CN1333046A - Xiangshen injection and preparation process and use thereof - Google Patents
Xiangshen injection and preparation process and use thereof Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine xiangshen injection with reliable therapeutic effect for curing malignant tumor, specially for curing carcinomatous ascites and its preparation method. Its preparation method includes the following steps: using fresh stem and leaf of pelargonium graveolens, distilling them with water vapour to obtain geranium oil, adding flavescent sophora root powder into the geranium oil, heating and refluxing to obtain flavescent sophora essential oil, then slowly adding Twene-80 and 5% glucose injection, grinding, filtering, filling, sealing and sterilizing so as to obtain the invented finished product. The composition of said invented product contains xiangshen essential oil 80-120 mg, Tween-80 80-120 mg, and adding 5% glucose injection to 2 ml.
Description
The present invention relates to a kind of medicine, being specifically related to a kind of is the injection of primary raw material with the Chinese herbal medicine.The invention still further relates to the preparation method of described injection 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.
At present, the western medical treatment cancer 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 chemicotherapy 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 injection for the treatment of cancer, this injection 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 injection, 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 injection in the medicament of preparation treatment cancer.
Consisting of of Xiangshen injection of the present invention:
80～120 milligrams of fragrant ginseng quintessence oils, 80～120 milligrams of tween 80s add 5% glucose injection to 2 milliliter.
The raw material Pelargonium gravelens that the present invention is used
Cattle Seedling section storksbill, Latin is called Polargonium Graveoleens L ' HE ' RIT.Medicinal part is its fresh stem and leaf, and through steam distillation, rectification promptly gets rose pelargonium essential oil, is called for short the Herba Pelargonii Graveolentis quintessence oil.Pelargonium gravelens originates in the ground such as the western regions of the Yunnan Province, the southern regions of the Yunnan Province and Binchuan in Yunnan Province, and resource is very abundant.Radix Sophorae Flavescentis is a cassia leguminous plant, and Latin is called Sophora Flavescens AIT.Medicinal part is its dry root, and all there is cultivation in many provinces and cities to Radix Sophorae Flavescentis in the whole nation.
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 an injection, so name is called " Xiangshen injection ".
The invention provides the preparation method of Xiangshen injection, this method comprises the step of following order:
(1) preparation rose pelargonium essential oil
Get the fresh stem and leaf of Pelargonium gravelens through steam distillation, rectification, get the pistac clear liquid, be rose pelargonium essential oil, be called for short the Herba Pelargonii Graveolentis quintessence oil.
(2) fragrant ginseng quintessence oil
Radix Sophorae Flavescentis is worn into coarse powder, take by weighing Radix Sophorae Flavescentis coarse powder 300 gram, 1200 milliliters of perfuming leaf essential oils placed 2000 milliliters of glass flask mixings, in 115 ℃ of reflux 6 hours.Leaching Radix Sophorae Flavescentis quintessence oil gets 800 milliliters of clear and bright oily liquids of buff, is fragrant ginseng quintessence oil.By described charge ratio, take by weighing fragrant ginseng quintessence oil and place mortar, slowly add tween 80 and 5% glucose injection on one side, grind on one side, make solution clear and bright, adjust
PH-number is 6.8～7.0 to filter, and is sub-packed in 2 milliliters the ampoule, seals, and 110 ℃ of sterilizations 15 minutes get product.
1. the acute toxicity test of white mice
Test method: get 18～22g healthy mice, the Kunming cenospecies, random packet, 10 every group, from the Xiangshen injection of tail vein, abdominal cavity injection various dose, to observe 7 days after the administration respectively, 7 days dead Mus numbers of accumulative total calculate with karber's method.Wherein, intravenous injection LD
50Be 164.3 ± 17.6mg/kg (P=0.95); Lumbar injection LD
50Be 334.8 ± 27.9mg/kg (P=0.95).Result of the test sees Table 1 respectively, table 2.
The intravenous acute toxicity LD50 of table 1. measures (injecting in 90 seconds)
| Dosage mg/kg | Administration volume ml/10g | Number of animals | Sex | Route of administration | Symptom | Death toll |
| 240 | 0.2 | 10 | ♀ | Iv | When being administered to half amount, accelerated breathing stops immediately. | 10 |
| 192 | 0.2 | 10 | ♀ | Iv | After the administration, accelerated breathing is quiet shape, rights disappearance, recovers in 5 minutes | 7 |
| 153.6 | 0.2 | 10 | ♀ | Iv | After the administration, be quiet shape, partly right disappearance, recovered in 10 minutes. | 4 |
| 122.98 | 0.2 | 10 | ♀ | Iv | Breathe slightly and accelerate, be quiet shape | 1 |
| 98.36 | 0.2 | 10 | ♀ | Iv | The same | 0 |
Table 2. abdomen is annotated Xiangshen injection acute toxicity LD
50Measure
| Dosage mg/kg | Administration volume ml/10g | Number of animals | Sex | Route of administration | Symptom | Death toll |
| 437.5 | 0.2 | 10 | ♀ | Ip | After the administration, be the sleep shape, right disappearance, death in 24 hours. | 10 |
| 350 | 0.2 | 10 | ♀ | Ip | After the administration, be the sleep shape, the part animal rights disappearance. | 6 |
| 280 | 0.2 | 10 | ♀ | Ip | Symptom is the same, but lighter, recovers in 3 hours. | 1 |
| 224 | 0.2 | 10 | ♀ | Ip | The same | 0 |
2. long-term toxicity test for animals research
Test method: with 12 of dogs, be divided into 3 groups at random, 4 every group, male and female half and half are carried out 2 months by a definite date long term toxicity test with Xiangshen injection.Administration is 2 times weekly, and administration changes administration weekly into 1 time after one month.
Matched group: the abdominal cavity injects normal saline 1ml/kg;
The clinical dosage group: the abdominal cavity injects Xiangshen injection 25mg/kg;
High dose group: the abdominal cavity injects Xiangshen injection 50mg/kg.
Observation index: 1. general signs: behavior, activity, outward appearance, body weight, appetite, defecation; 2. routine blood test: erythrocyte, leukocyte, hematochrome, leukocyte classification, platelet; 3. liver functional testing: SGPT; 4. renal function is measured: carbamide N.
Result of the test: behind the high dose group animal-use drug, appearance earlier is fidgety, the volt of crawling, abdominal cavity irritations such as friction abdominal part enter peace and quiet then in succession, recover in about 2 hours, above-mentioned symptom is directly proportional with dosage, and vomiting appears in 2 dogs of high dose group, repeatedly after the medication, about 4～6 times, vomiting disappears, and other symptom alleviates gradually, the medication treated animal, medication skin rubefaction all occurs after half an hour, recovers in about 4 hours, and other observation index is not seen obvious change.After the test, matched group, medication treated animal average body weight average have slight increase, and a monthly average body weight slightly alleviates after the high dose group medication, but no difference of science of statistics, (t=1.59).The erythrocyte of each treated animal is all in normal range.The high dose group medication is after one month, and leukocyte obviously increases (P＜0.01), and the statistical procedures significant difference has the different change of degree, no difference of science of statistics though other is equipped with group.Hematochrome, neutrophilic leukocyte before and after the matched group, the medication of medication group, all in normal range, lymphocyte, platelet all do not have obvious change to carbamide N.The medication of clinical dosage group after one month SGPT increase (P＞0.05) no difference of science of statistics, its each treated animal SGPT does not all have obvious change.
3. to the effect experimental condition of external human body adenocarcinoma of stomach cell strain (SGC): culture medium is 1640 to add 20% calf serum.3,000,000 cancerous cell/milliliters were cultivated 18 hours in 37 ℃ of cover plates, and the growth of cancer cells situation is observed in H.E dyeing back.The result shows that Xiangshen injection begins the effect that anticancer is grown to occur from 250ug/ml, and along with concentration increases, inhibitory action strengthens.During 1000ug/ml, cancerous cell all can be killed.
4. to the effect of experimental animal tumor inhibitory action to the ascites volume (AV) and the cancerous cell total measurement (volume) (CV) of animal ascitic type tumor.
Test method: begin administration next day after the cancerous cell intraperitoneal inoculation.Put to death animal in 8～12 days after on-test, and extracted ascites, measure ascites volume, then with 1500 rev/mins, centrifugal 5 minutes,, measure the cancerous cell total measurement (volume), and calculate ascites volume (AV) suppression ratio and cancerous cell total measurement (volume) (CV) and suppression ratio as follows.
Former ascites fluid smear is with the cancerous cell form of staining observation matched group and administration group.Experimental result sees Table 3.
Table 3. Xiangshen injection is to the inhibitory action of mouse hydroperitoneum type tumor AV and CV
| The tumor strain | Drug dose (mg/kg) | Route of administration * number of times | AV suppression ratio (%) | The P value | CV suppression ratio (%) | The P value |
| ???ECA | ????500 ????250 ????250 ????100 ????100 | ?ip×1 ?ip×7 ?ip×6 ?ip×6 ?ip×5 | ?81.10 ?95.53 ?95.48 ?99.50 ?98.92 | ＜0.01 ＜0.01 ＜0.001 ＜0.001 ＜0.001 | ??90.74 ??99.85 ??99.73 ??100.00 ??100.00 | ＜0.001 ＜0.001 ＜0.001 ＜0.001 ＜0.001 |
| ???HCA | ????250 ????250 ????100 ????100 | ?ip×6 ?ip×1 ?ip×6 ?iv×1 | ?98.60 ?96.50 ?100.00 ?-10.80 | ＜0.001 ＜0.001 ＜0.001 | ??99.93 ??99.92 ??100.00 ??10.90 | ＜0.001 ＜0.001 ＜0.001 |
| ?S/80(A) | ????100 | ?ip×5 | ?9.93 | ＜0.001 | ??99.80 | ＜0.001 |
| ?U/4(A) | ????100 | ?ip×5 | ?9.48 | ＜0.05 | ??99.80 | ＜0.05 |
In the table 3: ECA is an ehrlich carcinoma, and HCA is an ascitic type liver cancer, and S/80 (A) is ascitic type mouse tumor/80, and u/4 (A) is ascitic type mouse cervical cancer u/4, and ip is intraperitoneal injection, and iv is intravenous injection.
4. Xiangshen injection is to the lethal effect test method of ECA cancerous cell: the 6th day by behind the various dose single administration in the inoculation back, extracts ascites every 2 hours and carries out cancerous cell counting and ascites smear.The cancerous cell form is observed in ascites smear dyeing back.
Fig. 1. be the result of the test of Xiangshen injection to the lethal effect of ehrlich ascites cell.
As shown in Figure 1,100mg/kg, the cancer cell number average of 200mg/kg group has minimizing. 100mg/kg group cancer cell number gos up to some extent after 6 hours, but the 200mg/kg group is still descending. The visible administration group of cancer cell smear cancer cell degree descends, and the cell membrane breakage occurs, karyopycnosis, and nuclear is broken, and the cancer cells such as cytolysis are damaged, and kill phenomenon.
The present invention also uses described Xiangshen injection to the life prolongation effect of ascitic type tumour animal, and to the inhibitory action of animal solid type tumour, parenteral solution effective dose 50 (ED50) and therapeutic index are tested and measured.
In December, 2000, Italy general ball institute of pharmacology (PANLAB) has finished Xiangshen injection animal acute toxicity test and the test of human cancer cell's external activity, confirm that its toxicity is lower than most of existing chemotherapy medicine, and can suppress and kill the multiple human cancer cells such as liver cancer, lung cancer, breast cancer, the carcinoma of the rectum and prostate cancer.
Above-mentioned result of the test shows that the Xiangshen injection intraperitoneal administration has obvious inhibitory action to multiple ascitic type animal tumor. Because the local irritant effect of this parenteral solution, intravenously administrable is difficulty relatively, but at suitable dose concentration, in the situation of multiple dosing, also sees the inhibitory action to tumour. If illustrate when this medicine can reach finite concentration at the tumor focus position within the unit interval, the effect that suppresses tumor growth is just arranged. This medicine is respectively 8.05 and 7.73 to the therapeutic index of ascites volume and inhibition of cancer cell effect, all greater than 5, illustrates that the drug use security is good.
Compared with prior art, the present invention has following outstanding advantages:
1. pharmacodynamics, toxicologic study result show, Xiangshen injection provided by the invention has definite effect to suppressing and killing the human cancer cell, can be used for Hepatoma therapy, lung cancer, breast cancer, the carcinoma of the rectum, prostate cancer, cancer of the stomach, cervical carcinoma, cancer of the esophagus, leukemia, particularly to now clinically very thorny cancerous thoracoascites have good result for the treatment of.
2. the present invention selects existing anti-cancer and inhibiting tumor effect, and the kuh-seng that has again the fragrant sunflower seed oil of promoting flow of qi and blood circulation stagnation resolvation and heat-clearing and damp-drying drug, wind dispelling insecticide is primary raw material. Stagnation of QI due to depression of the liver, the interior knot of cancer knurl, mental disorder are handed in resistance, the hemostasis and are tied due to the two medicine compatibility cancers, and the chest ascites pathological change that causes is looked after more comprehensive. Catch main pathology machine to turn and treat, so evident in efficacy in clinical. Xiangshen injection provided by the invention is pure Chinese medicinal preparation, and pharmacological action is strong, and is easy to use, indicating well prospect in medicine.
3. its toxic and side effect on equal treatment level is lower than existing cancer therapy drug camptothecine and vincristine, and curative effect is higher than known anticancer drugs on same toxic level.
4. raw material of substance of the present invention is originated and is enriched, and preparation technology is advanced, 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 injection 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
Consisting of of Xiangshen injection: 80 milligrams of fragrant ginseng quintessence oils, 80 milligrams of tween 80s add 5% glucose injection to 2 milliliter.
Consisting of of Xiangshen injection: 100 milligrams of fragrant ginseng quintessence oils, 100 milligrams of tween 80s add 5% glucose injection to 2 milliliter.
Embodiment 3
Consisting of of Xiangshen injection: 120 milligrams of fragrant ginseng quintessence oils, 120 milligrams of tween 80s add 5% glucose injection to 2 milliliter.
Embodiment 4
Get the fresh stem and leaf of Pelargonium gravelens through steam distillation, rectification, get the pistac clear liquid, be rose pelargonium essential oil, be called for short the Herba Pelargonii Graveolentis quintessence oil.Radix Sophorae Flavescentis is worn into coarse powder, take by weighing Radix Sophorae Flavescentis coarse powder 300 gram, 1200 milliliters of perfuming leaf essential oils placed 2000 milliliters of glass flask mixings, in 115 ℃ of reflux 6 hours.Leaching Radix Sophorae Flavescentis quintessence oil gets 800 milliliters of clear and bright oily liquids of buff, is fragrant ginseng quintessence oil.By described charge ratio, take by weighing fragrant ginseng quintessence oil and place mortar, slowly add tween 80 and 5% glucose injection on one side, grind on one side, make solution clear and bright, adjust
PH-number is 6.9, filters, and is sub-packed in 2 milliliters the ampoule, seals, and 110 ℃ of sterilizations 15 minutes get product.
Clinical practice embodiment 1.
The youth * *, woman, 56 years old, workman.The patient is because of dyspnea one day, cough, and one week of chest pain is in hospital.Chest film inspection shows: the large stretch of increase in density of lower field in the right side, rib disappears every the angle, and is unclear every face, right lung door and right widened mediastinum.Breast is worn and is extracted 1420 milliliters of bloody pleural fluids out, finds cancerous cell in the hydrothorax.Adopt Xiangshen injection of the present invention to make intracavitary administration 15 times, through treating 40 days, remake rabat: right side pleural thickening, pleural effusion absorbs fully.B ultrasonic: the right side hydrothorax disappears.The patient is rehabilitation gradually.
Zhao * *, man, 31 years old, engineer.The patient because of the cough, sputum mixed with blood, chest pain is surplus August, becomes thin February, once is diagnosed as malignant lymphoma, gives 5-Fu and adds the dexamethasone chemotherapy once.The bilateral groin can touch several pieces of Semen Glyciness to Semen arachidis hypogaeae size lymph node, and matter is hard, no tenderness, and incidence swelling, the puffiness of the eyes, the thoracic wall venous engorgement, superior vena cava compressing syndrome, splenomegaly (A12 cm, B10 cm) expectorant exfoliative cyte find cancerous cell (minicell).Through with quiet of Xiangshen injection 5 days, uncomfortable in chest, chest pain is obviously improved, superior vena cava compressing sx, and spleen dwindles.The chest films showed mediastinal lymph nodes obviously dwindles, and the right upper lung focus is also dwindled.The treatment two months that holds on again, the state of an illness takes a turn for the better gradually, and result of laboratory test liver, renal function are normal, and B ultrasonic shows: a small amount of hydrops of right breast, the left side hydrothorax disappears.
Clinical practice embodiment 3.
The king * *, the man, 47 years old, the cadre, left side chest pain, February uncomfortable in chest, right mediastinal lymph node enlargement, the right side percussion is flatness, heart rate 102 times/minute, chest films showed right side moderate hydrothorax, it is olive drab(O that breast is worn drawing liquid, finds the undifferentiated type cancerous cell in the hydrothorax, is diagnosed as right lung cancer metastatic carcinoma of pleura hydrothorax.
Make intracavitary administration (topical therapeutic) with Xiangshen injection.In the therapeutic process, hydrothorax reduces gradually, and hemogram is normal, and after 6 months, the right side pleura extensively thickens, and B ultrasonic shows that the thoracic cavity, right side only has seldom measures hydrops.
Claims (6)
1. Xiangshen injection, it consists of:
80～120 milligrams of fragrant ginseng quintessence oils
80～120 milligrams of tween 80s
Add 5% glucose injection to 2 milliliter.
2. according to the Xiangshen injection of claim 1, it consists of:
100 milligrams of fragrant ginseng quintessence oils
100 milligrams of tween 80s
Add 5% glucose injection to 2 milliliter.
3. the preparation method of an Xiangshen injection, this method comprises the step of following order:
(1) preparation rose pelargonium essential oil
Get the fresh stem and leaf of Pelargonium gravelens through steam distillation, rectification, get the pistac clear liquid, be rose pelargonium essential oil, be called for short the Herba Pelargonii Graveolentis quintessence oil;
(2) fragrant ginseng quintessence oil
Radix Sophorae Flavescentis is worn into coarse powder, take by weighing Radix Sophorae Flavescentis coarse powder 300 grams, 1200 milliliters of perfuming leaf essential oils, place 2000 milliliters of glass flask mixings, in 115 ℃ of reflux 6 hours, leaching Radix Sophorae Flavescentis quintessence oil, get 800 milliliters of clear and bright oily liquids of buff, be fragrant ginseng quintessence oil,, take by weighing fragrant ginseng quintessence oil and place mortar by described charge ratio, slowly add tween 80 and 5% glucose injection on one side, grind on one side, make solution clear and bright, adjust
PH-number is 6.8～7.0 to filter, and is sub-packed in 2 milliliters the ampoule, seals, and 110 ℃ of sterilizations 15 minutes get product.
4. the application of Xiangshen injection in the medicine of preparation treatment or prevention malignant tumor.
5. the application of Xiangshen injection in the medicine of preparation treatment cancerous ascites pleural fluid.
6. the application of Xiangshen injection in the medicine of preparation treatment hepatocarcinoma, pulmonary carcinoma, breast carcinoma, rectal cancer, carcinoma of prostate, gastric cancer, cervical cancer, esophageal carcinoma, leukemia.
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2004087186A1 (en) * | 2003-04-03 | 2004-10-14 | Medigreen Biotechnology Corporation | Composition and method for supporting cancer treatments |
| 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 |
| CN102824404A (en) * | 2012-09-19 | 2012-12-19 | 白晶 | Traditional Chinese medicinal composition as well as preparation process and application thereof |
| CN106578199A (en) * | 2016-12-16 | 2017-04-26 | 横琴智库转化医学有限公司 | Oral solution for preventing malignant tumors |
-
2001
- 2001-06-14 CN CNB011085371A patent/CN1168457C/en not_active Expired - Fee Related
Cited By (4)
| 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 |
| WO2004087186A1 (en) * | 2003-04-03 | 2004-10-14 | Medigreen Biotechnology Corporation | Composition and method for supporting cancer treatments |
| CN102824404A (en) * | 2012-09-19 | 2012-12-19 | 白晶 | Traditional Chinese medicinal composition as well as preparation process and application thereof |
| CN106578199A (en) * | 2016-12-16 | 2017-04-26 | 横琴智库转化医学有限公司 | Oral solution for preventing malignant tumors |
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