Summary of the invention
The present invention is directed to above-mentioned problems of the prior art, according to modern medicine and Chinese medicine and pharmacy theory, developed a kind of treatment lung cancer drugs in conjunction with clinical practice for many years, solved that existing medium and advanced lung cancer can not be performed the operation and the chemicotherapy poison causes the problem of complication greatly easily, this medicine good effect can make the acceptant medicine of medium and advanced lung cancer patient, and is without any side effects, cost is low, and is safe and reliable.
Another object of the present invention provides a kind of preparation technology of above-mentioned treatment lung cancer drugs.
The weight ratio scope of each raw material of the present invention is to carry out a large amount of groping through the inventor to draw with Test Summary, and the weight ratio of each raw material all has effect preferably at following weight range.The present invention adopts following raw material to make up, and makes the effect of each raw material produce synergism these material combination, thereby reaches heat-clearing and toxic substances removing, reducing swelling and alleviating pain, the effect of dissipating phlegm and resolving masses.
Technical scheme of the present invention is as follows:
It is to count ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=(150-400): (50-300): (250-700): (80-350): (250-700): (100-350): (80-300).
Preparation technology of the present invention comprises the steps:
Clean: above-mentioned seven flavor medicine material is washed;
Processing is concocted: Radix Sophorae Tonkinensis, Rhizoma Menispermi, Cortex Dictamni, Poria, Polyporus processing are cut into slices; Fructus Trichosanthis is cut into thread; Herba Scutellariae Barbatae is cut into chunks;
Decoct: get the seven flavor medicine material behind the above-mentioned processing edulcoration, decoct with water three times, add water 6-10 for the first time doubly, soaked 0.5-1.5 hour, decocted 0.5-1.5 hour, respectively add water 3-8 for the second time, for the third time doubly, decocted 0.5-1.5 hour, collecting decoction, filtration gets filtrate;
Oven dry is pulverized: get above-mentioned filtrate, heating is evaporated to thick paste shape (about 1.35 (60 ℃ of heat are surveyed) of relative density), and 60-90 ℃ of decompression oven dry pulverized, and powder gets dry extract;
The system granule: get above-mentioned dried cream powder, add hydroxypropyl cellulose, starch, mixing adds the 60-85% alcohol granulation;
Tabletting: will add magnesium stearate in the above-mentioned granule, mixing, compacting is in blocks, promptly.
Advantage of the present invention and beneficial effect are as follows:
Among the present invention with the product of Radix Sophorae Tonkinensis bitter cold, the detoxifcation of relieving inflammation or internal heat, reducing swelling and alleviating pain, clearing throat.Both can control pyretic toxicity pent up laryngopharynx swelling and pain, nasal obstruction can be controlled the cough due to lung-heat again for monarch drug.As " Bencao Jingshu " cloud: " Radix Sophorae Tonkinensis, thus sweet and malicious, so cold heat extraction, all malicious Bi Rebixin, poor gas, the flavor of sweetness and bitterness, then all poison are explained by oneself, so be medicine on the heat clearing away of detoxifying.All pains must be because of in heat, and malicious analgesic diffusing, then pain is from ending, and skin ulcer swells and disappears certainly ".
Both can strengthen the antipyretic and antidote functions of Radix Sophorae Tonkinensis with Rhizoma Menispermi, but promoting the circulation of QI to induce diuresis again, damp eliminating is reduced phlegm, and falls along expectorant then in the hope of gas, and gasifying then, expectorant disappears; With Fructus Trichosanthis sweetness and bitterness, cold product lung moistening pathogenic fire reducing, the clearing away phlegm eliminating stagnation can clearing away lung-heat and reduce phlegm, again can the pain relieving of promoting the circulation of QI eliminating stagnation with the chest stuffiness relieving, can also clearing throat, the ministerial drug in the side of being all.As the Compendium of Material Medica cloud: " lung moistening is dry, pathogenic fire reducing for Fructus Trichosanthis.Control cough, clearing away phlegm knot, throat, subduing inflammation sore ".
With Herba Scutellariae Barbatae, Cortex Dictamni heat-clearing and toxic substances removing, to strengthen the antipyretic and antidote functions of monarch-minister drug.Herba Scutellariae Barbatae still can the circulation of qi promoting dissipating blood stasis and pain relieving in addition, and anastalsis is arranged.As " Quanzhou book on Chinese herbal medicine " cloud: Herba Scutellariae Barbatae " heat-clearing and toxic substances removing dispels the wind, the blood that looses, circulation of qi promoting, diuretic, collateral dredging, removing blood stasis with potent drugs pain relieving ".Cortex Dictamni and energy dispeiling pathogenic wind and removing dampness eliminate the phlegm and " treating lung coughs " (" the Ministry of War in feudal China hands collection side ") to help; As fiery upper punch also, must tremble with fear and loose, then cough with dyspnea ends ".Again according to the saying of " see that expectorant not controls expectorant, the kind rule of treatment is controlled its source of giving birth to expectorant ", and the spleen being the source of producing phlegm.In the event side again with Poria, Polyporus promoting diuresis to eliminate damp pathogen, and can spleen invigorating, but both reinforcing body resistance can make strong wet the eliminating the phlegm of spleen have no way of with life again, it gives birth to the source of expectorant and shut out.Adjuvant drug in the side of being all.
Wherein Herba Scutellariae Barbatae can circulation of qi promoting dissipating blood stasis, collateral dredging is to control phlegm and qi stasis, the disease of blood stasis resistance network is held concurrently and is the messenger drug in the side.All medicines share, and play heat-clearing and toxic substances removing altogether, dissipating phlegm and resolving masses, the merit of reducing swelling and alleviating pain.Can make lung-heat clear in this way, phlegm-damp stasis of blood poison must be separated, and the gas promoting the circulation of blood is lived, and meridians must be logical, only coughs that expectorant removes and make, and the swollen pain that disappears is ended.
1, heat-clearing and toxic substances removing, strengthening vital QI to eliminate pathogenic factors, blood stasis-eliminating and stagnation-dissipating are used for the treatment of medium and advanced lung cancer and can improve symptom, and tumor is dwindled, alleviating pain, stimulating appetite, the human body immunity improving function prolongs patient's life cycle; Especially to undergoing surgery and the patient of chemicotherapy has curative effect preferably.
2, good effect, treatment time is short, and is without any side effects, do not have taboo, safe and reliable, easy to use, is convenient to hold utilization.
3, process for machining and manufacturing is simple, and flow process is short, and raw material sources are easy to get, and cost is low, and volume is little, is convenient for carrying, and production and transport stores no any risk, has extensive market prospect.
The specific embodiment
Below by clinical, drug effect and toxicity test are further set forth the beneficial effect of medicine of the present invention.
Clinical trial curative effect of medication visual report of the present invention
One, be the curative effect of further examining medicine of the present invention, the patient who 103 examples is suffered from pulmonary carcinoma carries out clinical trial, now observed result is reported as follows:
1, clinical data:
In the 103 routine lung cancer patients, male 76 examples, women 27 examples; Age 32-77 year, the mean age is 58.2 years old, organizes case entirely all through the film making of X line, lung CT scan, fibre bronchus mirror's inspection and pathological diagnosis: scale cancer 34 examples, adenocarcinoma 28 examples, minicell efflorescence cancer 25 examples, other 16 example.
2, Therapeutic Method:
6 slices/time of medicines of the present invention, three times on the one, oral, 30 days is a course of treatment, sustainable taking medicine 6 months.
3, clinical efficacy criterion:
With reference to new drug (Chinese medicine) clinical guidance principle, criterion is alleviated (CR): the cancer complete obiteration fully; Part is alleviated (PR): carcinoma reduces 50%; Stable effectively (MR): carcinoma reduces or increases all less than 25%; Make progress invalid (PD): carcinoma increases and greater than 25% or new focus occurs.
4, result:
The oral white mountain of medium and advanced lung cancer patient sheet its observation of curative effect result 3 courses of treatment:
PR65 example, MR34 example, PD4 example.Effective percentage is 67%.
5, discuss:
Early diagnosis to pulmonary carcinoma does not still have breakthrough at present, has been middle and advanced stage when most patients go to a doctor, thereby has lost the surgical engine meeting, can not tolerate chemotherapy or radiotherapy owing to the condition difference.So the treatment by Chinese herbs medium and advanced lung cancer seems very important.
Two, medicine of the present invention (white mountain sheet) is to the experimental therapy effect of people's cancer transplanted tumor in nude mice small cell lung cancer
1, medicament sources and preparation
White mountain sheet powder is provided by the present side pharmaceutcal corporation, Ltd.
Be made into the suspension of desired concn before the experiment with distilled water.
Cyclophosphamide is provided by Hualian Pharmaceutical Co., Ltd., Shanghai.
Be made into the solution of desired concn before the experiment with normal saline.
2, laboratory animal:
Testing used nude mice BALB/C/nu is provided by zooscopy institute of the Chinese Academy of Medical Sciences.
The laboratory animal quality certification number is: the capital is moving is betrothed to 017.The male and female dual-purpose.Identical with animal sex in batch experiment.Male Mus body weight 18-24g, female Mus body weight 17-22g.
3, experimental technique:
Select the tumor-bearing mice of the vigorous human small cell lung carcinoma of tumor growth.The cervical vertebra dislocation is put to death.With iodine tincture alcohol disinfecting animal skin, cut off the skin peeling tumor in super-clean bench, with homogenizer tumor tissue is added physiological saline solution and make cell suspension, it is subcutaneous to be inoculated in animal right upper extremity axillary fossa.The inoculated tumour cell number is about 5 * 106.Grouping in the 6th day administration of inoculation back is also measured gross tumor volume.Experiment is established 5 groups altogether: 1, negative control group 2, cyclophosphamide group 3, white mountain sheet 24.8g crude drug/kg group 4, white mountain sheet 49.6g crude drug/kg group 5, white mountain sheet 74.4g crude drug/kg group.Cyclophosphamide 60mg/kg lumbar injection 1 time.White mountain sheet gastric infusion every day 1 time.Continuous 11 days.Put to death animal in 24 hours after the drug withdrawal, the stripping tumor is weighed, and uses the statistical method deal with data.In the experimentation every 1 tumor volume of 3-4 staggering amount.
4, result
By above experiment, white mountain sheet has tumor-inhibiting action preferably to the tumor-bearing mice human small cell lung carcinoma when 49.6g crude drug/kg and 74.4g crude drug/kg dosage.49.6g during crude drug/kg, male Mus suppression ratio is 44.1%, P<0.01; Female Mus suppression ratio is 56.4%, P<0.01.74.4g during crude drug/kg, male Mus suppression ratio is 54.9%, P<0.01; Female Mus suppression ratio is 62.6%, P<0.01.Detailed data sees Table.
Data is preserved: institute of Materia Medica,Chinese Academy of Medical Sciences
White mountain sheet is to the experimental therapy effect table of people's cancer transplanted tumor in nude mice small cell lung cancer
Male nude mouse
Group |
Dosage (g crude drug/kg * number of times) |
Number of animals (only) (beginning/end) |
Body weight (g) (beginning/end) |
Tumor heavy (g) (X ± SD) |
Suppression ratio (%) |
The P value |
Contrast |
—— |
7/7 |
20.8+4.0 |
3.22±1.598 |
—— |
—— |
Cyclophosphamide |
60mg×1 |
7/7 |
20.1+2.8 |
0.12±0.068 |
96.3 |
<0.01 |
White mountain sheet |
24.8×11 |
7/7 |
21.1+3.9 |
2.44±1.516 |
24.2 |
>0.05 |
White mountain sheet |
49.6×11 |
7/7 |
21.0+2.3 |
1.80±0.491 |
44.1 |
<0.01 |
White mountain sheet |
74.4×11 |
7/7 |
20.0+1.8 |
1.45±0.578 |
54.9 |
<0.01 |
Female nude mice
Group |
Dosage (g crude drug/kg * number of times) |
Number of animals (only) (beginning/end) |
Body weight (g) (beginning/end) |
Tumor heavy (g) (X ± SD) |
Suppression ratio (%) |
The P value |
Contrast |
—— |
8/8 |
19.9+1.3 |
2.89±1.312 |
—— |
—— |
Cyclophosphamide |
60mg×1 |
8/8 |
19.4+1.2 |
0.17±0.051 |
94.1 |
<0.01 |
White mountain sheet |
24.8×11 |
8/8 |
19.6+0.9 |
2.02±0.498 |
30.1 |
<0.01 |
White mountain sheet |
49.6×11 |
8/8 |
19.9-0.7 |
1.26±0.658 |
56.4 |
<0.01 |
White mountain sheet |
74.4×11 |
8/8 |
20.4-0.4 |
1.08±0.771 |
62.6 |
<0.01 |
Chmice acute toxicity test curative effect of medication visual report of the present invention
Relevant requirements according to " study of tcm new drug guide (pharmacy, pharmacology, toxicology) ", medicine of the present invention has been carried out the mensuration of mice maximum tolerated dose, purpose to be tried thing and is once given the acute toxic reaction and the death condition that are produced behind the animal in order to observe, and existing the result is reported as follows:
1, experiment material
Animal: Kunming mouse, body weight 18-22g, the one-level animal is provided by the institute for drug control, Wuhan City, the laboratory animal quality certification: No. the 032nd, the moving pipe of Hubei Province doctor (card) word, the Experimental Establishment quality certification: the moving word of (fine jade) doctor 30-005 number.
Reagent: medicine of the present invention, face the time spent to get final product with the suspension that distilled water is made into 0.75g/ml concentration.
2, method and result
Fail to measure the LD of single-dose through trial test because of medicine of the present invention
50So, carry out the mensuration of maximum tolerated dose.Get 20 of the kunming mices of body weight 18-22g, male and female half and half.Be 60g/kg by accumulated dose behind each Mus overnight fasting; Observe a week death toll, body weight change of record animal and the toxic and side effects that may occur behind the animals administer continuously.
The result shows: not seeing behind the animals administer has death, does not also have tangible ANOMALOUS VARIATIONS, and each Mus body weight all has growth in various degree; One week back execution animal carries out obduction to be observed, and each internal organs there is no macroscopic pathological change.
3, conclusion and discussion
By experimental result as seen, the day maximum tolerated dose of white mountain sheet mouse stomach administration is 60g/kg, is 800 times (be grown up 3 times/day, 6 slices/time, body weight is by 60kg, and dosage is 0.075g/kg) of Coming-of-Age Day with dosage, and does not see obvious toxic and side effects.
Embodiment 1
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=290: 150: 500: 200: 500: 250: 200;
Preparation technology of the present invention comprises the steps:
Clean: above-mentioned seven flavor medicine material is washed;
Processing is concocted: Radix Sophorae Tonkinensis and Rhizoma Menispermi are cut into 2~4mm sheet; Cortex Dictamni, Poria, Polyporus processing are cut into slices; Fructus Trichosanthis is cut into thread; Herba Scutellariae Barbatae is cut into chunks;
Decoct: get the seven flavor medicine material behind the above-mentioned processing edulcoration, decoct with water three times, add 7.5 times in water for the first time, soaked 1 hour, decocted 1 hour, for the second time and respectively add 5 times in water for the third time, decocted 1 hour, collecting decoction, filtration gets filtrate;
Oven dry is pulverized: get above-mentioned filtrate, heating is evaporated to thick paste shape (about 1.35 (60 ℃ of heat are surveyed) of relative density), and 80 ℃ of decompression oven dry are pulverized; After check discriminating and mensuration content are qualified, for granulation, tabletting;
The system granule: get above-mentioned dried cream powder, add 15.5 parts of hydroxypropyl celluloses, 5.5 parts of starch with above-mentioned medical material equal in quality unit, mixing adds 80% ethanol and makes granule, granulate;
Tabletting: in granule, add and 1.5 parts of the magnesium stearate of above-mentioned medical material equal in quality unit, mixing, compacting is in flakes;
Sugar coating: get above-mentioned plain sheet, after the inspection tablet weight variation is qualified, put in the coating pan, heating, the bag sealing coat wraps the pigment sugarcoating layer again, and polishing makes the surface complete, smooth, and color and luster is even.
Embodiment 2
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=150: 50: 250: 80: 250: 100: 80;
Described preparation technology decocts in the step, adds 6 times in water for the first time, soaks 0.5 hour, decocts 0.5 hour, respectively adds 3 times in water for the second time, for the third time, decocts 0.5 hour; In the oven dry pulverising step, 60 ℃ of decompression oven dry; In the system granule step, add 60% alcohol granulation, all the other are with embodiment 1.
Embodiment 3
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=400: 300: 700: 350: 700: 350: 300;
Described preparation technology decocts in the step, adds 10 times in water for the first time, soaks 1.5 hours, decocts 1.5 hours, respectively adds 8 times in water for the second time, for the third time, decocts 1.5 hours; In the oven dry pulverising step, 90 ℃ of decompression oven dry; In the system granule step, add 85% alcohol granulation, all the other are with embodiment 1.
Embodiment 4
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=150: 300: 250: 350: 250: 350: 300;
Described preparation technology decocts in the step, adds 10 times in water for the first time, soaks 1.5 hours, decocts 0.5 hour, respectively adds 3 times in water for the second time, for the third time, decocts 0.5 hour; In the oven dry pulverising step, 70 ℃ of decompression oven dry; In the system granule step, add 85% alcohol granulation, all the other are with embodiment 1.
Embodiment 5
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=400: 300: 700: 350: 250: 100: 80;
Preparation method is with embodiment 1.
Embodiment 6
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=200: 100: 400: 100: 400: 150: 100;
Preparation method is with embodiment 1.
Embodiment 7
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=350: 200: 600: 300: 600: 300: 250;
Preparation method is with embodiment 1.
Embodiment 8
The present invention counts ratio by following raw materials in parts by weight to be prepared from Radix Sophorae Tonkinensis: Rhizoma Menispermi: Herba Scutellariae Barbatae: Cortex Dictamni: Poria: Polyporus: Fructus Trichosanthis=300: 150: 500: 200: 500: 225: 175;
Preparation method is with embodiment 1.