CN1628786A - Medicine for treating hyperlipemia - Google Patents
Medicine for treating hyperlipemia Download PDFInfo
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- CN1628786A CN1628786A CN 200410051250 CN200410051250A CN1628786A CN 1628786 A CN1628786 A CN 1628786A CN 200410051250 CN200410051250 CN 200410051250 CN 200410051250 A CN200410051250 A CN 200410051250A CN 1628786 A CN1628786 A CN 1628786A
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Abstract
Disclosed is a Chinese medicinal preparatoinfor treating hyperlipemia, which is prepared from Chinese medicinal herbs including (by weight ratio), ligustrum japonicum 15-30%, root of japanese thistle 10-20%, white atractylodes rhizome 5-20%, radix salvia miltiorrhiza 5-20%, eucommia bark 5-15%, and Buddha's hand 5-15%.
Description
Technical field
The invention belongs to the medicinal preparation that derives from vegetable material, specifically relate to a kind of Chinese medicine preparation for the treatment of hyperlipemia.
Background technology
Hyperlipemia is a kind of common frdquently encountered disease, and crowd's recall rate the men and women be respectively about 11.6% and 18.2%.Hyperlipemia and hypertension, hyperglycemia and aging have confidential relation, and the closest with the cause of coronary heart disease relation.A survey result of World Health Organization (WHO) shows, the whole world has 75% people to be in sub-health state, hyperlipemia, hypertension, hyperglycemia, high body weight and immunologic function undesirable condition on the low side, therefore, effectively controlling hyperlipemia even curing hyperlipemia has important practical sense.
The endo-medicine of effectively controlling at present hyperlipemia and treatment hyperlipemia clinically has synthetic drug, and as (1) HMG-CoA reductase inhibitor (Statins), representing medicine is lovastatin, simvastatin, all based on cholesterol reducing; (2) phenoxy acetic acid class (the special class of shellfish), representing medicine is fenofibrate, can suppress VLDL and synthesize and promote its decomposition, increases the decomposition of LDL, effectively reduces serum triglycerides; (3) cholic acid is every putting agent, as colestyramine, based on cholesterol reducing; (4) nicotinic acid class preparation must heavy dose of just have the effect of the fat of accent; (5) unsaturated fatty acids is as bathypelagic fish oil ball, evening primrose oil capsule etc.; (6) other can promote the metabolism of fatty acid as pantethin, suppress the generation of fatty peroxide.Though above-mentioned lipid-regulation medicine can be received better effects in a short time, but still have many problems of inquiring into, solving of remaining: after 1. transferring fat up to standard, in case drug withdrawal, curative effect is difficult to stable the consolidation, even the pernicious knock-on of blood lipid level occurs; 2. lipid-regulation medicine often causes gastrointestinal upset in clinical practice, as untoward reaction such as stomachache, constipation, flatulence, nausea,vomiting,diarrhea, dyspepsia, inappetence, the adverse changes of hepatic and renal function and granulocyte count takes place easily in addition; 3. sharply senile spiritual mood change or the generation of sudden cardiovascular and cerebrovascular vessel incident are easily brought out in blood fat reducing; 4. women's blood fat reducing treatment before the menopause be prone to the endocrine disturbance, and postmenopausal women's blood fat reducing treatment makes easily the symptom of hormone in vivo parasecretion further increase the weight of.Above-mentioned defective has restricted lipid-regulation medicine application clinically.
The Chinese patent medicine of existing treatment hyperlipemia is a lot, but ripe medicine is few, that classifies the basic herbal species of country as has 10 kinds approximately, the Hedan tablet that helps digestion such as the Herb Gynostemmae Pentaphylli total glycosides tablet (capsule) of benefiting qi and removing blood stasis, the turbid descending that eliminates the phlegm, liver heat removing expectorant tea pigment capsule, eliminate the phlegm Xuezhikang, zhibituo of blood stasis dispelling etc., and can record the XUEZHINING WAN of having only nourishing the kidney for subduing the hyperactivity of liver-YANG of the 2000 new edition Pharmacopoeias of the People's Republic of China, but it need be forbidden or careful this medicine of using serious gastric ulcer, the many persons of gastric acid secretion.Said medicine remains in certain weak point, clinical research for the treatment by Chinese herbs hyperlipemia lacks unified standard, all inconsistent as aspects such as case selection, efficacy determination, matched group settings, there is difficult quality control, or the effect link is single, or side effect is big or take shortcomings such as producing drug resistance for a long time.So aspect control hyperlipemia and treatment hyperlipemia, excavate pools of traditional Chinese medicine, develop new efficiently, low toxicity, curative effect clearly, taking convenience and the pure Chinese medicinal preparation that meets international standard be necessary.
Summary of the invention
The objective of the invention is to develop a kind of new effective control hyperlipemia and the Chinese medicine medicine of treatment hyperlipemia.
To achieve the object of the present invention, through research repeatedly, clinical observation for many years and forefathers' summary of experience, technical scheme of the present invention is: it contains the medicament that the raw material of Chinese medicine of following percentage by weight is made in the medicine of this treatment hyperlipemia:
Fructus Ligustri Lucidi 15-35% Radix Cirsii Japonici 10-25% Rhizoma Atractylodis Macrocephalae 5-20%
Radix Salviae Miltiorrhizae 5-20% Cortex Eucommiae 5-15% Fructus Citri Sarcodactylis 5-15%.
Reuse Fructus Ligustri Lucidi in this medicine, its sweet in the mouth, little hardship, cool in nature, the moon of nourishing the liver and kidney, bone and muscle strengthening, blood fat reducing is monarch drug; Radix Cirsii Japonici sweet in the mouth, hardship, cool in nature, energy cooling blood for hemostasis, removing blood stasis to reduce swelling detoxifcation; Radix Cirsii Japonici also has the effect of tonify deficiency, and bright Miao Xiyong " Bencao Jingshu " is said it: " cool in nature and can manage it, row and band is mended, the removing heat from blood of enriching blood, then Ying Qi and, be good for so order is fertile ", so Radix Cirsii Japonici helps Fructus Ligustri Lucidi invigorating the liver and kidney, blood stasis dispelling detoxification and lipid lowering; Rhizoma Atractylodis Macrocephalae bitter in the mouth, sweet, warm in nature, can replenishing QI to invigorate the spleen, the dampness diuretic, turbid to eliminate the phlegm, match with Fructus Ligustri Lucidi, reinforce spleen and kidney together then is so the Radix Cirsii Japonici and the Rhizoma Atractylodis Macrocephalae are ministerial drug altogether; Fructus Citri Sarcodactylis acrid in the mouth, hardship, warm in nature, can liver-smoothing, qi-regulating, relieving pain by regulating middle-JIAO, drying dampness to eliminate phlegm, the expectorant in kind the purifying the blood is turbid, match with the Rhizoma Atractylodis Macrocephalae, the activating QI to eliminate phlegm damp eliminating knowingly follow the example of a wrongdoer work; The Radix Salviae Miltiorrhizae bitter in the mouth, cold nature can blood circulation promoting and blood stasis dispelling, nourishing blood to tranquillize the mind, with Fructus Citri Sarcodactylis be adjuvant drug altogether; Cortex Eucommiae sweet in the mouth, warm in nature, the sun of liver and kidney tonifying, bone and muscle strengthening matches with Fructus Ligustri Lucidi, and the tonifying both YIN and YANG of Liver and kidney becomes coordinating water and fire agent altogether, makes the work of knowingly following the example of a wrongdoer of liver and kidney tonifying, does not grow the anxiety of being bored with or helping fire and have, so be messenger drug.
Fructus Ligustri Lucidi, the Rhizoma Atractylodis Macrocephalae, Cortex Eucommiae invigorating liver and spleen kidney in the side, Radix Cirsii Japonici, Radix Salviae Miltiorrhizae, Fructus Citri Sarcodactylis activating QI to eliminate phlegm, blood stasis dispelling detoxifcation, all medicines share, make invigorating middle warmer that row be arranged, mend and oiliness, eliminating evil and do not hinder healthy energy, full side gathers the effect of tonifying speen and tonifying kidney, activating QI to eliminate phlegm, blood stasis dispelling detoxifcation altogether, then " void ", " stagnating ", " stasis of blood ", " poison " can be controlled, and all cards can be healed.
In sum, this pharmaceutical composition and blood sugar lowering, blood fat reducing, the anti-ageing pharmacological action of waiting for a long time are relevant, can be used for treating hyperlipemia, are particularly useful for old and with the patient of diabetes.
This pharmaceutical composition is through pharmacological evaluation and preliminary clinical observation, find that this medicine not only has tangible reduction serum total cholesterol (TC), serum levels of triglyceride (TG) and low density lipoprotein, LDL (LDL-C), and the effect of high density lipoprotein increasing (HDL-C), the accent blood fat mechanism that meets Western medicine, still the hemorheology that changes is learned index, improve blood vessel state, suppress atherosclerosis and form, reduce blood uric acid, the blood sugar regulation level, promote immunologic function and antidotal effect, and do not see obvious toxic-side effects, the necessary further investigation, and to clinical expansion.
In order to reach better therapeutic, be particularly suitable for hypertension, patient that blood glucose is high, in raw material of Chinese medicine, also have Radix Notoginseng, Rhizoma Coptidis, raw material of Chinese medicine is:
Fructus Ligustri Lucidi 15-35% Radix Cirsii Japonici 10-25% Rhizoma Atractylodis Macrocephalae 5-15% Radix Salviae Miltiorrhizae 5-15%
Cortex Eucommiae 5-15% Fructus Citri Sarcodactylis 5-15% Radix Notoginseng 5-15% Rhizoma Coptidis 3-10%
Radix Notoginseng is a blood circulation promoting dispels the silt medicine, has coronary artery dilator, increases coronary flow, anticoagulant, promotion fibrinolytic effect, has fat, blood sugar lowering and the anti-ageing effect of waiting for a long time of accent simultaneously.It is reported that Radix Notoginseng can reduce serum total cholesterol, the T-CHOL and the TL of aorta wall also had the minimizing effect, cause speckle to disappear.Its mechanism of action may be by the degraded of the formation of the absorption that influences lipid, lipoprotein, lipid or drainage etc.Radix Salviae Miltiorrhizae and Radix Notoginseng compatibility use in we, have both strengthened the effect of blood circulation promoting and blood stasis dispelling, make that the stasis of blood is turbid easily dispels, more strengthen and transfer fat, blood sugar lowering and anti-aging effects.Rhizoma Coptidis hardship, cold, but heat clearing and damp drying, eliminating fire and detoxication are used for antipyretic-antalgic, anti-enterobacterial infection clinically for a long time.The discovered in recent years Rhizoma Coptidis also has pharmacological actions such as arrhythmia, blood fat reducing, blood sugar lowering, antiplatelet aggregation.
Therefore, in former side, add Radix Notoginseng and Rhizoma Coptidis, can strengthen our blood fat reducing, blood sugar lowering, antiplatelet aggregation, improve effect such as hemorheology.
For in being more suitable for treating, old people's hyperlipemia, the preferable raw material of Chinese medicine of this medicine group is:
Fructus Ligustri Lucidi 20-25% Radix Cirsii Japonici 12-15% Rhizoma Atractylodis Macrocephalae 10-15% Radix Salviae Miltiorrhizae 10-15%
Cortex Eucommiae 10-15% Fructus Citri Sarcodactylis 10-12% Radix Notoginseng 10-12% Rhizoma Coptidis 6-10%.
Treatment hyperlipidemia provided by the invention adopts the above-mentioned made medicament of raw material of Chinese medicine, can be to get the extract of raw material of Chinese medicine such as the extract of water extract or ethanol extract or water extract-alcohol precipitation, or the medicated powder that the extract of part Chinese medicine adds part Chinese medicine be made medicament.As with Chinese medicine extraction process by water or aqueous extraction-alcohol precipitation technology fetch water the extract that molten position or alcohol reflux extraction process obtain of whole Chinese crude drugs by routine, further make preparation, or Chinese crude drug Fructus Ligustri Lucidi, Radix Cirsii Japonici, the Rhizoma Atractylodis Macrocephalae, Radix Salviae Miltiorrhizae, the Cortex Eucommiae, Rhizoma Coptidis got extract, Fructus Citri Sarcodactylis, Radix Notoginseng are directly worn into fine powder add and make medicament.Its pharmaceutical dosage form, being called for short medicament, can be to add the adjuvant that pharmaceutically allows with the method for Chinese medicinal of routine to make any dosage form, and the present invention is advisable with peroral dosage form, patient easily accepts, as: tablet, granule, capsule, pill, syrup, oral liquid etc.
Pharmaceutical preparation provided by the invention has the effect of tonifying speen and tonifying kidney, activating QI to eliminate phlegm, blood stasis dispelling detoxifcation, oral have a tangible reduction serum total cholesterol (TC), serum levels of triglyceride (TG) and low density lipoprotein, LDL (LDL-C), and the effect of high density lipoprotein increasing (HDL-C), the accent blood fat mechanism that meets Western medicine, be used to prevent and treat the hyperlipemia curative effect certainly, toxic and side effects is little; Preparation technology's preparation of available routine is suitable for large-scale industrial production; And have advantages such as raw material is easy to get.
Below prove the beneficial effect of pharmaceutical composition provided by the invention by the test of pesticide effectiveness and clinical research.
Test the drug action development test purpose of 1. different parts medicines of the present invention to the rat diet hyperlipemia:
1) tentatively understands the drug action of medicine of the present invention to the rat diet hyperlipemia; 2) medicine of Preliminary screening different extract parts of the present invention is to the drug action of rat diet hyperlipemia.
Test material:
The high lipoprotein emulsion of model group
Matched group: use the fenofibrate capsule
Test group: A. is that water is carried group a
Get it filled 3 kilograms of material Fructus Ligustri Lucidi, 2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Fructus Citri Sarcodactylis, 2 kilograms of Radix Cirsii Japonicis add water 75L, boil 2 hours, filter, filtering residue adds water 60L again, boils 1.5 hours, filter, merging filtrate is condensed into the thick paste of 4 gram crude drug/grams.
B. carry group b for water
Get it filled 3 kilograms of material Fructus Ligustri Lucidi, 2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Fructus Citri Sarcodactylis, 2 kilograms of Radix Cirsii Japonicis, 1.5 kilograms of Radix Notoginseng, 1.3 kilograms of Rhizoma Coptidis, add water 105L, boiled 2 hours, filter, filtering residue adds water 90L again, boiled 1.5 hours, and filtered, merging filtrate is condensed into the thick paste of 4 gram crude drug/grams
C. be the alcohol extraction group
Get it filled 3 kilograms of material Fructus Ligustri Lucidi, 2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Fructus Citri Sarcodactylis, 2 kilograms of Radix Cirsii Japonicis, 1.5 kilograms of Radix Notoginseng, 1.3 kilograms of Rhizoma Coptidis, add 70% ethanol 60L, boiled 2 hours, filter, filtering residue adds 70% ethanol 50L again, boiled 1.5 hours, and filtered, merging filtrate reclaims the thick paste that ethanol is condensed into 4 gram crude drug/grams.
D. be the water extract-alcohol precipitation group
Get it filled 3 kilograms of material Fructus Ligustri Lucidi, 2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Fructus Citri Sarcodactylis, 2 kilograms of Radix Cirsii Japonicis, 1.5 kilograms of Radix Notoginseng, Rhizoma Coptidis adds water 105L for 1.3 kilograms, boiled 2 hours, filter, filtering residue adds water 90L again, boils 1.5 hours, filters, merging filtrate concentrates, adds the concentration of 95% ethanol to 70%, place, filter, get the thick paste that filtrate recycling ethanol is condensed into 4 gram crude drug/grams.
E. carry for part water and add the medicated powder group:
Get it filled 3 kilograms of material Fructus Ligustri Lucidi, 2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 2 kilograms of Radix Cirsii Japonicis, Rhizoma Coptidis adds water for 1.3 kilograms and crosses powder, boiled 2 hours, filter, filtering residue added water boil 1.5 hours again, filtered, and merging filtrate concentrates, adds the concentration of 95% ethanol to 70%, place, filter, get filtrate recycling ethanol and be condensed into the fine powders that add 1.5 kilograms of 1.5 kilograms of Radix Notoginseng and Fructus Citri Sarcodactylis behind the clear paste and be stirred into thick paste, be equivalent to every gram and contain 4 gram crude drugs.
Test method:
To get 64 of rats, be divided into 8 groups at random: normal control group, high lipoprotein emulsion group (model group), high lipoprotein emulsion+fenofibrate (positive group), A group. high lipoprotein emulsion+water is put forward group a, B group. and high lipoprotein emulsion+water is put forward group b, C group. high lipoprotein emulsion+alcohol extraction group, D group. high lipoprotein emulsion+water extract-alcohol precipitation group, E group. high lipoprotein emulsion+part water is carried and is added the medicated powder group.The normal control group gives conventional feed, and all the other 7 groups by 10 milliliters of/kilogram high lipoprotein emulsions of interpolation.Administration respectively after 4 hours, successive administration 14 days.The last administration is taken eyeball after 1 hour and is got blood, with enzymatic assays rat blood serum T-CHOL (TC), serum levels of triglyceride (TG) and high density lipoprotein (HDL-C), by formula calculate low density lipoprotein, LDL (LDL+VLDL)-C=TC-HDL-C and extra-low density fat egg, atherogenic index (AI)
The result: the different parts pharmaceutical composition is to the influence of diet hyperlipidemia rats TC, TG, HDL-C, (LDL+VLDL)-C and AI (x ± SD)
Number of animals dosage TC TG HDL-C (LDL+VLDL)-C AI
Group (only) is (mmol/l) (mmol/l) (mmol/l) (mmol/l)
Normal group 8 1.95 ± 0.28 0.66 ± 0.20 1.03 ± 0.10 0.92 ± 0.30 1.92 ± 0.36
Model group 8 10.18 ± 4.50
*2.59 ± 1.26
*0.54 ± 0.46
*9.65 ± 4.62
*41.75 ± 34.95
*
Positive group 8 36mg 2.40 ± 0.74
△0.88 ± 0.24
△0.80 ± 0.52 4.19 ± 2.25
△7.99 ± 4.94
A????????8?????????3mg??????5.03±1.56
△???????????1.48±0.74
△??????????0.55±0.18?????????6.37±1.21
△?????????15.07±4.85
△
B????????8?????????3mg??????4.95±1.47
△???????????1.13±0.65
△▲????????0.58±0.13????????4.88±1.17
△▲???????10.93±4.98
△▲
C????????8?????????3mg??????4.53±2.69
△???????????1.25±0.68
△??????????0.97±0.79
△???????????4.74±1.45
△??????????7.21±3.46
△
D????????8?????????3mg??????3.57±1.42
△□#????0.95±0.29
△□#???0.98±0.37
△□????????4.25±1.39
△□#???7.04±2.52
△□
E????????8?????????3mg?????
??
?
?
?
Annotate: model group and normal group compare:
*P＜0.05; Administration group and model group compare:
△P＜0.05;
Water carries group b and water is carried group a relatively:
▲P＜0.05; Water carries group b and the alcohol extraction group compares: P＞0.05;
Water extract-alcohol precipitation group and water are carried group b relatively:
P＜0.05; Water extract-alcohol precipitation group and alcohol extraction group compare:
#P＜0.05
Part water is carried and is added medicated powder group and water and carry group b relatively:
Conclusion: relatively there were significant differences that (P＜0.05) prove that model is reliable for model group and normal group, and administration group and model group comparison there were significant differences p＜0.05 proves that the administration group is all effective; Water is carried group b and is reduced indexs such as TG, (LDL+VLDL)-C and AI and carry group a with water relatively there were significant differences (p＜0.05), prove that water puies forward the accent fat curative effect of organizing b and be better than water and carry and organize a; Water is carried group b and the alcohol extraction group does not relatively have significant difference (P＞0.05), proves that two groups of process acts are similar; The water extract-alcohol precipitation group improve each index of hyperlipemia all be better than water carry the group b, difference has significance (P＜0.05), and the water extract-alcohol precipitation group relatively there were significant differences (P＜0.05) with the alcohol extraction group improving aspect TC, TG and (LDL+VLDL)-C, the accent fat curative effect that prove the water extract-alcohol precipitation group is better than water and carries and organize b and alcohol extraction group; Part water is carried and is added the medicated powder group and transfer the fat curative effect to be better than water to carry group b (P＜0.05); Part water is carried and is added medicated powder group and water extract-alcohol precipitation group comparison there was no significant difference (P＞0.05), may be relevant very little with sample size.
Test 2, pharmaceutical composition provided by the invention are for the clinical observation on the therapeutic effect for the treatment of hyperlipemia
1, physical data
To hospital outpatient Primary hyperlipemia patient totally 310 examples.Wherein, male 167 examples, women 143 examples, year at age 31～79 (average 56.3).The experimenter does not suffer from acute myocardial infarction, acute cerebrovascular disease in nearly half a year, also do not stand severe trauma and major operation, female patient belongs to non-pregnant non-lactation period women, has got rid of the Secondary cases hyperlipemia and the high TC mass formed by blood stasis of familial of liver, gallbladder, kidney, endocrinopathy and drug-induced.
2, diagnostic criteria
Draft the standard of hyperlipemia with reference to Ministry of Public Health " the clinical research guideline of new drug (Chinese medicine) treatment hyperlipemia ": under the normal diet situation, 2 weeks are interior as 2 survey serum total cholesterols (TC) are equal 〉=6.0mmol/L, or triglyceride (TG) 〉=1.54mmol/L, or high density lipoprotein (HDL-C) male≤1.04mmol/L, women≤1.17mmol/L has each conformance with standard person promptly diagnosable.
3, Therapeutic Method
Select hyperlipidemia patient 310 examples altogether according to above-mentioned standard, be divided into three groups of treatment group I, treatment group II and matched group at random.Wherein treatment group I102 example, the capsule I that makes with medicine provided by the invention (medical material consists of the capsule that Fructus Ligustri Lucidi, Radix Cirsii Japonici, the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, Radix Salviae Miltiorrhizae, the Cortex Eucommiae are formed with decoction and alcohol sedimentation technique), each 2, every 300mg every day 3 times; Treatment group II110 example, with capsule II (medical material consists of the capsule that Fructus Ligustri Lucidi, Radix Cirsii Japonici, the Rhizoma Atractylodis Macrocephalae, Fructus Citri Sarcodactylis, Radix Salviae Miltiorrhizae, the Cortex Eucommiae, Radix Notoginseng and Rhizoma Coptidis are formed with decoction and alcohol sedimentation technique), each 2, every 300mg every day 3 times; Matched group 98 examples are with medicine Xuezhikang (Beijing University's dimension letter bio tech ltd provides), each 0.6g (0.3g/ grain), every day 3 times.Three groups was 1 course of treatment with 1 month all, added up curative effect after 2 courses of treatment.Viewing duration other any fat-reducing medicaments of stopping using, alcohol prohibition.
4, therapeutic evaluation
4.1 observation item
(1) clinical symptoms and sign (heart rate, blood pressure, picture of the tongue, pulse condition);
(2) blood lipids index: serum total cholesterol (TC), triglyceride (TG), high density lipoprotein (HDL-C), low-density albumen (LDL) were detected with automatic biochemistry analyzer in 4,8 weeks in before the treatment and the back of taking medicine, calculate atherogenic index (AI), i.e. AI=(TC-HDL-C)/HDL-C.Same empty stomach is 12 hours before the venous blood collection, extracts the ulnar vein blood test early morning.
(3) to being associated with impaired glucose tolerance person among the above-mentioned patient, before treating and after finishing the course of treatment, extracting vein blood is looked into and is reached 2h blood glucose after the meal on an empty stomach.
(4) hemorheology index: whole blood viscosity, reduced viscosity ratio, plasma viscosity, hematocrit value (HCT), RBC aggregate index, RBC rigidity index, RBC deformation index, ESR, ESR equation K value and Fibrinogen etc.
(5) untoward reaction: observe the patient in detail and have or not emerging uncomfortable reaction, exist before the treatment, the reaction of medication postemphasis, react initial, date of expiry and with the relation of trial drug.
4.2 criterion of therapeutical effect
Blood fat curative effect determinate standard: draft with reference to Ministry of Public Health " the clinical research guideline of new drug (Chinese medicine) treatment hyperlipemia ".
Clinic control: clinical symptoms, sign disappear, and the every inspection of laboratory recovers normal;
Produce effects: clinical symptoms, sign disappear substantially, and lipids detection reaches following wantonly 1 person: TC and descends 〉=20%, and TG descends 〉=40%, HDL-C rising 〉=0.26mmol/L, and TC-HDL-C/HDL-C descends 〉=20%;
Effectively: lipids detection reach following wantonly 1 person: TC descend 〉=10% but＜20%, TG descend 〉=20% but＜40%, HDL-C risings 〉=0.104mmol/L but＜0.26mmol/L, TC-HDL-C/HDL-C decline 〉=10% but＜20%;
Invalid: treatment back symptom, sign and lipids detection do not have obvious improver.
Worsen (reaching following any one person): TC and rise＞10%, TG rises＞10%, and HDL-C decline＞0.1mmol/L, TC-HDL-C/HDL-C increase＞and 10%.
5, therapeutic outcome
5.1 blood lipid level changes (seeing Table 1) before and after the treatment
Each group is after the treatment of 8 weeks, and blood fat all makes moderate progress before treating, P＜0.05, wherein, and TG reducing, LDL aspect, with being better than the Xuezhikang group behind the treatment group I capsule for treating, difference has significance (P＜0.05).Each index of blood fat is better than the Xuezhikang group behind treatment group II capsule for treating, difference has significance (P＜0.05).
Blood lipid level variation before and after table 1 treatment group capsule and the Xuezhikang treatment (x ± S, mmol/L)
Treatment group I (n=102) treatment group II (n=110) matched group (n=98)
After preceding treatment is treated in the treatment back before treating after the treatment before the treatment
TC????7.14±0.89???????5.56±1.10
*??????7.10±0.82??????4.97±1.20
**ρ????7.06±0.84?????5.88±1.04
*
TG????3.41±0.72???????1.88±1.03
**ρ????????3.43±0.91??????1.76±0.93
**ρ????3.45±0.89?????2.07±0.91
*
LDL???4.70±1.32???????2.64±1.31
**ρ????????4.75±1.49??????2.5±1.27
**ρ??????4.78±1.45?????3.18±1.21
*
HDL-C?0.97±0.31???????1.25±0.42
*??????0.94±0.28??????1.56±0.47
**ρ????0.95±0.23?????1.27±0.36
*
AI????5.80±1.41???????3.48±1.16
*??????5.88±1.34??????2.57±1.08
**ρ????5.87±1.36?????3.56±1.29
*
Annotate: relatively preceding with treatment,
*P＜0.05,
*P＜0.01:
Compare with matched group,
ρP＜0.05.
5.2 individual curative effect
Treatment group capsule and Xuezhikang improve the individual efficacy analysis contrast (seeing Table 2) of blood fat.
The individual curative effect (mmol/L) in table 2 treatment group and Xuezhikang treatment 8 weeks of hyperlipemia
Group n produce effects enabledisable worsens total effectively P value
TC treatment group I 102 57 (55.9) 35 (34.3) 9 (8.9) 1 (1.0) 92 (90.2)
Treatment group II 110 66 (60.0) 36 (32.7) 6 (5.5) 2 (1.8) 102 (92.7) P＜0.05
Matched group 98 54 (55.1) 31 (31.6) 8 (8.2) 5 (5.1) 85 (86.7)
TG treatment group I 102 39 (38.2) 30 (29.4) 27 (26.5) 6 (5.9) 69 (67.8) P＜0.05
Treatment group II 110 51 (46.4) 33 (30.0) 26 (23.6) 0 (0) 84 (76.4) P＜0.01
Matched group 98 37 (37.8) 24 (24.5) 25 (25.5) 12 (12.2) 61 (62.3)
LDL treatment group I 102 25 (24.5) 65 (63.7) 8 (7.8) 4 (3.9) 90 (88.2) P＜0.05
Treatment group II 110 28 (25.5) 75 (68.2) 7 (6.4) 0 (0) 103 (93.7) P＜0.01
Matched group 98 16 (16.3) 64 (65.3) 15 (15.3) 3 (3.1) 80 (81.6)
HDL-C treatment group I 102 12 (118) 20 (19.6) 57 (55.9) 13 (12.7) 32 (31.4)
Treatment group II 110 18 (16.4) 37 49 (44.5) 6 (5.5) 55 (50.0) P＜0.01
(33.6)
Matched group 98 9 (9.2) 17 (17.3) 53 (54.1) 19 (19.3) 26 (26.5)
AI treatment group I 102 77 (75.5) 15 (14.7) 8 (7.8) 2 (2.0) 92 (90.2)
Treatment group II 110 89 (80.1) 15 (13.6) 6 (5.5) 0 (0) 104 (93.7) P＜0.01
Matched group 98 74 (75.5) 13 (13.2) 7 (7.1) 4 (4.1) 87 (88.7)
Annotate: () is %
5.3 treatment group capsule and Xuezhikang treatment back are to impaired glucose tolerance patient fasting glucose and the influence of 2h blood glucose after the meal (seeing Table 3)
Table 3 impaired glucose tolerance patient fasting glucose before and after capsule of the present invention and Xuezhikang treatment reaches 2h blood glucose after the meal
(unit: mmol/L)
Blood glucose treatment group I (n=38) treatment group II (n=35) matched group (n=37)
After preceding treatment is treated in the treatment back before treating after the treatment before the treatment
Empty stomach 6.54 ± 0.89 5.03 ± 0.69
*6.58 ± 0.62 4.97 ± 0.72
* ρ6.48 ± 0.75 5.02 ± 0.76
*
2h 9.65 ± 1.06 7.03 ± 0.77 after the meal
* ρ9.70 ± 0.91 6.93 ± 0.75
* ρ9.62 ± 1.08 7.20 ± 0.87
*
5.4 the variation (seeing Table 4) of hemorheology index before and after each group treatment
Hemorheology index variation before and after table 4 capsule of the present invention and the Xuezhikang treatment (x ± S)
Treatment group I (n=102) treatment group II (n=110) matched group (n=98)
After preceding treatment is treated in the treatment back before treating after the treatment before the treatment
RBC deformation index 0.61 ± 0.07 0.67 ± 0.10
*0.62 ± 0.09 0.71 ± 0.15
* ρ0.60 ± 0.05 0.68 ± 0.09
*
ESR(mm/h)?????????18.43±5.74??????16.77±5.80?????18.47±4.95?????14.56±6.01
*ρ?????18.43±5.74?????17.82±7.12
ESR equation K value 80.21 ± 18.45 69.23 ± 17.42
*79.96 ± 18.48 65.36 ± 15.39
* ρ80.04 ± 18.24 72.47 ± 15.68
*
Whole blood viscosity (mPaS):
Low viscosity (the 10S that cuts
-19.35 ± 1.10 7.42 ± 1.16
*9.32 ± 1.20 7.01 ± 1.04
* ρ9.36 ± 1.18 7.45 ± 1.17
*)
In cut viscosity (60S
-15.23 ± 0.72 4.47 ± 0.67
*5.29 ± 0.81 4.05 ± 0.31
* ρ5.23 ± 0.72 4.48 ± 0.74
*)
Height is cut viscosity (150S
-1) 4.15 ± 0.32 3.56 ± 0.23
*4.15 ± 0.32 3.25 ± 0.31
* ρ4.15 ± 0.32 3.59 ± 0.28
*
The whole blood reduced viscosity is than 14.25 ± 2.64 10.36 ± 1.57
*14.34 ± 2.56 10.08 ± 1.48
*14.27 ± 2.47 10.48 ± 1.84
*
(mPa·S)
Plasma viscosity (mPaS) 1.65 ± 0.28 1.41 ± 0.24
*1.63 ± 0.28 1.37 ± 0.26
* ρ1.64 ± 0.28 1.43 ± 0.30
*
HCT(％)???????????44.97±3.41??????42.95±4.41?????44.39±3.95?????40.05±3.12
*ρ?????44.48±3.61?????43.82±4.06
RBC aggregate index 2.75 ± 0.44 2.44 ± 0.15
*2.66 ± 0.33 2.25 ± 0.40
* ρ2.69 ± 0.41 2.43 ± 0.45
*
RBC rigidity index 5.26 ± 0.50 4.89 ± 0.47
*5.29 ± 0.42 4.38 ± 0.45
* ρ5.27 ± 0.38 5.01 ± 0.52
*
Fibrinogen (g/L) 4.01 ± 1.17 3.56 ± 1.10
*3.98 ± 1.05 3.01 ± 0.68
* ρ3.99 ± 1.05 3.62 ± 1.04
*
Annotate: relatively preceding with treatment,
*P＜0.05,
*P＜0.01;
Compare with matched group,
ρP＜0.05.
5. side effect
Do not see that in therapeutic process the patient tells and significant discomfort arranged after taking medicine, check blood, routine urinalysis, blood glucose, liver, renal function and electrocardiogram etc. there is no significant change.
6, conclusion
(1) to hyperlipidemia patient, treated for 8 weeks with I, II capsule and XUEZHIKANG JIAONANG respectively after, make curative effect relatively, find respectively to organize and make moderate progress (P＜0.05) before blood fat is all treated, with the capsular curative effect the best of II, each index is all obviously improved (P＜0.01).TG reducing, LDL aspect, with being better than the Xuezhikang group behind the treatment group I capsule for treating, difference has significance (P＜0.05).And behind treatment group II capsule for treating, each index of blood fat all obviously is better than Xuezhikang group (P＜0.05).
(2) to being associated with the patient of impaired glucose tolerance in the hyperlipidemia patient, respectively after treatment group I, II capsule and Xuezhikang treated for 8 weeks, fasting glucose and all obviously reductions (P＜0.05) of 2h blood glucose after the meal, and the hypoglycemic curative effect of treatment group II capsule is better than Xuezhikang group (P＜0.05).
(3) it is unusual that all there is hemorheology in hyperlipidemia patient, after organizing I, II capsule and XUEZHIKANG JIAONANG with treatment and treating for 8 weeks, all can improve patient's hemorheology index, wherein treatment group I capsule and XUEZHIKANG JIAONANG all can not be improved HCT and erythrocyte sedimentation rate, treatment group II capsule then can make HCT and erythrocyte sedimentation rate reduce (P＜0.05), and the improvement of all the other indexs all is better than Xuezhikang group (P＜0.05).
7. discuss
Above-mentioned result of study shows that pharmaceutical composition provided by the invention has to be transferred fat, blood sugar lowering preferably and improve hemorheological effect.From the theory of the traditional Chinese medical science and the pharmacological research of modern Chinese medicine all the medicine the side of showing have fat, the blood sugar lowering of accent and improve effect such as hemorheology, treatment group II capsule has increased Radix Notoginseng and Rhizoma Coptidis than treatment group I capsule, because of Radix Notoginseng and Radix Cirsii Japonici, Radix Salviae Miltiorrhizae compatibility, then strengthen the effect of blood circulation promoting and blood stasis dispelling, detoxifcation, therefore and Radix Notoginseng and Radix Salviae Miltiorrhizae compatibility can generate new more effective composition, share the back and transfer fat, blood sugar lowering and improve hemorheological effect and all improve.Moreover Rhizoma Coptidis also has good accent fat, hypoglycemic activity, and therefore, eight medicines share, and gathers the merit of tonifying speen and tonifying kidney, activating QI to eliminate phlegm, blood stasis dispelling detoxifcation altogether, amounts to the effect of transferring fat, blood sugar lowering and improving hemorheology.
Set forth technical scheme of the present invention below in conjunction with embodiment.
The specific embodiment
Embodiment 1. get it filled 3 kilograms of material Fructus Ligustri Lucidi, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 0.5 kilogram of Fructus Citri Sarcodactylis, 1.5 kilograms of Radix Cirsii Japonicis, add water 75L, boiled 2 hours, filter, filtering residue adds water 60L again, boils 1.5 hours, filter, merging filtrate concentrates, dry, sieve, encapsulated every 300mg.
Embodiment 2,3 kilograms of the material Fructus Ligustri Lucidi of getting it filled, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 0.5 kilogram of Fructus Citri Sarcodactylis, Radix Cirsii Japonici add 70% ethanol 60L for 1.5 kilograms, boiled 2 hours, filter, filtering residue adds 70% ethanol 50L again, boils 1.5 hours, filter, merging filtrate reclaims ethanol and is condensed into thick paste, with Icing Sugar or dextrin, stirs, granulate, dry, sieve, be distributed into the granule (claiming electuary again) of every bag of 10g.
Get it filled 1.5 kilograms of material Fructus Ligustri Lucidi, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 2 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Fructus Citri Sarcodactylis, Radix Cirsii Japonici of embodiment 3. adds water 75L for 2 kilograms, boiled 2 hours, filter, filtering residue adds water 60L again, boiled 1.5 hours, and filtered, it is 1.25 thick paste that merging filtrate is concentrated into relative density, add water and flavoring agent etc. and be diluted to every ml and contain the 2g crude drug, be packed as the oral liquid of every 10ml.
Embodiment 4. get it filled 2.5 kilograms of material Fructus Ligustri Lucidi, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 1.0 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Radix Cirsii Japonicis, 0.5 kilogram of Rhizoma Coptidis, add water 95L, boiled 2 hours, filter, filtering residue adds water 60L again, boils 1.5 hours, filter, merging filtrate is condensed into the fine powder that thick paste adds 0.5 kilogram of 1.0 kilograms in Radix Notoginseng and Fructus Citri Sarcodactylis, sieves, and mixing, general ball are made pill.
Embodiment 5. get it filled 1.5 kilograms of material Fructus Ligustri Lucidi, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.5 kilograms of the Cortexs Eucommiae, 1.0 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Radix Cirsii Japonicis, 1.0 kilograms of Rhizoma Coptidis, adding water does not have powder to boil 2 hours, filter, filtering residue added water boil 1.5 hours again, filter, merging filtrate concentrates, adds the concentration of 95% ethanol to 70%, place, get supernatant recovery ethanol and be condensed into thick paste, add fine powder of 1.0 kilograms of 1.2 kilograms of Radix Notoginseng and Fructus Citri Sarcodactylis and an amount of auxiliary materials and mixing again, make granule, drying, tabletting or again coating promptly get tablet.
Embodiment 6. gets the thick paste 150g sugaring 400g that embodiment 3 extracts, and adds water to 100ml, and adding preservative agent boils dissolving, filters, and the alcoholic solution that adds essence is an amount of, and the back packing that stirs promptly gets syrup.
Extraction concentrated solution, drying cartridge capsule after embodiment 7. gets 2.5 kilograms of raw material Fructus Ligustri Lucidi, 1.2 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.2 kilograms of the Cortexs Eucommiae, 1.2 kilograms of Radix Salviae Miltiorrhizaes, 0.5 kilogram of Fructus Citri Sarcodactylis, 1.5 kilograms of Radix Cirsii Japonicis, 1.2 kilograms of Radix Notoginseng, Rhizoma Coptidis 0.7 kg of water and carries with the preparation method of embodiment 1, every 300mg.Embodiment 8,2.5 kilograms of the material Fructus Ligustri Lucidi of getting it filled, 1.5 kilograms of the Rhizoma Atractylodis Macrocephalaes, 1.0 kilograms of the Cortexs Eucommiae, 1.0 kilograms of Radix Salviae Miltiorrhizaes, 1.5 kilograms of Radix Cirsii Japonicis, 0.5 kilogram of Rhizoma Coptidis, 1.2 kilograms of Radix Notoginseng, Fructus Citri Sarcodactylis add water for 0.8 kilogram and do not have powder to boil 2 hours, filter, filtering residue added water boil 1.5 hours again, filtered, and merging filtrate is condensed into extractum, the concentration that adds 95% ethanol to 70%, place, after getting supernatant and reclaiming ethanol, add an amount of adjuvant, spray drying, packing, every bag of 2g promptly gets sugar-free medicinal granules.
Claims (5)
1, a kind of medicine for the treatment of hyperlipemia is characterized in that it contains the medicament of being made by the raw material of Chinese medicine of following percentage by weight:
Fructus Ligustri Lucidi 15-35% Radix Cirsii Japonici 10-25% Rhizoma Atractylodis Macrocephalae 5-20%
Radix Salviae Miltiorrhizae 5-20% Cortex Eucommiae 5-15% Fructus Citri Sarcodactylis 5-15%.
2, according to the medicine of the described treatment hyperlipemia of claim 1, it is characterized in that also having Radix Notoginseng, Rhizoma Coptidis in the said Chinese medicine, raw material of Chinese medicine is:
Fructus Ligustri Lucidi 15-35% Radix Cirsii Japonici 10-25% Rhizoma Atractylodis Macrocephalae 5-15% Radix Salviae Miltiorrhizae 5-15%
Cortex Eucommiae 5-15% Fructus Citri Sarcodactylis 5-15% Radix Notoginseng 5-15% Rhizoma Coptidis 3-10%.
3, according to the medicine of the described treatment hyperlipemia of claim 1, its feature at said raw material of Chinese medicine is:
Fructus Ligustri Lucidi 20-25% Radix Cirsii Japonici 12-15% Rhizoma Atractylodis Macrocephalae 10-15% Radix Salviae Miltiorrhizae 10-15%
Cortex Eucommiae 10-15% Fructus Citri Sarcodactylis 10-12% Radix Notoginseng 10-12% Rhizoma Coptidis 6-10%.
4, according to claim 1,2 or 3 described treatment hyperlipidemias, it is characterized in that said medicament is to get the extract of raw material of Chinese medicine such as the extract of water extract or ethanol extract or water extract-alcohol precipitation, or the extract of part Chinese medicine adds the medicament that the medicated powder of part Chinese medicine is made.
5,, it is characterized in that said medicament is to add the adjuvant that pharmaceutically allows with the method for Chinese medicinal of routine to make any peroral dosage form: tablet, granule, capsule, pill, syrup, oral liquid according to claim 1,2 or 3 described treatment hyperlipidemias.
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