CN104857435A - Chinese herbal compound composition with antineoplastic activity as well as preparation method and application thereof - Google Patents

Abstract

The invention discloses a compound traditional Chinese medicine composition with anti-tumor activity, its preparation method and its application. The compound traditional Chinese medicine composition comprises 12-36 parts of Radix Pseudostellariae, 10-30 parts of Ophiopogon japonicus, and 20-60 parts of Hedyotis diffusa 20-60 parts of Scutellaria barbata, 15-45 parts of Shanzi mushroom and 10-30 parts of Curcuma. Pharmacological experiments and clinical experiments show that the traditional Chinese medicine compound composition with anti-tumor activity provided by the present invention has scientific and reasonable proportioning, and has the effects of anti-cancer and detoxification, reducing phlegm and blood stasis, nourishing qi and nourishing yin, etc., and is effective against various malignant tumor cells. All of them have strong killing effect and have a wide range of applications; they can also regulate the content of cAMP in the body and promote the production of tumor necrosis factor (INF), improve the immunity of tumor patients, prolong the quality of life, and have high safety and low side effects. The preparation method provided by the invention has stable quality, high content of extracted active ingredients, strong operability, and is suitable for large-scale industrial production.

Description

A compound traditional Chinese medicine composition with antitumor activity and its preparation method and application

technical field

The invention relates to a traditional Chinese medicine, in particular to a compound traditional Chinese medicine composition with anti-tumor activity and its preparation method and application.

Background technique

Tumor has become the number one killer threatening human survival in the 21st century, with an average of more than 6 million people dying of various tumor diseases every year. China is one of the countries with high incidence of cancer in the world, and it shows a rapid growth trend every year. Clinically, the current drugs for treating tumors mainly include chemical drugs. However, due to the high toxicity of chemotherapy drugs, they can not selectively kill white blood cells, lymphocytes and other human immune cells while killing tumor cells. As a result, patients often suffer from autoimmune diseases. Complicated infection due to low ability, severe adverse reactions in patients, long course of treatment, high cost, and great limitations in clinical use.

Traditional Chinese medicine has unique advantages in the treatment of tumors. Natural drugs represented by traditional Chinese medicines have the characteristics of less toxic and side effects, diverse targets, and good tolerance, and are receiving more and more attention in the treatment of tumors. However, the currently reported antineoplastic drugs have relatively large doses and many impurities.

Therefore, it is of great significance to research and develop an anti-tumor Chinese patent medicine with good anti-tumor effect, low dosage, good therapeutic effect on various tumors, and low adverse reactions.

Contents of the invention

Purpose of the invention: the purpose of the present invention is to solve the deficiencies of the prior art, to provide a scientific and reasonable proportioning, definite curative effect, safe clinical use, low adverse reactions with anti-tumor active Chinese medicine compound composition, another purpose of the present invention is The preparation method of the traditional Chinese medicine compound composition with anti-tumor activity and its application in the preparation of medicines for treating malignant tumor diseases are provided.

Technical scheme: in order to realize above object, the technical scheme that the present invention takes is:

A traditional Chinese medicine compound composition with antitumor activity, which is made of the following raw materials in parts by weight: 12-36 parts of Radix Pseudostellariae, 10-30 parts of Radix Radix Radixae Radix, 20-60 parts of Hedyotis diffusa, Scutellaria barbata 20 to 60 servings, 15 to 45 servings of Shanzi mushroom, and 10 to 30 servings of Curcuma.

As a preferred version, the above-mentioned Chinese medicine compound composition with anti-tumor activity is made of the following raw materials in parts by weight: 12-24 parts of Radix Pseudostellariae, 10-20 parts of Ophiopogon japonicus, 20-20 parts of Hedyotis diffusa 40 parts, barbata 20-40 parts, Shanzi mushroom 15-30 parts, zedoary 10-20 parts.

As a more preferred solution, the above-mentioned Chinese medicine compound composition with anti-tumor activity is made of the following raw materials in parts by weight: 12 parts of heterophylla, 10 parts of Radix Radix, 20 parts of Hedyotis diffusa, half branch 20 parts of lotus, 15 parts of Shanzi mushroom, and 10 parts of curcuma.

The traditional Chinese medicine compound composition with anti-tumor activity of the present invention is prepared by preparing the extracts of various raw materials and pharmaceutically acceptable carriers into oral liquid, granules, capsules or tablets.

The preparation method of the Chinese medicine compound composition with antitumor activity of the present invention, it comprises the following steps:

(1) Take Curcuma in parts by weight, add 8 to 16 times the amount of water of Curcuma medicinal material, extract by steam distillation for 1 to 3 hours, and collect volatile oil;

(2) Get Radix Pseudostellariae, Ophiopogon japonicus, Hedyotis diffusa, Scutellaria barbata and Arrowhead mushroom in parts by weight, add the curcuma dregs after steam distillation in step (1), add 6 to 12 times the volume of the total medicinal materials amount of ethanol, reflux or continuous reflux for 2 to 3 times, each time for 1 to 3 hours, combine the extracts, concentrate under reduced pressure at 50 to 80 degrees Celsius, and put the concentrate on a macroporous adsorption resin column, first elute with water, and then Sequentially elute with ethanol with a volume concentration of 20% to 70%; collect the combined ethanol eluate with a volume concentration of 55%, and concentrate to obtain the extract;

(3) Take the volatile oil obtained in step (1), the extract obtained in step (2) and a pharmaceutically acceptable carrier to prepare a drug in the form of oral liquid, granule, capsule or tablet.

When the extracts of the raw materials of the compound Chinese medicine composition with antitumor activity provided by the present invention are made into oral liquids, the extracts of the raw materials are dissolved in distilled water, filtered, and syrup is added to adjust the pH value to make oral liquids.

When the extract of each raw material of the Chinese medicine compound composition provided by the invention with antitumor activity is made into a tablet, the extract of each raw material and lactose or cornstarch, if necessary, add lubricant magnesium stearate, mix uniformly , the whole grain, and then compressed into tablets.

When the extracts of the raw materials of the traditional Chinese medicine compound composition with antitumor activity provided by the invention are made into capsules, the extracts of the raw materials are uniformly mixed with the carrier lactose or cornstarch, granulated, and then packed into capsules to make capsules.

When the extracts of the various raw materials of the Chinese medicine compound composition with antitumor activity provided by the present invention are made into granules, the extracts of each raw material and the diluent lactose or cornstarch are mixed evenly, granulated, and dried to make granules .

As a preferred solution, in the preparation method of the above-mentioned Chinese medicine compound composition with anti-tumor activity, the macroporous adsorption resin described in step (1) is D101 resin.

Application of the traditional Chinese medicine compound composition with anti-tumor activity in the preparation of anti-tumor drugs.

As a preferred solution, the application of the traditional Chinese medicine compound composition with anti-tumor activity in the preparation of anti-lung cancer, gastric cancer, liver cancer, colon cancer, breast cancer, cervical cancer or human tongue squamous cell carcinoma.

The traditional Chinese medicine composition with anti-lung cancer activity provided by the invention, the nature and flavor of heterophylla heterophylla: sweet, slightly bitter; slightly cold in nature. , Return through: spleen meridian, lung meridian. Efficacy: Replenishing the spleen and lungs; replenishing qi and promoting body fluid. Indications: Weakness of the spleen and stomach; loss of appetite; fatigue and weakness; both qi and yin injuries; dry cough with little phlegm, and qi deficiency and fluid injury in the late stage of febrile disease; internal heat and thirst.

Ophiopogon japonicus is sweet and slightly bitter, cold, and enters the lung, stomach, and heart channels. It has the functions of nourishing yin and nourishing the lungs, clearing the heart and eliminating troubles, benefiting the stomach and promoting body fluid, and has the effect of treating dryness of the lung, dry cough, vomiting blood, hemoptysis, lung impotence, lung abscess, consumptive fatigue, thirst, fever, fluid injury, dry throat and mouth, and constipation. .

Herba Hedyotis diffusa is bitter and sweet, cold. Go into Heart Channel, Liver Channel, Spleen Channel. It has the effect of clearing away heat and detoxification; promoting dampness, and it can treat asthma and cough due to lung heat; throat swelling and pain; intestinal fistula; boils and sores; poisonous snake bites; hot stranguria and astringent pain; edema; dysentery; enteritis; damp-heat jaundice; cancer swelling.

Arrowhead Mushroom Nature and Flavor: Sweet in taste; Slightly pungent; Cold in nature; Returns Liver Meridian; Stomach Meridian; Lung Meridian. Have heat-clearing and toxic substances removing; The effect of reducing swelling and dissipating stagnation has the effect of treating carbuncle and malignant sore; Scrofula tuberculosis; Sore throat and sore throat.

Scutellaria barbata nature and flavor: acrid in the mouth; bitter; cold in nature. Efficacy: clearing heat and detoxifying; dissipating blood stasis to stop bleeding; inducing diuresis to reduce swelling. Indications: pyretic carbuncle, sore throat, lung abscess, intestinal abscess, scrofula, poisonous snake bites, bruises, hematemesis, epistaxis, hematuria, edema, ascites and cancer.

Zedoary is pungent in the mouth, bitter, warm. Return liver, spleen channel. It has the functions of dispelling blood and promoting qi, eliminating stagnation and relieving pain, expelling wind and dampness, reducing swelling and relieving pain. For rheumatic pain, head wind pain, chest and hypochondrium pain, diarrhea pain; external use for bruises, blood stasis, swelling and pain.

The combination of the above-mentioned medicines has good effects of anti-cancer and detoxification, reducing phlegm and blood stasis, nourishing qi and nourishing yin, etc., and has good effects of inhibiting tumor cell growth and promoting tumor cell apoptosis.

Beneficial effect: Compared with the prior art, the traditional Chinese medicine compound composition with anti-tumor activity provided by the present invention has the following advantages:

1. According to the theory of traditional Chinese medicine, the present invention adopts the theory of syndrome differentiation and treatment to screen traditional Chinese medicine prescriptions, and provides a Chinese medicine compound composition with anti-tumor activity in a scientific and reasonable proportion, and has good anti-cancer and detoxification, phlegm-removing, blood-stasis, and Qi-invigorating properties. Nourishing yin and other effects. Experimental results show that the traditional Chinese medicine compound composition with anti-tumor activity provided by the present invention has a good effect of inhibiting tumor cell growth and promoting tumor cell apoptosis, and has a strong killing effect on various malignant tumor cells. Wide range of applications.

2. Experimental results show that the Chinese medicine compound composition with anti-tumor activity provided by the present invention has the function of strengthening the body and promoting immune function, and can regulate the content of cAMP in the body and promote the production of tumor necrosis factor (INF), exerting multiple targets, The effect of treating tumors with multiple organs can reduce the pain of tumor patients, prolong the survival period, and improve the quality of life of patients. Long-term experimental studies have shown that the Chinese medicine compound composition with anti-tumor activity provided by the present invention has high safety and no toxic and side effects. Low.

3. The extract of the compound Chinese medicine composition with antitumor activity provided by the present invention can be conveniently prepared into various dosage forms with a pharmaceutical carrier, which is convenient to take clinically; at the same time, the compound Chinese medicine composition with antitumor activity provided by the present invention can be prepared The method has strong operability, especially the extraction and refining process is designed according to the chemical properties of the active ingredients of various medicines. The obtained extract has high content of active ingredients, less impurities, and has fast absorption and rapid drug effect, and the clinical dosage is small. And other advantages, and the process is stable, suitable for large-scale industrial production.

Detailed ways:

The present invention is further illustrated below in conjunction with specific embodiments, should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention, after having read the present invention, those skilled in the art will understand the various equivalent forms of the present invention All modifications fall within the scope defined by the appended claims of this application.

Implementation column 1

1. A Chinese medicine compound composition with antitumor activity, it is made of the raw material medicine of following parts by weight: Radix heterophylla 12 grams, Ophiopogon japonicus 10 grams, Hedyotis diffusa 20 grams, Scutellaria barbata 20 grams, Radix Scutellariae Radix Arrowhead mushroom 15 grams, Curcuma 10 grams.

2. the preparation method of the Chinese medicine compound composition with antitumor activity of the present invention, it may further comprise the steps:

(1) Take 10 grams of Zedoary Curcuma in parts by weight, add 12 times the amount of water of Curcuma Curcuma medicinal material, extract by steam distillation for 2 hours, and collect volatile oil;

(2) Take 12 grams of Radix Pseudostellariae in parts by weight, 10 grams of Ophiopogon japonicus, 20 grams of Hedyotis diffusa, 20 grams of Scutellaria barbata, 15 grams of Shanzi mushroom, and add the zedoary dregs after steam distillation in step (1) , add 10 times the volume of ethanol of the total medicinal material weight, reflux or continuous reflux extraction twice, each time for 3 hours, combine the extracts, concentrate under reduced pressure at 50-80 degrees Celsius, and get the concentrate on a macroporous adsorption resin column, first use water eluting, and then sequentially eluting with ethanol with a volume concentration of 20% to 70%; collecting ethanol eluents with a combined volume concentration of 55%, and concentrating to obtain an extract;

(3) Take the volatile oil obtained in step (1), add lactose and cornstarch to the extract obtained in step (2), mix evenly, add lubricant magnesium stearate, mix evenly, granulate, and then compress into tablets to make tablets. (Lot number: 001)

Implementation column 2

1. A compound Chinese medicine composition with anti-tumor activity, which is made of the following raw materials in parts by weight: 24 grams of Radix Pseudostellariae, 20 grams of Ophiopogon japonicus, 40 grams of Hedyotis diffusa, 40 grams of Scutellaria barbata, Arrowhead mushroom 30 grams, Curcuma 20 grams.

2. the preparation method of the Chinese medicine compound composition with antitumor activity of the present invention, it may further comprise the steps:

(1) Take 20 grams of Zedoary Curcuma according to parts by weight, add 10 times the amount of water of Curcuma Curcuma medicinal material, extract by steam distillation for 3 hours, and collect volatile oil;

(2) Get 24 grams of Radix Pseudostellariae in parts by weight, 20 grams of Ophiopogon japonicus, 40 grams of Hedyotis diffusa, 40 grams of Scutellaria barbata, 30 grams of Arrowhead mushroom, and add the zedoary dregs after steam distillation in step (1) , add 12 times the volume of ethanol of the total medicinal material weight, reflux or continuous reflux extraction for 3 times, each time for 2 hours, combine the extracts, concentrate under reduced pressure at 50-80 degrees Celsius, and get the concentrate on a macroporous adsorption resin column, first use water eluting, and then sequentially eluting with ethanol with a volume concentration of 20% to 70%; collecting ethanol eluents with a combined volume concentration of 55%, and concentrating to obtain an extract;

(3) Take the volatile oil obtained in step (1) and the extract obtained in step (2), then add diluent lactose or cornstarch, mix evenly, granulate, and dry to make granules. (Lot No.: 002)

Implementation column 3

1. A Chinese medicine compound composition with anti-tumor activity, it is made of the crude drug of following parts by weight: 36 grams of Radix Pseudostellariae, 30 grams of Ophiopogon japonicus, 60 grams of Hedyotis diffusa, 60 grams of Scutellaria barbata, 45 grams of arrowroot mushrooms and 30 grams of curcuma.

2. the preparation method of the Chinese medicine compound composition with antitumor activity of the present invention, it may further comprise the steps:

(1) Get 30 grams of Zedoary Curcuma in parts by weight, add 8 times the amount of water of Curcuma Curcuma medicinal material, extract by steam distillation for 3 hours, and collect volatile oil;

(2) Get 36 grams of Radix Pseudostellariae in parts by weight, 30 grams of Ophiopogon japonicus, 60 grams of Hedyotis diffusa, 60 grams of Scutellaria barbata, 45 grams of Shanzi mushroom, and add the zedoary dregs after steam distillation in step (1) , add 12 times the volume of ethanol of the total medicinal material weight, reflux or continuous reflux extraction for 3 times, each time for 2 hours, combine the extracts, concentrate under reduced pressure at 50-80 degrees Celsius, and get the concentrate on a macroporous adsorption resin column, first use water eluting, and then sequentially eluting with ethanol with a volume concentration of 20% to 70%; collecting ethanol eluents with a combined volume concentration of 55%, and concentrating to obtain an extract;

(3) Get the volatile oil obtained in step (1) and the extract obtained in step (2), mix them with lactose and cornstarch, granulate, and then pack into capsules to make capsules. (Lot No.: 003)

Embodiment 4 antitumor pharmacological experiment

Experimental Study on Inhibitory Effects of Traditional Chinese Medicine Compound Compositions with Antitumor Activity on Human Tumors in Nude Mice

(1) Inhibitory effect on human gastric cancer cell (MGC- ₈₀₃ ) cells in nude mice

Experimental method: MGC- ₈₀₃ cells adhered to the wall in the cell culture flask were prepared into a cell suspension, the cell concentration was adjusted, counted under a microscope, and 5×10 ⁶ MGC- ₈₀₃ cells were inoculated subcutaneously in the armpit of the right forelimb of each mouse. Inoculate 24 altogether, it is randomly divided into treatment group (the Chinese medicine compound composition with antitumor activity provided by the present invention, batch number 001, intragastric administration 2g/kg), and blank group (equal volume normal saline), each group 10 only. 48 hours after inoculation, the drug was administered for 21 consecutive days. After the drug was stopped, the animals were sacrificed to observe the growth of MGC- ₈₀₃ cells in nude mice and the tumor weight was weighed. The specific experimental results are shown in Table 1.

Table 1 Inhibitory effect on MGC- ₈₀₃ cells in nude mice

(2) Inhibitory effect on human liver cancer (SMMC-7451) cells in nude mice

Experimental method: prepare SMMC-7451 cell suspension, adjust cell concentration, inoculate SMMC-7451 cell 5 * 10 ⁶ pieces/0.2ml subcutaneously in the right anterior armpit of every mouse, inoculate 20 altogether, be divided into treatment group randomly (the invention provides The Chinese medicine compound composition of tumor activity, batch number 002. intragastric administration, 2g/kg) and blank group (equal volume normal saline), 10 in every group, after 24 hours, start medication, once a day, continuously 24 days, stop After taking the medicine, the animals were killed, the growth of the tumor was observed, and the tumor tissue was dissected and weighed. See Table 2 for the specific experimental results.

Table 2 Inhibition of SMMC-7451 cells in nude mice

(3) Inhibitory effect on human intestinal mucinous adenocarcinoma in nude mice

Get the tumor source nude mice, take out the tumor tissue, cut into small pieces of 0.3-0.4mm, inoculate the tumor tissue in the back subcutaneous of the nude mice, inoculate 20 of them altogether, and divide them into treatment groups at random 24 days after the inoculation (the invention provides The traditional Chinese medicine compound composition with antitumor activity, batch number 003, intragastric administration, 2g/kg) and blank group (equal volume normal saline), each group of 10, continuous medication for 21 days, put to death 24h after the last administration Animals were dissected and weighed, and the inhibition rate (%) was calculated. The specific experimental results are shown in Table 3.

Table 3 Inhibitory effect on human intestinal mucinous adenocarcinoma in nude mice

(4) Inhibitory effect on lung cancer (MCF-7) cells in nude mice

Experimental method: prepare lung cancer (MCF-7) cell suspension, adjust cell concentration, inoculate MCF-7 cell 5 * 10 /0.2ml subcutaneously in the right anterior armpit of every mouse, inoculate 20 altogether, divide into treatment group randomly (provided by the invention) Chinese medicine compound composition with anti-tumor activity, batch number 001. Intragastric administration, 2g/kg) and blank group (equal volume of normal saline), 10 in each group, after 24 hours, start medication, once a day, for 24 consecutive days , after drug withdrawal, the animals were sacrificed, the tumor growth was observed and the tumor tissue was dissected and weighed. The specific experimental results are shown in Table 4.

Table 4 Inhibition of MCF-7 cells in nude mice

The above experimental results show that: the Chinese medicine compound composition provided by the present invention has obvious inhibitory effect on human gastric cancer, liver cancer, human intestinal mucinous adenocarcinoma, and lung cancer transplantation in nude mice, indicating that the present invention has antitumor activity. The active Chinese medicine compound composition has a strong anti-human malignant tumor effect in vivo, and can be used for the treatment of malignant tumor diseases.

(5) In vitro anti-human tongue squamous cell carcinoma experiment

Cell lines: human tongue squamous cell carcinoma cells were provided by the pharmacology laboratory of Nanjing University of Traditional Chinese Medicine; 96-well plates were purchased from Costar; RMPI1640 medium was purchased from Gibco; DMEM medium was purchased from Gibco; newborn bovine serum was purchased from Hangzhou Sijiqing Company; Thiazolium Blue (MTT) and DMSO were purchased from Amresco;

The experimental equipment used in the following examples is as follows:

Experimental equipment: ultra-clean bench (Suzhou purification model SW-CJ-IFD), CO ₂ incubator (SANYO model: XD-101), microplate reader BIO-RAD (Model NO.550Serial NO.16971).

The experimental method used in the following examples is as follows:

Experimental method: use the improved MTT method to carry out in vitro anti-tumor cell experiment on the traditional Chinese medicine compound composition prepared in Example 1 of the present invention: human tongue squamous cell carcinoma cells (Tca-8113) are digested with trypsin, counted, and the concentration is 5 ×10 ⁴ cells/ml of cell suspension. Add 100 μl of cell suspension (5×10 ³ cells per well) to each well of the 96-well plate, and then place it in a 37°C, 5% CO ₂ incubator for 24 hours; dilute the drug to the required level with incomplete medium Add 100 μL of corresponding drug-containing medium to each well, set up a negative control group, a vehicle control group and a positive control group at the same time, and then place the 96-well plate in a 37°C, 5% CO ₂ incubator for 72 hours . Then add 20 μL MTT (5 mg/ml) to each well, continue to cultivate for 4 hours, terminate the culture, discard the medium, add 150 μL DMSO to each well to dissolve, and shake gently for 10 minutes to mix well. Use a microplate reader to detect the absorbance or OD value of each well at two wavelengths of λ=4570nm and 620nm, and use the average value of each multiple well as the OD value of the group of cells to calculate the inhibition rate of each drug.

Experimental results show that the traditional Chinese medicine compound composition prepared in Example 1 of the present invention has a strong inhibitory effect on human tongue squamous cell carcinoma cells, and each dosage group presents a better dose-effect relationship. The experimental results are shown in Table 5.

Table 5 The effect on human tongue squamous cell carcinoma cells

Embodiment column 5 has the experiment of the Chinese medicine compound composition of antitumor activity to immunomodulatory effect

(1) Effects on the content of IgA, IgG, and IgM in mice

Experimental method: 30 ICR mice, weighing 18-22g, were randomly divided into normal control group, tumor-bearing control group and treatment group, routinely inoculated with S180 sarcoma, and 24 hours after inoculation, the treatment group was fed with the anti-tumor activity of the present invention The traditional Chinese medicine compound composition (batch number 001) 0.3ml/only (2g/kg), the 15th day mouse eyeball blood sampling. The contents of IgA, IgG, and IgM were determined, and the specific experimental results are shown in Table 6.

Table 6 on the impact of mouse IgA, IgG, IgM content (mg/dl )

*P<0.01(compared with normal control group)**P<0.05(compared with tumor-bearing control group)

Shown by the experimental result of above table 6: tumor-bearing mice immunoglobulin IgA, IgG, IgM content are obviously lower than normal control mice; The content of IgA, IgG, and IgM shows that the Chinese medicine compound composition with anti-tumor activity provided by the present invention has an immune-promoting effect, can improve the immune function of tumor patients themselves, and thus is beneficial to the improvement of the quality of life of tumor patients and its own anti-tumor effect.

(2) Effects on cAMP content in plasma of rats

Experimental method: Take 45 Wistar rats with a body weight of 150-180g, both male and female, and randomly divide them into normal control group, tumor-bearing control group and treatment group, routinely inoculate S180 sarcoma, and after 24 hours, the treatment group is fed with the anti-inflammatory agent of the present invention. Tumor-active traditional Chinese medicine compound composition (batch number 002), 2ml/piece (2g/kg), for 14 consecutive days, the normal control group was fed with equal-volume normal saline, and on the 15th day, blood was collected from the heart of the rats, and the cAMP content was measured. The results are shown in Table 7.

Table 7 Effects on Rat Plasma cAMP Content

*P<0.05 (compared with tumor-bearing control group)

The experimental results in Table 7 show that: the Chinese medicine compound composition with antitumor activity provided by the present invention can increase the low cAMP content in tumor-bearing mice (*P<0.05), further indicating that the antitumor activity provided by the present invention The traditional Chinese medicine compound composition has the effect of obviously improving the immune function of tumor patients, and is beneficial to the recovery of tumor diseases.

(3) Enhancement of tumor necrosis factor (INF) induction

Experimental method: 20 Wistar rats were randomly divided into control group and treatment group. Each animal was intraperitoneally injected with 10 mg BCG, and on the 15th day, 80 μg LPS was intraperitoneally injected, and blood was collected 90 minutes later. The treatment group was fed with 2ml/piece of the compound traditional Chinese medicine composition with anti-tumor activity of the present invention (batch number 001, 2g/kg) for 14 consecutive days, and the control group was fed with equal volume of normal saline.

Take the serum to be tested and dilute it to different concentrations; the target cell L929 is adjusted to 2×106/ml cells with 10% calf serum and RPM1-1640 culture medium, and added to a 96-well cell culture plate; 100 μl/well, add different dilutions 100 μl/well of serum to be tested in multiples; culture in a 5% CO ₂ incubator at 37°C for 18 hours. Result determination: the INF titer was defined as the maximum dilution factor at which 50% of the target cells died. The specific results are shown in Table 8.

Table 8 Promoting effect on the induction of INF in rats

*P<0.001 (compared with normal control group)

The experimental results in Table 8 show that: the compound Chinese medicine composition with antitumor activity provided by the present invention can obviously promote the induction of INF, (P<0.001), indicating that the compound Chinese medicine composition with antitumor activity provided by the present invention can pass Induce tumor necrosis factor INF to achieve the purpose of anti-tumor.

Show by above experimental result, the traditional Chinese medicine compound composition with antitumor activity provided by the present invention has improving effect to the immune function of tumor patient, and can regulate the content of cAMP in the body and promote the generation of tumor necrosis factor (INF), can strengthen patient's self Antitumor function.

And the clinical trial results of the Chinese medicine compound composition with antitumor activity provided by the present invention show that: 60 patients with breast cancer chemotherapy and 50 patients with cervical cancer chemotherapy, all took the Chinese medicine compound composition with antitumor activity provided by the present invention (Example 1 of the present invention), through 2 months of clinical observation, the tumor patients who took the compound Chinese medicine composition provided by the present invention had obvious improvement in clinical symptoms, the quality of life of lung cancer patients was improved, and the toxic and side effects caused by chemotherapy were obviously alleviated. , indicating that the Chinese medicine compound composition with anti-tumor activity provided by the present invention has the effect of protecting and improving immune function, and has a protective effect on peripheral blood, and the effective rates of clinical observation are 83.5% and 80.7% respectively.

According to the theory of traditional Chinese medicine, the present invention adopts the theory of syndrome differentiation and treatment to carry out proportioning prescriptions. The above experimental results show that the compound traditional Chinese medicine composition with anti-tumor activity provided by the present invention has the functions of anti-cancer and detoxification, reducing phlegm and blood stasis, nourishing qi and nourishing yin. Efficacy, has the effect of inhibiting tumor growth and metastasis, and can reverse the drug resistance of tumor cells, promote the apoptosis of tumor cells, and has no obvious toxic and side effects, indicating that the traditional Chinese medicine compound composition with anti-tumor activity provided by the present invention can be used for the preparation of new antitumor drugs.

The above is only a preferred embodiment of the present invention, it should be pointed out that, for those of ordinary skill in the art, without departing from the principle of the present invention, some improvements and modifications can also be made, and these improvements and modifications can also be made. It should be regarded as the protection scope of the present invention.

Claims (8)

1. have a Traditional Chinese medicine compound composition for anti-tumor activity, it is characterized in that, it is made up of the crude drug of following parts by weight: Radix Pseudostellariae 12 ~ 36 parts, Radix Ophiopogonis 10 ~ 30 parts, Herba Hedyotidis Diffusae 20 ~ 60 parts, Herba Scutellariae Barbatae 20 ~ 60 parts, Pseudobulbus Cremastrae Seu Pleiones 15 ~ 45 parts, Rhizoma Curcumae 10 ~ 30 parts.

2. the Traditional Chinese medicine compound composition with anti-tumor activity according to claim 1, it is characterized in that, it is made up of the crude drug of following parts by weight: Radix Pseudostellariae 12 ~ 24 parts, Radix Ophiopogonis 10 ~ 20 parts, Herba Hedyotidis Diffusae 20 ~ 40 parts, Herba Scutellariae Barbatae 20 ~ 40 parts, Pseudobulbus Cremastrae Seu Pleiones 15 ~ 30 parts, Rhizoma Curcumae 10 ~ 20 parts.

3. the Traditional Chinese medicine compound composition with anti-tumor activity according to claim 2, is characterized in that, it is made up of the crude drug of following parts by weight: Radix Pseudostellariae 12 parts, Radix Ophiopogonis 10 parts, Herba Hedyotidis Diffusae 20 parts, Herba Scutellariae Barbatae 20 parts, Pseudobulbus Cremastrae Seu Pleiones 15 parts, Rhizoma Curcumae 10 parts.

4. the Traditional Chinese medicine compound composition with anti-tumor activity according to any one of claims 1 to 3, is characterized in that, the extract of each crude drug and pharmaceutically acceptable carrier is prepared into the medicine of oral liquid, granule, capsule or Tabules.

5. the preparation method with the Traditional Chinese medicine compound composition of anti-tumor activity described in any one of claims 1 to 3, is characterized in that comprising the following steps:

(1) get Rhizoma Curcumae by the parts by weight described in any one of claims 1 to 3, add the water of Rhizoma Curcumae medical material 8 ~ 16 times amount, adopt extraction by steam distillation 1 ~ 3 hour, collect volatile oil;

(2) Radix Pseudostellariae is got, Radix Ophiopogonis, Herba Hedyotidis Diffusae by the parts by weight described in any one of claims 1 to 3, Herba Scutellariae Barbatae and Pseudobulbus Cremastrae Seu Pleiones, add the Rhizoma Curcumae medicinal residues after step (1) vapor distillation, add the ethanol of total medical material weight 6 ~ 12 times of volumes, backflow or continuous circumfluence extraction 2 ~ 3 times, each 1 ~ 3 hour, merge extractive liquid, 50 ~ 80 degrees Celsius of lower concentrating under reduced pressure, obtain macroporous adsorptive resins on concentrate, first washing with water, is then 20% ~ 70% ethanol elution by volumetric concentration successively; Collecting merging volumetric concentration is the ethanol elution of 55%, concentrates and to obtain extract;

(3) get the volatile oil that step (1) obtains, the extract that step (2) obtains and pharmaceutically acceptable carrier are prepared into the medicine of oral liquid, granule, capsule or Tabules.

6. the preparation method with the Traditional Chinese medicine compound composition of anti-tumor activity according to claim 5, is characterized in that, the macroporous adsorbent resin described in step (1) is D101 resin.

7. the Traditional Chinese medicine compound composition with anti-tumor activity described in any one of claims 1 to 3 is preparing the application in antitumor drug.

8. the Traditional Chinese medicine compound composition with anti-tumor activity described in any one of claims 1 to 3 in the anti-pulmonary carcinoma of preparation, gastric cancer, hepatocarcinoma, colon cancer, cervical cancer, the application in breast carcinoma or Dendritic cell medicine.