CN1239170C - Chinese patent drug for treating liver cancer - Google Patents
Chinese patent drug for treating liver cancer Download PDFInfo
- Publication number
- CN1239170C CN1239170C CNB2004100371101A CN200410037110A CN1239170C CN 1239170 C CN1239170 C CN 1239170C CN B2004100371101 A CNB2004100371101 A CN B2004100371101A CN 200410037110 A CN200410037110 A CN 200410037110A CN 1239170 C CN1239170 C CN 1239170C
- Authority
- CN
- China
- Prior art keywords
- ethanol
- standby
- filtrate
- water
- fine powder
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to a Chinese patent medicine for treating liver cancer and a preparation method thereof. The Chinese patent medicine is prepared from red ginseng, milkvetch root, dried toad, cantharis and a proper amount of auxiliary material. Compared with the prior art, the Chinese patent medicine has better curative effects and higher safety. Some traditional Chinese medicine ingredients which have anticancer activity are fully utilized, and the content of toxic ingredients is strictly controlled. The Chinese patent medicine has the functions of vital energy benefit, health improvement, stasis dispersion and stagnation removal and has obvious curative effects on later-stage primary liver cancer, qi deficiency and stagnation, right abdominal mass, pain of fixed positions, abdominal distention, low food intake, fatigue, weakness, etc.
Description
Technical field: the present invention relates to a kind of Chinese patent medicine that is used for the treatment of hepatocarcinoma and preparation method thereof, belong to the field of traditional Chinese medicine technology.
Background technology: cancer is the common frdquently encountered disease of serious harm people's life health and lives.Annual about 1,600,000 people of China die from cancer in recent years, and rank first place with liver cancer mortality among the cancer mortality crowd at home.Because China has 1.2 hundred million HBV carriers at present, therefore,, particularly alleviate mid and late liver cancer patient's misery to the treatment of hepatocarcinoma disease, prolonging its life cycle and improving life quality etc. all is the research topic that this area very urgently solves.Western medical treatment hepatocarcinoma is except that operation at present, the main chemotherapy that adopts, chemotherapy is often carried out a large amount of kill cancer cells and normal cell on the one hand, carry out replenishing fast high nutrition on the other hand again, make patient's body cell be in all the time extremely tired among, though the tumor body can obviously dwindle at short notice, will soon recur.And traditional Chinese medicine to tumor treatment mode and medicine also have medication not comprehensively, problem such as curative effect is unstable and cure rate is low.The Chinese patent communique discloses name, and to be called " injection that contains Radix Ginseng and astragalus root components ", application number be 941014568 patent application, this application is used to improve immune function of human body, the inhibition tumor has certain effect, but there is the problem of three aspects at least in it: the one, and the amount ratio that medicine constitutes the toxic medical material is bigger; So side effect is also bigger, influences therapeutic effect; The 2nd, dosage form is too single, for the patient, only has only injection formulation obviously to be difficult to satisfy the demand of doctor and patient, administration inconvenience; The 3rd, production technology is relatively backward, and especially extraction and purification process is unreasonable, has a strong impact on the quality of injection, simultaneously, and injection complex process, cost height.After fully recognizing the defective that this patent exists, the inventor has carried out technical studying in great detail to its existing problems; The applicant had once submitted to name to be called on August 6th, 2003 to Patent Office: a kind of Chinese patent medicine that is used for the treatment of hepatocarcinoma, application number: 031344682; This application makes every effort to solve the problem that prior art exists; But because invention was not finished as yet fully at that time, so the application of submitting to and incomplete, complete; Through nearly 1 year work, the applicant has finished invention work substantially fully now.
Summary of the invention: the objective of the invention is to: a kind of Chinese patent medicine that is used for the treatment of hepatocarcinoma and preparation method thereof is provided.Prescription, the ratio of this preparation are more reasonable, and its dosage form selection relatively is suitable for the treatment to this disease patient of hepatocarcinoma, and the preparation method of development comparison science is feasible, and the manufactured goods that obtain are compared in existing product, and its toxic and side effects is little; Therapeutic effect is desirable more.The present invention constitutes like this: the Chinese patent medicine of treatment hepatocarcinoma, to calculate according to components by weight percent, and it is mainly by Radix Ginseng Rubra 500-1500 part; Radix Astragali 2000-4000 part; Bufo siccus 2.5-5.5 part; Mylabris 10-30 part is prepared from.Concrete: it is prepared from by 1000 parts of Radix Ginseng Rubra, 3000 parts of the Radixs Astragali, 4 parts of Bufo siccuss, 20 parts of Mylabris and appropriate amount of auxiliary materials.Described adjuvant comprises according to the different dosage form of preparation: starch, cyclamate, Fructus Citri tangerinae essence, potassium sorbate, mannitol etc.Preparation of the present invention comprises granule, capsule, tablet, drop pill, oral liquid, injection (comprising little pin, transfusion, freeze-dried powder), slow releasing preparation, controlled release preparation etc.The optimal preparation that described Chinese patent medicine is prepared into is: oral liquid formulations, capsule, freeze-dried powder.
The preparation method of the Chinese patent medicine of this treatment hepatocarcinoma is: with Radix Ginseng Rubra, the Radix Astragali, Bufo siccus, Mylabris extract respectively refining after, add suitable adjuvant again and be prepared into different preparations.
Chinese medicine liquor formulation preparation method of the present invention: with alcohol reflux 3 times, merge extractive liquid, filters with Radix Ginseng Rubra section, filtrate recycling ethanol, and it is standby to be condensed into clear paste 1; The medicinal residues water decocts, and filters, and filtrate is condensed into clear paste, and add ethanol and leave standstill, the leaching precipitation, cold drying, it is standby to get dry powder 1; Radix Astragali section decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back ethanol precipitation, filtrate recycling ethanol and to be condensed into clear paste 2 standby; The precipitation vacuum drying of leaching, it is standby to get dry powder 2; Give birth to the Venenum Bufonis fine powder and spend the night with 25 times of soak with ethanol, refluxed then 4 hours, filter, it is standby to get clear paste 3 behind the filtrate recycling ethanol; Living Mylabris fine powder soaks with hydrochloric acid-acetone solution, reclaims acetone, and debris is washed with alcohol-ether liquid, the leaching precipitation, the dry Mylabris extract that gets adds above-mentioned 3 kinds of clear paste, 2 kinds of dry powder and cyclamate, flavoring orange essence, potassium sorbate, stirring and dissolving adds water, regulates pH value, filter, fill, sterilization, promptly.The advantage of this dosage form is: delicious taste, and onset is rapid; The bioavailability height.
Chinese patent medicine capsule preparation method of the present invention: with Radix Ginseng Rubra section alcohol reflux 3 times, merge extractive liquid, filters, and filtrate recycling ethanol is condensed into clear paste, spray drying, and it is standby to get fine powder 1; The medicinal residues water decocts, and filters, and filtrate is condensed into clear paste, and add ethanol and leave standstill, the leaching precipitation, cold drying is ground into fine powder, and it is standby to get fine powder 2; The Radix Astragali is cut into slices, and decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back and uses ethanol precipitation, and filtrate recycling ethanol also is condensed into clear paste, spray drying, and it is standby to get fine powder 3; The precipitation vacuum drying of leaching is ground into fine powder, and it is standby to get fine powder 4; Give birth to the Venenum Bufonis fine powder and spend the night, refluxed then 4 hours, filter with 25 times of soak with ethanol, filtrate recycling ethanol, drying under reduced pressure is ground into fine powder, gets fine powder 5, and is standby; Living Mylabris fine powder reclaims acetone with hydrochloric acid-acetone solution immersion, and debris is washed with alcohol-ether liquid, the leaching precipitation, and the dry Mylabris extract that gets adds above-mentioned 5 kinds of fine powders and starch, mixing, alcohol granulation sieves, drying, granulate, fill, promptly.
Chinese patent medicine freeze-dried powder preparation method of the present invention: give birth to the Venenum Bufonis fine powder and spend the night, refluxed then 4 hours, filter with 25 times of soak with ethanol, standby behind the filtrate recycling ethanol; Living Mylabris fine powder soaks with hydrochloric acid-acetone solution, reclaims acetone, and debris is washed with alcohol-ether liquid, and the leaching precipitation is dry that Mylabris extract is standby; The Radix Ginseng Rubra section is measured 75% alcohol reflux 3 times, each 1.5 hours with 8 times, merge extractive liquid, filters filtrate recycling ethanol, concentrate the back and use extracted with diethyl ether, fling to ether, filter, the sec-butyl alcohol extraction that filtrate water is saturated, reclaim sec-butyl alcohol, add ethanol cold preservation after concentrating and spend the night, filter, filtrate is condensed into clear paste, and it is standby to get red ginseng saponin extract; Medicinal residues water behind the ethanol extraction decocts, and filters, and adds ethanol after filtrate concentrates and leaves standstill, leaching precipitation, the dry Radix Ginseng Rubra crude polysaccharides that gets, add the water boil dissolving, supernatant concentration, polyamide chromatography, water eluting, add ethanol after eluent concentrates and leave standstill, the leaching precipitation, vacuum drying gets the Radix Ginseng Rubra polysaccharide; Radix Astragali section, decoct with water 3 times, merge decoction liquor, filter, filtrate concentrates the back ethanol precipitation, filtrate recycling ethanol adds ethanol after also concentrating, and cold preservation is spent the night, and filters, filtrate recycling ethanol, concentrate the back with water saturated sec-butyl alcohol extraction, reclaim sec-butyl alcohol, it is clear and bright that the Radix Astragali saponin extracting solution is standby to concentrate after-filtration; The precipitation vacuum drying of leaching, dissolving is boiled with distilled water in the pulverizing back, and supernatant concentration becomes thick paste, the polyamide chromatography, the water eluting, eluent filters, and add ethanol after filtrate concentrates and leave standstill, the leaching precipitation, vacuum drying, it is standby to get astragalus polysaccharides; Get red ginseng saponin extracting solution and Radix Astragali saponin extracting solution, thin up is regulated pH, and activated carbon adsorption is filtered clear and bright standby; Get Radix Ginseng Rubra polysaccharide and astragalus polysaccharides, add water boil dissolving, filter clear and bright, boil dissolving with mannitol after, activated carbon adsorption is filtered clear and bright standby; Get Mylabris extract, add water, caustic lye of soda is regulated pH, add the Venenum Bufonis extract stirring and dissolving, filter filtrate and above-mentioned Radix Ginseng Rubra and Radix Astragali saponin extract filtrate mixing, again this mixed liquor is added in above-mentioned polysaccharide and the mannitol mixture, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, aseptic subpackaged, lyophilization is sealed, promptly.
Relatively backward in view of original production process, for the new technology of various dosage forms, we have also made experimental selection:
Bufo siccus: former injection technology is to measure 95% soak with ethanol 24 hours with 10 times, bufogenin and cinobufagin are only leached 50% as a result, also have 50% not leached, and now change 25 times of soak with ethanol into and spend the night, refluxed then 4 hours, this kind technology active constituent content improves 1 times.
Two kinds are extracted process for purification gained result relatively
Extract process for purification and extract liquid measure (ml) bufogenin and cinobufagin total amount (mg/ml)
Former injection infusion method 100ml 1.12
Soak circumfluence method 100ml 1.51
The result shows that the method effective ingredient after the improvement improves a lot, and soaks circumfluence method extraction, cold preservation reclaiming by filtration so select for use.
Mylabris: former injection is that decoct to extract stone sulfur method refining, and the method not only impurity such as fat-soluble pigment is not removed, and is dark-brown, and loss of effective components such as cantharidin is big, has a strong impact on the quality of injection.According to main effective ingredient Chinese blister beetle of class element, sodium cantharidinate physicochemical property, designed acetone immersion and alcohol-ether washing method and chloroform immersion and alcohol-ether washing method and extracted process for purification for two kinds.
Two kinds are extracted process for purification gained result relatively
Extract process for purification extract obtained (g) recovery rate (%) cantharidin content (%)
1. acetone method 3.24 16.2 56.42
2. the chloroform method 3.30 16.5 56.45
The result shows, two kinds of method gained are basically identical as a result, because of acetone for being low poison solvent, so use acetone method.
Radix Ginseng Rubra: former injection ginseng crude drug only uses the 45-55% alcohol reflux 3 times, and impurity is not removed, and ginsenoside's loss is too big; The ginseng polysaccharide is extraction and application not basically, and as anticarcinogen, the ginseng polysaccharide is main effective ingredient.
In view of the Radix Ginseng Rubra polysaccharide is insoluble to alcohol and soluble in water, therefore, the medicinal residues after the alcohol extraction can be used water boiling and extraction Radix Ginseng Rubra polysaccharide.
The red ginseng saponin extract process for refining
Sec-butyl alcohol extraction and the refining result of n-butanol extraction
Investigate index sec-butyl alcohol extraction n-butanol extraction
Red ginseng saponin extract (ml) 200 200
The extract red ginseng saponin contains (mg/ml) 11.02 10.78
The solid content of extract (mg/ml) 121.2 128.8
Protein does not detect
Tannin does not detect
Resin does not detect
Oxalates does not detect
Potassium ion does not detect
The result shows, the quality basically identical of sec-butyl alcohol extracting and refining method and the extract obtained sample of n-butanol extraction method for refining in view of the sec-butyl alcohol boiling point is lower, is easy to reclaim.
Radix Ginseng Rubra refinishing polyose craft screening result
Refining polysaccharide amount (g) polyoses content of investigation project gained is (with glucose meter, %)
Repeatedly alcohol deposition method 55.0 58.3
Polyamide chromatography method 50.2 65.5
The result shows that polyamide chromatography method is gained Radix Ginseng Rubra purity of polysaccharide height not only, and technology is easy, be easy to filter clear and bright, the material saving, time and labour saving.
The Radix Astragali: the former injection technology Radix Astragali only water decocts 3 times, and the use stone sulfur method fifties in last century is refining, and not only impurity is not removed, and extracts active ingredients is also incomplete.
The comparison of two kinds of extraction processes
| Extraction process | Astragaloside amount (mg) | First glycosides amount (mg) in the medical material | The first glycosides extracts the rate of transform (%) | Crude polysaccharides and polysaccharide percentage composition (g)/(%) |
| The ethanol refluxing process water alcohol method | 42.4 42.8 | 66.6 66.6 | 63.66 64.26 | 4.14/50.72 4.51/53.12 |
The crude polysaccharides that decoction and alcohol sedimentation technique is carried is more, and polyoses content is also higher, and extraction time reduces half simultaneously, saves time, saves trouble, economizes the energy.
Because of astragaloside and astragalus polysaccharides are to take water extract-alcohol precipitation to separate, therefore only need do purification research.
Two kinds of method purifying process of astragaloside result
Purifying process solid content (mg/ml) contains first glycosides amount (mg/ml) determination of foreign matter
Sec-butyl alcohol extraction 57 1.63 meets the requirements
Ethanol precipitation 94 1.47 meets the requirements
Above result shows that the extract obtained solid content of sec-butyl alcohol extraction is low, and purity height, Astragaloside content are also higher.
Astragalus polysaccharides purifying process result of study
| Purification process | The refining polysaccharide of gained is investigated the result | ||
| Gained is made with extra care polysaccharide amount (g) | Polyoses content (%) | Determination of foreign matter | |
| Ethanol precipitation polyamide absorb-elute method repeatedly | 24.34 20.42 | 48.10 56.41 | Meet the requirements |
The result shows that the refining purity of polysaccharide height of polyamide column chromatography method gained and institute's polysaccharide eluent are easy to filter clear and bright, and easily dissolving is clear and bright for the refining polysaccharide water of gained.
With respect to prior art (name be called " injection that contains Radix Ginseng and astragalus root components ", in please number be 941014568 patent application), improved the Radix Ginseng and the Radix Astragali consumption in the side among the application, and reduced Bufo siccus, the Mylabris consumption in the side; Both guaranteed that medicine provided by the invention had effective therapeutic effect; Guarantee again will arrive toxic and side effects minimum in its therapeutic process.Test as follows:
Test method
1. by the comparative study principle, test group and matched group are set up in test, matched group comprises blank and positive control, test group gives this medicine injection, the blank group gives normal saline, and it is the product of 941014568 technology preparation that positive control drug is selected " injection that contains Radix Ginseng and astragalus root components ", application number for use.
2. dosage setting:
Test group is established high, medium and low three dosage groups, and matched group is established low dose group.
2.1 the test group dosage is a parameter with this medicine injection mouse tail vein administration LD50, by LD50 1/15,, 1/50 dosage is dosage, respectively be: 1493mg/kg, 896mg/kg, 448mg/kg.Matched group is provided with dosage group, i.e. 452mg/kg by 1/25 dosage of LD50; Blank group intravenous injection normal saline only gives by 0.5ml/ at every turn.
2.2 administration volume
Each organizes white mice is 0.5ml/ through the agent of medicine appearance at every turn, adopts not isoconcentration administration of isometric(al).
2.3 medication
The route of administration of each group of test all adopts and clinical consistent intravenously administrable approach, from white mice tail intravenously administrable.Test group is administered once every day, successive administration seven days.The blank group is given normal saline once, continuous seven days every day.Positive controls is administered once every day, continuous seven days.
2.4 test procedure
Under aseptic condition, extracted tumor liquid in well-grown kind of Mus body in 7-8 days from inoculation, (1,000,000/0.1ml) to be inoculated in white mice right fore armpit subcutaneous to get tumor liquid 0.2ml, random packet after 24 hours, each group is observed reaction of animals by corresponding medication, dosage administration respectively after the administration, the 9th day execution animal after administration, the record body weight is dissected back record tumor and is weighed, and calculates the heavy suppression ratio of tumor.The result is as follows:
This medicine injection is to the effect of mice S180 solid tumor.
The average tumor of group N dosage suppression ratio is heavy
Model control group 30 3.89 ± 0.61
Positive controls 30 34.2 2.56 ± 0.51
*
Heavy dose of group 30 50.6 1.92 ± 0.49
*△
Middle dosage group 30 45.5 2.12 ± 0.78
*△ △
Small dose group 30 36.5 2.47 ± 0.55
*
Annotate: compare * P＜0.01 with model control group
Compare △ P＜0.01, △ △ P＜0.05 with positive controls
From last table as seen, this medicine injection small dose group and " injection that contains Radix Ginseng and astragalus root components " small dose group are to the effect of mice S180 solid tumor P＜0.05 of comparing, and no difference of science of statistics illustrates two groups therapeutic equivalence.
Two, test method
1. by the comparative study principle, test group and matched group are set up in test, and matched group comprises blank and positive control, and test group gives this medicine injection, and the blank group gives normal saline, and positive control drug is selected " injection that contains Radix Ginseng and astragalus root components " for use.
2. dosage setting:
Test group is established high, medium and low three dosage groups, and matched group is established low dose group.
2.1 the test group dosage is a parameter with this medicine injection mouse tail vein administration LD50, by LD50 1/15,, 1/50 dosage is dosage, respectively be: 1493mg/kg, 896mg/kg, 448mg/kg.Matched group is provided with dosage group, i.e. 452mg/kg by 1/25 dosage of LD50; Blank group intravenous injection normal saline only gives by 0.5ml/ at every turn.
2.2 administration volume
Each organizes white mice is 0.5ml/ through the agent of medicine appearance at every turn, adopts not isoconcentration administration of isometric(al).
2.3 medication
The route of administration of each group of test all adopts and clinical consistent intravenously administrable approach, from white mice tail intravenously administrable.Test group is administered once every day, successive administration seven days.The blank group is given normal saline once, continuous seven days every day.Positive controls is administered once every day, continuous seven days.
2.4 test procedure
Under aseptic condition, extracted tumor liquid in well-grown kind of Mus body in 7-8 days from inoculation, (1,000,000/0.1ml) to be inoculated in white mice right fore armpit subcutaneous to get tumor liquid 0.2ml, random packet after 24 hours, each group is by corresponding medication, dosage administration respectively, observe also record and respectively organize mice existence natural law, treat the whole death of white mice after, calculate increase in life span.The result is as follows:
The effect of this medicine injection mice ehrlich ascites tumor
Group n dosage increase in life span The average survival time natural law
Model control group 30 17.2 ± 5.21
Positive controls 30 34.2 33.2 ± 6.29
*
Heavy dose of group 30 50.6 39.1 ± 6.84
*△
Middle dosage group 30 45.5 35.6 ± 6.52
*
Small dose group 30 36.5 34.7 ± 5.97
*
Annotate: compare * P＜0.01 with model control group
Compare △ P＜0.01 with positive controls
From last table as seen, this medicine injection small dose group and " injection that contains Radix Ginseng and astragalus root components " small dose group are to the effect of mice S180 solid tumor P＜0.05 of comparing, and no difference of science of statistics illustrates two groups therapeutic equivalence.
Three, method is the same.The result is as follows:
This medicine injection is to the inhibitory action of mouse entity type hepatocarcinoma
The average tumor of group N dosage suppression ratio is heavy
Model control group 30 2.56 ± 0.37
Positive controls 30 17.2 2.12 ± 0.45
*
Heavy dose of group 30 59.4 1.04 ± 0.38
*△
Middle dosage group 30 42.4 1.52 ± 0.33
*△
Small dose group 30 21.5 2.01 ± 0.41
*
Annotate: compare * P＜0.01 with model control group
Compare △ P＜0.01 with positive controls
From last table as seen, this medicine injection small dose group and " injection that contains Radix Ginseng and astragalus root components " small dose group are to the inhibitory action of mouse entity type hepatocarcinoma P＜0.05 of comparing, and no difference of science of statistics illustrates two groups therapeutic equivalence.
Four, acute toxicity test
" injection that contains Radix Ginseng and astragalus root components " from two kinds of route of administration of vein and abdominal cavity to the white mice administration after, determining intravenous injection LD50 is 11.27g/kg, lumbar injection LD50 is 15.60g/kg; This medicine injection from two kinds of route of administration of vein and abdominal cavity to the white mice administration after, determining intravenous injection LD50 is 22.4g/kg, lumbar injection LD50 is 27.8g/kg.From above two groups of data as seen, the LD50 of this medicine injection approaches the twice of " containing the injection of Radix Ginseng and astragalus root components ".
Compared with prior art, the health giving quality and the safety of this medicine are higher, the Chinese medicine ingredients that makes some have active anticancer is fully utilized, the content of toxic component obtains strict control, has QI invigorating and sets upright, the function of repercussive eliminating stagnation, product is used for the long-pending piece of the right flank of advanced primary liver cancer deficiency of vital energy stasis card, unmovable pain, abdominal distention and little diet, diseases such as fatigue and weakness are evident in efficacy.
Primary hepatocarcinoma belongs to the category of the traditional Chinese medical science " note of the ancient Chinese is long-pending ", has both become the long-pending card of the stasis of blood of main syndrome with the weakened body resistance stasis of blood, and disease sees that right flank amasss piece, unmovable pain, abdominal distention and little diet, fatigue and weakness etc.The long-pending weakened body resistance stasis of blood knot syndrome of the stasis of blood is on weakened body resistance basis, and evil poison is fought mutually to tie with QI and blood and formed.Positive QI-insufficiency, evil poison is kept, stagnation of QI-blood, venation block, thus the long-pending piece of flank, pain in fixed position; On depression of liver-QI, wood were not dredged, transporting and transforming function of the spleen and stomach was not normal, so see poor appetite, abdominal distention; With the passing of time QI and blood biochemistry lacks the source, and then fatigue and weakness is become thin gradually; The liver failing to maintain the normal flow of QI, bile is obstructed, and does not follow Chang Dao, excessive flesh table, visible again jaundice.How sallow complexion is or dark, and the body of the tongue stasis of blood is dim, and the pulse condition stringy and thready pulse is the card of vital QI being weakened and pathogen being violent.According to the basic pathogenesis of the vital QI being weakened and pathogen being violent of weakened body resistance stasis of blood knot syndrome, strengthening vital QI to eliminate pathogenic factors is to be its Therapeutic Principle.Because of its deficiency of vital QI, stagnation of QI-blood, the pathogenic characteristic that stasis of blood poison pents up, QI invigorating consolidates, and note of the ancient Chinese eliminating stagnation that disappears, detoxifcation pain relieving are its method of treatment.In above system side, Radix Ginseng sweet and slightly bitter taste, property are put down, and strongly invigorating primordial QI is monarch, Radix Ginseng be middle medication empty eliminating evil first of, " herbal classic " calls its " tonifying five ZANG-organs, peace spirit is decided soul; spasmolytic is throbbed with fear; remove pathogen ", and Compendium of Material Medica is said: " controlling all deficiency syndrome of male woman ", " Bencao Jingshu " are stated " Radix Ginseng energy recuperating depleted YANG gas is exhausted in hanging down; but exogenous pathogen inclines in Russia ", so we are monarch with it; Radix Astragali QI invigorating is set upright and is minister, and " not Lu " claims its " it is deficient to mend the husband, the five kinds of over strain weakness and emaciation ", and " Records of Tradition Chinese and Western Medicine in Combination " says the Radix Astragali " for the merit optimum of QI invigorating ", the sweet temperature of the Radix Astragali, with the ginseng compatibility, then the QI invigorating and body resistance strengthening merit increases, these the monarch and his subjects are imitated altogether, and the prosperous essence and blood of the gas of waiting is given birth to, and then is expected just holding up Ben Pei.Really be so incensed that to fill, then the strong blood of gas is capable, can " hike and grind thing ", as " Bencao Jingshu " so-called " why pathogen is stayed for a long time and is not gone the person, does not have him, and the true deficiency of vital energy then can not be opposed, so linger on puzzled also.Now must mend and very first enriching, then heresy can not be from holding ... the person of promoting blood circulation, blood not voluntarily, gas is strong then goes, so promoting blood circulation, broken hard long-pending person, very QI-insufficiency then can not hike and grinds thing "; The hot temperature of Venenum Bufonis is poisonous, the removing toxic substances and promoting subsidence of swelling pain relieving, Mylabris is hot very toxic, counteracting toxic substances removing blood stasis eliminating stagnation, " book on Chinese herbal medicine converge with speech " record Venenum Bufonis " can be dissolved the malicious all diseases of the strongly fragrant heap soil or fertilizer over and around the roots of all stasis of bloods ", and Li Shicai calls Mylabris " attacking accumulation of blood, dredging water passages; control mass in the abdomen ... " and helps this two is distinguished the flavor of with eliminating evil in " this sketch Jies ", and then full side's strengthening vital QI to eliminate pathogenic factors merit is complete.The prescription strengthening the body resistance is not lost heresy, and detoxifcation disappears and just do not forget.Venenum Bufonis in the side, the hot temperature of Mylabris are poisonous, being used for we also has the meaning of " treating the poisonous disease with poisonous drugs ", right its toxicity is not dared to despise slightly, this two flavor and Radix Ginseng, the Radix Astragali are associated with, its toxicity is inhibited, and when preparation, control its dosage and PROCESS FOR TREATMENT and keep away as possible and press down its toxicity, so serve as that we help and make with this two flavor by strictness.The full presciption medicine of medicine of the present invention flavor is few, and monarch matches proper, tightly keeps pathogenesis, abides by method and 5, and prescription is rigorous, can play strengthening vital QI to eliminate pathogenic factors altogether, the usefulness of note of the ancient Chinese eliminating stagnation that disappears, and is applicable to the long-pending card of the stasis of blood of becoming main syndrome with the weakened body resistance stasis of blood especially.
Observation of curative effect (is example with the injection)
1, diagnostic criteria
1.1 tcm diagnosis, syndrome standard:
Primary hepatocarcinoma belongs to the category of the traditional Chinese medical science " note of the ancient Chinese long-pending ", according to " new drug (Chinese medicine) treatment primary hepatocarcinoma clinical guidance principle " differentiation of symptoms and signs for classification of syndrome standard, and in conjunction with the attending effectiveness of this medicine, cures mainly disease long-pending (primary hepatocarcinoma) and the accompanied symptoms thereof of qi deficiency and Stagnation type.
Qi deficiency and Stagnation card: spiritlessness and weakness, deficiency of QI with disinclination to talk, few fragrant, the uncomfortable in chest hypochondriac pain of Na Gu, abdominal distention, abdominal mass, pale tongue be fat an indentation, dark or purpura, deficient and weak pulse or string arranged.
Double yin deficiency syndrome;
Double syndrome of deficiency of blood;
Double damp syndrome.
1.2 Western medicine diagnose standard
The standard of being formulated according to " Chinese common cancer diagnosis and treatment standard " is a foundation.
1.2.1 pathological diagnosis
The inspection of liver inner disease foci turns out to be primary hepatocarcinoma.
The outer metastasis inspection of liver turns out to be hepatocellular carcinoma.
1.2.2 cytodiagnosis
A) typical symptoms and hepatocarcinoma iconography are arranged;
B) find hepatoma carcinoma cell in the ascites;
Have above two, meet cytodiagnosis.
1.2.3 clinical diagnosis
A) the AFP convection current is with the stream method positive or radioimmunology 〉=400ng/ml and more than lasting January or AFP 〉=200ng/ml and more than lasting February, and can get rid of pregnant, activeness hepatopathy, gonad embryo source property tumor and secondary liver cancer person;
B) imaging examination has substantive space occupying lesion in the liver;
Possess above two persons and meet clinical diagnosis.
2, include standard in:
2.1.1 all test cases must meet above-mentioned diagnosis or dialectical standard.
2.1.2 estimate to surpass February life cycle.
2.1.3KarnofskyShi scoring is more than 40 minutes.
2.1.4 the age: from 〉=18 years old to≤75 years old.
3, test method
3.1 grouping situation
458 routine Patients with Primary are divided into treatment group and matched group at random, and wherein 315 examples are organized in treatment, chemotherapy matched group 143 examples.Two groups of patients there was no significant difference between aspect groups such as sex, age, life quality, cancer size, cancer number, portal vein tumor thrombus, clinical stages, alpha-fetoprotein level, immune indexes, TCM Syndrome Type and accompanied symptoms situation has comparability.
3.2 administrated method
3.2.1 treatment group
Medicaments injection 40～60cc of the present invention
Quiet of 5%GS 500cc, 30～60 of per minutes, every day 1 time, * 45d.3.2.2 matched group (FAM)
Quiet the 1st of 5-FU 300mg/m2,2,4,5 weeks
Quiet the 1st, 4 week of notes of ADM 20-30mg/m2
Quiet the 1st, 2,4,5 weeks of notes of MMC 3-4mg/m2
Per 1 all medications once, 3 weeks were 1 cycle, totally two cycles.
3.3 observation item
3.3.1 clinical symptoms:
General disease, digestive system disease, cardiovascular system disease, urinary tract disease, nervous system disease.
3.3.2 life cycle
3.3.3 life quality
3.3.4 lab testing
3.3.5 electrocardiogram
3.3.6 primary tumor imaging examination
3.3.7 other position imaging examination
4, efficacy assessment standard:
4.1 tumor size
4.1.1 alleviate fully (CR): visible tumor disappears and continues more than one month.
4.1.2 part is alleviated (PR): the orthogonal diameter product of two maximums of tumor dwindles more than 50%, and continues more than one month.
4.1.3 stable (SD): the orthogonal diameter tax category of two maximums of tumor are dwindled less than 50%, increase to be no more than 25%, and continue more than one month.
4.1.4 worsen (PD): the swollen orthogonal diameter product that stays two maximums increases and surpasses 25% or new pathological changes occurs.
Total remission rate CR+PR
4.2 clinical therapeutic effect of syndrome standard
4.2.1 single index evaluation criteria
Produce effects: two differential persons relatively descend before this case treatment back and the treatment.
Effectively: a differential person relatively descends before this case treatment back and the treatment.
Invalid: as not reach above-mentioned standard person.
4.2.2 Comprehensive Assessment standard:
II phase produce effects: have in this patient's individual event symptom to reach the responder more than 2/3.
Effectively: have in this patient's individual event symptom to reach the responder more than 1/2.
Invalid: as not reach above-mentioned standard person.
III phase produce effects: have in this patient's individual event symptom to reach the responder more than 1/2.
Effectively: have in this patient's individual event symptom to reach the responder more than 1/3.
Invalid: as not reach above-mentioned standard person.
Total effective rate=produce effects+effectively
4.3 life quality evaluation criteria
Before pressing Karnofsky scoring treatment, the treatment back relatively:
Produce effects: the treatment back is than 20 fens persons of the preceding increase of treatment.
Effectively: the treatment back is than 10 fens persons of the preceding increase of treatment.
Invalid: as not reach above-mentioned standard person.
Total effective rate=produce effects+effectively
4.4 life cycle (control back life cycle) evaluation criteria
From treatment beginning till death or last are followed up a case by regular visits to.
Result of the test: injection provided by the invention and chemotherapy group tcm syndrome improvement rate are respectively 75.2% and 46.2%; The tumor section remission rate is 9.2% and 11.9%; AFP drops to 47.9% and 37.1%; Median survival interval is 7.0 months and 4.0 months, and what wherein existence surpassed December is 7% and 3.5%; Karnofsky quality of life score rise be respectively 67.6% and 36.4%; Immune indexes treatment back CD4/CD8 is respectively 1.63 and 1.39.Compare with chemotherapy, the untoward reaction of preparation of the present invention is lower, bone marrow depression that no chemotherapy is common and digestive tract reaction, and only a few patient has the urinary tract irritation.
In addition, need select different adjuvants for use for the preparation of various dosage forms, we have also made experimental selection:
Oral liquid adjuvant selection result:
| The investigation project | Adjuvant | ||
| Blank | Starch | Dextrin | |
| Granulate | Difficult | Easily | Difficult |
| Disintegration | 56 | 15 | 23 |
| Mobility of particle (°) | 49 | 37 | 43 |
| Granule CRH (%) | 31 | 53 | 41 |
Capsule adjuvant selection result:
| The investigation project | Adjuvant | |||
| Cyclamate (g) | Fructus Citri tangerinae essence (ml | Potassium sorbate (g) | The result | |
| Mouthfeel | 10 | 5 | 1.5 | + |
| 15 | 10 | 2 | +++ | |
| 20 | 15 | 2.5 | + | |
| Abnormal smells from the patient | 10 | 5 | 1.5 | ++ |
| 15 | 10 | 2 | +++ | |
| 20 | 15 | 2.5 | + | |
| Anticorrosion | 10 | 5 | 1.5 | + |
| 15 | 10 | 2 | ++ | |
| 20 | 15 | 2.5 | + | |
Mannitol be raising agent be again cosolvent, so normal the use separately selects for use mannitol as loose cosolvent.
The stability of lyophilized injectable powder in diluent
Study on the stability is the result show: the above-mentioned two kinds of injection dilution of injectable powder was placed 24 hours, and its appearance character, pH value and content have no significant change, and showed to use above-mentioned two kinds of injection dilution posterior vein to instil.
Concrete outcome sees the following form:
Lyophilized injectable powder is the study on the stability result in two kinds of transfusions
| The investigation time | The investigation project | Diluent title (being diluted to 500ml) | |
| 5% glucose injection | 0.9% sodium chloride injection | ||
| 0 hour | Appearance character pH value total saponin content (mg/ bottle) total polysaccharides content (mg/ bottle) bufogenin and cinobufagin total content (mg/ bottle) | Light yellow clear liquid 7.15 11.1 41.3 0.13 | Light yellow clear liquid 7.34 11.0 41.2 0.13 |
| 4 hours | Appearance character pH value total saponin content (mg/ bottle) total polysaccharides content (mg/ bottle) bufogenin and cinobufagin total content (mg/ bottle) | Light yellow clear liquid 7.15 11.1 41.3 0.13 | Light yellow clear liquid 7.34 11.0 41.2 0.13 |
| 8 hours | Appearance character pH value total saponin content (mg/ bottle) total polysaccharides content (mg/ bottle) bufogenin and cinobufagin total content (mg/ bottle) | Light yellow clear liquid 7.15 11.1 41.3 0.13 | Light yellow clear liquid 7.34 11.0 41.2 0.13 |
| 12 hours | Appearance character pH value total saponin content (mg/ bottle) total polysaccharides content (mg/ bottle) bufogenin and cinobufagin total content (mg/ bottle) | Light yellow clear liquid 7.15 11.1 41.3 0.13 | Light yellow clear liquid 7.34 11.0 41.2 0.13 |
| 24 hours | Appearance character pH value total saponin content (mg/ bottle) total polysaccharides content (mg/ bottle) bufogenin and cinobufagin total content (mg/ bottle) | Light yellow clear liquid 7.15 11.1 41.3 0.13 | Light yellow clear liquid 7.34 11.0 41.2 0.13 |
The specific embodiment:
Embodiments of the invention 1: with Radix Ginseng Rubra 500g section with 8 times of amount 75% alcohol reflux 3 times, merge extractive liquid,, filtration, filtrate recycling ethanol, the clear paste that is condensed into relative density and is 1.0-1.2 is standby; Medicinal residues decoct 3 times with 8 times of water gagings, merge decoction liquor, filter, and filtrate is condensed into the clear paste of 1.10-1.25, adds ethanol and reaches 75%, leave standstill, and the leaching precipitation, cold drying is standby.Radix Astragali 2000g section decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back ethanol precipitation, and filtrate recycling ethanol also is condensed into every 1ml to be equivalent to the clear paste of medical material 5-8g standby; The precipitation vacuum drying of leaching is standby.Give birth to Venenum Bufonis 2.5g and become fine powder to spend the night, refluxed then 4 hours, filter with 25 times of soak with ethanol, standby behind the filtrate recycling ethanol; Living Mylabris 10g becomes fine powder to soak with hydrochloric acid-acetone solution, reclaims acetone, debris alcohol-ether liquid washing, the leaching precipitation, the dry Mylabris extract that gets adds above-mentioned clear paste, medicinal residues extract and 45g cyclamate, 30ml flavoring orange essence, 6g potassium sorbate, stirring and dissolving adds water to 5000ml, regulate pH value to 5.5-7.0, filter fill, sterilized 30 minutes for 105 ℃, promptly.10ml/ props up, and is oral, 2～3 times on the one, one time 1.
Embodiments of the invention 2: Radix Ginseng Rubra 1500g section is measured 75% alcohol reflux 3 times with 8 times, and merge extractive liquid, filters, and filtrate recycling ethanol is condensed into the clear paste that relative density is 1.0-1.2, and spray drying is standby; Medicinal residues decoct 3 times with 8 times of water gagings, merge decoction liquor, filter, and filtrate is condensed into the clear paste of 1.10-1.25, adds ethanol and reaches 75%, leave standstill, and the leaching precipitation, drying, it is standby to be ground into fine powder.Radix Astragali 4000g section decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back and uses ethanol precipitation, and filtrate recycling ethanol also is concentrated to the clear paste that every 1ml is equivalent to medical material 5-8g, and spray drying is standby; The precipitation vacuum drying of leaching is ground into fine powder, and is standby.Give birth to Venenum Bufonis 5.5g and become fine powder to spend the night, refluxed then 4 hours, filter with 25 times of soak with ethanol, filtrate recycling ethanol, drying under reduced pressure is ground into fine powder.Living Mylabris 30g becomes fine powder with hydrochloric acid-acetone solution immersion, reclaims acetone, debris alcohol-ether liquid washing, leaching precipitation, the dry Mylabris extract that gets, add above-mentioned fine powder and 420g starch, mixing, 65% alcohol granulation is crossed 30 mesh sieves, 60 ℃ of dryings, granulate, fill, promptly.Oral, 2～3 times on the one, one time 5.
Embodiments of the invention 3: give birth to Venenum Bufonis 4g and become fine powder to measure soak with ethanol with 25 times, reflux, extract, 4 hours filters, and is standby behind the filtrate recycling ethanol; Living Mylabris 20g becomes fine powder to soak with adding 5 times of amount hydrochloric acid-acetone solutions, reclaims acetone, and debris is measured the washing of alcohol-ether liquid with 10 times, the leaching precipitation, and 60 ℃ are dry down that Mylabris extract is standby; Radix Ginseng Rubra 1000g section is measured 75% alcohol reflux 3 times, each 1.5 hours with 8 times, merge extractive liquid, filters filtrate recycling ethanol, be concentrated into about relative density 1.0-1.2, extracted with diethyl ether 3 times is flung to ether, filter, the equal-volume sec-butyl alcohol that filtrate water is saturated extracts 4 times, reclaims sec-butyl alcohol, add ethanol to 45% after being concentrated into relative density 1.0～1.15 (50 ℃), cold preservation is spent the night, and filters, filtrate is condensed into the clear paste that every 1ml is equivalent to medical material 4-5g approximately, and it is standby to get red ginseng saponin extract; Medicinal residues behind the ethanol extraction decoct 3 times with 8 times of water gagings, merge decoction liquor, filter, filtrate is concentrated into relative density 1.10～1.25 (60 ℃), adds ethanol to 75%, the leaching precipitation, the dry Radix Ginseng Rubra crude polysaccharides that gets adds the water boil dissolving, supernatant concentration, the polyamide chromatography, the water eluting adds ethanol after eluent concentrates and leaves standstill, the leaching precipitation, vacuum drying gets the Radix Ginseng Rubra crude polysaccharides; Add water boil dissolving, supernatant concentration (60 ℃) to the relative density 1.10-1.20, polyamide chromatography, water eluting, eluent are concentrated into (60 ℃) about relative density 1.20-1.30, after add ethanol and reach 80%, the leaching precipitation, vacuum drying gets the Radix Ginseng Rubra polysaccharide; Radix Astragali 3000g section decocts with water 3 times, merges decoction liquor, filter, filtrate is concentrated into every 1ml and is equivalent to medical material 1.5-2g, with ethanol precipitation (75%), supernatant precipitates 1 time with method, filters merging filtrate, reclaim ethanol and be concentrated into every 1ml and be equivalent to medical material 8-10g, add ethanol and reach 80%, filter, filtrate recycling ethanol also is concentrated into 180-200ml, with water saturated sec-butyl alcohol extraction 4 times, reclaims sec-butyl alcohol, be concentrated into 200ml, filter clear and bright that first glycosides intermediate is standby; 70 ~ 80 ℃ of vacuum dryings of the precipitation of leaching, pulverize the back and boil dissolving with distilled water, supernatant concentration becomes the thick paste of 1.10-1.20 (60 ℃), polyamide chromatography, water eluting, eluent filters, filtrate is concentrated into 1.20-1.30 (60 ℃), adds ethanol and reaches 70-80%, the leaching precipitation, vacuum drying, it is standby to get astragalus polysaccharides.Get red ginseng saponin extracting solution and Radix Astragali saponin extracting solution, thin up is regulated about pH7.0, and activated carbon adsorption 10 minutes is filtered clear and bright standby; Get Radix Ginseng Rubra polysaccharide and astragalus polysaccharides, add water boil dissolving, filter clear and bright, boil dissolving with mannitol after, activated carbon adsorption 15 minutes is filtered clear and bright standby; Get Mylabris extract, add water, caustic lye of soda is regulated about pH9.0, add the Venenum Bufonis extract stirring and dissolving, filter, filtrate and above-mentioned Radix Ginseng Rubra and Radix Astragali saponin extract filtrate mixing add to this mixed liquor in above-mentioned polysaccharide and the mannitol mixture again, add the injection water to 3000ml, regulate about pH7.5, fine straining is clear and bright, and is aseptic subpackaged, lyophilization is sealed promptly.Intravenous drip, the adult is metered among 5% glucose injection or the 0.9% sodium chloride injection 500ml by 15mg/kg.
Claims (8)
1, a kind of Chinese patent medicine that is used for the treatment of hepatocarcinoma is characterized in that: calculate according to components by weight percent: it mainly is prepared from by Radix Ginseng Rubra 500-1500 part, Radix Astragali 2000-4000 part, Bufo siccus 2.5-5.5 part, Mylabris 10-30 part.
2, according to the described Chinese patent medicine that is used for the treatment of hepatocarcinoma of claim 1, it is characterized in that: calculate according to components by weight percent: it is prepared from by 1000 parts of Radix Ginseng Rubra, 3000 parts of the Radixs Astragali, 4 parts of Bufo siccuss, 20 parts of Mylabris and suitable adjuvant.
3, according to claim 1 or the 2 described Chinese patent medicines that are used for the treatment of hepatocarcinoma, it is characterized in that: the preparation that described Chinese patent medicine is prepared into comprises: granule, hard capsule, soft capsule, tablet, drop pill, oral liquid, injection: comprise little pin, transfusion, freeze-dried powder, slow releasing preparation, controlled release preparation.
4, according to the described Chinese patent medicine that is used for the treatment of hepatocarcinoma of claim 3, it is characterized in that: the preparation that described Chinese patent medicine is prepared into is: oral liquid formulations, capsule, freeze-dried powder.
5, according to the described preparation method that is used for the treatment of the Chinese patent medicine of hepatocarcinoma of any claim among the claim 1-4, it is characterized in that: with Radix Ginseng Rubra, the Radix Astragali, Bufo siccus, Mylabris extract respectively refining after, add suitable adjuvant again and be prepared into different preparations.
6, according to the described preparation method that is used for the treatment of the Chinese medicine preparation of hepatocarcinoma of claim 5, it is characterized in that: with alcohol reflux 3 times, merge extractive liquid, filters with Radix Ginseng Rubra section, filtrate recycling ethanol, and it is standby to be condensed into clear paste 1; The medicinal residues water decocts, and filters, and filtrate is condensed into clear paste, and add ethanol and leave standstill, the leaching precipitation, cold drying, it is standby to get dry powder 1; Radix Astragali section decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back ethanol precipitation, filtrate recycling ethanol and to be condensed into clear paste 2 standby; The precipitation vacuum drying of leaching, it is standby to get dry powder 2; Give birth to the Venenum Bufonis fine powder and spend the night with 25 times of soak with ethanol, refluxed then 4 hours, filter, it is standby to get clear paste 3 behind the filtrate recycling ethanol; Living Mylabris fine powder soaks with hydrochloric acid-acetone solution, reclaims acetone, and debris is washed with alcohol-ether liquid, the leaching precipitation, the dry Mylabris extract that gets adds above-mentioned 3 kinds of clear paste, 2 kinds of dry powder and cyclamate, flavoring orange essence, potassium sorbate, stirring and dissolving adds water, regulates pH value, filter, fill, sterilization promptly gets oral liquid formulations.
7, according to the described preparation method that is used for the treatment of the Chinese patent medicine of hepatocarcinoma of claim 5, it is characterized in that: with Radix Ginseng Rubra section alcohol reflux 3 times, merge extractive liquid, filters, and filtrate recycling ethanol is condensed into clear paste, spray drying, and it is standby to get fine powder 1; The medicinal residues water decocts, and filters, and filtrate is condensed into clear paste, and add ethanol and leave standstill, the leaching precipitation, cold drying is ground into fine powder, and it is standby to get fine powder 2; The Radix Astragali is cut into slices, and decocts with water 3 times, merges decoction liquor, filters, and filtrate concentrates the back and uses ethanol precipitation, and filtrate recycling ethanol also is condensed into clear paste, spray drying, and it is standby to get fine powder 3; The precipitation vacuum drying of leaching is ground into fine powder, and it is standby to get fine powder 4; Give birth to the Venenum Bufonis fine powder and spend the night, refluxed then 4 hours, filter with 25 times of soak with ethanol, filtrate recycling ethanol, drying under reduced pressure is ground into fine powder, gets fine powder 5, and is standby; Living Mylabris fine powder reclaims acetone with hydrochloric acid-acetone solution immersion, and debris is washed with alcohol-ether liquid, the leaching precipitation, and the dry Mylabris extract that gets adds above-mentioned 5 kinds of fine powders and starch, mixing, alcohol granulation sieves, drying, granulate, fill promptly gets capsule.
8, according to the described preparation method that is used for the treatment of the Chinese patent medicine of hepatocarcinoma of claim 5, it is characterized in that: give birth to the Venenum Bufonis fine powder and spend the night, refluxed then 4 hours, filter with 25 times of amount soak with ethanol, standby behind the filtrate recycling ethanol; Living Mylabris fine powder soaks with hydrochloric acid-acetone solution, reclaims acetone, and debris is washed with alcohol-ether liquid, and the leaching precipitation is dry that Mylabris extract is standby; The Radix Ginseng Rubra section is used alcohol reflux 3 times, merge extractive liquid,, filter, filtrate recycling ethanol concentrates the back extracted with diethyl ether, fling to ether, filter, sec-butyl alcohol is reclaimed in the sec-butyl alcohol extraction that filtrate water is saturated, adding ethanol cold preservation after concentrating spends the night, filter, filtrate is condensed into clear paste, and it is standby to get red ginseng saponin extract; Medicinal residues water behind the ethanol extraction decocts, and filters, and adds ethanol after filtrate concentrates and leaves standstill, leaching precipitation, the dry Radix Ginseng Rubra crude polysaccharides that gets, add the water boil dissolving, supernatant concentration, polyamide chromatography, water eluting, add ethanol after eluent concentrates and leave standstill, the leaching precipitation, vacuum drying gets the Radix Ginseng Rubra polysaccharide; Radix Astragali section, decoct with water 3 times, merge decoction liquor, filter, filtrate concentrates the back ethanol precipitation, filtrate recycling ethanol adds ethanol after also concentrating, and cold preservation is spent the night, and filters, filtrate recycling ethanol, sec-butyl alcohol is reclaimed with water saturated sec-butyl alcohol extraction in concentrated back, concentrates the clear and bright Radix Astragali saponin extracting solution that gets of after-filtration; The precipitation vacuum drying of leaching, dissolving is boiled with distilled water in the pulverizing back, and supernatant concentration becomes thick paste, the polyamide chromatography, the water eluting, eluent filters, and add ethanol after filtrate concentrates and leave standstill, the leaching precipitation, vacuum drying, it is standby to get astragalus polysaccharides; Get red ginseng saponin extracting solution and Radix Astragali saponin extracting solution, thin up is regulated pH, and activated carbon adsorption is filtered clear and bright standby; Get Radix Ginseng Rubra polysaccharide and astragalus polysaccharides, add water boil dissolving, filter clear and bright, boil dissolving with mannitol after, activated carbon adsorption is filtered clear and bright standby; Get Mylabris extract, add water, caustic lye of soda is regulated pH, add the Venenum Bufonis extract stirring and dissolving, filter filtrate and above-mentioned Radix Ginseng Rubra and Radix Astragali saponin extract filtrate mixing, again this mixed liquor is added in above-mentioned polysaccharide and the mannitol mixture, add to the full amount of water for injection, regulate pH, fine straining is clear and bright, aseptic subpackaged, lyophilization is sealed, and promptly gets freeze-dried powder.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100371101A CN1239170C (en) | 2003-08-06 | 2004-06-01 | Chinese patent drug for treating liver cancer |
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN03134468 | 2003-08-06 | ||
| CN03134468.2 | 2003-08-06 | ||
| CNB2004100371101A CN1239170C (en) | 2003-08-06 | 2004-06-01 | Chinese patent drug for treating liver cancer |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1552434A CN1552434A (en) | 2004-12-08 |
| CN1239170C true CN1239170C (en) | 2006-02-01 |
Family
ID=34378725
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100371101A Active CN1239170C (en) | 2003-08-06 | 2004-06-01 | Chinese patent drug for treating liver cancer |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1239170C (en) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100457119C (en) * | 2006-03-30 | 2009-02-04 | 汤玉生 | Freeze dried ginseng polysaccharide powder for injection and its preparing process |
| CN102302542A (en) * | 2011-09-19 | 2012-01-04 | 谢媛媛 | Chinese medicinal oral liquid for treating cancers |
| CN106389739A (en) * | 2016-06-21 | 2017-02-15 | 向国强 | Traditional Chinese medicinal composition for treating cancer pain and preparation method |
-
2004
- 2004-06-01 CN CNB2004100371101A patent/CN1239170C/en active Active
Also Published As
| Publication number | Publication date |
|---|---|
| CN1552434A (en) | 2004-12-08 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN100337662C (en) | Medicinal composition for treating hyperlipemia and its preparing method | |
| CN101032560A (en) | Chinese medicine composition for treating somnipathy and preparing method thereof | |
| CN1565552A (en) | Chinese traditional medicine for treating immune hypofunction and disfunction | |
| CN1698878A (en) | Kidney replenishing medicinal composition and its preparation process and novel use | |
| CN1917895A (en) | Extracts of houttuynia cordata and rubus coreanus and their composition for preventing and treating allergic diseases | |
| CN1191082C (en) | Chinese medicinal composition for treating fatty liver and its preparation method | |
| CN1203872C (en) | Medicine for curing chronic colitis | |
| CN1245189C (en) | Composition for strengthening body resistance and restoring and function, strengthening spleen and kidney, relieving metal stress and promoting blood circulation to remove blood stasis | |
| CN1239170C (en) | Chinese patent drug for treating liver cancer | |
| CN1232267C (en) | Compound plant medicine and its application | |
| CN108567914B (en) | Traditional Chinese medicine preparation with sleep improving effect and preparation method and application thereof | |
| CN1745788A (en) | Chinese preparation for treating infantile diarrhea and its making method thereof | |
| CN1833695A (en) | Tonifying speen and tonifying kidney granular and its prepn. method | |
| CN1297290C (en) | Medicinal composition for treating coronary heart disease and stenocardia and its preparation method | |
| CN1559495A (en) | Deer's fetus granular Chinese madicinal preparation and its production technology | |
| CN100344304C (en) | Chinese medicinal preparation for treating consumptive disease and its making method thereof | |
| CN1256143C (en) | Chinese medicinal composite preparation against virus | |
| CN1184229C (en) | Furost saponine analogue and its separation process and use | |
| CN1211111C (en) | Antilipemic Chinese medicine | |
| CN101062374A (en) | Method for preparing Chinese traditional combination capsule for treating cancer and the product thereof | |
| CN1990022A (en) | Traditional Chinese medicine composition, its preparation and quality controlling means | |
| CN101062314A (en) | Medicine for curing gout and its preparing method | |
| CN101053626A (en) | Traditional Chinese medicine for treating coronary heart disease and angina pectoris and its preparation method | |
| CN1562114A (en) | Medicine for treating chronic prostatitis and its preparing method | |
| CN101181342A (en) | Pharmaceutical combination with resisting liver cancer activity |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| ASS | Succession or assignment of patent right |
Owner name: BEIJING ZHENGBANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: BUCHANG MEDICAL SCIENCE + TECHNOLOGY DEVELOPING CO., LTD., XIANYANG CITY Effective date: 20100108 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20100108 Address after: Beijing City, Haidian District Street No. 28 building four layer, five layer Zhiyuan Patentee after: Beijing Zhengbang Pharmaceutical Co. Ltd. Address before: Shaanxi city of Xi'an province high tech high road No. 50 Nanyang International Building, 20 floor Patentee before: Buchang Medical & Drug Science & Tech. Development Co., Ltd., Xianyang |
|
| ASS | Succession or assignment of patent right |
Owner name: SHANDONG ZHENGBANG PHARMACEUTICAL CO., LTD. Free format text: FORMER OWNER: BEIJING ZHENGBANG PHARMACEUTICAL CO., LTD. Effective date: 20110809 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 100085 HAIDIAN, BEIJING TO: HEZE, SHANDONG PROVINCE |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20110809 Address after: No. 1566 Zhonghua Road, Heze, Shandong province (Mudan Industrial Park) Patentee after: Shandong Zhengbang Pharmaceutical Co. Ltd. Address before: 100085 Beijing city Haidian District on the Street No. 28 building four layer, five layer Zhiyuan Patentee before: Beijing Zhengbang Pharmaceutical Co. Ltd. |
|
| C56 | Change in the name or address of the patentee |
Owner name: SHANDONG KANGAI PHARMACEUTICAL CO., LTD. Free format text: FORMER NAME: SHANDONG ZHENGBANG PHARMACEUTICAL CO., LTD. |
|
| CP01 | Change in the name or title of a patent holder |
Address after: 274000 No. 1566 Zhonghua Road, Heze City, Shandong province (Mudan Industrial Park) Patentee after: Shandong Kang'ai Pharmaceutical Co. Ltd. Address before: 274000 No. 1566 Zhonghua Road, Heze City, Shandong province (Mudan Industrial Park) Patentee before: Shandong Zhengbang Pharmaceutical Co. Ltd. |