CN102671078B - Medicine composition for curing myelofibrosis and hepatofibrosis and preparation method of medicine composition - Google Patents
Medicine composition for curing myelofibrosis and hepatofibrosis and preparation method of medicine composition Download PDFInfo
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Abstract
The invention discloses a medicine composition for curing myelofibrosis and hepatofibrosis and a preparation method of the medicine composition. The main raw materials of the medicine composition include, by weight, 200-300 of vinegar turtles, 300-400 of fried peach seeds, 50-150 of cooked rhubarb, 100-200 of common burreed rhizome, 300-400 of leeches, 100-200 of rehmannia roots, 10-110 of human placenta, 10-110 of panax notoginseng and 50-150 of liquorice. The preparation method comprises steps of weighing the raw materials in accordance with the above prescription, uniformly mixing the raw materials through smashing and water-extraction concentration or a combination method of the smashing and the water-extraction concentration and obtaining the medicine composition. The medicine composition can soften hard lumps and dispel nodes, removes blood stasis for promoting tissue regeneration and nourishes blood and can be used for curing syndromes such as accumulation lumps under the rib side, sallowness, weakness, palpitation, shortness of breath, primary myelofibrosis, liver cirrhosis, hepatosplenomegaly and anemia which are caused by blood stasis and non-generation of new blood.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, especially a kind of pharmaceutical preparation that is used for hard masses softening and resolving, promoting tissue regeneration by removing blood stasis, blood-nourishing blood-generating of making take vegetable Chinese herbal medicine as raw material and preparation method thereof.
Background technology
Myelofibrosis claims again myelosclerosis, shows as hepatosplenomegaly, and anemia belongs to traditional Chinese medical science “ ‘ mass in the abdomen " category, procatarxis depression of liver-QI, qi depression to blood stasis, stagnation of blood stasis; Or because of pyretic toxicity invasion, damage Liver Channel, blood stored in the liver, pyretic toxicity and the blood knot of fighting, long-pending and be shaped and see the lower long-pending piece (hepatosplenomegaly) of the side of body, blood stasis is not dispelled, and fresh blood is not given birth to, and shows and meet the virtual loss such as yellow, weak.Hepatic fibrosis is the important pathological characters of chronic hepatopathy, also is the only stage which must be passed by that liver cirrhosis occurs.Primary disease belongs to the categories such as Chinese medicine " hypochondriac pain ", " abdominal mass ", " gathering "." Ling Shu Miraculous Pivot or Divine Axis five pathogenic factors " piece of writing is said: " evil in liver, then pain in two sides of body "." Zhengzi Huibu hypochondriac pain " proposes its cause of disease: " hinder because of rage and to touch, grieved depressed, surfeit, air-cooled outer invading fallen and pounced on the impairment of the configuration ... or accumulation of phlegm multiple abscess, or blood stasis fights mutually, all can be pain ".So stagnation in liver meridian is Fibrotic main pathogenesis.Hepatic fibrosis refers to hepatic tissue inner cell epimatrix composition hyperplasia and abnormal deposition, causes liver structure or parafunctional pathological change, can show as in sinus hepaticus blood capillary, the lobules of liver on the structure and the portal area hepatic fibrosis; The performances such as hypofunction of liver, portal hypertension can appear on the function.There is no at present special special effect medicine therapeutic for this disease, adopt antiviral more, regulate immunity, recover the Comprehensive Treatments such as liver function and fibrosis.
Summary of the invention
The technical problem to be solved in the present invention provides a kind of Fibrotic pharmaceutical composition of myelofibrosis regulating liver-QI and preparation method thereof for the treatment of, can hard masses softening and resolving, promoting tissue regeneration by removing blood stasis, blood-nourishing blood-generating, be used for that long-pending piece under stagnation of blood stasis, the fresh blood side of body due to not giving birth to, yellowish complexion are weak, cardiopalmus, breathe hard and PMF, liver cirrhosis disease are seen the patients such as hepatosplenomegaly, anemia.
For solving the problems of the technologies described above, the technical solution used in the present invention is as follows.
A kind of Fibrotic pharmaceutical composition of myelofibrosis regulating liver-QI for the treatment of, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 200～300; Semen Persicae (parched) 300～400; Radix Et Rhizoma Rhei 50～150; Rhizoma sparganic 100～200; Hirudo 300～400; Radix Rehmanniae 100～200; Placenta Hominis 10～110; Radix Notoginseng 10～110; Radix Glycyrrhizae 50～150.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 230～250; Semen Persicae (parched) 300～340; Radix Et Rhizoma Rhei 75～85; Rhizoma sparganic 110～130; Hirudo 300～340; Radix Rehmanniae 110～130; Placenta Hominis 35～45; Radix Notoginseng 22～26; Radix Glycyrrhizae 75～85.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 240; Semen Persicae (parched) 320; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 120; Hirudo 320; Radix Rehmanniae 120; Placenta Hominis 40; Radix Notoginseng 24; Radix Glycyrrhizae 80.
As a kind of optimal technical scheme of the present invention, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 230; Semen Persicae (parched) 340; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 130; Hirudo 340; Radix Rehmanniae 110; Placenta Hominis 45; Radix Notoginseng 25; Radix Glycyrrhizae 75.
The preparation method of the Fibrotic pharmaceutical composition of above-mentioned treatment myelofibrosis regulating liver-QI: take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, by pulverize, water extraction is concentrated or the mode of the two combination with each pharmacodynamic raw materials mixing, and get final product.
As a kind of optimal technical scheme of above-mentioned preparation method, its characterization step comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, wherein Carapax Trionycis (processed with vinegar), Radix Et Rhizoma Rhei, Hirudo, Placenta Hominis, Radix Notoginseng powder are broken into fine powder;
B, Semen Persicae (parched), rhizoma sparganic, Radix Rehmanniae, Radix Glycyrrhizae four flavors decoct with water, and decocting liquid filters, and filtrate is concentrated into the clear paste that relative density is 1.15g/ml～1.25g/ml;
C, steps A gained fine powder is joined in the clear paste of step B, mixing, drying is ground into fine powder, sieves, and get final product.
As a kind of optimal technical scheme of above-mentioned preparation method, every 100g step C gained powder adds water with refined honey 27g～33g and makes water-honeyed pill 1000g, and drying gets finished product.
As a kind of optimal technical scheme of above-mentioned preparation method, among the step B, Semen Persicae (parched), rhizoma sparganic, Radix Rehmanniae, Radix Glycyrrhizae four flavors decoct with water 2～4 times, decoct altogether 2 hours～4 hours, continue subsequent step behind the collecting decoction.
A kind of optimal technical scheme as above-mentioned preparation method takes by weighing each pharmacodynamic raw materials according to above-mentioned prescription, is ground into fine powder, sieves, and get final product.
As a kind of optimal technical scheme of above-mentioned preparation method, every 100g gained powder adds water with refined honey 27g～33g and makes water-honeyed pill 1000g, and drying gets finished product.
The beneficial effect that adopts technique scheme to produce is:
Function of the present invention cures mainly: hard masses softening and resolving, promoting tissue regeneration by removing blood stasis, blood-nourishing blood-generating are used for that long-pending piece under stagnation of blood stasis, the fresh blood side of body due to not giving birth to, yellowish complexion are weak, cardiopalmus, breathe hard and PMF, liver cirrhosis disease are seen the patients such as hepatosplenomegaly, anemia.
This prescription is used for the treatment of PMF clinically, and liver cirrhosis is obtained reliable curative effect.Reuse the Radix Et Rhizoma Rhei blood circulation promoting and blood stasis dispelling in the side, dispelling toxins and dredging collaterals, eliminating blood stasis to promote regeneration of blood, Carapax Trionycis energy hard masses softening and resolving, the abdominal mass mass in the abdomen there is soft contracting effect, can increases the Radix Et Rhizoma Rhei blood circulation invigorating efficacies with the Radix Et Rhizoma Rhei compatibility, rhizoma sparganic, Semen Persicae eliminating stagnation removing blood stasis, the Bulbus Fritillariae Cirrhosae dissipating phlegm and resolving masses, Eupolyphaga Seu Steleophaga blood-activating analgetic, removing mass collateral dredging are enriched blood and are invigorated blood circulation.All medicines share, and amount to the effect of blood circulation promoting and blood stasis dispelling, activating collaterals and eliminating stagnation, thereby reduce the hepatic fibrosis tissue, alleviate hepatosplenomegaly, improve liver function.Verify that through clinical practice this preparation has no adverse reaction, toxicity is less, and is safe and reliable.
Following test example further illustrates beneficial effect of the present invention.Wherein employed outturn sample of the present invention is the pill product of following embodiment 1 preparation.Usage and dosage of the present invention is during human trial: oral, and one time 1 bag (8g), 2～3 times on the one.
Test (1), acute toxicity test in mice.
Hebei Academy of Medical Science is studied the acute toxicity test in mice of this product, the result shows: 20 of Kunming Strains of Mouses, twice on the one gastric infusion of per os, dosage is 50 times that 45g crude drug/kg(is equivalent to quantity) time, one week of Continuous Observation, mice is not found any untoward reaction without death.According to " study of tcm new drug guide " (94～0198) chapter 2 the acute toxicity tests evaluation criterion, this product oral administration acute toxicity is for substantially nontoxic.
Test (2), the white mice test of pesticide effectiveness.
Herbal pharmacology teaching and research room of the college of traditional Chinese medicine of Hebei Medical University has carried out experimentation to the drug effect of this product, the result shows that this product (0.7g/kg, 1.4g/kg, 2.8g/kg) can obviously reduce the Liver Fibrosis Model rat blood serum ALT level of tetrachloro-methane induction, rising ALB content, improve liver function, obviously lower carbon tetrachloride and cause hydroxyproline content in the hepatic tissue; Pathologic finding proof this product treatment group hepatic fibrosis pathological changes alleviates.
Test example (3), rat chronic toxicity test.
Toxicity inspection center of Hebei Academy of Medical Science has carried out rat chronic toxicity test to this product.The result shows, the oral suspension administration, dosage is 27g, 13.5g, 6.75g crude drug/kg(is equivalent to 30 of quantity, 15,7.5 doubly), tested medicine shows 90 days long term tests of Wistar rat oral gavage administration, animal general status no abnormality seen, the hemoglobin of each administration group, red blood cell count(RBC), platelet count, the physiochemical indice such as numeration of leukocyte and classification, the amino invertase of aspartic acid, the amino invertase of alanine, alkali phosphatase, blood urea nitrogen, total protein, albumin, blood glucose, total bilirubin, creatinine, the blood biochemicals such as T-CHOL are learned index, with the more equal no significant difference of blank group.The main organs weight coefficient of each administration treated animal and matched group compare, except high dose group liver coefficient increases (P＜0.05), and other unknown significance differences.Pathological examination occurs the liver fat degeneration except two rats of high dose, and all the other are respectively organized internal organs and are showed no unusually.After the drug withdrawal 14 days, the hematological indices of each administration treated animal, blood biochemical are learned index, main organs weight coefficient and the more equal zero difference of matched group; Pathological examination is respectively organized also no abnormality seen of internal organs, pathological examination no abnormality seen.Illustrate that this product medication under this experiment condition is basic security.Prompting this product is used under prescribed dose may be safe and reliable.
Test example (4), clinical observation on the therapeutic effect.
For clinical efficacy and the safety of verifying medicine composite for curing hepatic fibrosis of the present invention, Shijiazhuang City, Hebei Province safety hospital, adopt the at random observational technique of contrast, carry out the clinical contrast observation with the positive control drug FUFANG BIEJIA RUANGAN PIAN, it is stagnation of blood stasis that tested case is the diagnostic criteria, the Chinese medical discrimination that meet viral hepatitis, caused by liver and kidney deficiency card person and the case of signing Informed Consent Form.Test finished since year November in January, 2007 to 2010, finished altogether clinical observation 120 examples, test group 60 examples wherein, matched group 60 examples.This group result of study shows that 2 post-evaluations course for the treatment of of two groups for the treatment of disease treatments curative effect always has rate, obvious effective rate treatment group and matched group relatively, and there was no significant difference illustrates short term effect, and two groups suitable; Treat 3 the course for the treatment of observation group's total effective rate 80.0%, be better than matched group 66.7%, statistical significance (P＜0.05) is arranged; Two groups of traditional Chinese medical science disease efficacy analysis: the apparent in view improvement (P＜0.05) before liver function, tcm syndrome and the treatment after two group of 3 course for the treatment of, and observation group's improvement degree obviously is better than matched group (P＜0.05); Changes of liver function relatively before and after two groups of treatments: liver functions all are improved before and after two groups of treatments, and pharmaceutical composition of the present invention observation group Hepatic function improvement is significantly better than the FUFANG BIEJIA RUANGAN PIAN matched group after the treatment.Two groups of untoward reaction Macro or mass analysis: all do not find untoward reaction for two groups, as: diarrhoea, heating, anaphylaxis etc.The aspects such as renal function, hemogram and electrocardiogram also without unusual performance, illustrate that this preparation is safe and reliable in clinical use.Conclusion: medicine composite for curing hepatic fibrosis of the present invention is effective, and untoward reaction is rare, and slight.The pharmaceutical composition long period of the present invention is used and has no side effect, the treatment compliance is good, and it is better that Applicative time is got over the Changzhi therapeutic effect, compare its advantage of appearing suddenly with FUFANG BIEJIA RUANGAN PIAN, the less medicine of hemocyte due to myelofibrosis and the hepatic fibrosis has not only been enriched in the research of pharmaceutical composition of the present invention, and has filled up the blank of myelofibrosis Chinese Traditional Medicines treatments.
The specific embodiment
Following examples describe the present invention in detail.Various raw material used in the present invention and items of equipment are conventional commercially available prod, all can buy directly by market to obtain.
The instructions of taking of pharmaceutical composition of the present invention is: oral, one time 1 bag, every packed 8g, 2～3 times on the one, three months is a course for the treatment of; Avoid pungent, raw and cold, greasy food.
Relate to the concepts such as " coarse powder ", " fine powder ", " fine powder " among the following embodiment, its concrete meaning is as follows:
1. powder grades:
Coarse powder refers to and can all by a sieve, can be no more than 20% powder by No. three sieves but be mixed with;
Coarse powder refers to and can all by No. two sieves, can be no more than 40% powder by No. four sieves but be mixed with;
Middle powder refers to and can all by No. four sieves, can be no more than 60% powder by No. five sieves but be mixed with;
Fine powder refers to and can all sieve by No. five, and contains and can be no less than 95% powder by No. six sieves;
Fine powder refers to can be all by No. six sieves, and contain and can be no less than 95% powder by No. seven sieves;
Impalpable powder refers to and can all sieve by No. eight, and contains and can be no less than 95% powder by No. nine sieves;
2. medicine screening etc.:
Embodiment 1
A kind of Fibrotic pharmaceutical composition of myelofibrosis regulating liver-QI for the treatment of, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 240; Semen Persicae (parched) 320; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 120; Hirudo 320; Radix Rehmanniae 120; Placenta Hominis 40; Radix Notoginseng 24; Radix Glycyrrhizae 80.Its preparation process comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, wherein Carapax Trionycis (processed with vinegar), Radix Et Rhizoma Rhei, Hirudo, Placenta Hominis, Radix Notoginseng powder are broken into fine powder;
B, Semen Persicae (parched), rhizoma sparganic, Radix Rehmanniae, Radix Glycyrrhizae four flavors decoct with water 3 times, and each 1 hour, collecting decoction filtered, and it is 1.15g/ml～1.25g/ml(50 ℃～60 ℃ that filtrate is concentrated into relative density) clear paste;
C, steps A gained fine powder is joined in the clear paste of step B, mixing, drying is ground into fine powder, sieves;
D, every 100g step C gained powder add water with refined honey 27g～33g and make water-honeyed pill 1000g, and drying gets finished product.
Embodiment 2
A kind of Fibrotic pharmaceutical composition of myelofibrosis regulating liver-QI for the treatment of, the main pharmacodynamics raw material of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 230; Semen Persicae (parched) 340; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 130; Hirudo 340; Radix Rehmanniae 110; Placenta Hominis 45; Radix Notoginseng 25; Radix Glycyrrhizae 75.Its preparation process comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, be ground into fine powder, sieve;
B, every 100g gained powder add water with refined honey 27g～33g and make water-honeyed pill 1000g, and drying gets finished product.
In addition, dried cream, thick paste or the mixture of powders of the above embodiment of the present invention preparation can add Mel or other pharmaceutically acceptable excipient, make pill or other clinically acceptable granule, drop pill, tablet, capsule, suspensoid, oral liquid etc.
Foregoing description only proposes as the enforceable technical scheme of the present invention, not as the Single restriction condition to its technical scheme itself.
Claims (6)
1. the Fibrotic pharmaceutical composition for the treatment of myelofibrosis regulating liver-QI is characterized in that the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 230～250; Semen Persicae (parched) 300～340; Radix Et Rhizoma Rhei 75～85; Rhizoma sparganic 110～130; Hirudo 300～340; Radix Rehmanniae 110～130; Placenta Hominis 35～45; Radix Notoginseng 22～26; Radix Glycyrrhizae 75～85.
2. the Fibrotic pharmaceutical composition for the treatment of myelofibrosis regulating liver-QI according to claim 1, it is characterized in that: the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 240; Semen Persicae (parched) 320; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 120; Hirudo 320; Radix Rehmanniae 120; Placenta Hominis 40; Radix Notoginseng 24; Radix Glycyrrhizae 80.
3. the Fibrotic pharmaceutical composition for the treatment of myelofibrosis regulating liver-QI according to claim 1, it is characterized in that: the pharmacodynamic raw materials of making by ratio of weight and the number of copies this pharmaceutical composition is: Carapax Trionycis (processed with vinegar) 230; Semen Persicae (parched) 340; Radix Et Rhizoma Rhei 80; Rhizoma sparganic 130; Hirudo 340; Radix Rehmanniae 110; Placenta Hominis 45; Radix Notoginseng 25; Radix Glycyrrhizae 75.
4. the preparation method of the Fibrotic pharmaceutical composition of each described treatment myelofibrosis regulating liver-QI of claim 1-3, its characterization step comprises:
A, take by weighing each pharmacodynamic raw materials according to above-mentioned prescription, wherein Carapax Trionycis (processed with vinegar), Radix Et Rhizoma Rhei, Hirudo, Placenta Hominis, Radix Notoginseng powder are broken into fine powder;
B, Semen Persicae (parched), rhizoma sparganic, Radix Rehmanniae, Radix Glycyrrhizae four flavors decoct with water, and decocting liquid filters, and filtrate is concentrated into the clear paste that relative density is 1.15g/ml～1.25g/ml;
C, steps A gained fine powder is joined in the clear paste of step B, mixing, drying is ground into fine powder, sieves, and get final product.
5. preparation method according to claim 4, it is characterized in that: every 100g step C gained powder adds water with refined honey 27g～33g and makes water-honeyed pill 1000g, and drying gets finished product.
6. preparation method according to claim 4 is characterized in that: among the step B, Semen Persicae (parched), rhizoma sparganic, Radix Rehmanniae, Radix Glycyrrhizae four flavors decoct with water 2～4 times, decoct altogether 2 hours～4 hours, continue subsequent step behind the collecting decoction.
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| CN109820986A (en) * | 2019-03-27 | 2019-05-31 | 苏凤哲 | A kind of Chinese medicine composition and its preparation method and application for treating primary myelofibrosis |
| CN112057590A (en) * | 2020-10-23 | 2020-12-11 | 浙江省中医药研究院 | Chinese medicinal preparation for treating hepatic fibrosis and preparation method thereof |
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| CN1253013A (en) * | 1999-10-25 | 2000-05-17 | 车兴泉 | Medicine for treating hepatism and its preparing process |
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| CN1253013A (en) * | 1999-10-25 | 2000-05-17 | 车兴泉 | Medicine for treating hepatism and its preparing process |
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Inventor after: Niu Jingyue Inventor after: Tao Jun Inventor after: Wu Weihai Inventor after: Li Jianying Inventor after: Liang Chungeng Inventor after: Wu Dayong Inventor after: Feng Xinwang Inventor after: Pang Yuhui Inventor after: Ma Yahui Inventor after: Wang Rongxiao Inventor before: Wu Weihai Inventor before: Liu Qingchi Inventor before: Liang Chungeng Inventor before: Wu Dayong Inventor before: Feng Xinwang Inventor before: Pang Yuhui Inventor before: Ma Yahui Inventor before: Wang Rongxiao Inventor before: Tao Jun |
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