CN1167441C - Xiangshen soft capsule and preparation process and use thereof - Google Patents
Xiangshen soft capsule and preparation process and use thereof Download PDFInfo
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- CN1167441C CN1167441C CNB011085363A CN01108536A CN1167441C CN 1167441 C CN1167441 C CN 1167441C CN B011085363 A CNB011085363 A CN B011085363A CN 01108536 A CN01108536 A CN 01108536A CN 1167441 C CN1167441 C CN 1167441C
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Abstract
The present invention discloses a Xiangshen soft capsule, a preparation method thereof and application thereof, and the Xiangshen soft capsule has good therapeutic effect on cancer, especially esophagus cancer. The Xiangshen soft capsule comprises the following raw materials: 350 to 450 parts by weight of geranium oil, 300 to 400 parts by weight of lightyellow sophora root, 250 to 270 parts by weight of gelatin and 5 to 7 parts by weight of glycerol. The preparation method comprises that the lightyellow sophora root is processed by processing with wine, pulverization, sieving, hot reflux, filtration and concentration to obtain a lightyellow sophora root extract; the lightyellow sophora root extract is dissolved in distilled water, the glycerol and the gelatin are added, and the mixed solution is filled into a thermal insulation gelatin pot and is fed to one side of a filling machine by a flexible pipe; the geranium oil is added to a medicine storage pot, an encapsulating machine is started, and the Xiangshen soft capsule is prepared by No. 8 moulds in the encapsulating machine.
Description
The present invention relates to a kind of pharmaceutical composition, being specifically related to a kind of is the pharmaceutical composition of primary raw material with the Chinese herbal medicine, simultaneously, the invention still further relates to described preparation of drug combination method and the purposes in pharmaceutical field thereof.
In the modern life, because air, water and food are generally polluted, people are difficult to avoid the erosion of cancer, even also will worry recurrence after the treatment.Modern medicine study shows that cancer is a kind of gene alteration, is accumulated to the malignant diseases that to a certain degree just form, and incubation period is very long, and early stage difficult the discovery arrived middle and advanced stage mostly when symptom is obvious by the time.Cancer can be described as the serious illness of contemporary mankind's maximum, and cancerous protuberance is seriously threatening human life, and according to World Health Organization's statistics, the human body cancer has reached kind more than 100.The whole world has 6,000,000 people that tumor takes place every year, dead 5,000,000 people.In China's 1,200,000,000 populations, annual more than 100 ten thousand people morbidity, dead about 800,000 people.Cancer is global difficult medical problem of 20th century.
Statistics shows that in all kinds of cancer mortality ranks, esophageal carcinoma is in the 6th of male's cause of the death.At present, the western medical treatment esophageal carcinoma generally adopts operation, radiation and chemotherapy, but implement to put, chemotherapy kills and wounds in the cancerous cell process, the immune cell function and the hemopoietic system of human body also come to harm simultaneously, toxic and side effects is big, especially more unfavorable to the empty patient of body, so most of patients can not be adhered to treatment and be caused critically ill.
In order to seek the medicament of capturing cancer, numerous medical research personnel have paid hard work and unremitting effort, have developed the medicine of many treatment cancers.But up to now, the uncertain therapeutic efficacy that this class medicine has is cut; Though what have has certain curative effect, price is very expensive, and the economic capability of general patient can't be born at all, the decocting of the disease that can only endure quietly.
The object of the present invention is to provide a kind of Xiangshen soft capsule for the treatment of cancer, this capsule is safe and effective, has no side effect, and particularly its raw material sources are abundant, and cost is low, to save millions upon millions of patients' life.
Another object of the present invention is to provide a kind of preparation method of Xiangshen soft capsule, and this method technology is reasonable, easy to operate, and product yield is big.
The present invention also aims to provide the application of a kind of Xiangshen soft capsule in the medicament of preparation treatment cancer.
The parts by weight that the raw material of Xiangshen soft capsule of the present invention is formed are: Herba Pelargonii Graveolentis oil 350～450, Radix Sophorae Flavescentis 300～400, gelatin 250～270, glycerol 5-7.
The quality of described raw material is according to being:
(1) Herba Pelargonii Graveolentis oil should meet " Zhejiang Province's drug standard " Q/ws-302-83;
(2) Radix Sophorae Flavescentis should meet " one one the 176th page of Chinese pharmacopoeia nineteen ninety-five version;
(3) gelatin should meet " one one the 388th page of Chinese pharmacopoeia nineteen ninety-five version;
(4) glycerol should meet " one one the 78th page of Chinese pharmacopoeia nineteen ninety-five version.
The present invention is the compound preparation of being made by the total extract of the volatile oil of plant Pelargonium gravelens and plant Radix Sophorae Flavescentis, and therefore title of the present invention is to represent Pelargonium gravelens with " perfume (or spice) " word; Radix Sophorae Flavescentis represented in " ginseng " word, with the name of perfume (or spice) ginseng, main composition is come into plain view, and dosage form is a soft capsule, so name is called " Xiangshen soft capsule ".
The invention provides the preparation method of Xiangshen soft capsule, this method comprises the step of following order:
(1) processed with wine, pulverize, sieve: get the Radix Sophorae Flavescentis that is up to the standards, add the ethanol of 10% weight, stir, place after 12～15 hours, heating, drying is ground into fine powder, crosses 40 mesh sieves, and is standby.
(2) hot reflux: get Radix Sophorae Flavescentis powder, add 80% ethanol of 10 times of weight, went in the extraction pot hot reflux 2～4 hours, filter, add the ethanol of 6 times of weight, hot reflux 1～3 hour.
(3) filter, concentrate: after hot reflux liquid is filtered, add in the ethanol recovery tower, concentrate, reclaim ethanol, make Radix Sophorae Flavescentis extractum and check content of matrine.
(4) system soft capsule: feed intake by described prescription,, and add glycerol, gelatin with the Radix Sophorae Flavescentis extractum dissolved in distilled water that is up to the standards.After the dissolving, start vacuum dissolving tank valve fully equably, remove bubble in the gelatin solution with vacuum, the limit heating edge is removed the part moisture content in the gelatin solution, makes solution viscosity 40Pa, and it is changed in the insulation gelatin jar, sends into filling machine one side with flexible pipe; Herba Pelargonii Graveolentis oil is put into medicine tin, open encapsulating machine, in encapsulating machine, make soft capsule with No. 8 moulds.
(5) select, dry, packing: select qualified soft capsule and put into drying room, drying is 10～15 hours under 35 ℃～45 ℃, grain to finished product is heavy, shell heavy, inclusions recast qualitative identification and assay, hygiology are inspected qualified back packing, finished product warehouse-in as ready by random samples.
1. animal acute toxicity test research
Carried out acute toxicity LD with Xiangshen soft capsule of the present invention
50Mensuration, the oral Xiangshen soft capsule LD of mice as a result
50=2.35g/kg (the fiducial limit 2.10～2.62g/kg) of P=0.95; The oral Xiangshen soft capsule maximum tolerated dose of rat is 12g/kg.If the human daily dose is 72mg/kg, also behave 166.6 times of daily dosage of this dosage.
2. long-term toxicity test for animals research
The long malicious Xiangshen soft capsule dosage of rat is respectively 1600,800,400mg/kg/d, quite and people's clinical principium draft 22,11,5.5 times of dosage.The long toxic agent amount 800,400 of dog, 200mg/kg/d are equivalent to people's clinical principium and tentatively draft 11,5.5,2.75 times of dosage.Continuous oral 4 months, mainly seeing has the rat of causing (1600mg/kg/d) blood glucose to descend, and Glutamate pyruvate transaminase rises and dog (800mg/kg/d) alkali phosphatase raises and influences body weight gain, does not see influential to other every indexs.The rarely seen high dose group dog of pathology section examination has two hepatic tissues slight hydropic degeneration to occur, and other is organized all and belongs to normally.Drug withdrawal 4 week each influenced index all can return to normal level.Result of the test proves that it is reversible that this medicine is taken the untoward reaction that is produced for a long time to animal, and rat is lower than 400mg/kg/d and dog, and to be lower than 200mg/kg/d be safe dose.
3. the animal experiment of antitumor action research
(1) materials and methods
1. nude mouse: be provided at the Swiss and the BALB/c nude mouse of propagation production in the SPF barrier system by Animal Experimental Study chamber, institute of materia medica, Chinese Academy of Sciences Shanghai, the male and female dual-purpose, Mus age was 5～7 weeks.
2. people's cancer Nude Mice:
A. people's adenocarcinoma of stomach Nude Mice (solid type code name SGC-7901SC) is the undifferentiated type adenocarcinoma of stomach, and growth of xenografted is very fast, and subcutaneous transplantation 2 all posterior tuberosities footpaths can reach about 1cm, and inoculation survival rate is 100%.
B. people's pulmonary carcinoma Nude Mice (solid type code name LAX-83) is low differentiation adenocarcinoma of lung, and growth of xenografted is very fast, and subcutaneous transplantation 3 all posterior tuberosities footpaths can reach about 1cm, and inoculation survival rate is 100%.
3. medicine: Xiangshen soft capsule is dissolved in the sterilization distillation by desired concn,
(2) transplanted tumor inoculation and experimental therapy
Transplanted tumor is cut into the tumor piece of 2～3mm diameter in super-clean bench, it is subcutaneous to be inoculated in nude mouse right side armpit, or with 10
5Individual SGC-7901 oncocyte is inoculated in the nude mouse abdominal cavity expert SGC-7901 of one-tenth ascitic type transplanted tumor.Inoculate and divide the cage administration after 24 hours.Every day, oral or lumbar injection was 1 time, and all administrations 6 times chase after continuous 3 weeks of administration, and it is heavy to dissect the scale tumor in the next day after the drug withdrawal, calculated that respectively to organize average tumor heavy.Ascitic type transplanted tumor should write down mice with tumor date of death day by day and calculate the mean survival time of every cage nude mouse, by formula C-T/C * 100%.Calculate tumor control rate or the rate elongation and carry out the t check of surviving.
(3) result of the test:
1. the inhibition test by Xiangshen soft capsule is carried out, reticuloendothelial system function and influence and analgesic test show: fragrant ginseng capsule can obviously suppress sarcoma S-180, hepatocarcinoma H
22, ehrlich carcinoma EC and Lewis lung cancer growth, and have a certain amount of effect relationship; HCT-8, KB and K562 all there is certain cytotoxicity.2. the remarkable antagonism of Xiangshen soft capsule energy is induced the effect of the mice reticuloendothelial system phagocytic hypofunction of generation by cyclophosphamide.3. Xiangshen soft capsule has certain analgesic activity to the mice pain that thermostimulation has lured, and the mice pain that chemical stimulation has lured is not had influence.4. Xiangshen soft capsule all has certain inhibitory action to people's adenocarcinoma of stomach Nude Mice and human lung adenocarcinoma Nude Mice.
4. Xiangshen soft capsule is treated the esophageal carcinoma observation of curative effect
All cases all through X line esophagus canel barium meal contrast examination, make a definite diagnosis by pathology or cytolgical examination, and two groups of data differences are not obvious, male's 21 examples wherein, women's 9 examples, age 45-80 year (seeing Table 1)
Table 1
Length of lesion
Diseased region
Histological type
Group example several years age＜5.0 5.0-8.0〉8.0 cervicals part of esophagus
The breast sectionThe squama gland
Upper, middle and lower
Medication group 20 45-80 6 11 34358 17 3
Chemotherapy group 10 44-78 352223382
Therapeutic Method: oral Xiangshen soft capsule, 3 Tid, be a course of treatment January, observes 3 courses of treatment.
Chemotherapy group: cisplatin 100mg, quiet dl, CTX 0.8, the quiet d3 that pushes away, 9,0.75 quiet d4 of 5-Fu, 5,10,11, per 3 weeks are a course of treatment, observe three courses of treatment, the medicine or the radiotherapy measure of other treatment esophageal carcinoma of stopping using during the medication, supporting treatments such as fluid infusion can be carried out simultaneously.
The result:
Therapeutic evaluation: with reference to Changzhou in 1978 whole nation chemotherapy meeting universal standard, be divided into and alleviate (CR) fully, part is alleviated (PR), and stable (S) worsens (P).Therapeutic outcome relatively sees Table 2. tables 3.
Table 2.
Group example number CR PR S P
Medication group 20 11 342
Chemotherapy group 10 5221
Table 3.
The group example counts up to direct release rate remission rate
CR(％) CR+PR(％)
Medication group 20 55.0% 70.0%
Chemotherapy group 10 50.0% 70.0%
P value＞0.05＞0.05
Toxicity, the unified standard of pressing WHO, therapeutic outcome relatively sees Table 4.
Xiangshen soft capsule of the present invention, and in December, 2000 through the general ball institute of pharmacology＜PANLAB of Italy finish the test of animal acute toxicity test and human cancer cell's strain external activity, confirm that its toxicity is lower than most of existing chemotherapy medicine, and can suppress and kill 6 kinds of human cancer cells such as esophageal carcinoma, hepatocarcinoma, pulmonary carcinoma, breast carcinoma, rectal cancer and carcinoma of prostate.
Table 4.
The toxicity group
The WHO toxicity grading
0 I II III IV
Nausea and vomiting medication group 16 211
Chemotherapy group 32211
Platelet decline medication group 18 2000
Chemotherapy group 34111
Hemocyte decline medication group 18 2000
Chemotherapy group 25111
From above result, can draw and the invention has the advantages that:
1. Xiangshen soft capsule provided by the invention is a pure Chinese medicinal preparation, and pharmacological action is strong, and is applied widely, to hepatocarcinoma, pulmonary carcinoma, breast carcinoma, rectal cancer, carcinoma of prostate, gastric cancer, cervical cancer, leukemia particularly has good curative effect to esophageal carcinoma, simultaneously safety non-toxic, taking convenience is indicating well prospect in medicine.
2. the present invention selects existing anti-cancer and inhibiting tumor effect for use, and the Radix Sophorae Flavescentis that has the Herba Pelargonii Graveolentis oil of promoting flow of QI and blood blood stasis dispelling and heat clearing and damp drying, wind dispelling insecticide again is a primary raw material.Two medicine compatibilities are handed in resistance, the blood stasis and are tied knot, mental disorder in stagnation of QI due to depression of the liver, the carcinoma due to the esophageal carcinoma, cause the expectorant stasis of blood hinder in stomach, mouthful pathological change look after more comprehensive.Caught several main pathology machines such as knot in the carcinoma, qi depression to blood stasis, wet consor expectorant to change and treated, so evident in efficacy in clinical.
3. the esophageal cancer cell overwhelming majority is long squamous cell carcinoma proliferating cycle, and insensitive to chemotherapy, treatment is with operation at present, and radiotherapy is main.But centering, advanced esophageal cancer patient radiation alone can not improve tumor control rate and reduce metastasis, and survival rate is also very low, and therefore, Drug therapy is essential.The present invention has filled up the blank in this field, has strengthened the confidence of patient's Fighting Disease.
4. raw material of substance of the present invention source is abundant, preparation technology advanced person, and cost is low, the economic capability of general patient can be born, be the important breakthrough of capturing cancer drug, opened up a good effect and the few new way of medical expense makes applying of Xiangshen soft capsule have very strong practicality.
Can further be well understood to the present invention by specific embodiments of the invention given below.
But they are not limitation of the invention.
Embodiment 1
Get Radix Sophorae Flavescentis 390 grams that are up to the standards, 39 gram ethanol stir, and place after 13 hours, and heating, drying is ground into fine powder, crosses 40 mesh sieves.The ethanol that adds 3900 grams 80% was gone in the extraction pot hot reflux 3 hours, filtered, and added 3900 gram ethanol, hot reflux 2 hours; After the filtration of hot reflux liquid, add in the ethanol recovery tower, concentrate, reclaim ethanol, make Radix Sophorae Flavescentis extractum and check content of matrine; The Radix Sophorae Flavescentis extractum that is up to the standards is put into 1000 ml distilled waters dissolve, add glycerol 7 grams, gelatin 270 grams.After the dissolving, start vacuum dissolving tank valve fully equably, remove bubble in the gelatin solution with vacuum, the limit heating edge is removed the part moisture content in the gelatin solution, and making solution viscosity is 40Pa, and it is changed in the insulation gelatin jar, sends into filling machine one side with flexible pipe; 450 gram Herba Pelargonii Graveolentis oil are put into medicine tin, open encapsulating machine, in encapsulating machine, make soft capsule with No. 8 moulds, select qualified soft capsule and put into drying room, drying is 12 hours under 40 ℃, through after the assay was approved, obtains finished product.
Embodiment 2
Except the Radix Sophorae Flavescentis consumption is 300 grams, the consumption of Herba Pelargonii Graveolentis oil is 350 grams, and gelatin is 250 grams, and the consumption of glycerol is that other process makes Xiangshen soft capsule with embodiment 1 outside 5 grams.
Embodiment 3
Except the Radix Sophorae Flavescentis consumption is 350 grams, the consumption of Herba Pelargonii Graveolentis oil is 400 grams, and gelatin is 260 grams, and the consumption of glycerol is that other process makes Xiangshen soft capsule with embodiment 1 outside 6 grams.
Embodiment 4～embodiment 8
Because Herba Pelargonii Graveolentis oil is an oily mater, Radix Sophorae Flavescentis extract is pale brown color paste, and the two is immiscible, carries out emulsifying though add low quantity of surfactant, and fluid is opaque shape, and outward appearance is plain, and stability also is under some influence.In order to guarantee the pure of medicine, preferably do not add pharmaceutic adjuvant, the present invention Herba Pelargonii Graveolentis oil, Radix Sophorae Flavescentis extract are mixed with soft capsule carrying out contrast test, result of the test sees Table 5.Only take the Radix Sophorae Flavescentis paste soluble in waterly, the method that adds in the water miscible soft capsule shell material (gelatin, glycerol) is the soft capsule that the E method is prepared, and just reaches mix homogeneously, the intended purposes that outward appearance is good.Its product is that shell is pale brown color, and content is a clean oil grease in the shell, the soft capsule of good looking appearance.
Table 5.
| Mixed method | The result |
| A. with Herba Pelargonii Graveolentis oil and Radix Sophorae Flavescentis extract mixing post-heating treatments B. with Herba Pelargonii Graveolentis oil mix with Radix Sophorae Flavescentis extract back ultrasonic Treatment C. with behind Radix Sophorae Flavescentis extract and the glycerol fabaceous lecithin mix homogeneously again with after Herba Pelargonii Graveolentis oil mixing D. adds 95% ethanol Radix Sophorae Flavescentis extract is dissolved, E. is soluble in water with Radix Sophorae Flavescentis extract with the Herba Pelargonii Graveolentis oil mixing, add in the soft capsule adjuvant, again Herba Pelargonii Graveolentis oil is wrapped in the softgel shell | Immiscible one-tenth opaque emulsions, behind the colloid mill homogenizing, still become opaque emulsions for opaque emulsions, after placing 1～2 again layering get pale brown color softgel shell, contain transparent oily composition soft capsule |
Claims (6)
1. Xiangshen soft capsule, the parts by weight that its raw material is formed are: Herba Pelargonii Graveolentis oil 350～450, Radix Sophorae Flavescentis 300～400, gelatin 250～270, glycerol 5～7.
2. want 1 Xiangshen soft capsule according to right, the parts by weight that its raw material is formed are: Herba Pelargonii Graveolentis oil 450, Radix Sophorae Flavescentis 390, gelatin 270, glycerol 7.
3. the preparation method of the described Xiangshen soft capsule of claim 1, this method comprises the step of following order:
(1) processed with wine, pulverize, sieve: get the Radix Sophorae Flavescentis that is up to the standards, add the ethanol of 10% weight, stir, place after 12～15 hours, heating, drying is ground into fine powder, crosses 40 mesh sieves, and is standby;
(2) hot reflux: get Radix Sophorae Flavescentis powder, add 80% ethanol of 10 times of weight, went in the extraction pot hot reflux 2～4 hours, filter, add the ethanol of 6 times of weight, hot reflux 1～3 hour;
(3) filter, concentrate: after hot reflux liquid is filtered, add in the ethanol recovery tower, concentrate, reclaim ethanol, make Radix Sophorae Flavescentis extractum and check content of matrine;
(4) system soft capsule: feed intake by described prescription, with the Radix Sophorae Flavescentis extractum dissolved in distilled water that is up to the standards, and add glycerol, gelatin, after the dissolving, start vacuum dissolving tank valve fully equably, remove bubble in the gelatin solution with vacuum, the limit heating edge is removed the part moisture content in the gelatin solution, making solution viscosity is 40Pa, and it is changed in the insulation gelatin jar, sends into filling machine one side with flexible pipe; Herba Pelargonii Graveolentis oil is put into medicine tin, open encapsulating machine, in encapsulating machine, make soft capsule with No. 8 moulds;
(5) select, dry, packing: select qualified soft capsule and put into drying room, drying is 10～15 hours under 35 ℃～45 ℃, grain to finished product is heavy, shell heavy, inclusions recast qualitative identification and assay, hygiology are inspected qualified back packing, finished product warehouse-in as ready by random samples.
4. the application of the described Xiangshen soft capsule of claim 1 in the medicine of preparation treatment or prophylaxis of cancer.
5. the application of the described Xiangshen soft capsule of claim 1 in the medicine of preparation treatment or prevention esophageal carcinoma.
6. the application of the described Xiangshen soft capsule of claim 1 in the medicine of preparation or prevention hepatocarcinoma, pulmonary carcinoma, breast carcinoma, rectal cancer, carcinoma of prostate, gastric cancer, cervical cancer or leukemia.
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| Application Number | Priority Date | Filing Date | Title |
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| CNB011085363A CN1167441C (en) | 2001-06-14 | 2001-06-14 | Xiangshen soft capsule and preparation process and use thereof |
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| CNB011085363A CN1167441C (en) | 2001-06-14 | 2001-06-14 | Xiangshen soft capsule and preparation process and use thereof |
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| CN1333045A CN1333045A (en) | 2002-01-30 |
| CN1167441C true CN1167441C (en) | 2004-09-22 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7387806B2 (en) * | 2001-10-09 | 2008-06-17 | Medigreen Biotechnology Inc. | Method of using geranium oil and sophora root extracts as a supporting composition in cancer treatments |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP1620115A1 (en) * | 2003-04-03 | 2006-02-01 | Medigreen Biotechnology Corporation | Composition and method for supporting cancer treatments |
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2001
- 2001-06-14 CN CNB011085363A patent/CN1167441C/en not_active Expired - Lifetime
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7387806B2 (en) * | 2001-10-09 | 2008-06-17 | Medigreen Biotechnology Inc. | Method of using geranium oil and sophora root extracts as a supporting composition in cancer treatments |
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| CN1333045A (en) | 2002-01-30 |
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