CN100369622C - Blood fat-reducing Chinese medicine and preparation method thereof - Google Patents
Blood fat-reducing Chinese medicine and preparation method thereof Download PDFInfo
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Abstract
The present invention discloses a blood fat reducing Chinese medicine and a preparation method thereof, which relates to a Chinese medicine and a preparation method thereof. The present invention provides a blood fat reducing Chinese medicine and a preparation method thereof aiming at the problem of inexact therapeutic effects existing in the present blood fat reducing Chinese medicines. The blood fat reducing Chinese medicine is prepared by red sage roots of 140 g, lanceolata of 70g, angelica of 70g, sanqi of 47g, gastrodia elata of 90g, earthworms of 70g, cassia seeds of 70g, hawthorns of 70g, rhizoma polygonati of 70g, fleece-flower roots of 70g, dodder of 70g, dried old orange peels of 90g, pinellia tubers of 70g and bupleurum of 70g. The present invention has the preparation method that sanqi, angelica, bupleurum and earthworms are made into fine powders; alcohol extraction is carried out on red sage roots; water extraction and remixture are carried out on other constituents. The blood fat reducing Chinese medicine of the present invention has good curative effects on the treatment of hypercholesterolemia, hypertriglyceridemia and combined hyperlipidemia familial, and the present invention has the foremost clinical characteristics of conspicuous curative effects on blood fat in hypertriglyceridemia, simple and easy operation of the preparation method, and benefit to popularization and application.
Description
Technical field
The present invention relates to a kind of blood fat reducing Chinese medicine and preparation method thereof.
Background technology
Show that according to Ministry of Public Health Chinese residents Health Situation investigation report there am secret worry in I at 1 national health present situation.Subject matter is that the fat absorption is many, and physical exertion causes suffering from multiple chronic disease chance less and increases.Point out in the investigation statistics report, China adult blood fat anomalous number 1.6 hundred million, prevalence is 18.6%; The hyperpietic is 1.6 hundred million.Hyperlipidemia be cardiovascular and cerebrovascular disease initiating because of, the result shows according to Epidemiological study, the whole world has more than 3,600 ten thousand people to die from cardiovascular and cerebrovascular disease every year approximately, and the heart infarction that China causes because of hyperlipidemia every year, cerebral infarction, apoplexy, hemiplegia, the number that disables, causes death rise with the speed of average annual growth 12%.At present, adult's blood fat of China 1/3 is generally higher, causes nearly 3,500,000 people of patient of apoplexy every year.So develop the energy treating both the principal and secondary aspects of a disease, the preventing angiocardiopathy or cerebrovascular diseases medicine that carries out wholistic therapy is not only the urgent need of clinical medicine, also is above-mentioned patient's urgent need.
Hyperlipemia is atherosclerotic primary risk factor, and the cardiovascular and cerebrovascular disease due to the atherosclerosis is one of current principal disease that jeopardizes human health and life.The coronary heart disease study on prevention that U.S. cardiovascular and cerebrovascular vessel academy carried out 7 years confirms: the application of fat-reducing medicament can reduce heart and brain mortality rate 24%, reduces non-lethality heart attack rate 19%.Blood fat reducing can delay or alleviate the development of atherosclerotic lesion, and promotes it to disappear.At present, though multiple Western medicine has effect for reducing fat, prolonged application has untoward reaction more.Therefore, by the research to Chinese medicine, the medicine of seeking out a kind of safe, reliable and effective blood fat reducing just seems extremely important.
Chinese medicine preparation has curative effect and affirms, fills a prescription flexibly, few side effects, series of advantages such as medicine foodization.The clinical progress of Chinese medicine blood fat reducing, along with going deep into of Recent study, no matter experimentation or clinical research all obtained great success.But existing blood fat reducing medicine majority does not all reach comprehensive coordination treatment, the function for the treatment of both the principal and secondary aspects of a disease.
Summary of the invention
Have the problem that prescription is unreasonable, uncertain therapeutic efficacy is cut at existing blood fat reducing Chinese medicine, the invention provides a kind of blood fat reducing Chinese medicine and preparation method thereof with obvious blood fat reducing effect and determined curative effect.
A kind of blood fat reducing Chinese medicine, it is to be prepared from by each composition that accounts for following weight: Radix Salviae Miltiorrhizae 140g, Radix Codonopsis 70g, Radix Angelicae Sinensis 70g, Radix Notoginseng 47g, Rhizoma Gastrodiae 90g, Pheretima 70g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g, Radix Bupleuri 70g.
A kind of blood fat reducing preparation method of Chinese medicine, it may further comprise the steps:
A. standby with being ground into 120 purpose fine powders after Radix Notoginseng 47g, Radix Angelicae Sinensis 70g, Radix Bupleuri 70g and the Pheretima 70g drying;
B. Radix Salviae Miltiorrhizae 140g with account for its 6 times of weight, volumetric concentration is 95% ethanol extraction 3 times, extracts merge extractive liquid,, the extractum of the relative density 1.30 when reclaiming ethanol and being concentrated into 80 ℃ 1.5 hours at every turn;
C. the Radix Salviae Miltiorrhizae residue after Radix Codonopsis 70g, Rhizoma Gastrodiae 90g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g and b step being extracted adds the decocting that accounts for 12 times of amounts of gross weight and boils three times, each 2 hours, collecting decoction, filter, the relative density when filtrate is concentrated into 80 ℃ is 1.35 extractum;
D. with the Radix Salviae Miltiorrhizae extractum mix homogeneously of c step gained extractum and b step, add the fine powder of a step, 60 ℃ of oven dry are ground into 120 order fine powders, promptly.
The angle that Chinese medicine of the present invention is seen from human body integral is carried out scientific composition at the cause of disease, pathogenesis, and this medicine not only can benefiting QI for activating blood circulation, the dissipating blood stasis of promoting blood circulation, but also can dredge the regulating QI machine, and intestinal stasis relieving eliminates the phlegm.Can blood circulation and channel invigorating, blood fat reducing, can also QI invigorating to effect a permanent cure, eliminate the phlegm, dredge the regulating QI machine to take stopgap measures, accomplish to carry out the coordination treatment for the treatment of both the principal and secondary aspects of a disease at multiple factor disease.Show according to test statistics, Chinese medicine of the present invention can obviously reduce hyperlipidemia, triglyceride, cholesterol level, and low-density lipoprotein cholesterol, the high density lipoprotein increasing cholesterol, treatment hyperlipemia, cerebral thrombosis are reached diseases such as losing disease thereafter fabulous effect is arranged, test of pesticide effectiveness proof also can blood fat reducing, changes the effect of blood fluidity.
Therefore, Chinese medicine of the present invention with its prescription rationally, compatibility superior, the brilliance for the treatment of both the principal and secondary aspects of a disease is not only dredged blood vessels, blood fat reducing, and has the ability of immunoregulation effect and enhancing body adaptation former state, give full play to reinforcing and set upright, transfer the ability that body self is regulated.In these areas, Chinese medicine of the present invention not only is better than chemical medicine, and is better than similar Chinese patent medicine, and pharmacodynamic experiment and clinical studies result have also confirmed this point, and the simple operation easily of described preparation method, is beneficial to and applies.
The specific embodiment
The specific embodiment one: present embodiment is a kind of blood fat reducing Chinese medicine, and it is to be prepared from by each composition that accounts for following weight: Radix Salviae Miltiorrhizae 140g, Radix Codonopsis 70g, Radix Angelicae Sinensis 70g, Radix Notoginseng 47g, Rhizoma Gastrodiae 90g, Pheretima 70g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g, Radix Bupleuri 70g.
In the described component of present embodiment, Radix Salviae Miltiorrhizae is a monarch drug, benefiting blood and regulating blood circulation, blood circulation promoting and blood stasis dispelling; With Radix Codonopsis, Radix Angelicae Sinensis, Pericarpium Citri Reticulatae be ministerial drug, benefit gas and QI and blood, moisturize laxation, dissipating blood stasis blood; Be adjuvant drug with Radix Notoginseng, Rhizoma Gastrodiae, Pheretima, Semen Cassiae, Fructus Crataegi, Rhizoma Polygonati, Radix Polygoni Multiflori, Semen Cuscutae, the Rhizoma Pinelliae, Radix Bupleuri again.Wherein Radix Notoginseng, Rhizoma Gastrodiae, Pheretima principal drug assistance promoting blood circulation to remove obstruction in the collateral, hold concurrently with qi boosting calm panting; The Semen Cassiae liver heat removing and eyesight improving; Can stagnate, remove blood fat with Fructus Crataegi clearly with 5; Rhizoma Polygonati, Radix Polygoni Multiflori, Semen Cuscutae invigorating middle warmer gas, benefiting essence-blood, make eye bright and to help the merit of ministerial drug Radix Codonopsis, Radix Angelicae Sinensis tonification; The regulating QI machine is dredged in the Rhizoma Pinelliae, Radix Bupleuri one rise and one drop.Comprehensive this side, monarch, minister, the common compatibility of adjuvant drug, send medicine in order, through-supplementation, play the benefiting QI for activating blood circulation dissipating blood stasis of promoting blood circulation altogether, by the effect of expectorant intestinal stasis relieving, thin regulating QI machine.
The described blood fat reducing preparation method of Chinese medicine of present embodiment may further comprise the steps:
A. standby with being ground into 120 purpose fine powders after Radix Notoginseng 47g, Radix Angelicae Sinensis 70g, Radix Bupleuri 70g and the Pheretima 70g drying;
B. Radix Salviae Miltiorrhizae 140g with account for its 6 times of weight, volumetric concentration is 95% ethanol extraction 3 times, extracts merge extractive liquid,, the extractum of the relative density 1.30 when reclaiming ethanol and being concentrated into 80 ℃ 1.5 hours at every turn;
C. the Radix Salviae Miltiorrhizae residue after Radix Codonopsis 70g, Rhizoma Gastrodiae 90g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g and b step being extracted adds the decocting that accounts for 12 times of amounts of gross weight and boils 3 times, each 2 hours, collecting decoction, filter, the relative density when filtrate is concentrated into 80 ℃ is 1.35 extractum;
D. with the Radix Salviae Miltiorrhizae extractum mix homogeneously of c step gained extractum and b step, add the fine powder of a step, 60 ℃ of oven dry are ground into 120 order fine powders, promptly.
Present embodiment is divided into three parts according to the character of each herbal medicine in the prescription and the situation of chemical constituent with it: (1) Radix Angelicae Sinensis, Radix Notoginseng, Pheretima, Radix Bupleuri add with fine powder, wherein Radix Notoginseng is comparatively valuable, Radix Angelicae Sinensis, Radix Bupleuri contain volatile ingredient, Pheretima contains the enzyme composition, therefore not only can guarantee curative effect but also can replace excipient to play absorbent; (2) in the side in the monarch drug Radix Salviae Miltiorrhizae effective ingredient Radix Salviae Miltiorrhizae quinones fat-soluble stronger, and its water soluble ingredient still contains, thus Radix Salviae Miltiorrhizae with alcohol extraction, its residue is put forward part with water and is mixed and fry in shallow oil, and does not run off to possess the effect composition; (3) all the other compositions are with water extraction, and effective ingredient all can be extracted out in the group fries in shallow oil.
Preferably being investigated with orthogonal experiment of Radix Salviae Miltiorrhizae extraction process, the condition of investigation are four factors, three levels, and investigating index is the content of tanshinone.Be preferably 6 times of amounts of 95% ethanol through the test optimum condition and extract each 1.5 hours 3 times.
The orthogonal experiment that preferably also adopts of water extraction part technology is investigated, and the condition of investigation is three factors, three levels, and investigating index is the content of total solid.Be preferably the water extraction 3 times that adds 12 times of amounts, each 2 hours through the test optimum condition.
Problem about volatile oil has been carried out following research: volatile oil and medicine indication are irrelevant in (1) Pericarpium Citri Reticulatae, and be only relevant with gastroenteropathy, so only considered the flavones ingredient of its fixed oil; (2) volatile oil in the Radix Bupleuri and the volatile oil in the Radix Angelicae Sinensis add with fine powder form.
About the research of moulding process, because the Radix Salviae Miltiorrhizae extractum yield is lower, only have an appointment 8.33%, so for avoiding loss to be convenient to disperse, its relative density is decided to be 1.30 (80 ℃ of heat are surveyed).The water extracted immersing paste part then is concentrated into relative density 1.35 (80 ℃ of heat are surveyed), disperses to absorb all more suitable under this relative density.In three batches test agent show orthogonal test preferred process conditions and moulding process be feasible, can be used for producing in enormous quantities.
In addition, the weight of each component of the present invention is described purpose and is to illustrate proportionate relationship between each component, in actual use, so long as described ratio, promptly should be within protection scope of the present invention, and be not limited to concrete weight.In addition, each components in proportions neither absolute figure, allows to have in actual use up-down error, therefore all should be within protection scope of the present invention.
The pharmacodynamic experiment summary:
With component of the present invention: Radix Salviae Miltiorrhizae 140g, Radix Codonopsis 70g, Radix Angelicae Sinensis 70g, Radix Notoginseng 47g, Rhizoma Gastrodiae 90g, Pheretima 70g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g, Radix Bupleuri 70g make fine powder by above-mentioned preparation method, incapsulate every capsules 0.5g.
Blood fat reducing Chinese medicine I phase clinical human tolerance's test statistics statement statistical conclusions of the present invention.
(1) blood fat reducing Chinese medicine single-dose of the present invention untoward reaction all do not occur in predose (2/time/days in blood fat reducing Chinese medicine) and 2 times of (8/time/days in blood fat reducing Chinese medicine) scopes of clinical recommended dose.Clinical practice safety.Do not see that important vital sign (heart rate, breathing, blood pressure, body temperature) had obvious change in 24 hours, do not see abnormal changes such as hematology, hepatic and renal function, do not see that untoward reaction takes place, follow up a case by regular visits to no abnormality seen reaction in three days after the medication.
(2) blood fat reducing Chinese medicine successive administration of the present invention (4/time in blood fat reducing Chinese medicine, 3 times/day) is 7 days, does not see that important vital sign (heart rate, breathing, blood pressure, body temperature) has obvious change.Do not see that untoward reaction such as dizziness, weak, sialorrhea, tinnitus, abdominal distention, drowsy, nasal obstruction take place, and follow up a case by regular visits to no abnormality seen reaction in three days after the medication.August 14 2004 statistical report time.
Blood fat reducing Chinese medicine I phase clinical human tolerance's Test Summary conclusion of the present invention.
Blood fat reducing Chinese medicine I phase clinical tolerance test single-dose group and multiple dosing group (accumulative total) group be totally 25 routine health volunteers, in its predose and 2 times of scopes of clinical recommended dose, untoward reaction all do not occur.Clinical practice safety.Suggestion II clinical trial phase recommended dose is 4/time in a blood fat reducing Chinese medicine, 3 times/day.August 14 2004 final report time.
Blood fat reducing treatment by Chinese herbs hyperlipemia of the present invention (expectorant stasis of blood retardance card) II clinical trial phase statistical report.
Group 234 examples are gone in this test altogether, and wherein A organizes into group 116 examples, and each 4 with blood fat reducing Chinese medicine of the present invention, every day 3 times; Finish 106 examples, 2 examples that come off are rejected 8 examples.B organizes into group 118 examples, with " ZHIMAIKANG JIAONANG " of the Yellow River, Shanxi Chinese medicine company limited production, each 5, every day 3 times; Finish 103 examples, 5 examples that come off are rejected 10 examples.
The preceding A group of treatment and B group age, height, body weight, heart rate, systolic pressure, diastolic pressure, sex, nationality, drug allergy history, the past are treated the just preceding equal tool comparability of baseline inspection (P＞0.05) of treatment such as routine and Electrocardioscopy and tcm symptom scoring and total mark, blood fat, apolipoprotein and hemorheology of history, routine blood test, hepatic and renal function, urine.
1, blood fat curative effect analysis-by-synthesis
(1) PP analyzes: 4 week of treatment, back A organized clinic control rate 26.42%, total obvious effective rate 45.28%, total effective rate 64.15% (n=106), B group clinic control rate 15.53%, total obvious effective rate 40.78%, total effective rate 58.25% (n=103).Clinic control rate A group is better than B group (P＜0.05), total obvious effective rate, two groups of difference not statistically significants of total effective rate (P＞0.05).8 week of treatment, back A organized clinic control rate 36.79%, total obvious effective rate 64.15%, total effective rate 89.62% (n=106), B group clinic control rate 23.30%, total obvious effective rate 48.54%, total effective rate 71.84% (n=103).Clinic control rate, total obvious effective rate, total effective rate are the A group and are better than B group (P＜0.05).
(2) ITT analyzes: 4 week of treatment, back A organized clinic control rate 25.93%, total obvious effective rate 45.37%, total effective rate 63.89% (n=108), B group clinic control rate 14.81%, total obvious effective rate 39.81%, total effective rate 56.48% (n=108).Clinic control rate A group is better than B group (P＜0.05), total obvious effective rate, two groups of difference not statistically significants of total effective rate (P＞0.05).8 week of treatment, back A organized clinic control rate 36.11%, total obvious effective rate 63.89%, total effective rate 88.89% (n=108), B group clinic control rate 22.22%, total obvious effective rate 47.22%, total effective rate 69.44% (n=108).Clinic control rate, total obvious effective rate, total effective rate are the A group and are better than B group (P＜0.05).
2, TC (mmol/L) efficacy analysis
(1) PP analysis: 8 week of treatment back A group TC decline, 1.374 ± 1.032mmol/L (n=44); B group decline 0.727 ± 0.842mmol/L (n=38), the A group is better than B group (P＜0.05).
(2) ITT analysis: 8 week of treatment back A group TC decline, 1.374 ± 1.032mmol/L (n=44); B group decline 0.674 ± 0.833mmol/L (n=41), the A group is better than B group (P＜0.05).
3, TG (mmol/L) efficacy analysis
(1) PP analysis: 8 week of treatment back A group TG decline, 1.181 ± 2.266mmol/L (n=95); B group decline 0.442 ± 2.011mmol/L (n=92), the A group is better than B group (P＜0.05).
(2) ITT analysis: 8 week of treatment back A group TG decline, 1.188 ± 2.255mmol/L (n=96); B group decline 0.430 ± 1.991mmol/L (n=94), the A group is better than B group (P＜0.05).
4, HDL-C (mmol/L) efficacy analysis
(1) PP analysis: 8 week of treatment back A group HDL-C rising, 0.350 ± 0.448mmol/L (n=8); B group rising 0.390 ± 0.400mmol/L (n=12), two groups of difference not statistically significants (P＞0.05).
(2) ITT analysis: 8 week of treatment back A group HDL-C rising, 0.350 ± 0.448mmol/L (n=8); B group rising 0.390 ± 0.400mmol/L (n=12), two groups of difference not statistically significants (P＞0.05).
5, LDL-C (mmol/L) efficacy analysis
(1) PP analysis: 8 week of treatment back A group LDL-C decline, 0.929 ± 1.008mmol/L (n=45); B group decline 0.992 ± 1.287mmol/L (n=49), two groups of difference not statistically significants (P＞0.05).
(2) ITT analysis: 8 week of treatment back A group LDL-C decline, 0.929 ± 1.008mmol/L (n=45); B group decline 0.924 ± 1.260mmol/L (n=53), two groups of difference not statistically significants (P＞0.05).
6, tcm syndrome curative effect analysis-by-synthesis
(1) PP analyzes: 8 week of treatment, back A organized clinic control rate 8.49%, total obvious effective rate 41.51%, total effective rate 94.34% (n=106), B group clinic control rate 5.83%, total obvious effective rate 25.24%, total effective rate 86.41% (n=103).Two groups of difference not statistically significants of clinic control rate and total effective rate (P＞0.05), total obvious effective rate A group is better than B group (P＜0.05)
(2) ITT analyzes: 8 week of treatment, back A organized clinic control rate 8.33%, total obvious effective rate 40.74%, total effective rate 93.52% (n=108), B group clinic control rate 5.56%, total obvious effective rate 24.07%, total effective rate 83.33% (n=108).Two groups of difference not statistically significants of clinic control rate (P＞0.05), total obvious effective rate and total effective rate are the A group and are better than B group (P＜0.05).
7, tcm symptom total mark changing value is analyzed
(1) PP analysis: 8 week of treatment back A group tcm symptom total marks decline, 8.057 ± 4.105 (n=106); B group decline 7.388 ± 4.171 (n=103), two groups of difference not statistically significants (P＞0.05).
(2) I TT analysis: 8 week of treatment back A group tcm symptom total marks decline, 7.972 ± 4.128 (n=108); B group decline 7.130 ± 4.271 (n=108), two groups of difference not statistically significants (P＞0.05).
8, safety analysis
Untoward reaction 2 examples take place in the A group, and incidence rate is 1.72%; The B group has no adverse reaction two groups of difference not statistically significants (P＞0.05).June 29 2005 statistical report time.
II phase clinical research final report conclusion.
Clinical research is the result show: blood fat reducing treatment by Chinese herbs hyperlipemia of the present invention (expectorant stasis of blood retardance card) determined curative effect, no obvious adverse reaction takes place during the clinical trial.Security inspection is not found toxic and side effects.The III clinical trial phase is proceeded in suggestion.June 29 2005 final report time.
Blood fat reducing treatment by Chinese herbs hyperlipemia of the present invention (expectorant stasis of blood retardance card) III clinical trial phase statistical report.
Group 479 examples are gone in test altogether, and wherein A organizes into group 359 examples, and each 4 with blood fat reducing Chinese medicine of the present invention, every day 3 times; The A group is finished 319 examples, and 35 examples that come off are rejected 5 examples.B organizes into group 120 examples, with " ZHIMAIKANG JIAONANG " of the Yellow River, Shanxi Chinese medicine company limited production, each 5, every day 3 times; The B group is finished 107 examples, and 9 examples that come off are rejected 4 examples.
The preceding A of treatment organizes and B organizes age, sex, nationality, height, body weight, heart rate, systolic pressure, diastolic pressure, drug allergy history, previously treat history, hyperlipemia classification and tcm symptom scoring and total mark, blood fat, apolipoprotein etc. treats the preceding equal tool comparabilities of baseline inspection (P＞0.05).Except that reject and the case that comes off, two groups of case compliances are good (P＞0.05) all.
1, blood fat curative effect analysis-by-synthesis
(1) PPS analyzes: 8 week of treatment, back A organized clinic control rate 67.40%, total obvious effective rate 72.10%, total effective rate 80.56% (n=319), B group clinic control rate 54.21%, total obvious effective rate 60.75%, total effective rate 74.77% (n=107).Clinic control rate, total obvious effective rate are the A group and are better than B group (P＜0.05).
(2) FAS analyzes: 8 week of treatment, back A organized clinic control rate 65.82%, total obvious effective rate 70.62%, total effective rate 79.38% (n=354), B group clinic control rate 51.72%, total obvious effective rate 58.62%, total effective rate 72.41% (n=116).Clinic control rate, total obvious effective rate are the A group and are better than B group (P＜0.05).
2, TC (mmol/L) efficacy analysis
(1) PPS analysis: 8 week of treatment back A group TC decline, 1.45 ± 1.27mmol/L (n=97); B group decline 1.16 ± 1.45mmol/L (n=24), two groups of difference not statistically significants (P＞0.05).
(2) FAS analysis: 8 week of treatment back A group TC decline, 1.36 ± 1.25mmol/L (n=112); B group decline 1.11 ± 1.44mmol/L (n=25), two groups of difference not statistically significants (P＞0.05).
3, TG (mmol/L) efficacy analysis
(1) PPS analysis: 8 week of treatment back A group TG decline, 1.29 ± 1.71mmol/L (n=286); B group decline 0.89 ± 1.38mmol/L (n=98), the A group is better than B group (P＜0.05).
(2) FAS analysis: 8 week of treatment back A group TG decline, 1.26 ± 1.73mmol/L (n=312); B group decline 0.88 ± 1.40mmol/L (n=106), the A group is better than B group (P＜0.05).
4, tcm syndrome curative effect analysis-by-synthesis
(1) PPS analyzes: 8 week of treatment, back A organized clinic control rate 6.27%, total obvious effective rate 45.77%, total effective rate 90.28% (n=319), B group clinic control rate 6.54%, total obvious effective rate 37.38%, total effective rate 89.72% (n=107).Two groups of difference not statistically significants (P＞0.05).
(2) FAS analyzes: 8 week of treatment, back A organized clinic control rate 5.93%, total obvious effective rate 44.35%, total effective rate 90.11% (n=354), B group clinic control rate 6.90%, total obvious effective rate 36.21%, total effective rate 87.93% (n=116).Two groups of difference not statistically significants (P＞0.05).
5, tcm symptom total mark changing value is analyzed
(1) PPS analysis: 8 week of treatment back A group tcm symptom total marks decline, 8.04 ± 4.63 (n=319); B group decline 7.54 ± 4.45 (n=107), two groups of difference not statistically significants (P＞0.05).
(2) FAS analysis: 8 week of treatment back A group tcm symptom total marks decline, 7.77 ± 4.57 (n=354); B group decline 7.21 ± 4.48 (n=116), two groups of difference not statistically significants (P＞0.05).
6, safety analysis
The A group has no adverse reaction; Untoward reaction 3 examples take place in the B group, and incidence rate is 2.50%.Adverse reaction rate B group is higher than A group (P＜0.05).
III phase clinical research final report conclusion.
Clinical research is the result show: blood fat reducing treatment by Chinese herbs hypercholesterolemia of the present invention, hypertriglyceridemia and combined hyperlipidemia familial all have good efficacy, and its topmost clinical characters is evident in efficacy to the hypertriglyceridemia blood fat.No obvious adverse reaction takes place during the clinical trial.Security inspection is not found toxic and side effects.Blood fat reducing Chinese medicine is as a kind of lipid lowerers, and clinically be used for the treatment of and prevent cardiovascular and cerebrovascular disease, be effective and safe drug.
Claims (2)
1. a blood fat reducing Chinese medicine is characterized in that it is to be prepared from by each composition that accounts for following weight: Radix Salviae Miltiorrhizae 140g, Radix Codonopsis 70g, Radix Angelicae Sinensis 70g, Radix Notoginseng 47g, Rhizoma Gastrodiae 90g, Pheretima 70g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g, Radix Bupleuri 70g.
2. described blood fat reducing preparation method of Chinese medicine of claim 1 is characterized in that it may further comprise the steps:
A. standby with being ground into 120 purpose fine powders after Radix Notoginseng 47g, Radix Angelicae Sinensis 70g, Radix Bupleuri 70g and the Pheretima 70g drying;
B. Radix Salviae Miltiorrhizae 140g with account for its 6 times of weight, volumetric concentration is 95% ethanol extraction 3 times, extracts merge extractive liquid,, the extractum of the relative density 1.30 when reclaiming ethanol and being concentrated into 80 ℃ 1.5 hours at every turn;
C. the Radix Salviae Miltiorrhizae residue after Radix Codonopsis 70g, Rhizoma Gastrodiae 90g, Semen Cassiae 70g, Fructus Crataegi 70g, Rhizoma Polygonati 70g, Radix Polygoni Multiflori 70g, Semen Cuscutae 70g, Pericarpium Citri Reticulatae 90g, Rhizoma Pinelliae 70g and b step being extracted adds the decocting that accounts for 12 times of amounts of gross weight and boils three times, each 2 hours, collecting decoction, filter, the relative density when filtrate is concentrated into 80 ℃ is 1.35 extractum;
D. with the Radix Salviae Miltiorrhizae extractum mix homogeneously of c step gained extractum and b step, add the fine powder of a step, 60 ℃ of oven dry are ground into 120 order fine powders, promptly.
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| CN104306943A (en) * | 2014-10-31 | 2015-01-28 | 吴翠霞 | Traditional Chinese medicine combination for curing hyperlipidemia |
| CN106668150A (en) * | 2016-11-09 | 2017-05-17 | 江苏金氏丹科技有限公司 | Chinese medicinal composition for lowering lipid and preparation method thereof |
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| CN1437959A (en) * | 2002-02-10 | 2003-08-27 | 杨志东 | Chinese prepartory for treating cardiovascular and cerebrovascular disease and preparation method |
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