CN100361683C - Chinese medicinal preparation for treating fatly liver and its preparation method - Google Patents
Chinese medicinal preparation for treating fatly liver and its preparation method Download PDFInfo
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Abstract
The present invention discloses a Chinese medicine preparation for treating fatty liver, which is prepared from main materials and a proper quantity of auxiliary materials, wherein the mainly materials by the weight ratio are 10 to 20 portions of kudzu root, 6 to 15 portions of red peony root, 9 to 20 portions of hawthorn fruit and 9 to 15 portions of indian bread, and the auxiliary materials are proteoglycan, dextrin and lactose. The preparation method for the Chinese medicine preparation comprises the steps that 1. the kudzu root and the hawthorn fruit are heated in 40 to 80% ethanol and flow back 2 to 4 times, each time lasts for 0.5 to 3 hours, the kudzu root and the hawthorn fruit are filtered, and the filter liquid of the kudzu root and the hawthorn fruit are combined; the ethanol is recycled, and the mixture is decompressed and concentrated into concentrated liquid with the relative density of 1.05 to 1.25 at a temperature of 60 to 80 DEG C for standby use; 2. the remnant medicine dregs in step 1, the red peony root and the indian bread are combined and then decocted by adding water 2 to 4 times, each time lasts for 0.5 to 3 hours, decoction liquid of the dregs and the medicines are combined and filtered, and the mixture is decompressed and concentrated into concentrated liquid with the relative density of 1.05 to 1.25 at a temperature of 60 to 80 DEG C for standby use; 3. the obtained concentrated liquid in step 1 and step 2 are combined and dried by spray, a proper amount of the proteoglycan, the dextrin and the lactose are added, and the mixture is granulated and dried so as to prepare the Chinese medicine preparation. The pure Chinese medicine preparation provided by the present invention has obvious curative effect on hyperlipemia fatty liver and alcoholic fatty liver, and has the advantages of good safety and no toxic or side effect.
Description
Technical field
The present invention relates to the field of Chinese medicines, especially relate to a kind of Chinese medicine preparation that is used for the treatment of fatty liver, the invention still further relates to the preparation method of this Chinese medicine preparation.
Background technology
Fatty liver according to its clinical manifestation and the cause of disease, can be classified as sick categories such as " lump at the left hypochondrium ", " long-pending disease ", " distension ", " stagnation of phlegm ", " alcoholic jaundice " in Chinese medicine.Main diseases is because long-term surfeit delicious food savoury and insobriety cause is taken good care of oneself improperly, and water paddy can not turn to precise and tiny, and is poly-and for wetting, be expectorant, and with the passing of time stasis of blood resistance liver network is stranded in liver and forms primary disease.Being in the nature in the turbid damp of its disease stops, the turbid retardance of expectorant makes QI-mass stasis, and the strongly fragrant resistance of blood vessels causes gas, blood, the turbid knot of fighting mutually of expectorant, poly-stagnating to long-pending, and amassing in blood to expectorant is that the stasis of blood is the basic crisis of hyperlipemia, numbness hinders in liver and then is fatty liver.Therefore, the stasis of blood, long-pending, expectorant, wetting particularly outstandingly in early days in the primary disease morbidity, also is the principal contradiction that will solve in the treatment, and is used for the treatment of the Western medicine of fatty liver at present and the Chinese patent medicine kind is less and the indication specific aim is not strong.
Summary of the invention
The object of the present invention is to provide a kind of adaptability Chinese medicine preparation that is used for the treatment of fatty liver strong and evident in efficacy, the present invention also provides the preparation method of this kind preparation.
For achieving the above object, the present invention can take following technical proposals:
The Chinese medicine preparation that is used for the treatment of fatty liver of the present invention is prepared from according to the following weight parts proportioning by major ingredient Radix Puerariae, Radix Paeoniae Rubra, Fructus Crataegi, Poria and an amount of adjuvant protein sugar, dextrin, lactose: Radix Puerariae 10-20 part, Radix Paeoniae Rubra 6-15 part, Fructus Crataegi 9-20 part, Poria 9-15 part.
The weight portion proportioning of described major ingredient is: 10 parts of Radix Puerariaes, 6 parts of Radix Paeoniae Rubra, 9 parts of Fructus Crataegis, 9 parts in Poria.
The weight portion proportioning of described major ingredient also can be: 15 parts of Radix Puerariaes, 11 parts of Radix Paeoniae Rubra, 15 parts of Fructus Crataegis, 12 parts in Poria.
The weight portion proportioning of described major ingredient also can be: 20 parts of Radix Puerariaes, 15 parts of Radix Paeoniae Rubra, 20 parts of Fructus Crataegis, 15 parts in Poria.
The preparation method of Chinese medicine preparation of the present invention, it is prepared from according to following step:
The first step, to get Radix Puerariae, Fructus Crataegi be the alcohol heating reflux two to four times of 40%-80% with concentration, each 0.5-3 hour, filter, and merging filtrate reclaims ethanol, and the concentrated solution that is evaporated to relative density and is 1.05-1.25 in the time of 60-80 ℃ is standby;
Second step, the last medicinal residues of the first step and Radix Paeoniae Rubra, Poria are decocted with water two to four times after merging, each 0.5-3 hour, collecting decoction, filtration, the concentrated solution that is evaporated to relative density and is 1.05-1.25 in the time of 60-80 ℃ is standby;
The 3rd goes on foot, above-mentioned two step gained concentrated solutions is merged, and spray drying adds an amount of protein sugar, dextrin, lactose, makes granule, gets final product after the drying.
In the prescription of the present invention, Radix Puerariae suffering, sweet, cool is returned spleen, stomach two warps, can help spleen fortune wet; In works such as " property of medicine opinions ", all sayed the function of relieving the effect of alcohol, can be used for treating insobriety and the alcoholic jaundice that causes.Radix Paeoniae Rubra hardship, flat is returned liver, spleen two warps, stagnating in energy promoting blood circulation, blood stasis dispelling blood, the promoting the circulation of blood; " book on Chinese herbal medicine through " cloud: " merit of Radix Paeoniae, because of the cooperation benefit big ...." the diffusing property of Radix Puerariae suffering, cooperating and be good at the stagnant Radix Paeoniae of blood stasis dispelling, both compatibilities are dissolved the stagnant numbness of the liver pulse stasis of blood and are hindered to become mediation blood network, are to be the monarch and his subjects.Crataegolic acid, sweet, tepor are returned spleen, stomach, Liver Channel, and " daily book on Chinese herbal medicine " says its " stagnation of QI, the wide diaphragm that is good for the stomach, the blood mass at the hypochondrium that disappears piece are amassed, go in relieving dyspepsia ".Poria is sweet, light, flat, GUIXIN, spleen, kidney channel, invigorating the spleen and regulating the stomach, promoting diuresis to eliminate damp pathogen, cooperate the Fructus Crataegi spleen invigorating and in, turbid, the blood stasis dispelling saliva of dampness removing.Make a general survey of full side, dredging the network blood stasis dispelling is the monarch and his subjects, removing food stagnancyization is turbid, spleen invigorating and in, eliminating dampness by diuresis eliminates the phlegm and makes for assistant; complement each other, have collaborative effect, by eliminating the stasis of blood, long-pending, wet, expectorant in order to the treatment fatty liver; be the side of effecting a permanent cure, unnecessary blood fat in the clinical removing body of using, the liver protecting.
The drug efficacy study conclusion of this Chinese medicine preparation is summarized as follows:
1, preparation rat acute high blood lipid model is observed the effect of the multiple liver granule blood fat reducing of fat eliminating.The multiple liver granule of results suggest fat eliminating raises to acute blood fat and has the reduction effect.
2, give the fat eliminating of normal rat continuous irrigation stomach multiple liver granule, observe influence normal rat fat level.The multiple liver granule of results suggest fat eliminating does not have obvious influence to normal blood lipid level.
3, observe the influence of this product to fructose type triglyceride mass formed by blood stasis.The result shows that the serum TG level of positive controls and test high dose group is lower than model control group, and group difference is remarkable.The multiple liver granule of prompting fat eliminating has the effect of the blood lipid level that reduces rat fructose type triglyceride mass formed by blood stasis.
4, preparation Carnis Coturnicis japonicae high blood lipid model is observed the influence to the Carnis Coturnicis japonicae high blood lipid model.The result shows that serum TC, LDL, VLDL, TG level and the artery plaque area ratio of positive controls and test high dose group all are lower than model control group, are better than the model control group significant difference.
5, preparation rat chronic high blood lipid model is observed the influence of the multiple liver granule of fat eliminating to chronic high blood lipid model.The multiple liver granule of results suggest fat eliminating has prevention and therapeutical effect to fatty liver.
6, give the preparation animal acute ethanol liver injury model, the repair to acute ethanol hepatic injury is observed in medication.The result shows that ALT, AST, ALP and the GGT activated water of positive controls and test high dose group on average are lower than model control group, and group difference is remarkable.The multiple liver granule of prompting fat eliminating has the effect of repairing acute ethanol hepatic injury.
7, observe influence by preventive administration and therapeutic administration to chronic rat hyperlipidemia and alcoholic liver injury mixed model.The multiple liver granule of results suggest fat eliminating has prevention and therapeutical effect to fatty liver.
The toxicity test conclusion of this Chinese medicine preparation is as follows:
1, animal acute toxicity experiment
This Chinese medicine preparation can be irritated gastric capacity by Cmax and maximum, the maximum dosage-feeding that records this Chinese medicine preparation gastric infusion mice is 200.2g crude drug/Kgd (is equivalent to clinical consumption 216 times), animal does not have death, body weight change is normal, and hair, activity, the mental status and diet etc. there is no unusually.
2, animal long term toxicity test
This Chinese medicine preparation is given continuous gastric infusion of rat 6 months and 2 weeks of drug withdrawal with three dosage of 100.1g crude drug/kg body weight, 83.4g crude drug/kg body weight and 66.7g crude drug/kg body weight (be equivalent to respectively clinical application amount 108 times, 90 times and 72 times), three dosage treated animal body weight gains, food ration, electrocardiogram, hemocyte, blood biochemical and coagulation functions are measured, each main organs exponential sum histopathological examination there is no unusually, compares there was no significant difference with the blank group.Illustrate that this Chinese medicine preparation does not have obvious cumulative toxicity and retardance toxic reaction to rat.
Choose and observe case 129 examples, wherein 99 examples are organized in treatment, matched group 30 examples, and all case meets MethodsThe cases enrolled requirement (Chinese Medical Association's hepatology branch fatty liver and alcoholic liver disease group are adopted in diagnostic criteria).
Table 1 a liang group sex distributes relatively
| Group | Sample number n | Male n (%) | Women n (%) | X 2 | P |
| Treatment group matched group | 99 30 | 72(72.7) 22(73.3) | 27(27.3) 8(26.7) | 0.03 | ＞0.05 |
Table 1 shows, two groups of sex distribution there was no significant differences.
Table 2 liang group age distribution relatively
| Group | Sample number n | 30-40 year n (%) | 41-50 year n (%) | 51-60 year n (%) | X 2 | P |
| Treatment group matched group | 99 30 | 9(9.1) 3(10.0) | 60(60.6 17(56.7) | 30(30.3) 10(33.3) | 149 | ＞0.05 |
Table 2 shows that two groups of ages show there was no significant difference.
Table 3 a liang group state of an illness distributes relatively
| Group | Sample number n | Slight n (%) | Moderate n (%) | Severe n (%) | X 2 | P |
| Treatment group matched group | 99 30 | 13(13.1) 1(3.3) | 80(80.8) 28(93.3) | 6(6.1) 1(3.3) | 2.78 | ＞0.05 |
Table 3 shows, two groups of state of an illness distributing equilibriums.
Continuous use 3 months (oral, every day twice, each 10 grams, mixing in water for oral taking), every inspection medication front and back respectively once.
Main parameters for observation on effect a: inspection such as symptom, sign, triglyceride, high density lipoprotein, low density lipoprotein, LDL, cholesterol, transaminase, transpeptidase.
The liver puncture pathologic finding is done in liver ultrasound diagnosis, some cases.Efficacy determination is with clinical symptoms, sign, the basic disappearance, and it is produce effects that every inspection index is recovered normally, and it is effectively more than binomial that every inspection index is obviously improved, and every inspection does not have obvious improver for invalid.
Efficacy analysis after the medication:
Table 4 clinical efficacy compares for two groups
| Group | Sample number n | Produce effects n (%) | Effective n (%) | Invalid n (%) | Obvious effective rate % | Total effective rate % | u | p |
| The contrast of treatment group is thin | 99 30 | 59(59.6) 8(26.7) | 32(32.3) 15(50.0) | 8(8.1) 7(23.3) | 59.6 26.7 | 91.9 76.7 | 3.01 | ＜0.01 |
Table 4 shows that through the Ridit check, treatment group curative effect is better than matched group, and significant difference is arranged.
Show by pharmaceutical research and clinical verification: the Chinese medicine preparation of the present invention's protection is evident in efficacy to hyperlipemia fatty liver and alcoholic fatty liver, and safety is good, has no side effect.
The pure Chinese medicinal preparation of the present invention protection for instructing prescription, utilizes advanced preparation process technology with Traditional Chinese medical theory, and quality standard is rigorous, and said preparation is the drying property granule, and storage stability is good, takes, easy to carry, and dosage form is taken the human bioavailability height; Show safe and effective by modern medicine inspection means checking curative effect; Side's Chinese crude drug wide material sources do not have rare valuable medicinal, moderate cost, and indication is many, and patient's acceptance is good.
The specific embodiment
Embodiment 1:
The Chinese medicine preparation that is used for the treatment of fatty liver of the present invention, it is prepared from according to the following weight parts proportioning by major ingredient Radix Puerariae, Radix Paeoniae Rubra, Fructus Crataegi, Poria and an amount of adjuvant protein sugar, dextrin, lactose:
Radix Puerariae 10 grams, Radix Paeoniae Rubra 6 grams, Fructus Crataegi 9 grams, Poria 9 grams.
Preparation method is: the first step, to get Radix Puerariae, Fructus Crataegi be 40% alcohol heating reflux secondary with concentration, each 0.5 hour, filter, and merging filtrate reclaims ethanol, and it is standby to be evaporated to relative density and to be 1.05 concentrated solution in the time of 60 ℃;
Second step, the last medicinal residues of the first step and Radix Paeoniae Rubra, Poria are decocted with water secondary after merging, each 0.5 hour, collecting decoction, filtration, it is standby to be evaporated to relative density and to be 1.05 concentrated solution in the time of 60 ℃;
The 3rd goes on foot, above-mentioned two step gained concentrated solutions is merged, and spray drying adds an amount of protein sugar, dextrin, lactose, makes granule, gets final product after the drying.
Embodiment 2:
The Chinese medicine preparation that is used for the treatment of fatty liver of the present invention, it is prepared from according to the following weight parts proportioning by major ingredient Radix Puerariae, Radix Paeoniae Rubra, Fructus Crataegi, Poria and an amount of adjuvant protein sugar, dextrin, lactose:
Radix Puerariae 15 grams, Radix Paeoniae Rubra 11 grams, Fructus Crataegi 15 grams, Poria 12 grams.
Preparation method is: the first step, to get Radix Puerariae, Fructus Crataegi be 60% alcohol heating reflux three times with concentration, each 2 hours, filter, and merging filtrate reclaims ethanol, and it is standby to be evaporated to relative density and to be 1.15 concentrated solution in the time of 70 ℃;
Second step, the last medicinal residues of the first step and Radix Paeoniae Rubra, Poria are decocted with water three times after merging, each 2 hours, collecting decoction, filtration, it is standby to be evaporated to relative density and to be 1.15 concentrated solution in the time of 70 ℃;
The 3rd goes on foot, above-mentioned two step gained concentrated solutions is merged, and spray drying adds an amount of protein sugar, dextrin, lactose, makes granule, gets final product after the drying.
Embodiment 3:
The Chinese medicine preparation that is used for the treatment of fatty liver of the present invention, it is prepared from according to the following weight parts proportioning by major ingredient Radix Puerariae, Radix Paeoniae Rubra, Fructus Crataegi, Poria and an amount of adjuvant protein sugar, dextrin, lactose:
Radix Puerariae 20 grams, Radix Paeoniae Rubra 15 grams, Fructus Crataegi 20 grams, Poria 15 grams.
Preparation method is: the first step, to get Radix Puerariae, Fructus Crataegi be 80% alcohol heating reflux four times with concentration, each 3 hours, filter, and merging filtrate reclaims ethanol, and it is standby to be evaporated to relative density and to be 1.25 concentrated solution in the time of 80 ℃;
Second step, the last medicinal residues of the first step and Radix Paeoniae Rubra, Poria are decocted with water four times after merging, each 3 hours, collecting decoction, filtration, it is standby to be evaporated to relative density and to be 1.25 concentrated solution in the time of 80 ℃;
The 3rd goes on foot, above-mentioned two step gained concentrated solutions is merged, and spray drying adds an amount of protein sugar, dextrin, lactose, makes granule, gets final product after the drying.
Claims (5)
1. Chinese medicine preparation that is used for the treatment of fatty liver, it is characterized in that: it is prepared from by major ingredient Radix Puerariae 10-20 weight portion, Radix Paeoniae Rubra 6-15 weight portion, Fructus Crataegi 9-20 weight portion, Poria 9-15 weight portion and an amount of adjuvant protein sugar, dextrin, lactose proportioning.
2. the Chinese medicine preparation that is used for the treatment of fatty liver according to claim 1 is characterized in that: the weight portion proportioning of described major ingredient is: 10 parts of Radix Puerariaes, 6 parts of Radix Paeoniae Rubra, 9 parts of Fructus Crataegis, 9 parts in Poria.
3. the Chinese medicine preparation that is used for the treatment of fatty liver according to claim 1 is characterized in that: the weight portion proportioning of described major ingredient is: 15 parts of Radix Puerariaes, 11 parts of Radix Paeoniae Rubra, 15 parts of Fructus Crataegis, 12 parts in Poria.
4. the Chinese medicine preparation that is used for the treatment of fatty liver according to claim 1 is characterized in that: the weight portion proportioning of described major ingredient is: 20 parts of Radix Puerariaes, 15 parts of Radix Paeoniae Rubra, 20 parts of Fructus Crataegis, 15 parts in Poria.
5. the preparation method of Chinese medicine preparation according to claim 1, it is characterized in that: it is to be prepared from according to following step:
The first step, to get Radix Puerariae, Fructus Crataegi be the alcohol heating reflux two to four times of 40%-80% with concentration, each 0.5-3 hour, filter, and merging filtrate reclaims ethanol, and the concentrated solution that is evaporated to relative density and is 1.05-1.25 in the time of 60-80 ℃ is standby;
Second step, the last medicinal residues of the first step and Radix Paeoniae Rubra, Poria are decocted with water two to four times after merging, each 0.5-3 hour, collecting decoction, filtration, the concentrated solution that is evaporated to relative density and is 1.05-1.25 in the time of 60-80 ℃ is standby;
The 3rd goes on foot, above-mentioned two step gained concentrated solutions is merged, and spray drying adds an amount of protein sugar, dextrin, lactose, makes granule, gets final product after the drying.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN106421480A (en) * | 2016-11-10 | 2017-02-22 | 刘大仟 | Traditional Chinese medicinal formula for treating hepatitis B |
| CN107320468A (en) * | 2017-07-05 | 2017-11-07 | 刘彦博 | Composite phospholipid liposome oral liquid and its preparation method and application |
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