esophageal carcinoma, 40 years old to 82 years old age, Ka Shi scoring is greater than 60 points, estimate life cycle and be greater than 6 months, possesses radiotherapy indication, be ready to accept Chinese medicine associating radiotherapy, other antineoplastons capable in nearly 1 month, all patients or family members all sign Informed Consent Form.

1.1.4 case exclusion standard: gestation and women breast-feeding their children, psychotic, be associated with the serious primary disease of other system or complications, there is medicine food anaphylaxis history or knownly have allergy sufferers to this medicine component, participating in the patient of other drug clinical trial, the infull person of clinical data all can not enter group research.

1.1.5 short term effect standard: be divided into according to the objective efficacy assessment standard of WHO solid tumor: complete incidence graph (CR): visual tumors pathological changes disappears completely, maintains more than 1 month; Partial rcsponse (PR): the maximum gauge of tumor focus and perpendicular diameter product Suo little ≤50%, occurs continuing >1 month without new focus; Stable (SD): focus reduces <50% or increases <25%, occurs, maintain more than 1 month without new focus; Progress (PD): two footpath products of tumor focus increase >25%, or occur new focus; Untoward reaction is divided into 0 degree of-IV degree according to WHO toxic and side effects grade scale.

1.1.6 medical history information: whole 60 routine patients are First Hospital oncotherapy center, Nanjing Medical University attached Huaian in July, 2013 to 2015 year December inpatient, are divided into two groups with random digits table; Matched group 30 example, wherein man 18 example, female 12 example; Age 54-82 year, average 68.5517 ± 5.6671 years old; TNM classification II phase 28 example, III phase 1 example, IV phase 1 example; Ka Shi scoring 78.7097 ± 3.4078 points; Pathologic finding scale cancer 30 example; Observation group 30 example, wherein man 21 example, female 9 example, age 44-79 year, average 66.5161 ± 8.0812 years old, TNM classification II phase 26 example, III the phase 3 example, IV the phase 1 example; Ka Shi scoring 76.1667 ± 5.8359 points; Pathologic finding scale cancer 28 example, small cell carcinoma 1 example, neuroendocrine tumour 1 example; Two groups of ages, sex, clinical stages, histological type, Ka Shi scoring are through statistical procedures there are no significant difference (P>0.05).

1.2 Therapeutic Method: the capable simple three dimensional conformal radiation therapy of matched group.Radiotherapy localization under CT analog machine, take 5mm as Scan slice thickness, 3mm rebuilds image, import in TPS planning system, and drawing target outline and normal structure, tumor and metastasis size is shown for tumor target (GTV) substantially with CT spacer (mediastinum window and lung window), vertical diaphragm metastatic lymph node is GTVnd, to put 10mm outside GTV and GTVnd for clinical tumor target area (CTV), it is PTV that CTV puts 5mm towards periphery, adopt intensive modulated radiotherapy technology, 6/15Mv-x line isocentric treatment, normal tissue dose controls in tolerance range, the OncorImpression linear accelerator adopting German SIEMENS company to produce is treated, 60-66Gy/30-33 time, 5 times weekly, observation group gives matched group same conformal therapy, and takes the cancer antidote that disappears from radiotherapy, every day 1 dose, decoction, takes to radiotherapy and terminates, the cancer that disappears antidote forms: Rhizoma Pinelliae 20g, Herba Hedyotidis Diffusae 15g, Herba Scutellariae Barbatae 30g, Scolopendra 5g, Fructus Akebiae 15g, Radix Pseudostellariae 15g, Radix Ophiopogonis 15g and Radix Glycyrrhizae Preparata 10g etc., with card plus-minus: distending pain in the chest and hypochondrium, have a dizzy spell, generally tell saliva clearly, relevantly to emotion add Radix Bupleuri, Fructus Aurantii, the Radix Paeoniae Alba, sticky saliva comparatively adds Arisaema Cum Bile, Semen Armeniacae Amarum, chest and diaphragm pain, skin is shrivelled adds Semen Persicae, Radix Salviae Miltiorrhizae, pale or sallow complexion adds Radix Codonopsis, the Rhizoma Atractylodis Macrocephalae, the Radix Astragali, Radix Angelicae Sinensis, CT, routine blood test, hepatic and renal function inspection and appraisal of life quality is carried out respectively before and after treatment.

1.3 statistical method: all data EXCEL software administrations, adopt SPSS17.0 software analysis; Measurement data t checks, and ranked data Ridit checks, and measurement data adopts X2 inspection.

2 therapeutic outcomes

2.1 liang of group short term effects compare: before and after two groups of treatments, row breast CT checks, compare size of tumor, two groups of patients are all obviously alleviated, but short term effect compares without significant difference (P>0.05), in table 7.

A table 7 liang group patient short term effect compares (example, %)

* P<0.05**P<0.01 is compared with matched group

Compare with before treatment ^※p<0.05 ^{※ ※}p<0.01

2.2 liang of group radiotherapy toxic reactions compare: two groups of main toxicities of patient are the hematological change that bone marrow depression causes, wherein leukopenia to 4.0 × 10 ⁹/ below L person, matched group 8 example, accounts for 26.67%, treatment group 2 example, and account for 6.67%, observation group, lower than matched group, has significant difference (P<0.05); Radioactivity tracheitis matched group 4 example, observation group 0 example, observation group is significantly lower than matched group (P<0.05); Two groups of total toxicities compare, matched group 17 example, observation group 5 example, and observation group, lower than matched group, has significant difference (P<0.01); Two groups all have minority case appearance Esophageal Mucosa reaction in various degree, show as radiation period retrosternal pain, block and increase the weight of, generally energy spontaneous remission; Gastrointestinal reaction main manifestations is that appetite declines, Nausea and vomiting, and mostly be light moderate, general anti symptom treatment can disappear; Two groups are all damaged without Liver and kidney function, without stopping therapist because of toxic reaction, in table 8.

After table 8 liang group treatment, toxicity situation compares (example, %)

* P<0.05**P<0.01 is compared with matched group

Compare with before treatment ^※p<0.05 ^{※ ※}p<0.01

2.3 liang of group Kanofsky situations of marking compare: matched group and the front Kanofsky of observation group's treatment mark to compare and have no remarkable significant difference (P>0.05); Compare and have no significant difference (P>0.05) before matched group and observation group's treatment with after treating; More also significant difference (P>0.05) is had no, in table 9 after matched group and observation group's treatment.

The comparison of Kanofsky scoring before and after table 9 liang group treatment

* P<0.05**P<0.01 is compared with matched group

Compare with before treatment ^※p<0.05 ^{※ ※}p<0.01

2.4 liang of recent symptoms of group are improved situations and are compared: uncomfortable and foreign body sensation after patient's breastbone, uncomfortable in chest, pain, dysphagia, hoarseness, stomachache, body weight, feed, pulmonary's rale and other symptoms, 0-10 level is divided into according to the order of severity, asymptomatic is 0 point, the imaginabale most order of severity is 10 points, and the total score value calculating each patient after all for each patient sensory symptoms score values are added carries out statistics and compares.Before found that treatment, observation group's score value is significantly higher than matched group (P<0.01), matched group and the rear score value of observation group's treatment obviously reduce (P<0.01) before all comparatively treating, observation group comparatively matched group reduces more obvious (P<0.01), in table 10.

Before and after table 10 liang group treatment, symptom score compares in the recent period

* P<0.05**P<0.01 is compared with matched group

Compare with before treatment ^※p<0.05 ^{※ ※}p<0.01

2.5 liang of group neoplastic hematologic disorder Indexes Comparison: through clinical observation, compare at pre-treatment and after treatment according to group and observation group CEA and are showed no notable difference (P>0.05); Observation group CA50 is the comparatively front obviously rising (P<0.01) for the treatment of after the treatment, and matched group raises and has no notable difference (P>0.05); Notable difference (P>0.05) is had no before observation group and matched group CA199 treat, after treatment of control group, comparatively treatment is front obviously raises (P<0.01), and after observation group's treatment, comparatively treatment is front obviously reduces (P<0.01); Matched group CA724 is the comparatively front obviously rising (P<0.01) for the treatment of after treating, and the comparatively front obviously reduction (P<0.01) for the treatment of after observation group's treatment, in table 11.

Before and after table 11 liang group treatment, hematochezia liquid Tumor invasion compares

* P<0.05**P<0.01 is compared with matched group

Compare with before treatment ^※p<0.05 ^{※ ※}p<0.01

2.6 liang of group late results compare: two groups of patients will all follow up a case by regular visits to the end of the year 2015, and matched group 4 example is dead, and mortality rate is 13.33%, half annual survival rate 93.33%, 1 annual survival rate 86.67%.Observation group 1 example is dead, and mortality rate is 3.33%, half annual survival rate 100%, 1 annual survival rate 97.67%; Compare unknown significance difference (P>0.05) between 0.5 year, 1 year survival rates of two groups, 2 years survival rates, 5 years survival rates, owing to limiting observing time, fail to obtain definite result.

2.7 liang of group fatal factors: two groups of totally 5 routine deaths, all die from the concurrent bone marrow depression of tumor metastasis and Organ Failure.

The clinical research of the cancer that the disappears antidote treatment esophageal carcinoma, find obviously to alleviate leukocyte that bone marrow depression that radiotherapy causes causes and erythrocyte reduces, uncomfortable and foreign body sensation after obviously alleviating breastbone, uncomfortable in chest, pain, dysphagia, hoarseness, suffer from abdominal pain, lose weight, minimizing and the pulmonary's rale etc. of taking food symptom in the recent period, obviously reduce neoplastic hematologic disorder mark CA199 and CA724 (P<0.01); Research thinks that the Chinese medicine cancer antidote treatment esophageal carcinoma that disappears improves quality of life of patient, alleviates toxic and side effects, reduces Tumor invasion, improve combined therapy effect.

Experimental example 6: the impact of the cancer that disappears antidote centering patients with advanced malignant tumor immunologic function

1 object and method

1.1 objects: in January, 2013 ~ 2015 Nanjing Traditional Chinese Medicine Univ. affiliated hospital in year October, the hospitals of traditional Chinese and western medicine of attached province of Nanjing University of Traditional Chinese Medicine, Nanjing University of Traditional Chinese Medicine the 3rd Affiliated Hospital's Tumor Patients Hospitalized 198 example, all turn out to be III ~ IV phase malignant tumor through histopathology or cytology, Chinese medical discrimination belongs to the expectorant stasis of blood strongly fragrant poison card patient.Man 122 example, female 76 example, the age 24 ~ 78 (average 56.96) year; The esophageal carcinoma 49 example, 47 patients with lung cancer, breast carcinoma 42 example, gastric cancer 38 example, hepatocarcinoma 20 example, cancer of pancreas 2 example.KPS scoring >=60 points before all Chemotherapy in Patients, is divided into chemotherapy to add Chinese drug-treated group (therapeutic alliance group) 120 example, chemotherapy group (chemotherapy group) 78 example; Two groups of patients in case source, sex, age, the course of disease, sickly to plant, by stages etc. in carry out harmony and compare, equal no difference of science of statistics (P > 0.05), has comparability.

1.2 method

1.2.1 Therapeutic Method: therapeutic alliance group, except conventional chemotherapy, adds with the cancer detoxification Chinese traditional medicine decoction oral that disappears; Prescription: the compositions such as Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae, Radix Rhapontici; Start to take in chemotherapy the 1st cycle cancer detoxification Chinese traditional medicine decoction that disappears simultaneously, be used in conjunction 2 ~ 3 months; Chemotherapy group adopts chemotherapy.

1.2.2 Indexs measure

T cell Subsets: adopt indirect immunofluorescence, the peripheric venous blood T cell subgroup gathered for 2nd ~ 3 months before measuring patient treatment and after treatment; NK cytoactive detection: the peripheric venous blood gathered for 2nd ~ 3 months before getting patient treatment and after treatment, makes l × 10 ⁷/ ml cell suspension, joins and gets 0.1ml and add in 96 porocyte culture plates, then use ³h-TdR isotope-labeled YAC-l cell 0.1ml (as target cell) mixes, and each sample does 2 multiple holes, and culture plate puts into 37 DEG C of 5%CO ₂l6h in incubator, collecting cell, measures CPM (umber of pulse per minute); NK cytoactive cell toxicant index CI% represents; (CI%=[1-(experimental port A value-effector lymphocyte A value)/target cell A value] × 100%).

1.3 statistical procedures: detect data and represent with (x ± s), compare employing paired t-test in statistical method group, adopt independent samples t-test between group, P < 0.05 is considered to difference statistical significance.

2 results: treat front 2 groups of immune functional state no significant difference, therapeutic alliance group patient T cells sum (CD after treatment ₃ ⁺), helper T lymphocyte number (CD ₄ ⁺), CD ₄ ⁺/ CD ₈ ⁺value and NK cytoactive are apparently higher than chemotherapy group (P < 0.01), and corresponding difference and chemotherapy group more also have significant difference (P < 0.05, P < 0.01); Therapeutic alliance group CD after treatment ₈ ⁺t cell comparatively chemotherapy group decline, with chemotherapy group comparing difference without significance (P > 0.05); Compare with before treatment, CD in therapeutic alliance group T cell subgroup ₄ ⁺obvious rising, CD ₄ ⁺/ CD ₈ ⁺ratio obviously rise, NK cytoactive obviously increases (P < 0.05), and chemotherapy group obviously declines (P < 0.05, table 12) before comparatively treating.

Table 12 disappears the impact (x ± s) of cancer antidote on malignant tumor patient T cell subgroup and NK cytoactive

Note: compare with chemotherapy group ^*p < 0.05 ^*p < 0.01;

With with organize treat before compare ^▼p < 0.05.

Result shows, after the cancer Jiedu Fang treatment that disappears is closed in therapeutic alliance assembly, and patient CD ₃ ⁺, CD ₄ ⁺, CD ₄ ⁺/ CD ₈ ⁺value and NK cytoactive are apparently higher than matched group (P < 0.01); Compare with before treatment, CD in T cell Asia ₄ ⁺obvious rising, CD ₄ ⁺/ CD ₈ ⁺ratio obviously rise, NK cytoactive obviously increases (P < 0.05), and chemotherapy group obviously declines (P < 0.05) before comparatively treating; The result of study cancer antidote that shows to disappear can correct peripheral blood in patients T cell percentage ratio, improves NK cytoactive, regulates cellular immune function, thus improve patient's antitumor immunity of organism ability.

The above is only preferred implementation method of the present invention; it should be pointed out that the ordinary person for technical field, under the prerequisite not departing from the technology of the present invention principle; can also make some improvements and modifications, these improvements and modifications also should be considered as protection scope of the present invention.

Claims

1. treat the Chinese medicine composition of upper-digestive-tract malignant tumors, it is characterized in that this Chinese medicine composition is made up of following raw material components percentage by weight: Rhizoma Pinelliae, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Glycyrrhizae Preparata each 5.50%, Mel, Herba Scutellariae Barbatae each 16.48%, Herba Hedyotidis Diffusae, Bombyx Batryticatus, Fructus Akebiae, Radix Pseudostellariae, Radix Ophiopogonis each 8.24%, Radix Rhapontici 6.59%, Scolopendra 2.75%.

2. treat the preparation method of the Chinese medicine composition of upper-digestive-tract malignant tumors, it is characterized in that this preparation method comprises the following steps:

(3) extract: Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Herba Hedyotidis Diffusae, Herba Scutellariae Barbatae, Radix Rhapontici, Fructus Akebiae, Radix Pseudostellariae, Radix Ophiopogonis, Radix Glycyrrhizae Preparata are added water to submerge, boils 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar and concentrates, and obtains thick extractum;

3. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that the method that this Chinese medicine composition makes oral liquid is: by Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boil 40 minutes, stir, kick up 200 times, ultrasonic mixing 20min, precipitation, filters, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, 100 eye mesh screens sieve, and sterilizing obtains mixed powder; Thick extractum and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product adding distil water 1200ml, boils 20 minutes, precipitation, and filter, get filtrate, vacuum concentration is 600ml, sub-bottle fill, 200 milliliters every bottle, and sterilizing seals, and is No. two oral liquids.

4. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that the method that this Chinese medicine composition makes capsule is: by Rhizoma Pinelliae 100g, Mel 300g, adding distil water 500ml, boil 40 minutes, stir, kick up 200 times, ultrasonic mixing 20min, precipitation, filters, get filtrate, vacuum concentration is 300ml, sub-bottle fill, 100 milliliters every bottle, sterilizing seals, and is an oral liquid; By Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 100g, Herba Hedyotidis Diffusae 150g, Herba Scutellariae Barbatae 300g, Radix Rhapontici 120g, Fructus Akebiae 150g, Radix Pseudostellariae 150g, Radix Ophiopogonis 150g, Radix Glycyrrhizae Preparata 100g eight herbal medicine adds water to submerge, boil 40 minutes, with water extracting 2 times, each 3 hours, temperature controls at 80-85 degree Celsius, filtrate is moved into Cooling or heating jar concentrate, obtain thick extractum; By Bombyx Batryticatus 150g, Scolopendra 50g two herbal medicine, pulverize through pulverizer, sieve with 100 eye mesh screens, sterilizing, obtains mixed powder; Thick extractum obtained above and mixed powder are moved into hopper, and mix with three-dimensional mixer, rotating speed is 10 revs/min, and incorporation time is 10 minutes, obtains 300ml and to disappear cancer antidote semi-finished product; The cancer that disappears antidote semi-finished product move into container, are paved into thin layer, put into vacuum drying oven drying, temperature is set as 60-70 degree Celsius, dry 24 hours, and the cancer antidote semi-finished product that disappear of drying are moved into pulverizer, pulverize with 80 eye mesh screens, sterilizing, obtain with capsule filler is encapsulated the cancer detoxicating capsule that disappears, rotary speed is 30-40 rev/min, vacuum pressure pump 0.016MPa, the filled capsule polisher of capsule carries out polishing, every capsules 0.25g, packaging.

5. the preparation method of the Chinese medicine composition of the treatment upper-digestive-tract malignant tumors according to claim 3 or 4, it is characterized in that the instructions of taking of Chinese medicine composition is: oral liquid 10ml every day 3 times, add No. two oral liquid 20ml every days 3 times, 15 minutes, the two interval, two kinds of oral liquids are sequential to be taken; Or oral liquid 10ml every day 3 times, add capsule 3 every days 3 times, 15 minutes, the two interval, an oral liquid and capsule is sequential takes.

6. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that: the cancer antidote semi-finished product 2 that disappear of step (5), through granulation, dry, granulate, obtain granule.

7. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that: step (5) gained disappears cancer antidote semi-finished product 2 drying, tabletting, obtains tablet.

8. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that: step (5) gained disappears cancer antidote semi-finished product 2 through pill, drying, makes micropill.

9. the preparation method of the Chinese medicine composition for the treatment of upper-digestive-tract malignant tumors according to claim 2, is characterized in that: step (5) gained disappears, and the drying of cancer antidote semi-finished product 2 is rear to be mixed with appropriate vegetable oil, makes soft capsule.