CN1269521C - Compound medicine for treating cancer and preparing process thereof - Google Patents
Compound medicine for treating cancer and preparing process thereof Download PDFInfo
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- CN1269521C CN1269521C CN 200410013407 CN200410013407A CN1269521C CN 1269521 C CN1269521 C CN 1269521C CN 200410013407 CN200410013407 CN 200410013407 CN 200410013407 A CN200410013407 A CN 200410013407A CN 1269521 C CN1269521 C CN 1269521C
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Abstract
The present invention relates to compound medicine for curing cancers and a preparation method thereof, particularly to compound medicine for curing cancers, such as lung cancers, liver cancers, etc., and a perparation method thereof. Sirikaya total lactone, stir-frying lacca sinica exsiccata, paclitaxel, alum, fleeceflower root extract, rabdosia extract, stir-frying nux vomica, sphene, bezoar bovis, trogopterus dung extract, curcuma root extract, orange fruit extract, hairyvein agrimonia herd extract, etc. are pulverized, and low temperature extraction is carried out by using carbon dioxide as a solvent. Recovery and concentration are carried out for separating out effective components which are mixed, powder spraying granulation is carried out through carbon dioxide, and embedding is carried out for obtaining a product of the compound medicine. The medicine can be made into an injection and an oral taking enteric capsule. The present invention combines the sirikaya total lactone as natural medicine, the paclitaxel as natural medicine, traditional Chinese medicine and traditional Chinese medicine extract through a modern scientific technology, uses a nanometer embedding technique, and therefore, curative effects are enhanced. The medicine can replace chemotherapeutic medicine, make malignant tumor bodies shrink or disappear, prevent the recurrence and the metastasis of tumors, and relieve pain. The medicine has less side effects, and can prolong the survival time of patients with cancers.
Description
Technical field the present invention relates to a kind of treatment cancer, comprises pulmonary carcinoma, compound medicine of cancers such as hepatocarcinoma and preparation method thereof.
Background technology is from nineteen eighty-two ShivananD.JoLad etc. finds first annonaceous acetogenins in the annonaceae plant since, so far existing about 300 chemical compounds are found, these chemical compounds have one, two or three oxolane rings and a saturated or unsaturated lactone ring five membered, and performance has insecticidal activity to insects such as cotton aphid, mosquito larvae, nematicides.To the 9PS leukemic lymphoblastoid, the 9KB nasopharyngeal carcinoma, A549 pulmonary carcinoma, MCF-7 breast carcinoma, the AF29 colon cancer, L-1210 leukemia etc. has very strong inhibition activity.Several annonaceous acetogenins Acetogenin compounds are arranged, the strong 40-300 of in vivo test specific activity paclitaxel doubly, as bullatacin (Bullatacin) to the active ED50/10 of 9KB nasopharyngeal carcinoma
-15μ g/ml is strong far beyond maytansine and paclitaxel.Therefore, the research to active component in the annonaceae plant has become a focus of fitochemical studies in the world.
Domestic have with sirikaya total lactones and make medicine material aspect the research of sirikaya total lactones, and having with the Annonaceousacetogenicompounds compounds is the anti-tumor effective component medicine of effective ingredient.As " anticancer lichee lectone medicine and preparation method thereof " (number of patent application 01107594.5), be to be raw material with the Sirikaya seed, at first prepare sirikaya total lactones with organic solvent extraction, sirikaya total lactones is through silica gel column chromatography then, after petroleum ether-acetone eluting refinement treatment, being prepared into peaceful-2 total contents of Arnold peaceful-1 and Arnold is the anticarcinogen of mass fraction 50%～70%, and with fat milk as dosage form." a kind of medicine for the treatment of cancer " (number of patent application 0110828.5), it is the root bark of Annona glabra or the ethanol extraction of bark or branch and leaf or seed or their mixture." antineoplastic agent and insecticide total annonacin and manufacture method thereof " (number of patent application 98101363), it is to extract total effective ingredient total annonacin with organic solvent from Sirikaya seed; With the total annonacin content in the photoelectricity colorimetric method for determining goods, with four main content of effective in the high effective liquid chromatography for measuring total annonacin; By pressing down the tumor zoopery in tumor cell in vitro cultivation and the body, measure the anti-tumor activity of goods.
These researchs to Annonaceousacetogenicompounds compounds of above-mentioned home and abroad all have a common ground with application, all are to study, explore, develop, use in this field at Annonaceousacetogenicompounds compounds or at monomeric compound or at annonaceous acetogenins anti-AIDS, anti-tumor effective component medicine.So far not seeing as yet has application sirikaya total lactones and the synthetic compound preparation of Chinese drug-treated group to treat the report of acquired immune deficiency syndrome (AIDS), cancer aspect.
Summary of the invention purpose of the present invention aims to provide and can replace chemotherapeutics, malignant tumor tumor body is dwindled or disappears, and prevents the recurrence and the transfer of tumor, a kind of compound medicine for the treatment of cancer that toxic and side effects is little, curative effect is high and preparation method thereof.
The implementation of purpose of the present invention is, a kind of compound medicine for the treatment of cancer is formulated through the carbon dioxide low-temperature extraction by the composition that weight proportion is following,
Sirikaya total lactones 100～190mg processs Resina Toxicodendri 6～13g
Paclitaxel 1～5g Alumen 18～30g
Radix Polygoni Multiflori extract 30～90g Rabdosia rubescens extract 100～190g
Semen Strychni (processed) 12～18g Sal Nitri 18～30g
Calculus Bovis 5～30g Oletum Trogopterori extract 15～30g
Radix Curcumae extract 18～30g Fructus Aurantii extract 30～38g
Herba Agrimoniae extract 18～30g.
Particle diameter 45～85 nanometers of extract, medicine has injection, oral enteric capsule.
A kind of preparation method for the treatment of the compound medicine of cancer; with 100～190mg sirikaya total lactones; 6～13g processs Resina Toxicodendri; 1～5g paclitaxel; 18～30g Alumen; 30～90g Radix Polygoni Multiflori extract; 100～190g Rabdosia rubescens extract; 12～18g Semen Strychni (processed); 18～30g Sal Nitri; 5～30g Calculus Bovis; 15～30g Oletum Trogopterori extract; 18～30g Radix Curcumae extract; 30～38g Fructus Aurantii extract; 18～30g Herba Agrimoniae extract is crushed to 10～50 orders; make solvent with carbon dioxide; be dosed into and carry out low-temperature extraction in the carbon dioxide abstraction still; by 31.2 ℃ of temperature; pressure 7.32MPa, critical specific volume 95.5cm
3/ mol, extraction successively, through reclaiming, concentrates, isolate effective ingredient, through the carbon dioxide pelletize of dusting, must the nanometer extract, extract, lecithin carried out embedding with 10: 1 and get product.
It is monarch drug that the present invention mainly adopts the natural drug sirikaya total lactones, and Annonaceousacetogenicompounds compounds is considered to the anticancer star of 21 century.Action target spot is a mitochondrion NADH oxidoreductase, brings into play its antitumor action by the generation that suppresses ATP.Chinese medicine Rabdosia rubescens heat-clearing and toxic substances removing, promoting blood circulation to remove blood stasis, Radix Polygoni Multiflori invigorating the liver and kidney, bone and muscle strengthening, replenishing QI and blood, this two flavors medicine is a minister, collaborative monarch drug treating the poisonous disease with poisonous drugs, toxin expelling eliminating stagnation, strengthening the body resistance; Paclitaxel is the universally acknowledged natural drug that acts on the cancerous cell tubulin, is the anticarcinogen name star of twentieth century, broad spectrum anticancer, and clear away heart-fire is had one's ideas straightened out, the eliminating phlegm arresting convulsion, heat-clearing and toxic substances removing, this two flavors medicine is assistant; Sal Nitri is gone into the blood heavily fortified point that disappears, and Alumen is gone into gas and won wetly, and Radix Curcumae, Fructus Aurantii are strengthened the eliminating stagnation painful abdominal mass that disappears, and Resina Toxicodendri is strengthened blood stasis removing and cut heavily fortified point, and Semen Strychni is strengthened detumescence and relieved the pain, and Herba Agrimoniae, Oletum Trogopterori are strengthened blood circulation promoting and blood stasis dispelling, and this eight flavors medicine is for making, and collaborative monarch drug is played the merit of antitumor altogether.By the compatibility of monarch, compound effective ingredient of enrichment antineoplastic and effective site by CO 2 supercritical technology extraction effective ingredient, further improve composite efficacy again.
The present invention utilize Chinese medicine combine with natural drug form the additive effect of composite parts, its mechanism of action is that too many levels, multipath, many target spots act on human body, combine with microtubule, form non-functional microtubule fasolculus, upset the ordered arrangement of microtubule in cancerous cell, the mitosis of anticancer, suppress mitochondrion NADH reductase or nadh oxidase, ATP is reduced, cause ATP to exhaust, make cancerous cell that " death of hunger property " take place, thus anti-effectively curing oncoma.
The present invention compared with prior art has following advantage:
1, in treatment, in the cancer process such as advanced lung cancer, hepatocarcinoma, do not have any untoward reaction, the patient can be continuously, long-term prescription and be unlikely to produce the toxic and side effects of organ injuries such as bone marrow depression, granulocytopenia, liver and kidney;
2, can not cause phenomenons such as the patient vomits, feels sick, stomachache, diarrhoea, inappetence, hematuria;
3, preparation method is compared with organic solvent method, has extraction efficiency height, no solvent residue, active component and the thermally labile component advantages such as destruction that are difficult for being decomposed;
4, medication is convenient, economical, only is equivalent to 30% of chemotherapy regimen such as paclitaxel-cisplatin scheme medicine expense;
5, compound preparation reaches nanoscale, can produce magnetic, and its targeting is strong, and effective ingredient can be stormed through sick institute (local lesion) fast.
Specific embodiment compound medicine of the present invention by sirikaya total lactones, process Resina Toxicodendri, paclitaxel, Alumen, Radix Polygoni Multiflori extract, Rabdosia rubescens extract, Semen Strychni (processed), Sal Nitri, Calculus Bovis, Oletum Trogopterori extract, Radix Curcumae extract, Fructus Aurantii extract, Herba Agrimoniae extract etc. through pulverizing; make the solvent low-temperature extraction with carbon dioxide; reclaim, concentrate, isolate effective ingredient; mix; through the carbon dioxide pelletize of dusting, embedding gets product.Medicine has injection, oral enteric capsule.
Chinese medicine extract in the present invention fills a prescription all is according to " pertinent regulations of Chinese pharmacopoeia, the dry extract of making respectively.Sirikaya total lactones comprises from sirikaya total lactones isolated monomeric compound, mixture or contains plant extract and the effective site and the compound preparation medicine of this chemical compound.
Particle diameter 45～85 nanometers of extract, medicine has injection, oral enteric capsule.Get 45～85 nanometer extract 20mg, add dual distilled water 20ml, making every specification in sterilizing room is the injection that 2ml, confession venoclysis are used.Get 45～85 nanometer extract 0.33g and be divided in No. 2 enteric coated capsules, make the oral enteric capsule.
Application process; Each 3 of injection joins among the 5% glucose solution 250ml, intravenous drip, and once a day, 30 is a course of treatment.Oral each 5 of enteric coated capsule, every day 3 times, serveing on 30 is a course of treatment.Can the continuous a plurality of medications course of treatment up to recovering.
Enumerate embodiments of the invention below:
Example 1, get 100g sirikaya total lactones, 6g and process Resina Toxicodendri, 1g paclitaxel, 18 Alumens, 30g Radix Polygoni Multiflori extract, 100g Rabdosia rubescens extract, 12g Semen Strychni (processed), 18g Sal Nitri, 5g Calculus Bovis, 15g Oletum Trogopterori extract, 18g Radix Curcumae extract, 30g Fructus Aurantii extract, 18g Herba Agrimoniae extract and be crushed to 10～50 orders; make solvent with carbon dioxide; be dosed into and carry out low-temperature extraction in the carbon dioxide abstraction still; by 31.2 ℃ of temperature; pressure 7.32MPa, critical specific volume 95.5cm
3/ mol, extraction successively, through reclaiming, concentrate, isolate high purity effective component, through the carbon dioxide pelletize of dusting, extract, lecithin carried out embedding with 10: 1, formed a kind of duricrust, and it effectively protects effective ingredient not oxidized and volatilize.Get product.The particle diameter of extract is 45～85 nanometers.Get 45～85 nanometer extract 20mg, add dual distilled water 20ml, in sterilizing room, make ten injections.Get 45～85 nanometer extract 0.33g and be divided in No. 2 enteric coated capsules, make the oral enteric capsule.
Example 2, get 120g sirikaya total lactones, 8g and process Resina Toxicodendri, 2g paclitaxel, 20g Alumen, 40g Radix Polygoni Multiflori extract, 120g Rabdosia rubescens extract, 13g Semen Strychni (processed), 20g Sal Nitri, 10g Calculus Bovis, 18g Oletum Trogopterori extract, 20g Radix Curcumae extract, 32g Fructus Aurantii extract, 20g Herba Agrimoniae and prepare injection and oral enteric capsule by the method for example 1.
Example 3, get 190g sirikaya total lactones, 10g and process Resina Toxicodendri, 3g paclitaxel, 22g Alumen, 90g Radix Polygoni Multiflori extract, 190g Rabdosia rubescens extract, 14g Semen Strychni (processed), 22g Sal Nitri, 30g Calculus Bovis, 20g Oletum Trogopterori extract, 22g Radix Curcumae extract, 34g Fructus Aurantii extract, 22g Herba Agrimoniae and prepare injection and oral enteric capsule by the method for example 1.
Example 4, get 170g sirikaya total lactones, 128 and process Resina Toxicodendri, 4g paclitaxel, 25g Alumen, 70g Radix Polygoni Multiflori extract, 170g Rabdosia rubescens extract, 15g Semen Strychni (processed), 25g Sal Nitri, 20g Calculus Bovis, 25g Oletum Trogopterori extract, 25g Radix Curcumae extract, 35g Fructus Aurantii extract, 25g Herba Agrimoniae and prepare injection and oral enteric capsule by the method for example 1.
Example 5, get 150g sirikaya total lactones, 13g and process Resina Toxicodendri, 5g paclitaxel, 30g Alumen, 60g Radix Polygoni Multiflori extract, 150g Rabdosia rubescens extract, 18g Semen Strychni (processed), 30g Sal Nitri, 15g Calculus Bovis, 30g Oletum Trogopterori extract, 30g Radix Curcumae extract, 38g Fructus Aurantii extract, 30g Herba Agrimoniae and prepare injection and oral enteric capsule by the method for example 1.
Hubei Province has made pharmacodynamics test to this medicine in Chinese medicine institute study of tcm new drug development centre, and conclusion is as follows: the effects such as toxicity that compound medicine has antitumor enhancing human body immunity power clinically and alleviates radiotherapy, chemotherapy.Experimental results show that the oral enteric capsule is to mice transplanted tumor S
180And H
22The growth of solid tumor all has significant inhibitory effect, two batches of experimental result basically identicals.The life span of ascites tumor animal is not had the significance influence, but the behavior states of the general situation of administration treated animal such as food-intake, hair luster degree, animal etc. all are better than matched group.
Done acute toxicity test, conclusion is that the oral enteric capsule is pressed the heap(ed) capacity gastric infusion with 12.15g/kg (this dosage is equivalent to 164.19 times of people's consumption per day 4.44g/60kg) through mice one twice-daily, observes 7 days, do not see obvious acute toxic reaction, all mice survivals.Show that this medicine acute toxicity testing passes through, it is big to take safety range, and positive usual amounts is safe in utilization.
The People's Hospital, Tuanfeng County, Hubei Province oral enteric capsule for treating late malignant tumour 38 examples, according to the domestic method of commonly using of International Union Against Cancer (UICC), 38 examples are III, IV phase patient, wherein gastric cancer 12 examples, hepatocarcinoma 10 examples, cancer of pancreas 2 examples, colon cancer 3 examples, pulmonary carcinoma 7 examples, breast carcinoma 2 examples, osteosarcoma 2 examples.Take medicine before and after look liver function and renal function, the other medicines toxic and side effects does not appear in the person that finds to cause the hepatic and renal function injure because of taking medicine.Diet, body weight all have increase after taking medicine.
Hemoglobin the results are shown in Table 1 before and after the treatment,
Table 1
| The sick kind | The example number | Hemoglobin counting (g/L) | Numeration of leukocyte (* 10 9/L) | ||
| Before taking medicine | After taking medicine | Before taking medicine | After taking medicine | ||
| Gastric cancer | 12 | 72.0 | 84.9 | 5.5 | 8.2 |
| Hepatocarcinoma | 10 | 85.5 | 97.0 | 5.3 | 7.5 |
| Cancer of pancreas | 2 | 75.2 | 86.1 | 6.5 | 7.2 |
| Colon cancer | 3 | 74.4 | 80.2 | 6.3 | 7.8 |
| Pulmonary carcinoma | 7 | 80.2 | 92.4 | 5.4 | 8.2 |
| Breast carcinoma | 2 | 85.5 | 110.5 | 5.6 | 7.0 |
| Osteosarcoma | 2 | 70.5 | 76.6 | 6.6 | 7.2 |
Is sure from last visible this oral enteric capsule to the protective effect of various tumor patient peripheral hemograms.
Pain classification contrast inspection table 2 before and after the treatment,
Table 2
| Rank | Before taking medicine | After taking medicine |
| 0 | 0 | 19 |
| 1 | 8 | 12 |
| 2 | 20 | 7 |
| 3 | 10 | 0 |
| Add up to | 38 | 38 |
As seen this oral enteric capsule has obvious analgesic activity.
Back situation life cycle of taking medicine sees Table 3,
Table 3
| Life cycle (example) | ||||
| The sick kind | The example number | 6 months | 1 year | More than 1 year |
| Gastric cancer | 12 | 12 | 10 | 8 |
| Hepatocarcinoma | 10 | 10 | 8 | 6 |
| Cancer of pancreas | 2 | 2 | 2 | 1 |
| Colon cancer | 3 | 3 | 3 | 2 |
| Pulmonary carcinoma | 7 | 7 | 7 | 5 |
| Breast carcinoma | 2 | 2 | 2 | 1 |
| Osteosarcoma | 2 | 2 | 1 | 1 |
Enumerate the model case of treatment below:
Case 1: Tan, the woman, 82 years old, be diagnosed as thyroid carcinoma late period through The Mirror Lake, Macao hospital, merging breastbone, lumbar vertebra and lung shifts, after making a definite diagnosis, The Mirror Lake hospital changes Guangzhou Nanfang Hospital May calendar year 2001 over to, because of carninomatosis has belonged to late period, satisfy abandoning cure, July calendar year 2001, by the agency of was taken this oral enteric capsule three months, patient's cervical region thyroid lump obviously dwindles, transference cures such as the hemoptysis that metastatic cancers of lung causes, dyspnea, breastbone pain, food are received and are recovered normal, body weight and increase to some extent, have survived 3 years.
Case 2: Wang, the man, 57 years old, Huangshi, the Hubei Province cadre of discipline inspection commission, pathological diagnosis: hepatocarcinoma III level, 3～May of calendar year 2001 earlier after Wuhan hospital of Tongji University, Tang of The Fourth Military Medical University all hospital diagnosis be hepatocarcinoma, alpha-fetoprotein 30000 is found right lobe of liver lump 5.7 * 3.2cm through B ultrasonic, CT examination, make a definite diagnosis back work done in the manner of a certain author excision tumor body, the back is feared operation and is changed mind, and satisfies this oral enteric capsule and treats 3 courses of treatment, ultrasound diagnosis, liver's lump disappears, food is received and is recovered normal, weight increase, survival three and half.
Claims (6)
1, a kind of compound medicine for the treatment of cancer, it is formulated to it is characterized in that passing through the carbon dioxide low-temperature extraction by the following composition of weight proportion,
Sirikaya total lactones 100～190mg processs Resina Toxicodendri 6～13g
Paclitaxel 1～5g Alumen 18～30g
Radix Polygoni Multiflori extract 30～90g Rabdosia rubescens extract 100～190g
Semen Strychni (processed) 12～18g Sal Nitri 18～30g
Calculus Bovis 5～30g Oletum Trogopterori extract 15～30g
Radix Curcumae extract 18～30g Fructus Aurantii extract 30～38g
Herba Agrimoniae extract 18～30g.
2, the compound medicine of treatment cancer according to claim 1 is characterized in that particle diameter 45～85 nanometers of extract, and medicine has injection, oral enteric capsule.
3, the compound medicine of treatment cancer according to claim 1, it is characterized in that sirikaya total lactones, it is characterized in that: it comprises from sirikaya total lactones isolated monomeric compound, mixture or contains plant extract and the effective site and the compound preparation medicine of this chemical compound.
4; the described a kind of preparation method for the treatment of the compound medicine of cancer of claim 1; it is characterized in that sirikaya total lactones with 100190m g; 6～13g processs Resina Toxicodendri; 1～5g paclitaxel; 18～30g Alumen; 30～90g Radix Polygoni Multiflori extract; 100～190g Rabdosia rubescens extract; 12～18g Semen Strychni (processed); 18～30g Sal Nitri; 5～30g Calculus Bovis; 15～30g Oletum Trogopterori extract; 18～30g Radix Curcumae extract; 30～38g Fructus Aurantii extract; 18～30g Herba Agrimoniae extract is crushed to 10～50 orders; make solvent with carbon dioxide; be dosed into and carry out low-temperature extraction in the carbon dioxide abstraction still; by 31.2 ℃ of temperature; pressure 7.32MPa, critical specific volume 95.5cm
3/ mol, extraction successively, through reclaiming, concentrates, isolate effective ingredient, through the carbon dioxide pelletize of dusting, must the nanometer extract, extract, lecithin carried out embedding with 10: 1 and get product.
5, the preparation method of the compound medicine of treatment cancer according to claim 4 is characterized in that getting 45～85 nanometer extract 20mg, adds dual distilled water 20ml, and making every specification in sterilizing room is the injection that 2ml, confession venoclysis are used.
6, the preparation method of the compound medicine of treatment cancer according to claim 4 is characterized in that getting 45～85 nanometer extract 0.33g and is divided in No. 2 enteric coated capsules, makes the oral enteric capsule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN 200410013407 CN1269521C (en) | 2004-07-01 | 2004-07-01 | Compound medicine for treating cancer and preparing process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410013407 CN1269521C (en) | 2004-07-01 | 2004-07-01 | Compound medicine for treating cancer and preparing process thereof |
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| CN1269521C true CN1269521C (en) | 2006-08-16 |
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| CN 200410013407 Expired - Fee Related CN1269521C (en) | 2004-07-01 | 2004-07-01 | Compound medicine for treating cancer and preparing process thereof |
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| WO2009043176A1 (en) | 2007-10-03 | 2009-04-09 | Sabell Corporation | Herbal compositions and methods for treating hepatic disorders |
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