CN1098087C - Chinese medicine for treating cancers and its preparing process - Google Patents

Abstract

The present invention relates to a traditional Chinese medicine preparation for treating malignant tumors and a method for the preparation thereof, which is characterized in that trichosanthes root, fresh oyster and heartleaf houttuynia herb are pulverized and ground into the powder of which the grain size is 0.15mm, the powder is immersed by black bean milk, filtrated liquid is collected and is provided with the enzyme fermentation of photosynthetic bacterium liquid, and oral liquid is made by sterilization and filling operation or a solid formulation is made by freeze-drying operation. The traditional Chinese medicine preparation has an obvious treating effect on treating malignant tumors, and can use the traditional Chinese medicine preparation which can correct the balance disorder of trace elements in an organism internal environment for promoting the organism internal environment to return to the normal state, the erzyme controlling cancer genes to return the normal activity, the immune function to return to the normal state, and cancer cells to be converted to normal cells and finally and entirely return to the normal cells.

Description

A kind of Chinese medicine preparation and preparation method for the treatment of malignant tumor

The present invention relates to a kind of Chinese medicine preparation for the treatment of malignant tumor and preparation method thereof.

Malignant tumor practise to claim cancer, be at present in the world sickness rate height, mortality rate height, to the great a kind of disease of human health risk.According to statistics, Chinese annual New Development malignant tumor patient 1,600,000 people, dead 1,050,000 people.It is big that this class disease is not only treated difficulty, and patient and family members' misery is also very big, also very big to patient unit and influence of society.

Therapeutic Method to malignant tumor has two big classes at present, one class is that the local excision of doctor trained in Western medicine, blood supply, the local injection of local blocking-up tumor body suppress the medicine of tumor bulk-growth and chemotherapy, the radiotherapy of general, another kind of is the strengthening vital QI to eliminate pathogenic factors of the traditional Chinese medical science, the whole therapy of human body immunity improving function, to reach the therapeutic purposes that prolong patient's life, raising life quality, reduce patient's misery.But at present the curative effect of Therapeutic Method is lower, and mortality rate is still up to 65% in the malignant tumor patient 1 year.

Purpose of the present invention is the shortcoming and deficiency in order to overcome above-mentioned prior art just, and provides a kind of tumor cell that makes to become the Chinese medicine preparation of Normocellular treatment malignant tumor to normal cell conversion and final full recovery, thereby makes the patient recover health.

The present invention also provides the preparation method of this Chinese medicine preparation.

The objective of the invention is to realize by following technical proposal:

A kind of Chinese medicine preparation for the treatment of malignant tumor is characterized in that oral administration solution or solid preparation that it is also made as follows by following weight proportioning raw material:

Radix Trichosanthis 30-50 part, Concha Ostreae 30-40 part, Herba Houttuyniae 20-30 part, black soya bean soymilk 300-500 part,

With 30-50 part Radix Trichosanthis, 30-40 part Concha Ostreae, 20-30 part Herba Houttuyniae mixed grinding to particle diameter is the 0.15mm powdery, put and add 300-500 part black soya bean soymilk in the container, under 20-25 ℃ of temperature, soaked 10-15 days, filter and remove residue, collect filtrate and pack in the fermentation tank, add photosynthetic bacteria liquid again, its proportioning is filtrate by volume: bacterium liquid=5: 1, enzymology fermented 10-30 days under 25-30 ℃ of temperature and anaerobic condition then, the gained medicinal liquid is sterilized, and fill is sealed, make the oral liquid product, or medicinal liquid is carried out lyophilization make solid preparation and make capsule or granule.

Primary raw material of the present invention is Radix Trichosanthis, Concha Ostreae, Herba Houttuyniae, by the fermentation of photosynthetic bacteria enzymology, drug effect is brought into play more fully, Radix Trichosanthis wherein has another name called and is the Fructus Trichosanthis root, is used as medicine with the dry root of cucurbitaceous plant Fructus Trichosanthis or trichosanthes rosthornii Harms, sweet in the mouth, little picric acid are slightly cold, and attach to the lung and stomach meridians.Sweet not injuring one's stomach and the tonify deficiency regulating the spleen and stomach, little bitter pathogenic fire reducing causes detumescence and apocenosis, and acid can be promoted the production of body fluid and quench the thirst and be moisturized, so for monarch drug, fall the heat-phlegm on the diaphragm, profit excessive thirst in the heart, the fanaticism of expectorant when removing, the wet yellow of numbness that disappear of dispelling is especially with the eliminating carbuncle infections, dissipating blood stasis is long-pending, removing toxic substances and promoting pus discharge, and effect is very prompt, have heat clearing away and give birth to dregs, detumescence suppuration, be used for the calentura excessive thirst, lung-heat type cough, interior-heat is quenched one's thirst, the sore swollen toxin effect.Study the effect that Radix Trichosanthis has good antitumor, anti AIDS virus and raising immunologic function according to modern pharmacy, choriocarcinoma, the esophageal carcinoma, pulmonary carcinoma, hepatocarcinoma, breast carcinoma, pulmonary carcinoma, the esophageal carcinoma etc. are had definite curative effect.

Concha Ostreae is with the long Concha Ostreae of Ostreidae animal, and the shell of Dalian Bay Concha Ostreae or Crassostrea rivularis is used as medicine, and flavor alkali is slightly cold.Return liver, gallbladder, kidney channel.To become cold Concha Ostreae softening and eliminating sputum, go to dislike meat and hold back routed carbuncle, eliminating mass abdominal mass and remove goiter, but and yin fluid astringing YANG hyperactivity suppressing and strengthening vital QI to eliminate pathogenic factors, sun is satisfied with the moon both benefit and also, so this product adjuvant drug, has tranquillization with heavy prescription, YANG hyperactivity suppressing nourishing YIN, hard masses softening and resolving, restrain astringent or styptic treatment for spontaneous sweating, be used for insomnia, dizzy, tinnitus, tuberculous lymphadenitis, lump in the abdomen mass in the abdomen, spontaneous sweating, the seminal emission metrorrhagia and leukorrhagia, the function of stomachache pantothenic acid.Concha Ostreae has obvious suppression virus and antitumaous effect, and lymphatic cancer, the esophageal carcinoma, pulmonary carcinoma, intestinal cancer are had significant curative effect.

Herba Houttuyniae is used as medicine with the dry aerial parts of saururaceae plant houttuynia cordata.Acrid in the mouth, acid are slightly cold.Return lung meridian.Heat-clearing and toxic substances removing is specialized in pulmonary's pus infections carbuncle pyretic toxicity expectorant blood, and Herba Houttuyniae has stronger antibacterial antitumaous effect, and pneumonia, pulmonary abscess, pulmonary carcinoma etc. are had preferable curative effect.Above-mentioned three flavor Chinese medicines, tool suffering, acid, sweet, bitter, one-tenth is bittersweet, i.e. Radix Trichosanthis sweet in the mouth, hardship, acid, Concha Ostreae distinguishes the flavor of, puckery, Herba Houttuyniae acrid in the mouth, acid.Wood, fire, soil, gold, the water five elements are various, and promptly Radix Trichosanthis belongs to gold, native, and Concha Ostreae belongs to wood, water, and Herba Houttuyniae belongs to gold, fiery, power is grand to be specialized in, and giving consideration to both the incidental and fundamental for cancer-resisting, is eliminated pulmonary disease and can be reached except that disliking meat, dissipating blood stasis is long-pending, detumescence and apocenosis, the effect of promoting pus discharge and tissue regeneration strengthening.

Below with clinical experiment and pharmacodynamic study as a result branch chat as follows:

The clinical experiment result:

One, clinical data:

1. case is selected

Above provincial hospital is made a definite diagnosis through a family, have laboratory reports such as CT, X line at least, preferably there are pathology or cytology to make a definite diagnosis, do not accept antineoplaston in nearly 4 weeks, active state Karnofsky scoring 〉=60 minutes, measurable tumor focus or clinical indexes are arranged, can estimate short term effect, and the above person two courses of treatment that adheres to taking medicine.

2. physical data

Various late malignant tumour patient 86 examples that meet the case choice criteria.Man's 54 examples, women 32 examples.Age 2-84 year, average 54.72 years old, less than 18 years old 3 example, greater than 70 years old 9 example, peasant 35 people, citizen 51 people.

3. Therapeutic Method

Oral liquid of the present invention, every 10ml is by the loyal photosynthetic bacteria Research Institute of the Henry of Shanxi unit, lot number 20000508.One of oral liquid one time, 3 times on the one, 30 days courses of treatment, the 1st course of treatment effectively after, continue 2-6 the course of treatment, judge whether the 1st course of treatment is effective, generally feel and be improved as the master with patient, lab testing is auxilliary, and from the 2nd course of treatment, efficacy determination is based on lab testing.

4. efficacy assessment standard

Estimate curative effect according to the objective criterion of therapeutical effect of WHO (1981) antitumor drug.Alleviate fully (CR): all pathological changes complete obiterations, and keep more than 4 weeks.Part is alleviated (PR): tumor focus maximum perpendicular two footpath products dwindle 〉=and 50%, and keep more than 4 weeks.(MR) takes a turn for the better: tumor dwindles 〉=and 25%, but＜50%.Stablizing (SD) tumor dwindles＜and 25%, or increase＜25%.Development (PD): tumor increases 〉=25%, or new focus occurs.Total remission rate calculates with CR+PR, and total effective rate calculates with CR+PR+MR.

Two, result:

1. clinical efficacy:

Clinical efficacy sees Table 1, table 2.Full group 86 examples took altogether for 357 courses of treatment (two the courses of treatment 6 example, three the courses of treatment 14 example, four the courses of treatment 37 example, five the courses of treatment 19 example, six the courses of treatment 10 example), the decidable curative effect.Total effective 55 examples, total effective rate 63.95%.Total remission rate 48.72% of pulmonary carcinoma, total effective rate 74.36%.

Table 1 clinical efficacy table tumour name is accepted the efficient tumour name of the effective routine number of routine number for medical treatment and is accepted 63 subtotals 86 55 63.95% such as effective routine number lung cancer 39 29 74.36% bronchiolar carcinomas 11 cancers of the esophagus 96 66.67% cancer of the stomach 21 liver cancer 83 37.50% carcinoma of the rectum 54 colon cancers 21 carcinomas of urinary bladder 11 nasopharyngeal carcinoma 32 cervical carcinomas 1 kidney 1 osteocarcinoma 21 cutaneum carcinomas 1 cancer of the brain 22 leukaemia 31 lymph cancers of routine number for medical treatment

Table 2 treatment pulmonary carcinoma clinical efficacy table tumor type example number CR PR MR SD PD, (CR+PR) %, (CR+PR+MR) % adenocarcinoma of lung 21 39441 57.14 76.19 lung squamous cancers 13 13522 30.77 69.23 small cell lung canceres 52111 60.00 80.00 subtotals 39 6 13 10 73 48.72 74.36 pharmacodynamic study results:

1. reagent

RPMT 1640 cultivates and is GIBCO company product.Newborn calf serum is provided by Sijiqing Bioengineering Material Inst., Hangzhou City.Thiazole bromide blue tetrazolium (MTT) is the Pluka product.2,5-diphenyl oxazole (PPO), 1, two (the 5-oxazolyl phenyl base-2) benzene (POPOP) of 4-are Merck company product.Oleum Tiglii is the orange colour thick liquid, uses acetone diluted during use.DMSO, thiobarbituricacid (TBA), 30%H ₂O ₂Be Beijing Chemical Plant's product.Cyclophosphamide (CTX) is Shanghai No.12 Pharmaceutical Factory's product.India ink is a chemical plant product in the west, Beijing.Dinitrofluorobenzene (DNFB) is a Sigma company product.[ ³H]-Tdr (50ci/mmol) is the inferior brightness of a Chinese atomic energy academy bio-engineering corporation product.

2. animal and the strain of animal tumor

Kunming mouse, ICR mice and C57BL/6 mouse inbred lines, 18-22g, male and female half and half are provided by Chinese Academy of Medical Sciences's Experimental Animal Center.

Animal transplanting tumor strain sarcoma S ₁₈₀, Lewis lung cancer, hepatocarcinoma H ₂₂, melanoma B ₁₆Go down to posterity by Institute of Experimental Animals, Chinese Academy of Medical Sciences and to protect kind.

3. method

Inoculation: select that tumor growth is good, overall health of patients tumor-bearing mice preferably, dislocation is put to death, fixing back iodine tincture, alcohol disinfecting, aseptic condition takes out the tumor piece down, weighs, and shreds, grind, filter, homogenate is with normal saline dilution in 1: 3, and the tumor liquid with every Mus 0.2ml under the laboratory animal axillary fossa is inoculated.

Next day after the inoculation, animal is divided into 6 groups at random, use preparation of the present invention, if high low dose group and 4 matched groups, the nutrient chemical matched group is to compare with photosynthetic casate, the Chinese herbs decoction matched group is to decoct the medicinal liquid that forms with traditional method, and the cyclophosphamide-a control group is to adopt known Western medicine as the positive drug matched group.Every group of 10 mices, male and female half and half.

4. administration:

Give the medicine of equal-volume variable concentrations next day in the inoculation back, be administered once every day, successive administration 10 days.Oral liquid high dose group administration 10ml/kg (be human dosage 50 times), low dose group administration 2ml/kg (be human dosage 10 times), the blank group is given distilled water 10ml/kg, and the nutrient chemical matched group is given nutrient chemical 10ml/kg, and positive controls is given cyclophosphamide lumbar injection 50mg/kg.After the last administration 24 hours, animal was put to death in the cervical vertebra dislocation, take by weighing respectively body weight, tumor heavy, calculate tumour inhibiting rate, carry out therapeutic evaluation, and each group result carried out statistical procedures.Tumour inhibiting rate=100% * (it is heavy that average tumor is organized in the average tumor weight-treatment of blank group)/(the average tumor of blank group is heavy).

5. result

(1) to rat liver cancer H ₂₂Tumor-inhibiting action observe: see Table 3

Table 3 couple rat liver cancer H ₂₂Tumor-inhibiting action

Heavy (g) tumour inhibiting rate of number of animals body weight (g) tumor

After the front administration of administration, (X ± SD), (%) blank 10 19.9 ± 1.91 25.9 ± 2.60 2.34 ± 0.68 nutrient chemical groups 10 20.3 ± 0.82 24.5 ± 1.24 2.31 ± 0.58 1.3 Chinese herbs decoction 10 20.1 ± 1.42 26.2 ± 3.77 2.22 ± 0.79 5.1 endoxan 10 19.7 ± 0.82 19.1 ± 1.55 0.06 ± 0.05 97.4 low dose group 10 20.2 ± 1.25 22.5 ± 2.72 1.31 ± 0.39 44.0 high dose group 9 19.8 ± 1.52 23.2 ± 1.77 1.13 ± 0.79 51.7

The result shows that the tumour inhibiting rate of positive controls and oral liquid treatment group all has extremely significantly meaning, P＜0.001 (2). the tumor-inhibiting action to Mice Bearing Lewis Lung Cancer is observed: see Table 4

The tumor-inhibiting action of table 4 pair Mice Bearing Lewis Lung Cancer is observed

Heavy (g) tumour inhibiting rate of number of animals body weight (g) tumor

After the front administration of administration, (X ± SD), (%) blank 10 20.2 ± 1.30 20.2 ± 1.92 2.96 ± 0.72 nutrient chemical groups 10 20.0 ± 0.22 20.1 ± 0.34 2.89 ± 0.88 2.3 Chinese herbs decoction 10 19.1 ± 0.42 19.8 ± 2.45 2.84 ± 0.97 2.4 endoxan 10 19.0 ± 2.19 18.4 ± 1.14 0.05 ± 0.07 98.7 low dose group 10 19.6 ± 2.19 19.5 ± 2.02 1.32 ± 0.63 55.4 high dose group 10 19.8 ± 0.45 20.0 ± 1.41 0.09 ± 0.47 69.6

The result shows that the tumour inhibiting rate of positive controls and oral liquid treatment group all has extremely significantly meaning, P＜0.001.

(3). the tumor-inhibiting action to mouse melanin cancer B16 is observed: see Table 5

The tumor-inhibiting action of table 5 couple mouse melanin cancer B16 is observed

Heavy (g) tumour inhibiting rate of number of animals body weight (g) tumor

After the front administration of administration, (X ± SD), (%) blank 10 20.4 ± 1.07 23.1 ± 1.60 2.49 ± 0.53 nutrient chemical groups 10 20.1 ± 1.66 23.2 ± 1.55 2.43 ± 0.58 2.4 Chinese herbs decoctions 10 19.1 ± 0.42 19.8 ± 2.45 2.34 ± 0.96 6.0 endoxan 10 19.1 ± 1.20 19.4 ± 1.34 0.04 ± 0.07 98.4 low dose group 10 20.8 ± 1.23 23.4 ± 3.34 0.04 ± 0.79 45.0 high dose group 10 19.4 ± 1.15 21.6 ± 2.41 0.95 ± 0.77 61.8

The result shows that the tumour inhibiting rate of positive controls and oral liquid treatment group all has extremely significantly meaning, P＜0.001.(4). murine sarcoma S ₁₈₀Tumor-inhibiting action observe: see Table 6

Table 6 murine sarcoma S ₁₈₀Tumor-inhibiting action observe

Heavy (g) tumour inhibiting rate of number of animals body weight (g) tumor

After the front administration of administration, (X ± SD), (%) blank 9 8.1 ± 1.34 22.4 ± 2.70 2.98 ± 0.69 nutrient chemical groups 10 8.4 ± 11.37 24.3 ± 3.34 2.92 ± 0.84 2.0 Chinese herbs decoctions 10 8.0 ± 1.46 22.3 ± 2.44 2.84 ± 1.26 4.7 endoxan 10 8.5 ± 1.80 20.4 ± 3.25 0.48 ± 0.37 83.9 low dose group 10 9.3 ± 1.23 24.0 ± 2.57 1.68 ± 0.74 43.6 high dose group 10 8.0 ± 1.46 21.7 ± 3.67 1.27 ± 0.73 57.4

The result shows that the tumour inhibiting rate of positive controls and oral liquid treatment group all has extremely significantly meaning, P＜0.001.

Conclusion: oral liquid of the present invention has good inhibitory effect to mice transplanted tumor, and its tumor-inhibiting action is about half of Western medicine cyclophosphamide, is a kind of preferably in numerous Chinese medicine anticancer preparations.The tumor-inhibiting action of Western medicine cyclophosphamide is extremely strong, but its toxic and side effects is also extremely strong, and patient can't be accepted.Through and nutrient chemical and Chinese herbs decoction matched group relatively, prove it is not merely the inorganic microelement in the photosynthetic bacteria nutrient chemical group and the effect of Chinese medicine, Chinese herbs decoction tumour inhibiting rate after photosynthetic bacteria enzymology fermentation process obviously improves.

Model case:

Xue * *, the man, 65 years old, because of asthma, cough, companion's bloody sputum, through X line rabat and laminagram, be diagnosed as upper right pulmonary carcinoma, take oral liquid, a 10ml, 3 times on the one, doing well,improving after 10 days, cough reduces, and recovers normal gradually, the positive side of X line rabat position check in 40 days, the primary tumo(u)r focus is before dwindled, and tumor bed place texture increases thick weightening finish, and local density lowers, be clearly better, followed up a case by regular visits to, the basic recovery normally through 1 year.

The king * *, woman, 64 years old, feed dysphagia three months is diagnosed as esophago mesomere cancer by esophagogram, takes oral liquid, a 10ml, 3 times on the one, doing well,improving after the week, the stream juice of can taking food, available after a while normal diet is in five middle of the month of treatment, repeatedly carry out the esophagogram inspection, with observe the curative effect, visible esophagus stage casing mucosa breakage is repaired gradually, narrow improvement gradually, the final recovery normally.

Owing to take technique scheme, make the technology of the present invention compared with the prior art have following advantage and effect:

A) medicine of the present invention is a primary raw material with Chinese medicine and Semen sojae atricolor; adopt photosynthetic bacteria through biotechnology and technology conversion processing; and the medicament of making; contain the necessary trace element of multiple human body and the photosynthetic bacteria factor; polysaccharide; glycoprotein; polypeptide; complex etc.; it has the function of rectifier internal milieu trace element balance disorder; thereby promote organismic internal environment to recover normal; promote the enzyme of regulation and control oncogene to recover normal activity; promote immunologic function to recover normal condition; promote that cancerous cell transforms to normal cell; and finally full recovery becomes normal cell, is a kind of Chinese medicine preparation of treatment malignant tumor for the treatment of both the principal and secondary aspects of a disease.

B) selection of clinical case history great majority are to adopt operation or put, change inapparent patient of therapeutic effect or patients with terminal, can obtain the therapeutic effect of effective percentage 63.95%, still feel quite pleased, as first-selected therapeutic scheme, will be higher to the alleviation and the effective percentage of malignant tumor.

C) contain organic selenium in the medicine of the present invention, selenium polysaccharide, selenium protein, selenoamino acid, the multiple selenium organic substances that contain such as selenium porphyrin are that a kind of se complementary effect is good, have no side effect safe and reliable cancer therapy drug.

D) photosynthetic bacteria is that a big class is not under anaerobic put the photosynthetic antibacterial of oxygen it is had with changes in environmental conditions the characteristic that changes its metabolic way flexibly, have fixed nitrogen, product hydrogen, solid carbon, desulfurization, the ability of oxidable decomposing hydrogen sulfide, amine and multiple poisonous substance, be the new way of preparation biologics, in Chinese medicine is now changed for process, be with a wide range of applications.

E) preparation method is simple, and is pollution-free, the no three wastes.

Embodiment 1:

Get the 30kg Radix Trichosanthis, the 40kg Concha Ostreae, 30kg Herba Houttuyniae mixed grinding to particle diameter is the 0.15mm powdery, pack in the container, add the 300kg black soya bean soymilk, under 20 ℃ of temperature, soaked 15 days, filter and remove residue, collection filtrate is packed in the fermentation tank, add photosynthetic bacteria liquid 56kg again in filtrate, enzymology fermented 30 days under 25 ℃ of temperature and anaerobic condition then, the sterilization of gained medicinal liquid, fill, seal, make oral liquid, every 10ml.

Embodiment 2:

Get the 50kg Radix Trichosanthis, the 30kg Concha Ostreae, 20kg Herba Houttuyniae mixed grinding to particle diameter is the 0.15mm powdery, pack in the container, add the 400kg black soya bean soymilk, under 20 ℃ of temperature, soaked 12 days, filter and remove residue, collection filtrate is packed in the fermentation tank, in filtrate, add photosynthetic bacteria liquid 72kg again, enzymology fermented 20 days under 25 ℃ of temperature and anaerobic condition then, made solid preparation through lyophilization, incapsulated, every 0.2-0.3g is capsule preparations.

Embodiment 3:

Get the 40kg Radix Trichosanthis, the 35kg Concha Ostreae, 25kg Herba Houttuyniae mixed grinding to particle diameter is the 0.15mm powdery, pack in the container, add the 500kg black soya bean soymilk, under 20 ℃ of temperature, soaked 10 days, filter and remove residue is collected filtrate, pack into and in filtrate, add photosynthetic bacteria liquid 90kg in the fermentation tank again, enzymology fermented 10 days under 30 ℃ of temperature and anaerobic condition then, through lyophilization, made fine grained, every bag 0.2-0.3g is granular preparation.

Claims (1)

1, a kind of Chinese medicine preparation for the treatment of malignant tumor is characterized in that oral administration solution or solid preparation that it is also made as follows by following weight proportioning raw material:

Radix Trichosanthis 30-50 part, Concha Ostreae 30-40 part, Herba Houttuyniae 20-30 part, black soya bean soymilk 300-500 part,

With 30-50 part Radix Trichosanthis, 30-40 part Concha Ostreae, 20-30 part Herba Houttuyniae mixed grinding to particle diameter is the 0.15mm powdery, put and add 300-500 part black soya bean soymilk in the container, under 20-25 ℃ of temperature, soaked 10-15 days, filter and remove residue, collect filtrate and pack in the fermentation tank, add photosynthetic bacteria liquid again, its proportioning is filtrate by volume: bacterium liquid=5: 1, enzymology fermented 10-30 days under 25-30 ℃ of temperature and anaerobic condition then, the gained medicinal liquid is sterilized, and fill is sealed, make the oral liquid product, or medicinal liquid is carried out lyophilization make solid preparation and make capsule or granule.