CN101327310B - Chinese medicinal composition for treating hyperlipemia and preparation thereof - Google Patents
Chinese medicinal composition for treating hyperlipemia and preparation thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicine combination for remedying hyperlipidemia and a preparation method thereof. The Chinese medicine combination is made from the raw materials with the following weight portions of 300-600 portions of red sage root, 200-300 portions of Szechwan lovage rhizome, 200-300 portions of peach kernel, 130-180 portions of rosewood, 200-300 portions of burreed, 200-300 portions of zedoary turmeric, 130-180 portions of trifoliate orange, and 60-100 portions of rhubarb. The Chinese medicine combination of the invention can be used to cure the hyperlipidemia of palpitation and discomfort, heartache recurred from time to time, chest distress, losing breath, dizziness, headache and so on caused by qi stagnation and blood stasis. The observation of clinical effect testifies that the Chinese medicine combination has significant efficacy for hyperlipidemia, good effect for lowering serum lipid, short treatment period and no side effect. Besides, the Chinese medicine combination also has the pharmacological effect of improving blood high viscosity.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition, relate in particular to a kind of Chinese medicine composition for the treatment of hyperlipemia, the invention still further relates to the preparation method of this Chinese medicine composition, belong to the field of Chinese medicines.
Background technology
Hyperlipemia is one of common disease clinically, especially in recent years, change along with China people dietary structure, making mid-aged population suffer from this patient increases day by day, this disease is very big to the healthy potential hazard of body, be considered to one of key factor of bringing out cardiovascular disease such as coronary heart disease, cerebral arteriosclerosis, confirm through a large amount of clinical experimental studies, take hypolipidemic, can obviously and effectively reduce the sickness rate of above-mentioned disease, and the microcirculation of the important organ of body is improved, thereby keep the normal of its function, slow down aging.
From the hyperlipemia pathogenic factor, it forms and is mostly to rise because of having a liking for food delicious food savoury or internal injury caused by excess of seven emotions, surfeit delicious food savoury then influences the strong then water-damp not being transformed of transporting of fortuneization, spleenization of taste, give birth in the phlegm-damp, in burnt taste be the pivot of logical accents of mechanism of qi, make taste not transport, stingy machine is unfavorable, then mechanism of qi is uncomfortable, and the stagnation of QI is not all right.Its property of the heresy of phlegm-damp is sticky in addition, also easily block the operation that mechanism of qi influences QI and blood, because qi as the commander of blood, the capable then blood of gas is capable, and the stagnation of QI is blood stasis then, and modern gas is capable not smooth, therefore form qi depression to blood stasis disease, primary disease morbidity in early days often phlegm-damp be main, disease is qi depression to blood stasis long afterwards, then often becomes main pathogenesis, phlegm-damp then shows not obvious, the disgruntled then impairing the liver of internal injury caused by excess of seven emotions in addition, the liver failing to maintain the normal flow of QI then stagnation of QI is obstructed, and QI-blood circulation is not smooth, or it is depressed to be worried, the retardance mechanism of qi influences QI-blood circulation, thereby forms the disease of qi depression to blood stasis.
It is so-called that " the capable then blood of gas is capable for qi being the governor of blood, blood being the material foundation of QI, and the stagnation of QI is blood stasis then." qi-blood disharmony be that one of basic pathogenesis with development takes place for multiple disease, say as " interior warp "; " term discord is that all kinds of diseases and ailments change and give birth to." in the majority with person in middle and old age at suffering from this disorder; the function degradation of middle-aged and elderly people is an objective reality; a large amount of especially in the last few years scientific research datas confirm: " old body ubiquity microcirculation disturbance, the destruction of unusual and each the main organs vascular morphology of hemorheology." miopragias such as function in this and the theory of Chinese medical science weakly then gasifies, fortuneization, the mechanism of qi retardance, hematogenous blockage, in become the stasis of blood, the mechanism that changes because of the stasis of blood comparatively meets.
Up to now, the Chinese patent medicine of the treatment hyperlipemia of having gone on the market has a variety of, and these Chinese patent medicines all have certain curative effect for hyperlipemia, but mostly in various degree exist curative effect inadequately significantly, certain defectives such as side effect are arranged, have much room for improvement.
Summary of the invention
One of the object of the invention provides a kind ofly has definite curative effect, the Chinese medicine composition that has no side effect for hyperlipemia.
Two of the object of the invention provides a kind of method of Chinese medicine composition for preparing above-mentioned to the treatment hyperlipemia.
The present invention seeks to be achieved through the following technical solutions:
A kind of Chinese medicine composition for the treatment of hyperlipemia comprises that each crude drug of following weight portion is made:
Radix Salviae Miltiorrhizae 300-360 part, Rhizoma Chuanxiong 200-300 part, Semen Persicae 200-300 part, Lignum Dalbergiae Odoriferae 130-180 part, rhizoma sparganic 200-300 part, Rhizoma Curcumae 200-300 part, Fructus Aurantii 130-180 part and Radix Et Rhizoma Rhei 60-100 part;
Preferably, the weight portion of each crude drug is: 334 parts of Radix Salviae Miltiorrhizaes, 250 parts of Rhizoma Chuanxiongs, 250 parts in Semen Persicae, 167 parts of Lignum Dalbergiae Odoriferaes, 250 parts of rhizoma sparganic, 250 parts of Rhizoma Curcumae, 167 parts of Fructus Aurantiis, 84 parts of Radix Et Rhizoma Rhei.
Chinese medicine composition of the present invention is based on the inventor to pathogenetic research of hyperlipemia deep layer and Therapeutic Principle thereof, simultaneously according to inventor clinical experience and pharmaceutical research achievement for many years, filter out the crude drug of blood circulation promoting and blood stasis dispelling, promoting of the circulation of QI and removing the obstruction in the collaterals, promoting blood circulation to remove obstruction in the collateral, according to certain weight proportion prescription, be prepared from.
Hyperlipemia belongs to the frequently-occurring disease of middle-aged and elderly people, and person in middle and old age's function is in the degradation state.Utilization modern medicine study means confirm, old body ubiquity microcirculation disturbance, and blood-hyperviscosity phenomenon, and hyperlipemia is to produce one of high sticking principal element of blood, therefore, the inventor thinks that the many void of old people are superficial phenomena, catch this principal contradiction and " old many stasis of bloods " are only its essence, promptly effect a permanent cure.The principle of abideing by " interior warp " " promoting circulation of QI-blood makes its accent reach " is so the Chinese medicine composition of the present invention that adopts " blood circulation promoting and blood stasis dispelling " to form for the treatment rule has with QI and blood, regulate yin-yang, promoting blood circulation, blood fat reducing, falls the sticking effect of blood.
The main component of Rhizoma Chuanxiong is a ligustrazine etc. in the side, has coronary artery dilator, increase coronary flow and myocardial nutrition, reduction myocardial oxygen consumption, increase brain and LBF amount, prevention of brain thrombosis, effects such as anticoagulant.Radix Salviae Miltiorrhizae can microcirculation improvement, clinical practice Radix Salviae Miltiorrhizae and compound red sage root preparation treatment angina pectoris are evident in efficacy, and the treatment cerebrovascular disease is also received better curative effect, in addition, Semen Persicae, Lignum Dalbergiae Odoriferae, rhizoma sparganic, Radix Et Rhizoma Rhei all have similar effect, and Fructus Aurantii has the effect of tangible cholesterol reducing.
The crude drug of respectively distinguishing the flavor of that the present invention is used can be bought at pharmacy and obtain.
Medicine activity component of the present invention can add various adjuvants required when preparing different dosage form, for example disintegrating agent, lubricant, adhesive etc., method of Chinese medicinal with routine is prepared into any suitable clinical preparation, for example can be pill, powder, granule, capsule, tablet, oral liquid or drop pill etc.
Preferably, a kind of method for preparing the pharmaceutical composition of above-mentioned treatment hyperlipemia comprises:
(1), takes by weighing each crude drug by described weight portion;
(2), the Radix Salviae Miltiorrhizae alcohol reflux, filter, filtrate recycling ethanol is concentrated into clear paste;
(3), Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted volatile oil; Aqueous solution after distillation device is in addition collected, and is standby;
(4), will extract Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and Fructus Aurantii medicinal residues behind the volatile oil and the resulting Radix Salviae Miltiorrhizae decoction dregs of step (2) and Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei and add water, decoction liquor and the collected aqueous solution of step (2) are merged, filter, filtrate is concentrated into clear paste;
(5), the resulting clear paste of step (2) and step (4) is merged, add the adjuvant or the excipient of preparations shaping, mixing, dry, pulverize, make granule, drying, granulate, spray adds volatile oil, mixing, promptly.
In the said method,, wherein, preferably Radix Salviae Miltiorrhizae is used the ethanol extraction secondary in the step (2), wherein, added 6 times of weight of ethanol for the first time, refluxed 1.5 hours, filter in order to reach better technique effect; For the second time add 4 times of weight of 80% ethanol, refluxed 1 hour;
Preferably, to extract Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and Fructus Aurantii medicinal residues behind the volatile oil and the resulting Radix Salviae Miltiorrhizae decoction dregs of step (2) and Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei in the step (4) and decoct with water secondary, wherein, add for the first time 3 times of weight of water, decocted 2 hours, for the second time add 6 times of weight of water, decocted 1 hour;
Relative density was the clear paste of 1.30-1.35 when the clear paste described in step (2) and the step (4) was preferably 55 ℃ of heat surveys;
Chinese medicine composition of the present invention can be used for treating the caused palpitation and restlessness of qi stagnation and blood stasis type, does when pained, and is uncomfortable in chest, breathes hard dizziness, hyperlipemias such as headache.Clinical observation on the therapeutic effect confirms that Chinese medicine composition of the present invention has significant curative effect for hyperlipemia, and lipid-lowering effect is good, and short treating period has no side effect, and removes this, and Chinese medicine composition of the present invention can also effectively improve blood-hyperviscosity.
The usage of Chinese medicine composition of the present invention and consumption: dosage of the present invention depends on factors such as concrete dosage form, patient's age, health status.As guidance: for granule, oral: each 10g, 3 times on the one, boiled water is taken after mixing it with water.
The specific embodiment
Further describe the present invention below in conjunction with specific embodiment, advantage of the present invention and characteristics will be more clear along with description.But these embodiment only are exemplary, scope of the present invention are not constituted any restriction.It will be understood by those skilled in the art that and down can make amendment or replace without departing from the spirit and scope of the present invention, but these modifications and replacing all fall within the scope of protection of the present invention the details of technical solution of the present invention and form.
The preparation of embodiment 1 granule
Take by weighing each raw material by following weight: Radix Salviae Miltiorrhizae 334g, Rhizoma Chuanxiong 250g, Semen Persicae 250g, Lignum Dalbergiae Odoriferae 167g, rhizoma sparganic 250g, Rhizoma Curcumae 250g, Fructus Aurantii 167g, Radix Et Rhizoma Rhei 84g; Radix Salviae Miltiorrhizae adds the alcohol reflux secondary, adds 6 times of weight of 95% ethanol for the first time, refluxes 1.5 hours, filters, for the second time add 4 times of weight of 80% ethanol, refluxed 1 hour, filter, merge filtrate twice, reclaim ethanol, and be concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted volatile oil, and the aqueous solution after distillation device is in addition collected, and collected aqueous solution is standby; Medicinal residues, Radix Salviae Miltiorrhizae decoction dregs that Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted behind the volatile oil decoct with water secondary with Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei, add 3 times of weight of water for the first time, decoct 2 hours, add 6 times of weight of water for the second time, decoct 1 hour; The decoction liquor merging is in the same place with above-mentioned aqueous solution, filters, filtrate is concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Merge clear paste twice, add dextrin 700g, Flos Chrysanthemi total glycosides 10g, mixing, dry, pulverize, add ethanol and make granule in right amount, drying, granulate, spray adds volatile oil, mixing, packing, promptly.
The preparation of embodiment 2 capsules
Take by weighing each raw material by following weight: Radix Salviae Miltiorrhizae 300g, Rhizoma Chuanxiong 200g, Semen Persicae 200g, Lignum Dalbergiae Odoriferae 130g, rhizoma sparganic 200g, Rhizoma Curcumae 200g, Fructus Aurantii 130g, Radix Et Rhizoma Rhei 60g; Radix Salviae Miltiorrhizae adds the ethanol extraction secondary, adds 6 times of weight of 95% ethanol for the first time, refluxes 1.5 hours, filters, for the second time add 4 times of weight of 80% ethanol, refluxed 1 hour, filter, merge filtrate twice, reclaim ethanol, and be concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted volatile oil, and the aqueous solution after distillation device is in addition collected, and collected aqueous solution is standby; Medicinal residues, Radix Salviae Miltiorrhizae decoction dregs that Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted behind the volatile oil decoct with water secondary with Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei, add 3 times of weight of water for the first time, decoct 2 hours, add 6 times of weight of water for the second time, decoct 1 hour; The decoction liquor merging is in the same place with above-mentioned aqueous solution, filters, filtrate is concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Merge clear paste twice, add appropriate amount of starch, mixing, dry, pulverize, add ethanol and make granule in right amount, drying, granulate, spray adds volatile oil, mixing, filled capsules, promptly.
The preparation of embodiment 3 tablets
Take by weighing each raw material by following weight: Radix Salviae Miltiorrhizae 360g, Rhizoma Chuanxiong 300g, Semen Persicae 300g, Lignum Dalbergiae Odoriferae 180g, rhizoma sparganic 300g, Rhizoma Curcumae 300g, Fructus Aurantii 180g, Radix Et Rhizoma Rhei 100g; Radix Salviae Miltiorrhizae adds the ethanol extraction secondary, adds 6 times of weight of 95% ethanol for the first time, refluxes 1.5 hours, filters, for the second time add 4 times of weight of 80% ethanol, refluxed 1 hour, filter, merge filtrate twice, reclaim ethanol, and be concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted volatile oil, and the aqueous solution after distillation device is in addition collected, and collected aqueous solution is standby; Medicinal residues, Radix Salviae Miltiorrhizae decoction dregs that Rhizoma Curcumae, Lignum Dalbergiae Odoriferae, Fructus Aurantii are extracted behind the volatile oil decoct with water secondary with Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei, add 3 times of weight of water for the first time, decoct 2 hours, add 6 times of weight of water for the second time, decoct 1 hour; The decoction liquor merging is in the same place with above-mentioned aqueous solution, filters, filtrate is concentrated into the clear paste that relative density is 1.30-1.35 (55 ℃ Celsius); Merge clear paste twice, dry, pulverize, add ethanol and make granule in right amount, drying, granulate, spray adds volatile oil, adds an amount of carboxymethylstach sodium, starch, magnesium stearate again, mixing, tabletting, the bag film-coat, packing, promptly.
The terms and conditions optimization test of test example 1 preparation of pharmaceutical compositions technology of the present invention
(1) extracts volatile oil
1, the investigation of extraction time
Contain volatile oil in crude drug Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and the Fructus Aurantii of the present composition.At first extract volatile oil.Test as can be known, the principal element that influences the volatile oil extraction is the time of extracting.Through result of the test as can be known, in 3 hours, prolong the volatile oil extraction ratio in time and increase, substantially no longer increase after 3 hours.So should be advisable to extract 3 hours.
Table 1
2, volatile oil adding method
Volatile oil is added dehydrated alcohol dilution back spray to be added granule, mixing, moistening, packing and gets final product.
(2) the extraction optimum condition of Radix Salviae Miltiorrhizae is investigated:
Main effect composition in the Radix Salviae Miltiorrhizae is a water-insoluble materials, but be soluble in ethanol, so it is that solvent extracts that the extracting method of Radix Salviae Miltiorrhizae adopts with ethanol, for guaranteeing that extracts active ingredients is complete in the Radix Salviae Miltiorrhizae, determine second extraction according to practical experience in the experiment, to influencing the principal element that Radix Salviae Miltiorrhizae extracts is concentration of alcohol, add the solvent amount, extraction time, adding middle Radix Salviae Miltiorrhizae with thin layer chromatography scanning with Radix Salviae Miltiorrhizae in the Radix Salviae Miltiorrhizae in the side is index because of II A content, adopt orthogonal test, and carry out data analysis with the method for intuitive analysis method and variance analysis and handle, to determine rational extraction conditions.
1, the design of orthogonal table
Experimental factor water-glass (table 2)
Table 2
2, test method and data
Testing by L (3) orthogonal table, is that quantitative target carry out intuitive analysis and difference analysis see Table 3 and table 4 with Radix Salviae Miltiorrhizae because of IIA with thin layer chromatography scanning.
Table 3
The red content analysis of variance table of ginseng ketone II A percentage sees Table 4.
The red content analysis of variance table of table 4 ginseng ketone IIA percentage
Above result of the test shows: concentration of alcohol is to the extract yield influence very big (P＜0.05) of tanshinone, and yield increases with the concentration of alcohol increase, is key factor.The solvent consumption is almost as broad as long in this scope.Though on extreme difference (R) value, still there is certain influence extraction time P＞0.05.Thereby the extraction conditions of determining Radix Salviae Miltiorrhizae is: add 6 times of weight of 95% ethanol for the first time, refluxed 1.5 hours, add 4 times of weight backflows of 80% ethanol for the second time and be advisable in 1 hour.
(3) all the other all medicines (Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei) adopt the method for water boiling and extraction, in order to guarantee product quality,, adopt orthogonal test also to analyze with the method for variance analysis to the key factor that influence is extracted, actual in conjunction with producing, determine rational extracting method.
1, the design of orthogonal table
Experimental factor water-glass (table 5)
Table 5
| Factor level | A (amount of water) (doubly) | B (decoction number of times) (inferior) | C fry in shallow oil and hour boil the time (hour) |
| 1 | 12 (7,5 or 5,4,3) | 2 | 2 (1,1 or 1,0.5,0.5) |
| 2 | 14 (8,6 or 6,4,4) | 3 | (2.5 1,5,1 or 1.1,0.5) |
| 3 | 16 (9,7 or 7,5,4) | 2 | 3 (2,1 or 1,1,1) |
Annotate: above is the pseudo level method.Because factor A and C are 3 levels, having only B is 2 levels.According to practical experience, be necessary investigate 1 time of 1 level, so virtual one 3 level to the B factor more.So just problem is converted into 3 hydraulic tests.List of references, the 159th page in high medical institute teaching material (mathematical statistics method).Chief editor Zhang Chunhua.
2, test method and test data
Experimentizing by L (3) orthogonal table, is that index is carried out analysis in table 6 and table 7 with the clear paste yield.
Table 6
Table 7
Above result shows, it is key factor that two factors of amount of water such as decocting time all have significant difference, and decoction secondary and three difference are less, actual (few to consume energy under the situation that the result accepts according to interpretation of result and production, with short production cycle is good principle) definite secondary that decocts, for the first time add 8 times of weight of water, decocted 2 hours, 6 times of weight of amount of water decoct and were advisable in 1 hour for the second time.
Think that according to above experimentation this technology is rationally through this feasible process of five batch samples production proof.
Annex V batch sample data.
Table 8
The pharmacodynamics test of test example 2 pharmaceutical compositions of the present invention
One, test material
1, given the test agent: embodiment of the invention 1-3 drug prepared;
2, other medicines: (1) inositol nicotinate sheet: Beijing No.2 Pharmaceutical Factory produces, lot number 92117073; (2) the solid ferment of gallbladder: Long March biochemical-pharmaceutical factory in Shanghai is produced, lot number 880301; (3) propylthiouracil sheet: morning sunlight pharmaceutical factory of The 2nd Army Medical College produces, and lot number 920710: cholesterol, triglyceride, HDL-C enzymatic assays, test kit is provided by Eastern Europe bio-engineering corporation, lot number 940223.
3, laboratory animal: the male wistar rat, body weight 180 ± 20g, male new zealand rabbit, body weight 2.25 ± 0.31kg provides by Shandong Province's Experimental Animal Center.Animal quality certification lot number: No. 930101, Shandong kinoplaszm.
Two, test method and result
(1) given the test agent is to the preventive effect of food hyperlipemia rat
Get 50 of healthy male rats, be divided into 5 groups at random, be respectively normal control group, high fat group, the heavy dose of group of given the test agent 4.5g clear paste/kg (containing crude drug 15.12g), given the test agent small dose group 1.8g clear paste/kg (containing crude drug 6.05g), and inositol nicotinate group 0.2g/kg.Except that normal control group feedstuff, all the other each groups all give high lipid food (cholesterol 2%, Adeps Sus domestica 5%, propylthiouracil 0.2%), and the while gastric infusion, every day 1 time, continuous 10 days, fasting blood serum cholesterol (TC), triglyceride (TG) are got in the last administration after 21 hours, and high-density lipoprotein cholesterol (HDL) level, the results are shown in Table 9.
Table 9 given the test agent to the preventive effect of food hyperlipemia rat (mmol/L, SD)
P＜0.01VS normal control
The high fat group of P＜0.05VS
P＜0.01
Result of the test shows, rat is raised serum TC behind the high lipid food, TG level obviously rise (P＜0.01), give serum TC behind the given the test agent, TG is starkly lower than high fat group (P＜0.05), HDL is not had obvious influence (P＞0.05), illustrate that rising has tangible preventive effect to given the test agent to food hyperlipemia rat fat.
(2) given the test agent is to food hyperlipemia rabbit hyperlipemia and atherosclerotic influence.
Get 30 of healthy male rabbits, raise normal feedstuff as normal control for 6, all the other 24 give high lipid food (yolk powder 15%, Adeps Sus domestica 5%, cholesterol 0.5%, normal feedstuff 79.5%) raises 28 days continuously, get fasting blood and survey serum TC, TG and HDL level, determine that model builds up, be divided into 4 groups at random according to the cholesterol lift-off value, be respectively the heavy dose of group of given the test agent 6.75g clear paste/kg (containing crude drug 22.68g), given the test agent small dose group 1.89 clear paste/kg (containing crude drug 6.05g), inositol nicotinate group 0.49/kg and high fat group are admixed absorption voluntarily in the feedstuff with medicine, continue to raise 30 days, (no longer add cholesterol in the feedstuff, only feed and contain the feedstuff of yolk powder and Adeps Sus domestica) get fasting blood after 30 days and survey serum TC, TG and HDL, only feeding contains the feedstuff of yolk powder and Adeps Sus domestica) get fasting blood after 30 days and survey serum TC, TG and HDL the results are shown in Table 10,11,12.
Table 10 given the test agent is to the influence (n=6, mmol/L X=SD) of hyperlipemia rabbit anteserum cholesterol
P＜0.05
The high blood group of P＜0.01VS
Table 11 given the test agent is to hyperlipemia rabbit anteserum triglyceride influence (n=6, mmol/L, X ± SD)
Table 12 given the test agent is to the influence of hyperlipemia rabbit anteserum HDL-C
(n＝6.mmol/L，X±SD)
Result of the test shows that the heavy dose of group of given the test agent can obviously reduce experimental hyperlipidemia rabbit anteserum cholesterol levels (P＜0.05), and triglyceride is had reduction trend, but does not have the statistics suggestion, and HDL is not had obvious influence.Above-mentioned rabbit is put to death, take out aorta (from aorta to bone aortic bifurcation place), at the dorsal surface longitudinal incision, the aorta that cuts is tiled on the filter paper, fatty tissue is rejected, fixed, stain color with blood with the Sudan with 10% formalin, make speckle be orange colour, plaque in various degree all takes place in the results model group, and pathological changes is more serious, wherein 4 tremulous pulsies of 4 grades of pathological changes, 1 of 3 grades of person, 1 of 2 grades of person; 4 grades 2 of low dose of levels, 3 grades 1,2 grades 2,1 grade 1; 4 grades 1 of heavy dose of level, 3 grades 1,2 grades 2,0.5 grade 2; 3 grades 2 of inositol nicotinate groups, 2 grades 1,1 group 1,0.5 grade 2.By grade marking 1-5 branch, the results are shown in Table 13.
Table 13 given the test agent is to the influence of rabbit artery plaque
Experimental result shows that given the test agent has significant study of anti-atherogenic effect.The high fat group of aortosclerosis degree is the most serious, and the positive controls lesion degree is the lightest, and big small dose group and model group comparison lesion degree alleviate.
(3) given the test agent causes the hemorheological property influence of rabbit blood stasis model to dextran.
Get 20 of healthy male rabbits, body weight 1.5---2.5kg, ear vein inject 6% high molecular dextran 8.3mlkg, every day twice, cause " blood stasis " model.Second day, twice after 15 minutes, heart extracting blood 5ml added test tube (heparin does and coagulates pipe), measures whole blood viscosity to high molecular dextran, and 7 indexs of hemorheologies such as plasma viscosity are for being worth before the medicine.
After five days, irritate stomach 6.75g/kg with 60% given the test agent clear paste, the niacin inositol lipid group was irritated stomach 0.40g/kg. continuous irrigation stomach three days, in the 3rd day of administration and the 3rd day simultaneously in medication, give high molecular dextran as stated above, and 7 indexs of hemorheologies such as whole blood viscosity after injection is measured administration after 15 minutes again, see table 14 for details.
Table 14 given the test agent is to the hemorheological property influence of rabbit " blood stasis " model due to the dextran
Result of the test shows: given the test agent can make the blood-hyperviscosity state of " blood stasis " model rabbit due to artificial that obvious reduction effect is arranged.Illustrate that this medicine except that having effect for reducing fat, also has good blood circulation promoting and blood stasis dispelling, improve the effect of hemorheological property.
Experimental result shows in sum: given the test agent has tangible preventive effect to food hyperlipemia rat; The effect that experimental hyperlipemia rabbit is had blood fat reducing, alleviates the atheromatous plaque degree.Remove this, this medicine also has dextran institute to causing rabbit " blood stasis " model, the high sticking effect of the blood that has clear improvement.Given the test agent has blood fat reducing, alleviates the effect that atherosclerosis takes place and improves blood-hyperviscosity.
The pharmacodynamics test of test example 3 Chinese medicine compositions of the present invention (the different amounts proportionings of 8 kinds of crude drug)
The function of Chinese medicine composition cures mainly according to the present invention, and this test is made the drug effect of pharmaceutical composition to the made pharmaceutical composition property verified of the different proportionings of 8 kinds of raw materials pharmacodynamics test with more different proportionings.
The inventor is according to research and clinical practice for many years, and " Chinese pharmacopoeia is put down in writing the conventional amount used of 8 kinds of crude drug, is prepared into 16 samples that contain different proportionings respectively, is numbered 1-16 (seeing Table 15) in conjunction with authoritative document.Sample all is prepared into granule by present specification embodiment 3 disclosed preparation methoies.
24 situation (units: g) of table 15 for the different proportionings of 8 kinds of raw materials in the reagent matter sample
| Sample number into spectrum | Radix Salviae Miltiorrhizae | Rhizoma Chuanxiong | Semen Persicae | Lignum Dalbergiae Odoriferae | Rhizoma sparganic | Rhizoma Curcumae | Fructus Aurantii | Radix Et Rhizoma Rhei |
| 1 | 300 | 200 | 200 | 130 | 200 | 200 | 130 | 60 |
| 2 | 334 | 250 | 250 | 167 | 250 | 250 | 167 | 84 |
| 3 | 360 | 300 | 300 | 180 | 300 | 300 | 180 | 100 |
| 4 | 350 | 280 | 280 | 160 | 280 | 280 | 160 | 90 |
| 5 | 340 | 290 | 290 | 175 | 295 | 295 | 175 | 95 |
| 6 | 355 | 265 | 265 | 130 | 300 | 300 | 175 | 60 |
| 7 | 330 | 245 | 245 | 160 | 250 | 250 | 160 | 80 |
| 8 | 334 | 250 | 250 | 160 | 245 | 245 | 167 | 84 |
| 9 | 365 | 305 | 305 | 185 | 305 | 305 | 185 | 105 |
| 10 | 375 | 315 | 315 | 195 | 315 | 320 | 190 | 110 |
| 11 | 390 | 320 | 320 | 200 | 320 | 320 | 200 | 115 |
| 12 | 360 | 305 | 305 | 185 | 300 | 300 | 170 | 87 |
| 13 | 400 | 220 | 220 | 120 | 150 | 150 | 125 | 45 |
| 14 | 295 | 195 | 195 | 125 | 195 | 195 | 125 | 55 |
| 15 | 280 | 185 | 185 | 120 | 180 | 180 | 120 | 50 |
| 16 | 270 | 200 | 220 | 185 | 195 | 195 | 130 | 80 |
One, for reagent thing and main agents
(1) for the reagent thing: the sample that will be numbered 1-16 all is prepared into granule according to the method for embodiment 1, again it is made into desired concn (the about 4g crude drug of mice consumption/kg body weight) by distilled water, and is standby.
(2) positive control medicine: inositol nicotinate sheet: Beijing No.2 Pharmaceutical Factory produces, lot number 92117073;
(3) other medicines: the solid ferment of gallbladder: Long March biochemical-pharmaceutical factory in Shanghai is produced, lot number 880301; The propylthiouracil sheet: morning sunlight pharmaceutical factory of The 2nd Army Medical College produces, and lot number 920710: cholesterol, triglyceride, HDL-C enzymatic assays, test kit is provided by Eastern Europe bio-engineering corporation, lot number 940223.
(4), laboratory animal: the male wistar rat, body weight 180 ± 20g, male new zealand rabbit, body weight 2.25 ± 0.31kg provides by Shandong Province's Experimental Animal Center.Animal quality certification lot number: No. 930101, Shandong kinoplaszm.
Two, test method and result
Get 114 of healthy male rabbits, raise normal feedstuff as normal control for 6, all the other 108 give high lipid food (yolk powder 15%, Adeps Sus domestica 5%, cholesterol 0.5%, normal feedstuff 79.5%) raises 28 days continuously, get fasting blood and survey serum TC, TG and HDL level, determine that model builds up, be divided into 17 groups at random according to the cholesterol lift-off value, be respectively given the test agent 1-16 group (corresponding given the test agent 1-16 number, dosage: 6.75g clear paste/kg (containing crude drug 22.68g), positive controls: inositol nicotinate group 0.49/kg and high fat group, medicine is admixed absorption voluntarily in the feedstuff, continue to raise 30 days, (no longer add cholesterol in the feedstuff, only feed and contain the feedstuff of yolk powder and Adeps Sus domestica) get fasting blood after 30 days and survey serum TC, TG and HDL, only feeding contains the feedstuff of yolk powder and Adeps Sus domestica) get fasting blood after 30 days and survey serum TC, TG and HDL the results are shown in Table 16.
Table 16 n=6, unit: mmol/L X ± SD
Result of the test shows: the content that all can obviously reduce hyperlipemia rabbit anteserum cholesterol and serum triglycerides for the reagent thing for 1-9 number, compare with 10-16 number, significant difference (P＜0.05) is arranged, wherein, the effect that reduces the content of hyperlipemia rabbit anteserum cholesterol and serum triglycerides for the reagent thing No. 2 obviously is better than No. 1, the 2-9 number effect for the reagent thing again.
The 4 medicine composite for curing hyperlipemia II phase clinical summary reports of the present invention of test example
One, physical data:
(1) case source:
All observe all being in hospital and the outpatient of case from three tame hospitals.Its patient distribution situation of originating sees Table 17.
Table 17 case source distribution situation
Observe case and amount to 420 examples, wherein 300 examples are organized in treatment, matched group 120 examples, and two groups of outpatients are totally 95 examples, account for 22% of patient's sum.
(2) sex:
Observe case totally 420 routine patients, wherein male's 228 examples, women's 192 examples, treatment group and matched group patient sex distribution situation see table 18 for details.
Table 18 a liang group patient sex distributes
Two groups of sexes distribute through X
2Check X
2Value 2.21.There was no significant difference relatively between P＞0.05 group has comparability.
(3) age:
Treatment group minimal ages person 28 years old, maximum age person 70 years old, 59.2 years old mean age, matched group minimal ages 30 years old, maximum 69 years old age, 62.6 years old mean age.Age distribution is through X between group
2Check X
2Value 4.65.P＞0.05 there was no significant difference has comparability.
(4) course of disease:
Two groups of courses of disease distribute through X
2Check X
2Value 8.27.P＞0.05 there was no significant difference has comparability.
(5) picture of the tongue distributes:
Treat preceding picture of the tongue distribution situation for two groups and see table 19 for details.
Picture of the tongue distributed before table 19 a liang group was treated
Treat preceding picture of the tongue integration cloth through X for two groups
2Check, X
2Value 0.49.P＞0.05, there was no significant difference has comparability.
(6) pulse condition distributes:
Treat preceding pulse condition distribution situation for two groups and see table 20 for details.
Pulse condition distributed before table 20 a liang group was treated
Treating preceding pulse condition for two groups distributes through X
2Check, X
2Value 0.27.P＞0.05, there was no significant difference has comparability.
(7) state of an illness weight distributes:
Two groups treat before by the state of an illness of the clinical research planned hierarchical synthesis integration standard of committing suicide, the light disease person integration of (being clinical symptoms integration and biochemical indicator integration summation) genus exists: between 8～13; Middle disease person integration exists: 14～24 minutes; Serious symptom person's integration exists: more than 25 minutes.Two groups of state of an illness weight distribution situations see table 21 for details.
State of an illness weight distributed before table 21 a liang group was treated
Treat preceding state of an illness weight distribution situation through X for two groups
2Check, X
2Value 1.37.P＞0.05, there was no significant difference has comparability.
Two, case choice criteria:
(1) case diagnosis standard:
1, differential diagnosis in tcm standard
(1) primary symptom
Formulate with reference to " new drug (Chinese medicine) clinical research guideline " (second volume).
Syndrome of qi stagnation and blood stasis:
(a) even chest distress with precordialgia
(b) distending pain in the chest and hypochondrium
(c) palpitation and restlessness
(d) dizziness or companioned with headache
(e) limb general anesthesia wood
(f) dark, petechia of purplish tongue or ecchymosis
(g) stringy pulse or string are puckery
(z) tcm diagnosis standard
Allly possess three above cardinal symptoms and tongue, arteries and veins was both diagnosable.
2, hyperlipemia Western medicine diagnose standard:
Under the normal diet situation, survey serum cholesterol (TC) 〉=6.0mmol/L (230mg/dl) or triglyceride (TG) 〉=1.54mmol/L (140mg/dl) or high density lipoprotein (HDL-G) as secondary in two weeks, male≤1.04mmol/L (40mg/dl), women≤1.17mmol/L (45mg/dl) person can make a definite diagnosis.
(2) the test case is included standard in:
1, meets above-mentioned Western medicine diagnose standard and the dialectical standard of traditional Chinese medical science syndrome of qi stagnation and blood stasis.
2, the age is 18～70.
3, body constitution is better usually, does not have obvious deficiency syndrome shower.
(3) get rid of the case standard: (comprising inadaptation or rejecting standard)
1, the age is at 18 times or more than 70 years old, gestation or women breast-feeding their children, allergic constitution and to this medicine allergy sufferers.
2, once suffered from patient after acute myocardial infarction, cerebrovascular accident, the serious major operation in half a year.
3, because of the nephrotic syndrome, the hyperlipemia due to hypothyroidism, gout, acute or chronic liver and gall diseases, the diabetes etc.
4, the hyperlipemia zygosity high-cholesterol disease patient who causes by medicine (phenothiazine class, beta-Blocking agent, adrenocortical steroid and some contraceptive etc.).
5, using heparin, thyroxine therapy and other to influence the patient of blood lipid metabolism medicine, and the patient who nearly two weeks once adopted other blood fat reducing measures.
6, merge serious primary disease such as liver, kidney and hemopoietic system, psychotic.
7, do not meet the standard of including in, do not stipulate medication, can't judge curative effect, or data is not congruent affects the treatment or safety judgement person.
8, body void person usually.
9, suffers from cerebral hemorrhage and other bleeding tendency person is arranged.
(4) state of an illness weight grade scale
1, symptom and tongue, arteries and veins classification, be divided into light, in, weigh three grades (table 22).
Table 22 symptom and tongue arteries and veins weight hierarchical table
Asymptomatic beating " 0 " divided.
2, every of biochemistry detection index grade scale is divided equally three grades.
3, state of an illness weight total score grade standard
(1) slight: 1. tcm symptom is learned integration 5～7 minutes
2. lipids detection belongs to slight hyperlipidemia person
3. integrated integral and 8～13 minutes
(2) moderate: 1. tcm symptom is learned integration 8～13 minutes
2. lipids detection belongs to medium and high blood fat disease person
3. integrated integral and 14～24 minutes
(3) severe 1. tcm symptom learn 14 fens above persons of integration
2. during lipids detection belongs to, severe hyperlipidemia person
3. integrated integral and more than 25 minutes.
Three, test method
(1) grouping
This test to meet diagnostic criteria, include standard in, the case that is selected into study subject totally 420 examples.Adopt list blind, organize 300 examples in " table of random number " ratio, random assortment treatment, matched group 120 examples, the ratio of two groups of case loads is: 2.5: 1.0.
(2) medication
Adopt single blind method.Because of two groups of drug formulation differences, the treatment group is taken the prepared granule (given the test agent) of the embodiment of the invention 1." XUEZHINING WAN " (control sample), its authentication code that matched group is taken Darentang Traditional Chinese Medicine Factory, Tianjin's production are: the accurate word of medicine is defended No. 595 in (85) Tianjin.Disturb for psychological factor for getting rid of the people, adopt JIAOSANXIAN (Fructus Crataegi, Fructus Hordei Germinatus, Massa Medicata Fermentata) to go Fructus Crataegi to add Radix Glycyrrhizae, make " given the test agent " placebo by Dalian natural drug pharmaceutical factory more respectively, and make " XUEZHINING WAN " placebo by Darentang Traditional Chinese Medicine Factory, Tianjin.The outer package of its two kinds of placebo and former medicine with therapeutical effect are roughly the same.(only only be marked with and distinguished) for the labelling of clinician's identification in outer package.
Method of administration and consumption: treatment group clothes given the test agent granule, each 10g, 3 times on the one, boiled water is taken after mixing it with water, and adds the XUEZHINING placebo simultaneously, each 2 balls, 2 times on the one.Matched group clothes XUEZHINING WAN, each 2 balls, 2 times on the one, add given the test agent granule placebo simultaneously, usage, consumption is the same.
(3) course of treatment:
Two groups of patients are a course of treatment to take medicine all around all.
(4) observation index:
(1) safety indexes:
1., to the observation of body deficient syndrome shape: as whether occur breathing hard the observation of symptoms such as the whole body is weak, pale complexion, stomach poor appetite are few, spontaneous perspiration, soreness of the waist and knees after taking medicine.Before the treatment observed and recorded once, and after the treatment weekly each observed and recorded once whether the wound effect of paying is just arranged to understand this product;
2., the hematuria stool routine examination is checked;
3., liver, kidney function test;
4., Electrocardioscopy;
5., go out, the clotting time inspection;
6., blood pressure;
Each is checked once before the treatment of above index and when finishing.
(2) health giving quality observation index:
1., the variation of tcm symptom, tongue, arteries and veins;
2., the variation of body weight;
3., serum total cholesterol;
4., serum triglycerides;
5., high density lipoprotein;
6., the hemorheological property index comprises:
A, whole blood viscosity; (height is cut, is hanged down and cut)
B, Fibrinogen;
C, plasma viscosity;
D, packed cell volume;
E, erythrocyte sedimentation rate;
(look into once before above every index treatment, look into once after the treatment).
(5) observational technique:
1, the overall process of clinical trial will be carried out in strict accordance with the clinical research plans, and any randomness must not be arranged.
2, in the observation process, study subject must not use other medicines relevant with treating primary disease and treatment means during treating.
3, respectively look into once before study subject is all wanted 100% carry out the safety indexes inspection, treat, after treating.
4, in the observation process, patient takes medicine the back as untoward reaction occurring, record strictly according to the facts.
5, in study subject, clinic case must not surpass 1/3, if the outpatient is selected into study subject, then should control its variable factor as far as possible.
(6) statistical procedures method:
Data that this test obtains adopt mean ± standard deviation (X ± S) expression without exception.Before treating and treatment back self curative effect is relatively all used t and Redit, X in the statistics
2The significance judgement is done in check, with the judgement boundary of P＜0.05～0.01 as significant difference.
Four, therapeutic outcome:
(1) curative effect determinate standard:
1, biochemical indicator curative effect determinate standard:
(1) clinic control: every biochemical indicator such as lab testing blood fat recovers normal.
(2) produce effects: lipids detection reaches following wantonly 1 person: TC and descends 〉=20%, and TG descends 〉=40%, HCL-G rising 〉=0.26mmol/L (10mg/dl);
(3) effective: lipids detection reaches following wantonly 1 person:
TC descend 〉=10% but＜20%, TG descend 〉=20% but＜40%, HCL-G rising 〉=0.104mmol/L (4mg/dl) but＜026mmol/L (10mg/dl);
(4) invalid: lipid determination does not have obvious improver.
2, clinical symptoms is imitated criterion:
(1) clinical recovery; Clinical symptom disappearance, picture of the tongue, the normal symptomatology integration of pulse condition are zero.
(2) produce effects: clinical symptoms and tongue arteries and veins are transferred to slightly by severe.Calculate 2 level degree of change with the symptomatology integration.
(3) effective: clinical symptoms and tongue arteries and veins transfer moderate to by severe, or are transferred to slightly by moderate.Calculate 1 level degree of change with the symptomatology integration.
(4) invalid: clinical symptoms and tongue arteries and veins do not have improvement.Or the symptomatology integration improves not enough 1 level degree.
3, hemorheological property curative effect determinate standard: check as the efficacy determination foundation with statistics t.
4, comprehensive therapeutic effect criterion:
By clinical symptoms, picture of the tongue, pulse condition and biochemical indicator classification marking standard calculate before the treatment respectively and treatment back integration summation, calculate with following formula:
Integration * 100% before (integration before the treatment-treatment back integration)/treatment.
Clinic control: score value should be 100%.
Produce effects: score value 〉=60%＜100%
Effectively: score value 〉=30%＜60%
Invalid: score value＜30%
(2) total effects analysis:
Table 23 liang group curative effect (comprehensive therapeutic effect) relatively
Two groups of total effectses are analyzed:
Treatment group effective percentage 91.7% shows control rate 51.3%.Matched group effective percentage 76.7% shows control rate 27.5%.Always treat for two groups through X
2Check is compared, X
2=9.54, P＜0.05 liang group relatively has significant difference.Two groups of total effectses are checked u=1.98 through redit, and there is significant difference P＜0.05.
(3) analysis of clinical symptom:
1, picture of the tongue analysis:
Table 24 a liang group is treated back picture of the tongue integration contrast
Two groups of picture of the tongue efficacy analysis: the treatment of treatment group is preceding, treatment back difference is checked through t, and there is the highly significant meaning P＜0.01.Matched group picture of the tongue curative effect also has the highly significant meaning through the t check, and two groups of Comparison of therapeutic are through t check, P＞0.05, there was no significant difference.
2, pulse analysis:
Table 25 a liang group is treated back pulse condition integration contrast
Two groups of pulse condition efficacy analysis: the treatment group is checked through t the pulse condition curative effect, and P＜0.01ee has significant differences, and matched group is checked through t the pulse condition curative effect, and also there is significant differences P＜0.01.Two groups of difference contrasts are through t check, P＞0.05, there was no significant difference.
3, analysis of clinical symptom:
Table 26 a liang group is treated back clinical symptoms integration relatively
Two groups of clinical symptoms curative effect integral analysis: two groups of treatments are learned t check by statistics to the curative effect integration of clinical each symptom, P all＜0.01, two group of contrast P all＞0.05, there was no significant difference.The above results shows that two kinds of medicines all have significant curative effect to improving clinical symptoms.
Remarks: T
3It is the T value of difference contrast before and after two groups.
(5) picture of the tongue distributes:
Treat preceding picture of the tongue distribution situation for two groups and see table 27 for details
Picture of the tongue distributed before table 27 a liang group was treated
Treat preceding picture of the tongue integral distribution experience X for two groups
2Check, X
2Value is 0.49.The no significant difference in P＞0.05 has comparability.
(6) pulse condition distributes:
Treat preceding pulse condition distribution situation for two groups and see table 28 for details.
Pulse condition distributed before table 28 a liang group was treated
Treat preceding pulse condition distribution for two groups and test X
2Check, X
2Value is 0.27.The no significant difference in P＞0.05 has comparability.
(4) the biochemical indicator blood fat changes analysis:
1, T-CHOL analysis:
Table 29 liang group T-CHOL (TC)
Two groups of T-CHOL Comparison of therapeutic are analyzed: two groups to the T-CHOL curative effect, and through the t check, P all＜0.01 all has significant differences, and two groups of differences contrasts are through t check, t=1.27, P＞0.05. there was no significant difference.
2, triglyceride analysis:
Table 30 liang group glyceride (TG) relatively
The ester Comparison of therapeutic of two groups of glycerol is analyzed: two groups of curative effects to triglyceride, and through the t check, group difference contrast of treatment group and matched group difference P＜0.01 and P＜0.05, two is through the t check, and there is significant difference P＜0.05.
3, HDL-C analysis:
Table 31 liang group high density lipoprotein (HBL-C) contrast
Two groups of high density lipoprotein Comparison of therapeutic are analyzed: the treatment group is treated after t checks, and there is the highly significant meaning P＜0.01, and matched group is treated after t checks P＞0.05 nonsignificance.Two groups of difference contrasts, through the t check, t=4.59, there is significant differences P＜0.01.
4, total effective rate analysis between the blood lipids index group:
1., T-CHOL effective percentage contrast
Table 32 T-CHOL effective percentage comparing result
The relative analysis of two groups of total gallbladder intrinsic efficiencies: treatment group total effective rate is 78.6%, and matched group is 62.5%, and the former is higher than the latter.But handle X by statistics
2Check, X
2=5.71, P＞0.05, no significance is poor.
2., triglyceride effective percentage contrast
Table 33 triglyceride effective percentage comparing result
The relative analysis of two groups of triglyceride effective percentage: treatment group total effective rate is 73%, and matched group is that 54.8%, two group of contrast is through X
2=7.92, P＜0.05, there were significant differences.
3., HDL-C effective percentage contrast
Table 34 HDL-C effective percentage comparing result
The relative analysis of two groups of high density lipoprotein level cholesterol effective percentage: treatment group total effective rate is 74.1%, and matched group is that 52.4%, two group of effective percentage is through X
2Check, X
2=8.79, there is significant difference P＜0.05.
5, blood lipids index two all efficacy analysis:
For observing given the test agent granule and XUEZHINING minimum active period, to the part patient, after two weeks of taking medicine, detect three indexs of blood fat once, contrast its two groups of curative effect situations (seeing table 35,36 for details)
Table 35 liang group blood fat two all Comparison of therapeutic
Two groups of blood fat two all curative effect comparative analysiss: the treatment group is taken medicine and two weeks was detected three indexs of blood fat TC.TG.HDL-G, and through the t check, P all＜0.01 has the highly significant meaning.Matched group was taken medicine after two weeks, through the t check, had only T-CHOL P＜0.01 that the highly significant meaning is arranged, and the solid P of glyceride and high density lipoprotein gallbladder all＞0.05 there are no significant meaning.Two groups of difference contrasts are checked through t, T-CHOL P＞0.05 there was no significant difference, and there is significant differences triglyceride P＜0.01, and there is significant difference high density lipoprotein gallbladder alcohol P＜0.05.
(5) the hemorheological property index changes analysis
Table 36 a liang group is treated back hemorheological property contrast
Two groups of hemorheological property curative effects are imitated relative analysis: 5 indexs of treatment group, through the t check, P all＜0.01 has the highly significant meaning.Matched group, whole blood viscosity is low cuts P＜0.01 the highly significant meaning, and the whole blood viscosity height is cut, Fibrinogen, plasma viscosity P＜0.05 significance.Hematocrit, erythrocyte sedimentation rate P＞0.05 nonsignificance.The contrast of two groups of differences is respectively through the t check, P all＞0.05, there was no significant difference (remarks: T
3Be two groups of difference contrast t values).
Five, safety indexes inspection and untoward reaction situation:
Three tame hospitals, treatment group patient is totally 300 examples, the matched group patient is totally 120 examples, by " II clinical trial phase scheme " regulation to the experimenter treat preceding, treating back equal 100%, to accept hematuria just conventional, hepatic and renal function, go out item conventional sense such as clotting time, blood pressure and electrocardiogram (its check result laboratory test report and report all are attached to every example and examine table back), check result does not find that a routine patient causes that because of taking this medicine above-mentioned routine examination is unusual.
Untoward reaction: occur slight anorexia after having two routine patients to take medicine, laxativeness occurs after two routine patients take medicine in addition, without special handling, spontaneous remission is not given and being withdrawed from.
The clinical observation conclusion:
1, clinical efficacy is remarkable: from two groups of total effects relative analyses as seen, treatment group total effective rate is 91.7%, the matched group total effective rate is 76.7%, and through Redit check P＜0.05, treatment group total effective rate is higher than matched group, and significant difference is arranged.
2, treatment clinical symptoms effect is obvious: find out from observed result, after employing is subjected to the treatment of reagent thing, to picture of the tongue, pulse condition and palpitation and restlessness, the curative effect of symptoms such as chest distress or companion's precordialgia, its integration differential is checked through t, and P all＜0.01 has the highly significant meaning.Compare with matched group, through t check P＞0.05, this explanation contrast medicine also has good curative effect to the treatment above-mentioned symptom.
3, blood fat reducing is evident in efficacy: the curative effect of treatment group treatment T-CHOL, triglyceride, HDL-C, difference all has the highly significant meaning through t check (P＜0.01) before and after it.Prompting curative effect ideal.Compare two groups of every differences with matched group, through the t check, except that cholesterol P＞0.05 there was no significant difference, and there are significant difference, high density lipoprotein gallbladder ferment rising value in two groups of contrasts of triglyceride P＜0.05, and two groups of difference contrasts are checked through t, also there is significant differences P＜0.01.
4, be subjected to reagent thing curative effect rapid: 73 routine patients are organized in treatment, and two weeks of taking medicine are detected three indexs of blood fat, and difference through t check P all＜0.01 has the highly significant meaning before and after it.With the routine patients of matched group 30 relatively, before three indexs of two groups are treated, treat back difference contrast t experience, except that T-CHOL P＞0.05, and triglyceride, HDL-C P value difference＜0.05,＜0..01, significant differences is all arranged.
5, the treatment blood-hyperviscosity is evident in efficacy: the treatment group is to reducing every hemorheological property indexs such as whole blood viscosity, plasma viscosity, Fibrinogen, and difference through t check P all＜0.01 all has the highly significant meaning before and after it.The whole blood viscosity of matched group is low cuts P＜0.01, and the highly significant meaning is arranged, and the whole blood viscosity height is cut, Fibrinogen, plasma viscosity P＜0.05, significant difference is arranged, hematocrit, erythrocyte sedimentation rate P＞0.05 there was no significant difference.
7, application is subjected to the reagent thing safe and reliable: this test is to 420 routine experimenters, by before " II clinical trial phase scheme " predetermined treatment and after the treatment, all carried out hematuria, stool routine examination is checked, and going out the clotting time hepatogastric function, the safety indexes inspection of aspects such as electrocardiogram does not find that a routine patient causes the routine test abnormal change because of taking this medicine, this result shows that employing is had no side effect by reagent thing treatment hyperlipemia, and is safe and reliable.
Through the II clinical trial phase, observed result proves that this is subjected to its clinical efficacy of reagent thing treatment hyperlipemia remarkable, and its blood fat reducing effective percentage is higher, it is respond well to improve clinical symptoms, has the blood-hyperviscosity of improvement effect, has the curative effect height, short treating period, advantage such as have no side effect.
Claims (9)
1. Chinese medicine composition for the treatment of hyperlipemia comprises that each crude drug of following weight portion is made:
Radix Salviae Miltiorrhizae 300-360 part, Rhizoma Chuanxiong 200-300 part, Semen Persicae 200-300 part, Lignum Dalbergiae Odoriferae 130-180 part, rhizoma sparganic 200-300 part, Rhizoma Curcumae 200-300 part, Fructus Aurantii 130-180 part and Radix Et Rhizoma Rhei 60-100 part.
2. according to the Chinese medicine composition of claim 1, it is characterized in that the weight portion of each crude drug is: 334 parts of Radix Salviae Miltiorrhizaes, 250 parts of Rhizoma Chuanxiongs, 250 parts in Semen Persicae, 167 parts of Lignum Dalbergiae Odoriferaes, 250 parts of rhizoma sparganic, 250 parts of Rhizoma Curcumae, 167 parts of Fructus Aurantiis, 84 parts of Radix Et Rhizoma Rhei.
3. according to claim 1 or 2 described Chinese medicine compositions, it is characterized in that: be prepared into any preparation of acceptable drug clinically according to Chinese medicine conventional formulation method.
4. according to the described Chinese medicine composition of claim 3, it is characterized in that: described pharmaceutical preparation is pill, powder, granule, capsule, tablet or oral liquid.
5. method for preparing claim 1 or 2 described Chinese medicine compositions may further comprise the steps:
(1), takes by weighing each crude drug by described weight proportion;
(2), the Radix Salviae Miltiorrhizae alcohol reflux, filter, filtrate recycling ethanol is concentrated into clear paste, and is standby;
(3), Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and Fructus Aurantii are extracted volatile oil, standby; Aqueous solution after distillation device is in addition collected, and is standby;
(4), will extract the medicinal residues of Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and Fructus Aurantii behind the volatile oil and the resulting Radix Salviae Miltiorrhizae decoction dregs of step (2) and Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei decocts with water, decoction liquor and the collected aqueous solution of step (2) are merged, filter, filtrate is concentrated into clear paste, and is standby;
(5), the resulting clear paste of step (2) and step (4) is merged, add the adjuvant or the excipient of preparations shaping, spray adds volatile oil, preparations shaping, promptly.
6. according to the method for claim 5, it is characterized in that: in the step (2) with Radix Salviae Miltiorrhizae with ethanol extraction 2 times, wherein, add 6 times of weight of ethanol, refluxed filtration 1.5 hours for the 1st time; Add 4 times of weight of 80% ethanol for the 2nd time, refluxed 1 hour.
7. according to the method for claim 5, it is characterized in that: will extract the medicinal residues of Rhizoma Curcumae, Lignum Dalbergiae Odoriferae and Fructus Aurantii behind the volatile oil and the resulting Radix Salviae Miltiorrhizae decoction dregs of step (2) and Semen Persicae, Rhizoma Chuanxiong, rhizoma sparganic and Radix Et Rhizoma Rhei in the step (4) and decoct with water 2 times, wherein, add 3 times of weight of water for the 1st time, decocted 2 hours, add 6 times of weight of water for the 2nd time, decocted 1 hour.
8. according to the method for claim 5, it is characterized in that: relative density was the clear paste of 1.30-1.35 when the clear paste described in step (2) or the step (4) was 55 ℃ of heat surveys.
9. claim 1 or 2 described Chinese medicine compositions are preparing the purposes for the treatment of in the hyperlipidemia.
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