CN101480438A - Use of compound Chinese lobelia preparation for preparing medicament for treating tumor - Google Patents
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Abstract
The invention discloses a new purpose of a compound Chinese Lobelia formulation for treating tumor or treating tumor in conjunction with chemotherapeutic treatment and radiation treatment, which belongs to the field of traditional Chinese medicine. Aiming at various injuries such as universal and serious damage to immunity of the organism, obvious reduction of white blood cells, bacterial infection, pain, and the like caused by simulative chemotherapeutic treatment and radiation treatment to a patient who suffers from tumor, experimental results indicate that the compound Chinese Lobelia formulation can obviously enhance the immunologic function, can remarkably increase the phagocytic function of scavenger cells, has protective action for reducing white blood cells, and has the weighting function for spleen and thymus; the compound Chinese Lobelia formulation has a certain in-vitro antibacterial action for staphylococcus aureus (G+) and colon bacillus (G-), has obvious protective function for a mouse infected by staphylococcus aureus and colon bacillus, can obviously reduce the death rate of the infected mouse and delay the death time to some extent; and the compound Chinese Lobelia formulation has obvious analgestic action for rats and mousse. The experimental results explain that the compound Chinese Lobelia formulation can be used for treating tumor or used for treating tumor in conjunction with chemotherapeutic treatment and radiation treatment and can increase the tolerance and the adaptability of a patient for chemotherapeutic treatment, strengthen the immunity of an organism, shorten the period of chemotherapeutic treatment or radiation treatment, reduce the toxic side reaction in chemotherapeutic treatment or radiation treatment, lower the death rate of a tumor patient and improve the life quality of a patient.
Description
Technical field
The present invention relates to the new purposes of Chinese medicine compound Herba Lobeliae Chinensis preparation, particularly be used for new purposes aspect the tumor in treatment tumor or combined with chemotherapy radiotherapy.Belong to the field of Chinese medicines.
Background technology
FUFANG BANBIANLIAN ZHUSHEYE is that State Food and Drug Administration's approval is applied to clinical modern Chinese medicine preparation.The sterile water solution of FUFANG BANBIANLIAN ZHUSHEYE for extracting from Chinese medicine Herba Lobeliae Chinensis, Herba Scutellariae Barbatae, Herba Hedyotidis Diffusae has heat-clearing and toxic substances removing, and the effect of reducing swelling and alleviating pain is used for the treatment of multiple furuncle and phyma, tonsillitis, mastitis etc. clinically.
Tumor is a performance of the unordered propagation of cells in vivo, and intravital most cells can cancerization, and carcinogenic reason is diversified, comprises heredity, environment, infection, age or the like.From present trend, the tumor incidence of various countries improves year by year, might become the modal lethal factor of 21 century, has become a great problem of mankind nowadays.
The main means that are used for oncotherapy at present have operation, radiotherapy, chemotherapy and Biotherapeutics etc.Because existing various treatment meanss respectively have its optimal adaptation disease, and its deficiency is also respectively arranged, so, in order to improve cure rate, should and carry out in order various effective means comprehensive reasonable utilizations.Operative treatment is many morning, the topmost effective Therapeutic Method of entity tumor in mid-term, and about 60% solid tumor is to perform the operation as main treatment means.But to the tumor of existing diffusion, operative treatment often can only be as the palliative treatment means.Perioperative reasonable chemotherapy helps to improve curative effect.Malignant tumor is the most responsive to lonizing radiation, and lonizing radiation (mainly being X line and г line) are also the strongest to the inhibition and the damage of malignant tumor.The tumor that has is through radiotherapy even can cure or replace operative treatment.
Present conventional therapy pattern: operation+postoperative chemotherapy, radiotherapy, treatment biology, traditional Chinese medical herbal treatment to various tumour patients.The chemicotherapy of postoperative has many poison, side reaction, and such as: immunity subject to severe risks of damage, alopecia, easy infected, pain or the like, patient generally feels this to very painful.
The combination of Chinese and Western medicine is combined therapy of tumour pattern with Chinese characteristics.Secular practice shows that the therapy of combining Chinese and Western medicine tumor is the better scheme for the treatment of tumor at present.Western medicine and medical practitioners kills that the ability of killing and wounding cancerous cell is stronger, and short term effect is better, but because the toxic and side effects of chemotherapeutic, for most of tumors, single with the Western medicine chemotherapy can not improve cure rate, prolong life cycle, the raising life quality.Though Chinese medicine kill kill and wound cancerous cell ability a little less than, short term effect is relatively poor, it is better that Chinese medicine can improve patient's life quality, long-term effect.Organically western medical treatment means and traditional Chinese medical herbal treatment are combined, not only can kill tumor cell effectively, and can also improve patient immunity, improve life quality, reduce chemotherapy and radiation toxic and side effects, shorten the course of treatment, reduce relapse rate, reduce mortality rate etc.
Generally speaking, the therapy of combining Chinese and Western medicine of tumor at present should be auxilliary mutually based on western medical treatment means, Chinese traditional treatment method, and the two complements each other.The theoretical basis of prevention and treatment in Chinese and western tumor is: the operation of doctor trained in Western medicine, radiotherapy, laser etc. are the local lumps of treatment; Chemotherapy is a systemic treatment, and its therapeutic purposes also are to eliminate the tumor of local primary tumo(u)r and transfer, and do not lie in regulate oncosis human body internal memory pathophysiological change.This shows, doctor trained in Western medicine mainly is the primary tumor and the metastasis of treatment tumor, the traditional Chinese medical science mainly is to regulate the pathophysiological change that occurs in the patient body, therefore, the combination of Chinese and Western medicine has the local lump of treatment and regulates the dual function of the pathophysiological change of general, and mechanism and theoretical basis that its curative effect improves just are being this.
Summary of the invention
The invention reside in open Compuond Chinese lobelia herb preparation and be used for new purposes aspect the oncotherapy in treatment tumor or combined with chemotherapy radiotherapy.
Described Compuond Chinese lobelia herb preparation comprises clinical practice dosage forms such as injection, oral liquid, granule, tablet, capsule, soft capsule, masticatory, aerosol, suppository, drop pill.
Content of the present invention and main points are: at tumor patient immunity of organisms in the chemotherapy radiotherapy process generally be seriously damaged, links such as significantly reduction of leukocyte, bone marrow depression, bacterial infection, pain, result of the test shows: using Compuond Chinese lobelia herb preparation has tangible potentiation, can significantly improve the phagocytic function of macrophage, leucocytes reduction is had protective effect, spleen and thymus are also had effect of gain immunologic function; Use Compuond Chinese lobelia herb preparation staphylococcus aureus (G+), escherichia coli (G-) are had vitro antibacterial activity to a certain degree, staphylococcus aureus, coli-infection mice had significant protective effect, can significantly reduce the mortality rate of infecting mouse, also there is certain delay the death time; Use Compuond Chinese lobelia herb preparation mice and rat are all had significant analgesia role; Use the determined curative effect of Compuond Chinese lobelia herb preparation combination chemotherapy 280 routine malignant tumor patients.
The technical solution adopted in the present invention is: cyclophosphamide causes normal mouse leukocyte count, spleen index and thymus index all obviously to reduce, the influence of Compuond Chinese lobelia herb preparation to leucocytes reduction and spleen and thymic weight investigated in all injuries that the simulation chemotherapy radiotherapy causes; Investigate Compuond Chinese lobelia herb preparation to the mice reticuloendothelial system to the influence of engulfing the ability of cleaning up of inertia carbon granule in the blood flow and to the influence of mouse immune organ thymus, spleen weight; Investigate Compuond Chinese lobelia herb preparation and Turnover of Mouse Peritoneal Macrophages is engulfed the influence of chicken red blood cell ability; Investigate the vitro antibacterial activity (Plating) of Compuond Chinese lobelia herb preparation to staphylococcus aureus; Investigate Compuond Chinese lobelia herb preparation to colibacillary vitro antibacterial activity (Plating); Investigate the therapeutical effect of Compuond Chinese lobelia herb preparation to the infection of staphylococcus aureus mice; Investigate the therapeutical effect of Compuond Chinese lobelia herb preparation to the coli-infection mice; Investigate the analgesic activity (hot plate method) of Compuond Chinese lobelia herb preparation to mice; Investigate the analgesic activity (writhing method) of Compuond Chinese lobelia herb preparation to mice; Investigate the analgesic activity (press tail method) of Compuond Chinese lobelia herb preparation to rat; Investigate Compuond Chinese lobelia herb preparation to 280 effect of routine malignant tumor patient chemotherapeutic sensitivity and safeties thereof.
Its concrete grammar is:
1. Compuond Chinese lobelia herb preparation is to the influence of hypoimmunity model
Get 60 of the mices of body weight 18～22g, male and female half and half are divided into six groups at random, and every group of 10 animals are divided into: 1. blank group; 2. model control group; 3. positive controls (burnet for raising white cell preparation); 4. high dose group (2 times of clinical equivalent dosage); 5. middle dosage group (clinical equivalent dosage); 6. low dose group (0.5 times of clinical equivalent dosage).Gastric infusion, every day 1 time, continuous 7 days.Administration the 4th, 5 days, except that the blank group, all the other respectively organize intraperitoneal injection of cyclophosphamide 100mg/kg (5mg/ml, 0.2ml/10g body weight).24h after the last administration, the eye socket vein is got blood, and the counting leukocyte count is got behind the execution animal and is cutd open spleen, thymus rapidly, weighs, and calculates spleen, thymus index by following formula.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out the t check to the result with mean ± standard deviation.
The result shows that model control group and blank group compare, and leukocyte count, spleen index and thymus index all obviously reduce, and difference has highly significant meaning (P＜0.01), and the modeling success is described.
Positive controls and model control group compare, and leukocyte count has rising to a certain degree, and difference has highly significant meaning (P＜0.01), and spleen index and thymus index are not had influence, the difference nonsignificance (P〉0.05); Compuond Chinese lobelia herb preparation high dose group and model control group compare, and leukocyte count, spleen index and thymus index all have rising to a certain degree, difference significance (P＜0.05); Middle dosage group and model control group compare, and leukocyte count, thymus index have rising to a certain degree, and difference significance (P＜0.05) is though the spleen index not statistically significant also is higher than model control group; Low dose group and model control group compare, the difference nonsignificance (P〉0.05).The results are shown in Table 1.
Normal murine interleukin is reduced table 1 Compuond Chinese lobelia herb preparation and the influence of immune organ weight (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with model control group P＜0.01
The leucocytes reduction that above results suggest Compuond Chinese lobelia herb preparation causes cyclophosphamide has the certain protection effect, and spleen and thymus are also had certain effect of gain, illustrates that it has certain Attenuation to cyclophosphamide.
2. Compuond Chinese lobelia herb preparation is tested to the influence test of engulfing the ability of cleaning up of inertia carbon granule (RES) in the blood flow and to the influence of mouse immune organ thymus, spleen weight the mice reticuloendothelial system
Get 50 of the mices of body weight 18～22g, male and female half and half are divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (Radix Et Caulis Acanthopanacis Senticosi preparation); 3. high dose group (2 times of clinical equivalent dosage); 4. middle dosage group (clinical equivalent dosage); 5. low dose group (0.5 clinical equivalent dosage).Gastric infusion, every day 1 time, continuous 7 days.24h after the last administration, tail vein injection india ink 0.1ml/10g body weight.1min and 6min get blood 0.025ml from the eye socket rear vein beard after injecting prepared Chinese ink, are blown into immediately among the 0.1%Na2CO3 solution 2.0ml, shake up, and are dissolved in 2.0ml0.1%Na2CO3 solution school zero with 0.025ml normal mouse blood, measure absorbance in the 675nm place.Put to death animal after getting blood the 2nd time, cut open rapidly and get liver, spleen, thymus, weigh, by following formula calculate phagocytic index K, engulf coefficient (correction phagocytic index) α and spleen, (OD1 is the absorbance of 1min institute blood sampling after the injection to thymus index in the formula, OD6 is the absorbance of 6min institute blood sampling after the injection, T is the time, and W is a body weight, and WLS closes heavily for the liver spleen).(x ± s) expression adopts SPSS 14.0 statistical analysis softwares to carry out the t check to the result with mean ± standard deviation.
The result shows that positive controls and blank group compare, the difference nonsignificance (P〉0.05); The half of preparation high dose group of compound recipe and blank group relatively, phagocytic index with engulf the coefficient difference and highly significant meaning (P＜0.01) arranged, thymus index and spleen index difference significance (P＜0.05); In the comparison of dosage group and blank group, the phagocytic index difference has highly significant meaning (P＜0.01), engulfs coefficient difference nonsignificance (P〉0.05), but also is higher than the blank group, thymus index and spleen index difference significance (P＜0.05); Low dose group and blank group compare, the difference nonsignificance (P〉0.05).The prompting Compuond Chinese lobelia herb preparation has tangible potentiation to mice RES phagocytic function and immunologic function.The results are shown in Table 2 and table 3.
Table 2 Compuond Chinese lobelia herb preparation to the influence of mice RES phagocytic function (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
Table 3 Compuond Chinese lobelia herb preparation to mouse immune organ weight's influence (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
3. Compuond Chinese lobelia herb preparation is engulfed the influence of chicken red blood cell ability to Turnover of Mouse Peritoneal Macrophages
Get 50 of the mices of body weight 18～22g, male and female half and half are divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (Radix Et Caulis Acanthopanacis Senticosi preparation); 3. high dose group (2 times of clinical equivalent dosage); 4. middle dosage group (clinical equivalent dosage); 5. low dose group (0.5 clinical equivalent dosage).Gastric infusion, every day 1 time, continuous 10 days.1h after the last administration, every Mus lumbar injection 5% chicken red blood cell 0.4ml, 12h pneumoretroperitoneum injection A Shi liquid 2.5ml, then animal being taken off cervical vertebra puts to death, gently rub abdominal part 1min, extract peritoneal fluid 1.0ml and put in the test tube, shake up, getting 0.05ml is applied on the microscope slide, be placed in the enamel box that is lined with wet gauze, place 37 ℃ of incubator incubation 30min, take out slide, drop into rinsing in 0.9% sodium chloride injection, to remove the not cell of paster, dry, with acetone-methanol solution (1: 1, v: v) fixing 5min, reuse 4% Ji's nurse Sa liquid dyeing 5min uses the purified water rinsing, dries, under oily mirror, engulf the RBC number of being engulfed in the macrophage number of chicken red blood cell and the every macrophage in 200 macrophages of counting, calculate phagocytic percentage and phagocytic index by following formula.(x ± s) expression adopts SPSS 14.0 statistical analysis softwares to carry out the t check to the result with mean ± standard deviation.
The result shows that Radix Et Caulis Acanthopanacis Senticosi group and blank group compare, the difference nonsignificance (P〉0.05); Compuond Chinese lobelia herb preparation high dose group and blank group compare, and phagocytic percentage and phagocytic index difference all have highly significant meaning (P＜0.01); Middle dosage group and low dose group and blank group compare phagocytic percentage and the equal significance of phagocytic index difference (P＜0.05).The prompting Compuond Chinese lobelia herb preparation can significantly improve the phagocytic function of macrophage.The results are shown in Table 4.
Table 4 Compuond Chinese lobelia herb preparation to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
4 Compuond Chinese lobelia herb preparations are to the vitro antibacterial activity (Plating) of staphylococcus aureus
4.1 the preparation of medicine plating medium
Take by weighing nutrient agar 1.7g, totally 5 parts, join respectively among the medicinal liquid 50ml that contains Compuond Chinese lobelia herb preparation 100,50,25,12.5,6.25mg (crude drug)/ml, rock and make dissolving, 121 ℃ of autoclaving 15min.Get 10 aseptic plates (90mm diameter, down with), number covering, add respectively and above-mentionedly melted and be cooled to pastille culture medium 20ml about 40 ℃, 2 plates of the parallel preparation of each concentration, treat that agar solidifies after, promptly be made for the plating medium that contains medicine.Other gets 4 aseptic plates, does not contain the blank plating medium of medicine with the method preparation.
4.2 the preparation of bacterium liquid and inoculation
The fresh cultured thing of inoculation staphylococcus aureus is to nutrient broth medium, behind 33 ℃ of cultivation 24h, with the 0.9% sodium chloride injection bacterial suspension that is variable concentrations such as 10-1,10-2,10-3,10-4,10-5 with 10 times of serial dilutions, the bacterium liquid 0.2ml that gets 10-5 concentration respectively is inoculated on each plating medium, take out behind 33 ℃ of cultivation 24h, observe the growing state of antibacterial on the medicine flat board of variable concentrations.The least concentration that antibacterial is not grown is the MIC of medicine to this bacterium.
The result shows, Compuond Chinese lobelia herb preparation has to a certain degree inhibitory action to staphylococcus aureus, and its MIC is 50mg (crude drug)/ml.The results are shown in Table 5.
Table 5 Compuond Chinese lobelia herb preparation is to the vitro antibacterial activity of staphylococcus aureus
5 Compuond Chinese lobelia herb preparations are to colibacillary vitro antibacterial activity (Plating)
5.1 the preparation of medicine plating medium
Take by weighing nutrient agar 1.7g, totally 5 parts, join respectively among the medicinal liquid 50ml that contains Compuond Chinese lobelia herb preparation 500,400,300,200,100mg (crude drug)/ml, rock and make dissolving, 121 ℃ of autoclaving 15min.Get 10 aseptic plates, number covering, add respectively and above-mentionedly melted and be cooled to pastille culture medium 20ml about 40 ℃, 2 plates of the parallel preparation of each concentration, treat that agar solidifies after, promptly be made for the plating medium that contains medicine.Other gets 4 aseptic plates, does not contain the blank plating medium of medicine with the method preparation.
5.2 the preparation of bacterium liquid and inoculation
Inoculate colibacillary fresh cultured thing to nutrient broth medium, behind 33 ℃ of cultivation 24h, with the 0.9% sodium chloride injection bacterial suspension that is variable concentrations such as 10-1,10-2,10-3,10-4,10-5 with 10 times of serial dilutions, the bacterium liquid 0.4ml that gets 10-5 concentration respectively is inoculated on each plating medium, take out behind 33 ℃ of cultivation 24h, observe the growing state of antibacterial on the medicine flat board of variable concentrations.The least concentration that antibacterial is not grown is the MIC of medicine to this bacterium.
The result shows, Compuond Chinese lobelia herb preparation has to a certain degree inhibitory action to escherichia coli, and its MIC is 500mg (crude drug)/ml.The results are shown in Table 6.
Table 6 Compuond Chinese lobelia herb preparation is to colibacillary vitro antibacterial activity
6 Compuond Chinese lobelia herb preparations are to the therapeutical effect of infection of staphylococcus aureus mice
6.1 the preparation of bacterium liquid
The fresh cultured thing of inoculation staphylococcus aureus to nutrient broth medium, 33 ℃ cultivate 24h after, being variable concentrations such as 10-1,10-2,10-3,10-4,10-5,10-6 with 0.9% sodium chloride injection with 10 times of serial dilutions, bacterial suspension is standby.Choose the bacterium liquid of 10-6 concentration, with the viable count of plate surface viable bacteria counting method determination experiment infection.
6.2 the foundation of mouse peritoneal infection model
Get 24 of mices, difference tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight), every day 1 time, continuous 2 days.The 3rd day respectively lumbar injection variable concentrations (stock solution, 10-1,10-2,10-3,10-4,10-5) bacterium liquid 0.5ml/ only, 4 mices of each concentration are observed the death condition of animal in 4 days.Select minimum lethal dose (MLD), can cause after promptly infecting that the bacterial concentration of mice 80～100% death carries out the medical treatment experiment.
6.3 medical treatment experiment
Get 60 of the mices of body weight 18～22g, male and female half and half are divided into six groups at random, every group of 10 animals: 1. blank group; 2. model control group; 3. positive controls ('Shuang Hualian '); 4. high dose group (2 times of clinical effective); 5. middle dosage group (clinical effective); 6. low dose group (0.5 times of clinical effective).Gastric infusion, every day 1 time, continuous 10 days.Administration the 4th, 5 days, except that the blank group, each organizes tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight).Administration the 6th day, except that the blank group, each organizes bacterium liquid 0.5ml/ (3.725 * 108 bacterium/Mus) that lumbar injection concentration is 7.45 * 108/ml, causes infection.Day by day observe the death condition of animal, observed continuously 7 days.Make index with life span, survival rate, adopt the simplification exact propability that the result is carried out statistical analysis.
The result shows that the model control group mouse death rate is 90%, and the modeling success is described.Compare with model control group, 'Shuang Hualian ' group and Compuond Chinese lobelia herb preparation high dose group have significant protective effect to the infection of staphylococcus aureus mice, can significantly reduce the mortality rate of infecting mouse, and also there is certain delay the death time; Though in, the low dose group not statistically significant, mortality rate also decreases.The results are shown in Table 7.
Table 7 Compuond Chinese lobelia herb preparation is to the therapeutical effect (n=10) of infection of staphylococcus aureus mice
Annotate:
*P＜0.05,
*Compare with model control group P＜0.01
7 Compuond Chinese lobelia herb preparations are to the therapeutical effect of coli-infection mice
7.1 the preparation of bacterium liquid
Inoculate colibacillary fresh cultured thing to nutrient broth medium, 33 ℃ cultivate 24h after, being variable concentrations such as 10-1,10-2,10-3,10-4,10-5,10-6,10-7 with 0.9% sodium chloride injection with 10 times of serial dilutions, bacterial suspension is standby.Choose the bacterium liquid of 10-7 concentration, with the viable count of plate surface viable bacteria counting method determination experiment infection.
7.2 the foundation of mouse peritoneal infection model
Get 24 of mices, difference tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight), every day 1 time, for three days on end.The 4th day respectively lumbar injection variable concentrations (stock solution, 10-1,10-2,10-3,10-4,10-5) bacterium liquid 0.5ml/ only, 4 mices of each concentration are observed the death condition of animal in 4 days.Select minimum lethal dose (MLD), can cause after promptly infecting that the bacterial concentration of mice 80～100% death carries out the medical treatment experiment.
7.3 medical treatment experiment
Get 60 of the mices of body weight 18～22g, male and female half and half are divided into six groups at random, every group of 10 animals: 1. blank group; 2. model control group; 3. positive controls ('Shuang Hualian '); 4. high dose group (2 times of clinical effective); 5. middle dosage group (clinical effective); 6. low dose group (0.5 times of clinical effective).Gastric infusion, every day 1 time, continuous 10 days, the administration volume was the 0.2ml/10g body weight.Administration the 4th, 5,6 days, except that the blank group, each organizes tail vein injection hydrocortisone 40mg/kg (2mg/ml, 0.2ml/10g body weight).Administration the 7th day, except that the blank group, each organizes bacterium liquid 0.5ml/ (4.625 * 109 bacterium/Mus) that lumbar injection concentration is 9.25 * 109/ml, causes infection.Day by day observe the death condition of animal, observed continuously 7 days.Make index with life span, survival rate, adopt the simplification exact propability that the result is carried out statistical analysis.
The result shows that the model control group mouse death rate is 100%, and the modeling success is described.Compare with model control group, 'Shuang Hualian ' group and Compuond Chinese lobelia herb preparation high dose group have significant protective effect to the coli-infection mice, can significantly reduce the mortality rate of infecting mouse, and also there is certain delay the death time; Though middle dosage group not statistically significant, mortality rate has certain reduction, and the death time slightly postpones.The results are shown in Table 8.
Table 8 Compuond Chinese lobelia herb preparation is to the therapeutical effect (n=10) of coli-infection mice
Annotate:
*P＜0.05,
*Compare with model control group P＜0.01
8 Compuond Chinese lobelia herb preparations are to the analgesic activity (hot plate method) of mice
Get the female mice of body weight 18～22g, on each 1 metallic plate that is placed in advance the hot-plate instrument that is heated to (55 ± 0.5) ℃, from the contact hot plate to the pain threshold of metapedes required time (second) occurring licking as this Mus, pain threshold 5～30 seconds and not the leaper be qualified Mus.Get 50 of qualified mices, measure its normal pain threshold,, be divided into five groups then at random, every group of 10 animals: 1. blank group as pain threshold before the administration; 2. positive controls (aspirin); 3. high dose group (2 times of clinical effective); 4. middle dosage group (clinical effective); 5. low dose group (0.5 times of clinical effective).Gastric infusion, every day 1 time, continuous 4 days.Water 12h is can't help in the animal fasting before the last administration, and 30min after the last administration measures the mice pain threshold.As 60 seconds still reactionless, mice is taken out, in order to avoid scald, its pain threshold calculated with 60 seconds.(expression of x ± s) adopts the SPSS14.0 statistical analysis software to match the check of t value method to the pain threshold result with mean ± standard deviation.
The result shows, aspirin group and Compuond Chinese lobelia herb preparation high dose group compare respectively with before the administration, difference has highly significant meaning (P＜0.01), compare before middle dosage group and the administration, difference significance (P＜0.05), compare difference nonsignificance (P＜0.05) before low dose group and the administration.The prompting Compuond Chinese lobelia herb preparation has significant analgesia role to mice.The results are shown in Table 9.
Table 9 Compuond Chinese lobelia herb preparation to the analgesic activity (hot plate method) of mice (x ± s, n=10)
Annotate:
*P＜0.05,
*P＜0.01 is with comparison before the administration
9 Compuond Chinese lobelia herb preparations are to the analgesic activity (writhing method) of mice
Get 50 of the mices of body weight 18～22g, male and female half and half are divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. high dose group (2 times of clinical effective); 4. middle dosage group (clinical effective); 5. low dose group (0.5 times of clinical effective).Gastric infusion, every day 1 time, continuous 4 days, the administration volume was the 0.2ml/10g body weight.Water 12h is can't help in the animal fasting before the last administration, 30min after the last administration, respectively lumbar injection 0.6% glacial acetic acid solution 0.2ml/ only observes and writes down turning round the body number of times and the number of animals of writhing response occurring of animal in the 20min immediately, calculates the analgesia percentage rate of administration group by following formula.(x ± s) expression adopts the SPSS14.0 statistical analysis software to carry out nonparametric statistics (Mann-Whitney method), adopts χ 2 (2 * 2) method that the number of animals result who writhing response occurs is carried out statistical analysis with mean ± standard deviation to turn round body number of times result.
The result shows, aspirin group and blank group are relatively, difference has highly significant meaning (P＜0.01), the analgesia percentage rate reaches 80%, and Compuond Chinese lobelia herb preparation high dose group and blank group compare, difference significance (P＜0.05), the analgesia percentage rate reaches 70%, in, low dose group and blank group relatively, difference nonsignificance (P〉0.05), but the animal number average of turning round the body number of times and writhing response occurring is lower than the blank group.The prompting Compuond Chinese lobelia herb preparation has certain analgesic activity to mice.The results are shown in Table 10.
Table 10 Compuond Chinese lobelia herb preparation to the analgesic activity (writhing method) of mice (x ± s, n=10)
Annotate:
*P＜0.05,
*Compare with the blank group P＜0.01
10 Compuond Chinese lobelia herb preparations are to the analgesic activity (pressing the tail method) of rat
Get 60 of the male rats of body weight 130～150g, be divided into five groups at random, every group of 10 animals: 1. blank group; 2. positive controls (aspirin); 3. high dose group (2 times of clinical effective); 4. middle dosage group (clinical effective); 5. low dose group (0.5 times of clinical effective).Gastric infusion, every day 1 time, continuous 6 days, the administration volume was the 1.0ml/100g body weight.Adopt the tenderness instrument in the most advanced and sophisticated 1/3 place's tenderness of rat tail, the weight when shouting with generation (g) is as pain threshold.Measure the normal pain threshold of rat before the first administration, as pain threshold before the administration.Water 12h is can't help in the animal fasting before the last administration, and 30min after the last administration measures the rat pain threshold.Animal does not shout yet when reaching 1000g as weight, and its pain threshold calculates with 1000g.(expression of x ± s) adopts the SPSS14.0 statistical analysis software to match the check of t value method to the pain threshold result with mean ± standard deviation.
The result shows, aspirin group and Compuond Chinese lobelia herb preparation high dose group compare respectively with before the administration, difference has highly significant meaning (P＜0.01), high, middle dosage group compares respectively with before the administration, difference significance (P＜0.05), compare before low dose group and the administration, the difference nonsignificance (P〉0.05).The prompting Compuond Chinese lobelia herb preparation has significant analgesia role to rat.The results are shown in Table 11.
Table 11 Compuond Chinese lobelia herb preparation to the analgesic activity of rat (pressing the tail method) (x ± s, n=10)
Annotate:
*P＜0.05,
*P＜0.01 is with comparison before the administration
The observation of curative effect of 11 Compuond Chinese lobelia herb preparation combination chemotherapy malignant tumor patients.
Observe 280 routine cancer patients, all make a definite diagnosis, and press the international TNM cancer patient of standard by stages through pathology or cytology.KPS marked average 40 minutes; More than numeration of leukocyte 4.0 * 109/L, more than platelet count 100 * 109/L; Liver and kidney and cardiac function are normal, and expection above person in existence March is divided into two groups at random.Two groups of sexes, age, histological type, diagnosis and treatment situation previously, the KPS scoring is learned by statistics and is handled no significant difference, has comparability.Two groups all give same chemotherapy regimen.
The treatment group: 280 examples, with the FUFANG BANBIANLIAN ZHUSHEYE combined chemotherapy, 2ml/ time, 2 times/day, intramuscular injection 10 days, treated for 3 courses of treatment.
Positive controls: 186 examples, with the BAIHUASHESHECAO ZHUSHEYE combined chemotherapy, 2ml/ time, 2 times/day, intramuscular injection 10 days, treated for 3 courses of treatment.
Clinical observation result shows: compound recipe side's Herba Lobeliae Chinensis injection combination chemotherapy pulmonary carcinoma, hepatocarcinoma short term effect total effective rate are respectively 50.8%, 41.1%, compare the no significance difference opposite sex, p with matched group (being respectively 49.3%, 40.7%)〉0.05.Treatment back treatment group and matched group survival rate compare no significant difference, p〉0.05.The results are shown in Table 12, table 13.
Short term effect relatively behind the table 12 liang group patient treatment
Annotate: the treatment group is compared with positive controls, no significant difference, p〉0.05.
Table 13 liang group survival rate is (%) relatively
Annotate: the treatment group is compared with positive controls, no significant difference, p〉0.05.
Draw to draw a conclusion in conjunction with above result:
1, Compuond Chinese lobelia herb preparation has tangible potentiation to mice RES phagocytic function and immunologic function;
2, Compuond Chinese lobelia herb preparation can significantly improve the phagocytic function of macrophage;
3, Compuond Chinese lobelia herb preparation leucocytes reduction that cyclophosphamide is caused has the certain protection effect, and spleen and thymus are also had certain effect of gain.
4, Compuond Chinese lobelia herb preparation has vitro antibacterial activity to a certain degree to staphylococcus aureus (G+), escherichia coli (G-), and its minimum inhibitory concentration (MIC) is respectively 50,500mg (crude drug)/ml; Staphylococcus aureus, coli-infection mice are had significant protective effect, can significantly reduce the mortality rate of infecting mouse, also there is certain delay the death time.
5, Compuond Chinese lobelia herb preparation all has significant analgesia role to mice and rat.
6, Compuond Chinese lobelia herb preparation combined with chemotherapy treatment malignant tumor has better clinical efficacy.
Illustrate that based on the above results Compuond Chinese lobelia herb preparation not only can treat tumor effectively, perhaps combined with chemotherapy radiotherapy is used for tumor, and can also improve patient immunity, reduce pain, improve life quality, reduce chemotherapy and radiation toxic and side effects, shorten the course of treatment, reduce relapse rate, reduce mortality rate etc.
Embodiment
Further specify the present invention by the following examples, should be noted that, these embodiment only are used for illustrative purposes, do not constitute the restriction to scope of the present invention.It will be apparent to those skilled in that under situation without departing from the spirit and scope of the present invention, can make some variations and improvement, these all are included in the category of the present invention.
Embodiment 1
FUFANG BANBIANLIAN ZHUSHEYE, a 2～4ml, 1～2 time on the one, intramuscular injection or, intravenous drip with after the normal saline 500ml dilution.Be used for various treatment for cancer such as leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 2
FUFANG BANBIANLIAN ZHUSHEYE, a 2～4ml, 1～2 time on the one, intramuscular injection or, intravenous drip with after the normal saline 500ml dilution.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Embodiment 3
Compound Chinese lobelia oral liquid, a 10～20ml, 3 times on the one, oral.Be used for various treatment for cancer such as leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 4
Compound Chinese lobelia oral liquid, a 10～20ml, 3 times on the one, oral.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Embodiment 5
The Compuond Chinese lobelia herb soft capsule, one time 3～5,3 times on the one, oral.Be used for various treatment for cancer such as leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 6
The Compuond Chinese lobelia herb soft capsule, one time 3～5,3 times on the one, oral.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Embodiment 7
Compuond Chinese lobelia herb suppository, one time 1,3 times on the one, anum administration.Be used for various treatment for cancer such as rectal cancer, leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 8
Compuond Chinese lobelia herb suppository, one time 1,3 times on the one, anum administration.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Embodiment 9
The Compuond Chinese lobelia herb spray, 3～4 times on the one, oral administration.Be used for various treatment for cancer such as rectal cancer, leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 10
The Compuond Chinese lobelia herb spray, 3～4 times on the one, oral administration.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Embodiment 11
The Compuond Chinese lobelia herb chewable tablet, one time 3～4,3～4 times on the one, oral.Be used for various treatment for cancer such as rectal cancer, leukemia, hepatocarcinoma, pulmonary carcinoma, bladder cancer, cancer of pancreas, breast carcinoma, gastric cancer, osteocarcinoma, the brain cancer, skin carcinoma, oral cancer, cervical cancer.
Embodiment 12
The Compuond Chinese lobelia herb chewable tablet, one time 3～4,3～4 times on the one, oral.Combined with chemotherapy or radiotherapy are used for tumor, to improve toleration, the compliance of patient to chemotherapy, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote patient's life quality.
Claims (4)
1, the application of Compuond Chinese lobelia herb preparation in preparation medicine for treating tumor thing.
2, application as claimed in claim 1 is characterized in that being used at the preparation combined with chemotherapy application of tumour medicine.
3, application as claimed in claim 1 is characterized in that cooperating radiotherapy to be used for the application of tumour medicine in preparation.
4, application as claimed in claim 1, it is characterized in that improving toleration, the compliance of patient to chemotherapy or radiotherapy in preparation, strengthen the immunocompetence of collective, shorten chemotherapy or radiotherapy the course of treatment, reduce in chemotherapy or the radiotherapy toxicity, reduce the mortality rate of tumor patient, promote the application in patient's the life quality medicine.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103520596A (en) * | 2013-10-25 | 2014-01-22 | 扈晓楠 | Traditional Chinese medicine composition for treating bladder cancer |
| CN104547151A (en) * | 2015-01-27 | 2015-04-29 | 黑龙江中医药大学 | Traditional Chinese medicine extract and preparation method thereof |
| CN104547679A (en) * | 2014-12-25 | 2015-04-29 | 姜新帅 | Anti-cancer medicinal liquor |
| CN114886994A (en) * | 2022-04-08 | 2022-08-12 | 贵州中医药大学 | Miao medicine for treating liver cancer and preparation method thereof |
-
2008
- 2008-01-07 CN CNA200810000331XA patent/CN101480438A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103520596A (en) * | 2013-10-25 | 2014-01-22 | 扈晓楠 | Traditional Chinese medicine composition for treating bladder cancer |
| CN103520596B (en) * | 2013-10-25 | 2015-04-08 | 滨州医学院附属医院 | Traditional Chinese medicine composition for treating bladder cancer |
| CN104547679A (en) * | 2014-12-25 | 2015-04-29 | 姜新帅 | Anti-cancer medicinal liquor |
| CN104547151A (en) * | 2015-01-27 | 2015-04-29 | 黑龙江中医药大学 | Traditional Chinese medicine extract and preparation method thereof |
| CN114886994A (en) * | 2022-04-08 | 2022-08-12 | 贵州中医药大学 | Miao medicine for treating liver cancer and preparation method thereof |
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Open date: 20090715 |