CN106344832A - Assistant blood lipid reducing tablets and preparation method thereof - Google Patents

Abstract

The invention provides assistant blood lipid reducing tablets, belonging to the technical field of traditional Chinese medicine. The assistant blood lipid reducing tablets contain the following raw materials in parts by weight: 500-700 parts of salvia miltiorrhiza, 500-700 parts of radix puerariae, 150-300 parts of red yeast rice, 10-50 parts of propolis, 10-50 parts of green tea extract, 80-120 parts of xylitol, 30-60 parts of hydroxypropyl cellulose, 5-15 parts of silicon dioxide and 2-10 parts of magnesium stearate. The invention also provides a preparation method of the assistant blood lipid reducing tablets. The assistant blood lipid reducing tablets provided by the invention have the advantages of exact assistant blood lipid reducing effect, strong targeting property, good effect, safe dosage and sufficient theoretical basis of reducing blood lipid; the adopted raw materials are sufficient, easily available and safe to eat; the tablets of the product are more easily accepted by consumers; and the finished product is prepared by adopting the modern preparation technology through a reasonable quality control method and strict product management measures, the quality is stable, and the tablets are convenient to take. Therefore, with accurate positioning and obvious advantages, the assistant blood lipid reducing tablets provided by the invention have good development potential.

Description

A kind of auxiliary blood fat reducing piece and preparation method thereof

Technical field

The present invention relates to technical field of Chinese medicines, specifically a kind of auxiliary blood fat reducing piece and preparation method thereof.

Background technology

The lipoid material that blood fat refers in blood is referred to as, including cholesterol (tc), triglyceride (tg), phospholipid and non-free Fatty acid etc., they are combined together from different protein in blood, presented in " lipoprotein ".Wherein most Cholesterol is human body itself synthesis, and small part is obtained by diet.Triglyceride is contrary, and major part obtains from diet, Small part is synthesized by human body itself.

The abnormal response that hyperlipemia behaviour body lipid metabolic disorder occurs, is a kind of systemic disease, refers to tc in blood Or tg is too high or HDL-C (hdl-c) is too low, modern medicine is referred to as dyslipidemia.Excessive lipidosiss In endarterium, form atheromatous plaque, so that tube chamber is reduced, lead to atherosclerosiss, cause blood supply position ischemic lesions, draw Send out disease a series of, such as coronary heart disease, hypertension, apoplexy, diabetes etc..These diseases of being caused by hyperlipemia and associated Disease, serious threat China residents ' health, living standard, bring heavy spirit and financial burden also to family and society.

Research shows, the living standard of hyperlipemia and people, life style relation are very big.With rapid development of economy With the acceleration of process of industrialization, the raising of people's living standard, the life style such as the diet of people, trip also changes very big.Than As diet from " the cured fish green vegetable " in past " the chicken and duck flesh of fish " by now, high fat, high sugar, hyperpyrexia etc. are pass by 1 year seldom several times Hear, have the food occurring once in a while of celebrating the New Year or the Spring Festival only, become now everyday like the New Year.Originally go out and substantially leaned on lower limb, now wagon flow rolling inside the city Rolling is it is simply that in most of rural area, automobile is also all ordinary thing.In addition, with industrialized propulsion, people's rhythm of life is therewith Accelerate, night life is rich and varied, from child to old man, bellied person, visible at any time.Corresponding, blood fat water in recent years Gentle abnormal rate improves with our living standard, and successively raises, and current dyslipidemia has become as more serious public affairs Hygienic issues altogether.National " six or five " to " 95 " brainstorm subject discloses, and different enumeration district (ED)s, professional population blood lipid level are in serum There is notable difference in lipid level and abnormal rate.The beginning of the eighties in last century, Sino-U.S.'s Cardiovascular epidemiology joint study and north The international cooperating research such as capital-monica confirm that population of China blood lipid level is significantly lower than most of western countries.2002 " in The report of state resident's nutrition and health survey " result shows, in recent ten years, hypercholesterolemia prevalence, height in different crowd Triglyceride prevalence generally increases, and in China resident adult, high triglyceride prevalence is 11.9%, low hdl Cholesterol is 7.4%.

Blood fat raises, and can induce a lot of secondary diseases.Blood fat raises, and microvascular perfusion is difficult, and blood pressure raises.Excessive Lipidosiss, in endarterium, form atheromatous plaque, so that tube chamber is reduced, lead to atherosclerosiss, cause blood supply position ischemia Property infringement, cause a series of diseases, such as coronary heart disease, hypertension, apoplexy, diabetes etc..Clinical discovery, dyslipidemia, high blood Pressure, hyperglycemia, metabolic arthritis, fatty liver etc. often mutually advance, and mutually and deposit, have a strong impact on human life quality.Research confirms, no By be the developed countries such as America and Europe or in Asia low, middle income developing country, overweight with fat is all dyslipidemia generation The Major Risk Factors of thanking property relevant disease, dyslipidemia, type 2 diabetes mellitus, hypertension, cardiovascular and cerebrovascular vessel disease in Overweight-obesity crowd The sickness rate of disease and cancer etc. significantly raises compared with normal type crowd, and compares developed country, the body weight of developing country crowd Rising healthhazard bigger.Numerous studies confirm, serum total cholesterol increases, low-density lipoprotein cholesterol both at home and abroad Raise and HDL-C to reduce be the main of coronary heart disease and the medium atheromatosiss of ischemic cerebral apoplexy Risk factor.

The Liang Yongqian type 2 diabetes mellitus patients overweight or fat to the large sample merging of Guangdong the whole province carry out ASSOCIATE STATISTICS and divide Analysis finds: in Guangdong Province's Overweight-obesity type 2 diabetes mellitus patient's all kinds dyslipidemia prevalence, high triglyceride prevalence is Height, next to that high T-CHOL, high low density lipoprotein cholesterol and low hdl cholesterol also substantially increase；At this In the crowd of a little merging dyslipidemia, the crowd having nearly half does not accept any Drug therapy, and treatment compliance rate is relatively low.Thus it is clear that it is right The intervention early of dyslipidemia crowd is extremely urgent.

The traditional Chinese medical science does not have the name of disease of hyperlipemia, due to having uncomfortable in chest, dizziness, asthenia, the symptom such as drowsiness its clinical manifestation more, with The card such as " dizziness ", " thoracic obstruction " of the traditional Chinese medical science is quite similar." the infirmity body fluid of Ling Shu Miraculous Pivot or Divine Axis five is other " points out: " the body fluid of grain rice and combined into cream Person, endosmosis empty in bone, tonification brains, and dirty in cloudy stock." " Ling Shu Miraculous Pivot or Divine Axis disorder of defensive QI " say: " the many gas of cream person, many gas person heat, heat Person resists cold." Zhang Jingyue once said: " body fluid and the person that is combined into cream to fill up among bone sky, are then marrow for brain, are blood for essence." think fat Cream derives from body fluid, is one of base substance of human body.And " Ling Shu Miraculous Pivot or Divine Axis blood network opinion " is said: " vim and vigour are all contained and the cloudy many persons of gas, its blood Sliding, then the penetrating of thorn, yang-energy is accumulated, and stays for a long time and does not rush down person, its blood black with turbid, therefore can not penetrate." wherein " its blood black with turbid " visually Illustrate qi-blood-body fluid Metabolic disorder so that phlegm-blood stasis are cemented in the situation in blood vessels, with modern hyperlipemia, high blood viscosity general Read very close.According to " cream ", " fat " operation not normal after with the turbid stasis of blood of phlegm-damp property this feature very close, treatment from expectorant The stasis of blood is started with, and can eliminate that unnecessary fat in blood is turbid, reaches the purpose for the treatment of hyperlipemia.Because hyperlipemia is mainly in person in middle and old age People, all dirty virtual loss of spleen, kidney are that it is inevitable, therefore on the basis of dissipating phlegm and removing blood stasis method for the treatment of, in conjunction with adjustment spleen, all dirty functions of kidney, Treating both the principal and secondary aspects of a disease can be reached, consolidate the purpose radically reformed.

Chinese medicine lipid-loweringing has the advantages that stable curative effect, Small side effects.Each traditional Chinese medical science scholar is all in terms of lipid-lowering therapy There is achievement.Wherein Li Yulan proposes, and hyperlipemia Etiological is due to natural endowment defect, eating and drinking without temperance, disorder of emotion, dirty The deficiency of vital energy declines, FU QI being obstructed etc..Therefore advocate to control primary disease from phlegm-damp, blood stasis opinion.

Human lives tend to urbanization and industrialized result, are on the one hand to bring promising intellectual treasure, but separately On the one hand, at this stage, people with hyperlipidemia is but led to quickly to increase.Hyperlipidemia causes a series of diseases, such as coronary heart disease, high blood Pressure, apoplexy, diabetes etc., serious threat China residents ' health, living standard, bring heavy spirit also to family and society And financial burden.

Through consulting state food pharmaceuticals administration general bureau health food official written reply data base, end in April, 2016, granted The accurate health food with auxiliary lipid-lowering function reaches 571.Wherein it is mainly soft capsule (216), raw material is with fish oil, depth Based on ocean fishes oil, phospholipid substance；Hard capsule (180)；Next to that tablet (46), medicinal tea (49).It can be seen that having auxiliary Commercially competing product are less to help the Chinese medicine lipid-lowering health food of hypolipemic function, constantly sending out with modernization of Chinese medicine industry process Exhibition is perfectly combined with modern crafts with growth, genuine selection, makes the safety of modern Chinese medicine compare Western medicine again even better, more It is important that Reducing Blood Lipid by Chinese medicine can be set about from old complaint, and nurse one's health blood fat effect stability, Small side effects, be specialty conditioning hyperlipidemia Most scientific method, also reflects the huge consumer group of hyperlipidemia crowd and the larger market space simultaneously.

Make a general survey of present Research in recent years, Chinese medicine is used for assisting blood fat reducing to have long history, motherland's culture of 5,000 years Develop Chinese medicine auxiliary blood fat reducing for us and established solid foundation, have many to have the ancient name side of effect for reducing blood fat.

Content of the invention

In view of this, the present invention is intended to provide a kind of assist blood fat reducing piece.

For reaching above-mentioned purpose, the technical scheme is that and be achieved in that: a kind of auxiliary blood fat reducing piece, by weight Number meter includes the following raw material component: Radix Salviae Miltiorrhizae 500-700 part, Radix Puerariae 500-700 part, Monas cuspurpureus Went 150-300 part, propolis 10-50 part, green Tea extract 10-50 part, xylitol 80-120 part, Hydroxypropyl Cellulose 30-60 part, silicon dioxide 5-15 part, magnesium stearate 2-10 Part.

Further, also include film coating agent 20-50 part.

Further, meter includes the following raw material component by weight: Radix Salviae Miltiorrhizae 600-700 part, Radix Puerariae 600-700 part, red Bent 150-200 part, propolis 20-50 part, green tea extract 20-50 part, xylitol 80-120 part, Hydroxypropyl Cellulose 30-50 part, two Silicon oxide 5-10 part, magnesium stearate 2-6 part, film coating agent 30-45 part.

Further, meter includes the following raw material component: 625 parts of Radix Salviae Miltiorrhizae, 625 parts of Radix Puerariae, Monas cuspurpureus Went 187.5 by weight Part, 37.5 parts of propolis, 37.5 parts of green tea extract, 109 parts of xylitol, 45 parts of Hydroxypropyl Cellulose, 9 parts of silicon dioxide, stearic acid 4.5 parts of magnesium, 36 parts of film coating agent.

Present invention also offers the preparation method of above-mentioned auxiliary blood fat reducing piece it is characterised in that: comprise the steps:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are sieved, obtains mixing Powder i；Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are sieved respectively；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add decocting to boil, filter, merging filtrate, by filtrate Concentrating under reduced pressure, obtains extractum；

(3) it is dried: extractum is spray-dried, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mix Close, obtain mixed powder ii.

(5) pelletize: appropriate 80%-90% ethanol will be added in mixed powder ii to make soft material, granulation, dry, granulate, obtain dry Granule；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mixing, always obtain Mixture；

(7) tabletting is carried out to always mixed thing, add film coating agent that coated tablet is obtained.

Further, the decocting of 10 times amount is added to boil in described step (2) 2 times, each 1.5h.

Further, in described step (2), the condition of concentrating under reduced pressure is 60-80 DEG C, -0.06--0.1mpa.

Further, in described step (2), filtrate reduced in volume being obtained relative density when 70 DEG C is 1.05-1.15g/ cm³Extractum.

Further, spray drying EAT 170-180 DEG C in described step (3).

Further, the incorporation time in described step (4) is 20-50min.

Further, appropriate 90% ethanol will be added in mixed powder ii to make soft material in described step (5), with 18 mesh sieve series Grain, is 5% in 50 DEG C of dryings to moisture, with 16 mesh granulate, obtains dry particl.

Further, the incorporation time in described step (6) is 10-30min.

Further, described step (7) is to carry out tabletting to always mixed thing, film coating agent is made dense with 70% ethanol Spend the coating solution for 12% and be coated to obtain coated tablet.

Safety research

1. the safety research of Radix Salviae Miltiorrhizae

Poplar solution people etc. measure mice and rat ld50 with bliss method；Rabbit auricular vein instillation, erythrocyte in vitro suspension Cause haemolysis and agglutination test, vascular stimulation tests and Cavia porcelluss sensitization test (STT) to observe local application's toxicity, observe Radix Salviae Miltiorrhizae glucose The acute toxicity of injection (Radix Salviae Miltiorrhizae) and local application's toxicity.Result shows the ld50 of large and small tail vein injection Radix Salviae Miltiorrhizae respectively For 27.02g/kg and 26.89g/kg, mice i.p is 36.09g/kg；Rabbit i.v5d no obvious irritation；Cavia porcelluss have no allergy Reaction；External variable concentrations Radix Salviae Miltiorrhizae no causes haemolysis and agglutination to rabbit red cell suspension.It is taken as that Radix Salviae Miltiorrhizae acute toxicity Very little, nothing substantially local application's toxic reaction.

2. the safety research of Radix Puerariae

Chen little Qing etc. with horn method, tested by oral contamination approach, inquires into the acute oral toxicity of Radix Puerariae.Conclusion Pueraria lobota The median lethal dose(LD 50) (ld50) of root is more than 21.509/kg bw, belongs to nontoxic level.The research of Zhan Jian etc. [21] shows, the warp of Radix Puerariae Mouthful to the ld50 of mice within 20g/kg, belong to nontoxic scope；From screening mutagenicity test, mouse inbred strain, bone Marrow polychromatic erythrocyte micronucleus test and ames test as feminine gender, do not find that Radix Puerariae has and cause mammalian somatic cell, reproduction is thin Born of the same parents and bacterial gene mutation effect, show Radix Puerariae edible safety.

3. the safety research of Monas cuspurpureus Went

Du Xinfang etc. adopts maximum tolerated dose method research acute toxicity；Using ames test (ames test), Micronucleus test and mouse inbred strain research mutagenicity, the urgency of research Monas cuspurpureus Went extract Property toxicity and mutagenicity.Result shows Kunming mouse with maximum dosage-feeding for 15g/kg gavage, the no obvious nosotoxicosiss of mice Shape is also no dead；Ames test, is tried from tetra- kinds of bacterial strains of ta97, ta98, tal00, tal02 in the case of adding and being not added with two kinds of s9 Testing result is that mutation is negative；The microkernel incidence of 3 Liu's amount groups of mouse marrow cell micro nuclear test is compared with negative control group no Significant difference: the cacospermia rate of test group also no significant difference compared with negative control group in mouse inbred strain. It is taken as that the toxicity level of Monas cuspurpureus Went extract is nontoxic level；Under test conditions, do not find that it has mutagenicity.State food State's food medicine prison that Drug Administration issues is permitted [2010] No. 2 files " with regard to Monas cuspurpureus Went etc. for raw material healthy food products Shen Report and the notice evaluating relevant issues " clear stipulaties: Monas cuspurpureus Went recommended dose is fixed tentatively daily and is less than 2g.In this product, Monas cuspurpureus Went is every Day dose is 1.5g, is therefore safe.

4. the safety research of propolis

The maximum dose levels such as Fu Jianhua press 100 times of tested material day for human beings recommended amounts, in rat continuous gavage bee glue soft capsule Tolerant 30 days, the toxicity of research propolis.Result shows body weight and its weightening, food-intake, the food utilization of each dosage group rat All not statistically significant with matched group comparing difference (p ＞ is o.05)；Individual dose group blood biochemistry, routine blood indexes and matched group ratio Relatively, difference statistically significant (p ＜ 0.05), but all in range of normal value, therefore think abiology meaning；Other each dosage Group animal routine blood test (content of hemoglobin, red blood cell count(RBC), numeration of leukocyte, leukocyte differential count), every biochemical indicator (serum Glutamate pyruvate transaminase, glutamic oxaloacetic transaminase, GOT, blood urea nitrogen, creatinine, T-CHOL, triglyceride, blood glucose, total protein, albumin) measured value All in range of normal value；The dirty body of rat compares than with matched group, no significant difference；Make tissue disease to by inspection internal organs Inspection of science, has no specific lesions.It is taken as that rat continuously takes propolis 30d, harmful effect is had no to body.

5. the safety research of green tea extract

To white mouse respectively with dosage 4.5,3.57,2.84,2.26 and 1.8g/kg, disposable gavage (ig) is administered Lu Yi etc., Observe 7d, calculating ld50 by improvement karber's method is (2.64 ± 0.254) g/kg.To rat with high dose be 833,83.3mg/ The green tea extract ig of kg tea polyphenols, continuous gavage 6 months, observe long term toxicity reaction.Result shows that rat gavages for a long time After tea polyphenols, body weight increase, routine blood test, blood biochemical and organ coefficient indices all within normal range, histopathology Check no abnormality seen.It is taken as that tea polyphenols acute toxicity is low.Rat gavages tea polyphenols (833mg/kg d-1), phase for a long time When intending with 100 times of daily dose being also safe in people.

With respect to prior art, present invention has the advantage that

The present invention is the producing cause in comprehensive analysis hyperlipidemia, the symptom of hyperlipidemia, and the situation of crowd, according to mesh Before be mainly used in the functional characteristics prescription reducing hyperlipidemia raw material.Formula is with Radix Salviae Miltiorrhizae, Radix Puerariae, Monas cuspurpureus Went, propolis (essence System), green tea extract be primary raw material composition, wherein Radix Salviae Miltiorrhizae blood circulation promoting and blood stasis dispelling, inducing menstruation to relieve menalgia, relieving restlessness that clears away heart-fire, cool blood to disappear carbuncle.Radix Puerariae Yang invigorating dredge the meridian passage promotes the production of body fluid；Monas cuspurpureus Went strengthening the spleen to promote digestion, benefiting QI for activating blood circulation, " book on Chinese herbal medicine asks former " calls it: " can walk ying-qi to invigorate blood circulation, dry diabetes involving middle-JIAO Food.The disease of all the seven emotions and the six sensory pleasures all preferably helps it in gas so that the puckery person of blood ".Propolis pharmacopeia calls it: qi-restoratives is weak, changes turbid fat.Plus tea Effective site green tea extract, Tang's supplement to the Herbal says " long food makes us thin ".All medicines share, invigorating the spleen for eliminating dampness, blood circulation promoting and blood stasis dispelling, rise Sunization is turbid, reaches the effect that the fat that disappears is made light of one's life by commiting suicide, and may also operate as improving the effect of the sub-health state of hyperlipidemia crowd.

Another research through animal function test and human experiment shows that the present invention has definite auxiliary lipid-lowering efficacy, specific aim By force, effect is good, consumption safety, and blood fat reducing theoretical foundation is abundant；The raw materials used ample supply and prompt delivery of the present invention, be easy to get, edible safety；And The present invention selects tablet to be easier to be esthetically acceptable to the consumers；Finished product adopt Modern preparations technique, rational method of quality control with And make under strict management of product measure, steady quality, taking convenience.Therefore, accurate positioning of the present invention, with the obvious advantage, tool There is good development potentiality.

Specific embodiment

Each raw material components of the present invention are commercially available prod, and its supplier and manufacturer are as shown in table 1.

The source of each raw material components of table 1 present invention

Embodiment one

A kind of auxiliary blood fat reducing piece, meter by weight includes the following raw material component: Radix Salviae Miltiorrhizae 625g, Radix Puerariae 625g, Monas cuspurpureus Went 187.5g, propolis 37.5g, green tea extract 37.5g, xylitol 109g, Hydroxypropyl Cellulose 45g, silicon dioxide 9g, magnesium stearate 4.5g, film coating agent 36g.

Present invention also offers the preparation method of above-mentioned auxiliary blood fat reducing piece it is characterised in that: comprise the steps:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are crossed 80 mesh sieves, obtains Mixed powder i；Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are crossed respectively 80 mesh sieves；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add the decocting of 10 times amount to boil 2 times, each 1.5h, Filter, merging filtrate, by filtrate reduced in volume, the condition of concentrating under reduced pressure is 60-80 DEG C, and -0.06--0.1mpa obtains 70 DEG C of phases It is 1.05-1.15g/cm to density³Extractum；

(3) it is dried: extractum is spray-dried, 170 DEG C of inlet temperature, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mix Close 30min, obtain mixed powder ii；

(5) pelletize: appropriate 90% ethanol will be added in mixed powder ii to make soft material, pelletized with 18 mesh sieves, in 50 DEG C of dryings It is 5% to moisture, with 16 mesh granulate, obtain dry particl；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mix 15min, Obtain total mixture；

(7) to always mix thing carry out tabletting, obtain 1000, control sheet again be 0.9g/ piece, by film coating agent with 70% second Alcohol is made the coating solution that concentration is 12% and is coated to obtain coated tablet.

Embodiment two

A kind of auxiliary blood fat reducing piece, meter by weight includes the following raw material component: Radix Salviae Miltiorrhizae 600g, Radix Puerariae 600g, Monas cuspurpureus Went 200g, propolis 50g, green tea extract 50g, xylitol 100g, Hydroxypropyl Cellulose 30g, silicon dioxide 5g, magnesium stearate 6g, thin Film coating agent 45g.

Present invention also offers the preparation method of above-mentioned auxiliary blood fat reducing piece it is characterised in that: comprise the steps:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are crossed 80 mesh sieves, obtains Mixed powder i；Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are crossed respectively 80 mesh sieves；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add the decocting of 10 times amount to boil 2 times, each 1.5h, Filter, merging filtrate, by filtrate reduced in volume, the condition of concentrating under reduced pressure is 60-80 DEG C, and -0.06--0.1mpa obtains 70 DEG C of phases It is 1.05-1.15g/cm to density³Extractum；

(3) it is dried: extractum is spray-dried, 175 DEG C of inlet temperature, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mix Close 20min, obtain mixed powder ii；

(5) pelletize: appropriate 90% ethanol will be added in mixed powder ii to make soft material, pelletized with 18 mesh sieves, in 50 DEG C of dryings It is 5% to moisture, with 16 mesh granulate, obtain dry particl；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mix 30min, Obtain total mixture；

(7) to always mix thing carry out tabletting, obtain 1000, control sheet again be 0.9g/ piece, by film coating agent with 70% second Alcohol is made the coating solution that concentration is 12% and is coated to obtain coated tablet.

Embodiment three

A kind of auxiliary blood fat reducing piece, meter by weight includes the following raw material component: Radix Salviae Miltiorrhizae 700g, Radix Puerariae 700g, Monas cuspurpureus Went 200g, propolis 20g, green tea extract 20g, xylitol 80g, Hydroxypropyl Cellulose 50g, silica 1 0g, magnesium stearate 2g, thin Film coating agent 30g.

Present invention also offers the preparation method of above-mentioned auxiliary blood fat reducing piece it is characterised in that: comprise the steps:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are crossed 80 mesh sieves, obtains Mixed powder i；Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are crossed respectively 80 mesh sieves；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add the decocting of 10 times amount to boil 2 times, each 1.5h, Filter, merging filtrate, by filtrate reduced in volume, the condition of concentrating under reduced pressure is 60-80 DEG C, and -0.06--0.1mpa obtains 70 DEG C of phases It is 1.05-1.15g/cm to density³Extractum；

(3) it is dried: extractum is spray-dried, 180 DEG C of inlet temperature, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mix Close 45min, obtain mixed powder ii；

(5) pelletize: appropriate 90% ethanol will be added in mixed powder ii to make soft material, pelletized with 18 mesh sieves, in 50 DEG C of dryings It is 5% to moisture, with 16 mesh granulate, obtain dry particl；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mix 20min, Obtain total mixture；

(7) to always mix thing carry out tabletting, obtain 1000, control sheet again be 0.9g/ piece, by film coating agent with 70% second Alcohol is made the coating solution that concentration is 12% and is coated to obtain coated tablet.

Example IV

A kind of auxiliary blood fat reducing piece, meter by weight includes the following raw material component: Radix Salviae Miltiorrhizae 500g, Radix Puerariae 500g, Monas cuspurpureus Went 150g, propolis 10g, green tea extract 10g, xylitol 120g, Hydroxypropyl Cellulose 60g, silica 1 5g, magnesium stearate 10g, Film coating agent 20g.

Present invention also offers the preparation method of above-mentioned auxiliary blood fat reducing piece it is characterised in that: comprise the steps:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are crossed 80 mesh sieves, obtains Mixed powder i；Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are crossed respectively 80 mesh sieves；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add the decocting of 10 times amount to boil 2 times, each 1.5h, Filter, merging filtrate, by filtrate reduced in volume, the condition of concentrating under reduced pressure is 60-80 DEG C, and -0.06--0.1mpa obtains 70 DEG C of phases It is 1.05-1.15g/cm to density³Extractum；

(3) it is dried: extractum is spray-dried, 180 DEG C of inlet temperature, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mix Close 35min, obtain mixed powder ii；

(5) pelletize: appropriate 90% ethanol will be added in mixed powder ii to make soft material, pelletized with 18 mesh sieves, in 50 DEG C of dryings It is 5% to moisture, with 16 mesh granulate, obtain dry particl；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mix 25min, Obtain total mixture；

(7) to always mix thing carry out tabletting, obtain 1000, control sheet again be 0.9g/ piece, by film coating agent with 70% second Alcohol is made the coating solution that concentration is 12% and is coated to obtain coated tablet.

Dosage form technical study

1. extraction conditions

Radix Salviae Miltiorrhizae is carried out water extraction together with Radix Puerariae by the present invention, with total pyrite as inspection target, designs three factors three Horizontal quadrature experimental factor level, the results are shown in Table 1.

Table 1 orthogonal test factor level table

Weigh Radix Salviae Miltiorrhizae and each 250g of Radix Puerariae, for a test dose, totally 9 parts, according to according to l₉(3⁴) table arrangement test, examination Test arrangement and variance analyses, the results are shown in Table 2；Variance analyses, the results are shown in Table 3.

Table 2 orthogonal test and result l₉(3⁴)

Table 3 analysis of variance table

Source of error	Sum of deviation square	Degree of freedom	Mean square	F value	P value	Significance
							a	1.84	2	0.92	13.09	P ＞ 0.05	Not notable
b	4.96	2	2.48	35.24	P ＜ 0.05	Significantly
							c	0.38	2	0.19	2.68	P ＞ 0.05	Not notable
Error (d)	0.14	2	0.07	-	-	-

f_0.05(2,2)=19.00

Conclusion: extraction time has a significant impact (p ＜ 0.05) to the extracted amount of total flavones, extraction time and the multiple pair that adds water The extracted amount impact of total flavones is not notable (p ＞ 0.05), and orthogonal experiments show that optimum process condition is a₃b₂c₂.Directly perceived point Analysis is more or less the same it can be seen that adding 10 times amount with 12 times amount water extraction results, considers selection plus 10 times amount from actual big production, because This, optimum extraction process is set to a₂b₂c₂, that is, add water 10 times amount, extracts 2 times, each 1.5h.

2. drying process

By filtrate reduced in volume, the condition of concentrating under reduced pressure is 60-80 DEG C, -0.06--0.1mpa, relative density when obtaining 70 DEG C For 1.05-1.15g/cm³Extractum, standby.

Spray drying has the advantages of drying time is fast, and material heated time is short, production operation is convenient, becomes Chinese medicine liquid A kind of ideal method of dry materials.

Extractum is sprayed in drying tower under different inlet temperature and is spray-dried by the present invention respectively, with dry materials Situation, dry powder yield, moisture content is index, observes inlet temperature to the impact being spray-dried effect, is spray-dried and investigates, result It is shown in Table 4.

Table 4 is spray-dried to be investigated

Inlet temperature (DEG C)	Drying regime	Dry powder yield (%)	Moisture content (%)
				170-180	Spray powder is loose, does not stick tower	96.2	4.5
180-190	Spray powder is loose, does not stick tower	96.7	4.1
				190-200	Spray powder is loose, does not stick tower	97.8	3.6

Conclusion: in spray-drying process, inlet temperature is different, the no significant change of dry materials situation, it is thus determined that spray The inlet temperature that mist is dried is 170～180 DEG C.

3. the selection of adjuvant

Coated tablet needs label to have certain hardness, and disintegrate also to be ensured is qualified.Therefore with pelletization, mouldability, friability Degree, disintegration time, complexity of tabletting etc. are index, take 100 slice prescription content of starting materials, investigate dosage regulator and hydroxypropyl respectively The consumption of two kinds of adjuvants of cellulose, the results are shown in Table 5, table 6.

Table 5 adjuvant selects to investigate

Prescription	1	2	3
				Extract powder	46.4	46.4	46.4
Monas cuspurpureus Went propolis mixed powder	22.5	22.5	22.5
				Green tea extract	3.75	3.75	3.75
Hydroxypropyl Cellulose	4.5	4.5	4.5
				Microcrystalline Cellulose	12.85	-	-
Dextrin	-	12.85	-
				Xylitol	-	-	12.85

Result investigated by table 6

Prescription	Hardness (kg)	Friability	Granulation situation	Disintegration time (min)
					1	～6.5	Qualified	Easily pelletize, compressibility is good	52
2	～4.6	Qualified	Easily pelletize, compressibility is good	48
					3	～6.0	Qualified	Easily pelletize, compressibility is good	45

Conclusion: Hydroxypropyl Cellulose consumption is that 0.5% and xylitol combined effect of total amount are optimal, and gained granule uniformly, can Pressure property is good, and hardness is moderate, and friability is qualified, and gained is unilateral bright and clean attractive in appearance, therefore determines that Hydroxypropyl Cellulose consumption is 45g/1000 Piece.

4. the determination of incorporation time

Take appropriate extract powder, Monas cuspurpureus Went propolis mixed powder, green tea extract, xylitol and Hydroxypropyl Cellulose, respectively mixed Close 10min, 20min, 30min sampling, investigation material mixing uniformity, and measure the content of lovastatin, the results are shown in Table 7.

Table 7 incorporation time is investigated

Conclusion: after mixing 20min, material, by evenly mixing it is contemplated that the property of material, for ensureing fully to mix, mixes Time proper extension is to 30min, therefore determines that incorporation time is 30min.

5. the selection of wetting agent

The overall hygroscopicity of raw material of the present invention is stronger, is directly pelletized with water, material too viscous it is impossible to pelletize, therefore select different The ethanol of concentration is pelletized as wetting agent, with the complexity screening wetting agent pelletized.Concrete operations are as follows: take 500 slice prescriptions Content of starting materials, is separately added into the ethanol mix homogeneously of appropriate variable concentrations, is pelletized with 18 mesh sieves, in 50 DEG C of dryings, whole with 16 mesh sieves Grain, investigates the complexity pelletized, the results are shown in Table 8.

Table 8 wetting agent selects to investigate

Determining alcohol	Phenomenon
		70%	Glutinous, difficult separation
80%	Slightly glutinous, separable
		90%	Glutinous scattered suitable

Conclusion: 70% soft material is more glutinous, difficulties in dispersion；80% slightly glutinous, dispersible；90% glue is scattered moderate, makes Unilateral smooth after tablet, hardness is moderate, therefore selects 90% ethanol to be wetting agent.

6. the determination of particle drying time

The water content of granule has a certain impact to tabletting, therefore is dried with 50 DEG C, has investigated the particle drying time, with Moisture and tabletting situation are inspection target, the results are shown in Table 9.

Table 9 is investigated drying time

Numbering	Drying time (h)	Moisture (%)	Tabletting result
				1	0.5	6.6	Slight sticking
2	1.0	4.2	Unilateral bright and clean
				3	2.0	2.6	Unilateral bright and clean

Conclusion: after drying time 1h, tabletting is unilateral bright and clean, completely, therefore determines particle drying time about 1h, moisture Control exists Less than 5%.

7. the selection of fluidizer

Raw material of the present invention is mainly some Chinese medicine extract, and mobility is poor, therefore selects silicon dioxide as fluidizer. Take 1000 slice prescription content of starting materials, by investigating mixed powder angle of repose, determine silica content, the results are shown in Table 10.

Table 10 fluidizer consumption is investigated

Conclusion: it is generally believed that mobility can reach the requirement of smooth tabletting when angle of repose is below 40 °, so confirming The addition of silicon dioxide is 9.0g/1000 piece.

8. the selection of lubricant

Through preliminary experiment, magnesium stearate consumption is can to play lubrication when 0.5%, therefore determines that magnesium stearate consumption is 4.5g/1000 piece.

9. coating weight gain determines

In order to increase the stability of tablet, cover abnormal smells from the patient, therefore film coating is carried out to plain piece.The present invention selects film coating Agent (brown), makes the coating solution that concentration is 12% and is coated with 70% ethanol, investigates coating powder consumption, is shown in Table 11.

Table 11 coating materials consumption is investigated

Numbering	Plain piece (g)	Coating powder consumption (g)	Coating result
				1	450	9	Unilateral do not covered completely
2	450	13	Substantially cover, uneven once in a while
				3	450	18	Cover uniformly, smooth surface

Conclusion: test 1,2 can cover plain piece completely, unilateral not bright and clean, tests 3 coated tablet any surface finish, and clothing layer is uniform, therefore Determine that the inventory of film coating agent is about 36g/1000 piece.

Experimental study

1. safety toxicology test

1.1 materials and method

1.1.1 sample treatment: take the sample crowd recommended intake 0.098g/kg of the removal adjuvant of the embodiment of the present invention one (according to adult's 60kg mean value computation).

1.1.2 animal varietiess and source: spf level Kunming mouse, wistar rat and feedstuff are by Hubei laboratory animal Research center provides.The weight of animals is depending on every test requirements document.20-25 DEG C of laboratory temperature, humidity 40-70%.

1.2 chmice acute Oral toxicity tests

1.2.1 dosage setting: given the test agent mouse stomach dosage is 20.0g/kgbw, is equivalent to adult and recommends daily intaking amount 204.1 times of 0.098g/kgbw.

1.2.2 sample preparation: weigh the sample 20.0g of the removal adjuvant of the embodiment of the present invention one, plus a small amount of distilled water fills It is settled to 40ml after dividing dissolving.The concentration of the given the test agent preparing is 0.5g/ml.

1.2.3 test method: maximum tolerated dose method.From spf level Kunming mouse, body weight is 18-22g, male and female each 10 Only, water is can't help in 16h animal fasting before gavage, and after mouse weights, gavage gives tested material twice, two minor tick 4h, and single oral gavage holds Measure as 20ml/kgbw, accumulative gavage twice is measured as 20.0g/kgbw.Gavage same day Continuous Observation, later daily observe until 14th day, and record animal poisoning symptom and death toll, during off-test, non-dead animal is weighed.

1.3 genetic toxicity test

1.3.1 mouse marrow cell micro nuclear test

1.3.1.1 experimental animal: from the Kunming mouse for 25-30g for the body weight, each 25 of male and female, it is randomly divided into 5 groups, Each 5 of every group of male and female.

1.3.1.2 reagent and instrument: cyclophosphamide, provided by Hengrui Medicine Co., Ltd., Jiangsu Prov.；Profit Bath difficult to understand shows Micro mirror (Japan produces).

1.3.1.3 dosage packet: (1) negative control group gives distilled water；(2) the oral gavage of positive controls gives ring phosphorus Amide 40mg/kgbw；(3) basic, normal, high three dosage groups of given the test agent, respectively 2.5g/kgbw, 5.0g/kgbw, 10.0g/ kgbw.

1.3.1.4 sample preparation: accurately weigh the removal sample 20.0g of adjuvant of the embodiment of the present invention one, 10.0g, 5.0g, is settled to 40ml with distilled water respectively and does high, medium and low dosage group, concentration be respectively 0.500g/ml, 0.250g/ml, 0.125g/ml.The preparation of positive substance: weigh cyclophosphamide 0.08g, plus appropriate pure water fully dissolves and is settled to 40ml.

1.3.1.5 test method: using 30h test method(s), that is, gavage gives tested material at twice, is spaced 24h, given the test agent Each group each mouse stomach capacity is 20ml/kgbw.After giving tested material for the second time, 6h puts to death animal, takes femur to do bone marrow Smear, is fixed with methanol after natural drying, and giemsa dyes.1000 polychromatic erythrocytes of every animal oil Microscopic observation, note The polychromatic erythrocyte number of micronucleus in record, and its microkernel incidence is in terms of the pce permillage containing micronucleus；Count 200 thermophilic polychromatophilia RBC number (pce), counts mature erythrocyte number (nce) simultaneously, and calculates pce and account for Erythrocytes (pce+nce) percentage ratio.

Micronuclear rateses are pressed animal using X 2 test by 1.3.1.6 data statistics processing method: data base set up by spss software Sex counts respectively.

1.3.2 mouse inbred strain

1.3.2.1 experimental animal: from the Male Kunming strain mice 25 for 25-35g for the body weight, it is randomly divided into 5 groups, every group 5.

1.3.2.2 reagent and instrument: same to 1.3.1.2.

1.3.2.3 dosage is grouped: same to 1.3.1.3.

1.3.2.4 sample preparation: same to 1.3.1.4.

1.3.2.5 test method: each test group mice gives corresponding tested material in all continuous 5 days, and mouse stomach capacity is equal For 20ml/kgbw, after continuing to feed 30 days, (i.e. the 35th day after first to tested material) puts to death animal.Both sides epididymis is taken to be placed in In 0.5ml normal saline, epididymis is longitudinally cut 1-2 knife with eye scissorss, smear after being filtered with four layers of lens paper, after air is dried, Methanol is fixed, then uses 1% eosin stains.1000 sperms of every animal high power Microscopic observation, record teratospermia number, calculate abnormal Shape spermatogenesis rate (in terms of permillage), and carry out statistical disposition.

1.3.2.6 data statistics processing method: data base set up by spss software, each dosage group respectively with corresponding feminine gender Matched group compares, and evaluates sperm deformity positive rate with rank test method.

1.4 30 days feeding trials

1.4.1 dosage and packet: select 80 body weight 60-80g wistar rats, male and female half and half, adaptability is fed 3 days, with Machine is divided into a negative control group and three dosage groups, i.e. 0.00g/kgbw, 2.45g/kgbw, 4.90g/kgbw, 9.80g/ Kgbw, the basic, normal, high dosage group of given the test agent is respectively equivalent to be grown up and recommends 25,50, the 100 of daily intaking amount 0.098g/kgbw Times.Set negative control group simultaneously, give normal feedstuff.Each group is continuous to feed 30 days, each 10 rats of every group of male and female, method for breeding Feed for single cage.

1.4.2 sample preparation and giving: given the test agent is given using the method mixing feedstuff.Accurately weigh each dosage group Given the test agent and normal feedstuff, mix thoroughly, make granulated meal.Rat daily intaking amount based on the 10% of its body weight, each dosage Group feed formulation 16kg, is shown in Table 12.

30 days feeding trial dose design tables of table 12 rat

Note: because Fractional group given the test agent mixed ratio is more than 5%, therefore casein (protein content need to be mixed in proportion For 80%), make crude protein content in each dosage group feedstuff basically identical.According to feed nutrient assay, in feedstuff Crude protein content is 22%.

High dose group adds casein amount=1.568 × 22%/(80-22) %=0.595kg

Middle dose group adds casein amount=0.784 × 22%/(80-22) %=0.297kg

Low dose group adds casein amount=0.392 × 22%/(80-22) %=0.149kg

1.4.3 observation index

1.4.3.1 general clinical symptoms: general performance, behavior, poisoning symptom and death condition.

1.4.3.2 body weight, food-intake and food utilization

1.4.3.3 hematological examination: measure hemoglobin (hb), red blood cell count(RBC) (rbc), leukocyte during off-test (wbc) counting and classification, lymphocyte (ly%), mononuclear cell (mo%), granulocyte (gr%), all use Japanese photoelectricity mek- 6318k type automatic hemacytometer measures.

1.4.3.4 blood biochemistry checking: measure serum glutamic pyruvic transminase (alt), glutamic oxaloacetic transaminase, GOT during off-test (ast), serum urea nitrogen (bun), T-CHOL (tch), triglyceride (tg), creatinine (cr), blood glucose (glu), the white egg of serum The index such as (alb), total protein (tp) in vain.Detecting instrument is: Hitachi 7020 type automatic clinical chemistry analyzer.Detectable is: on Converge the test kit that medical science and technology company limited produces in Haifeng county.

1.4.3.5 organ weights and dirty/body ratio (for the body weight after fasting, that is, cut open and kill weight)

1.4.3.6 histopathologic examination: gross anatomy: each dosage group Rat Fast 16h, 3% Nembutal sodium solution (80mg/kgbw) anaesthetize, ventral aorta is taken a blood sample, then sacrificed by exsanguination animal immediately, dissect, every animal heart of perusal, liver, The chest and abdomen intracavity organ such as spleen, lung, kidney, gastrointestinal has or not the pathological changes such as color change, transudate, edema, hypertrophy, atrophy, makes a record. Separate the internal organs such as liver,spleen,kidney, gastrointestinal, testis (male) with eye scissorss with ophthalmic tweezers, remove totally each internal organs surrounding connective tissue And fatty tissue, weighed one by one (except gastrointestinal) with electronic balance (degree of accuracy is 0.01g), then stood with 10% formalin solution Fix.

Check pathological section: gross anatomy naked eyes no abnormality seen, therefore selection negative control group and high dose group are done pathology and are cut Piece.Choose negative control group and high dose group each 20 animals (male and female half and half) part internal organs (liver,spleen,kidney, gastrointestinal, ovary and Testis), after drawing materials, conventional dehydration, transparent, waxdip, film-making and he dyeing, observed each under an optical microscope by low power to high power The morphological change of tissue, and morphological change observed by itemized record description.

Pathological examination evaluation criterion: different according to each internal organs morphological structure, but mainly using the degeneration of cell as observation Index, and according to pathological change "-", "+", " ++ ", " +++ " quantify, this test data acquired carried out using nonparametric methods in statistics The evaluation that case changes.

Cytopathy: include cloudy swelling, the change of cavity sample, hydropic degeneration and steatosis, inflammatory cell infiltration, (wherein kidney is little Ball is still needed not of uniform size, the muddy swelling of the bent tiny pipe main detection cell of near-end of observation, the tiny pipe main detection water of far-end song Sample becomes and steatosis, gastrointestinal tissue with observe mucosa, under mucosa, the position such as muscle layer, placenta percreta) be divided into 3 grades.

+ individual cells the cloudy swelling, fat drips and the born of the same parents' slurry that are dispersed in and stove shape inflammatory cell infiltration.(include glomerule size Differ, gastrointestinal mucosa epithelium degeneration) --- -1 point

++ stove shape cell cloudy swelling, fat drips or formation transparence cavity.(3-5 cell formation stove shape and glomerule size are not One more than 3-5) --- -2 points

+++ several cell phases melt slabbing cavity and entire fat drips, visible obvious inflammatory cell in glomerular capsule Infiltration or glomerule are not of uniform size substantially, the pathological change such as visible multiple inflammatory cell infiltration stove of each layer of gastrointestinal mucosa --- and -3 points

1.5 result

1.5.1 chmice acute Oral toxicity is tested

The present invention, to acute toxicity test in mice result, is shown in Table 13.

Table 13 present invention is to acute toxicity test in mice result (mean ± standard deviation)

Conclusion: animal has no obvious poisoning symptom within two week observation period, also no animal dead, mtd value is more than 20.0g/ Kg bw, by acute toxicity grading criteria evaluation, this given the test agent belongs to nontoxic rank.

1.5.2 genetic toxicity test

1.5.2.1 mouse marrow cell micro nuclear test

The present invention, to mouse marrow cell micro nuclear test result, is shown in Table 14.

Table 14 present invention is to mouse marrow cell micro nuclear test result (mean ± standard deviation)

*: compare with negative control group, p ＜ 0.01；Pce: polychromatic erythrocyte, nce: mature erythrocyte.

Conclusion: compare with negative control group, positive controls male and female micronuclei in mice rate has significant difference (p ＜ 0.01), And given the test agent each dosage group male and female micronuclei in mice rate difference there are no significant (p ＞ 0.05), and all in this test measured value just Often in scope, indicate that this given the test agent Micronucleus test result is feminine gender.Tested material each group immature erythrocyte accounts for red The ratio [pce/ (pce+nce) sum] of total cellular score is no less than the 20% of negative control group.

1.5.2.2 mouse inbred strain

The present invention, to mouse inbred strain result, is shown in Table 15.

Table 15 present invention is to mouse inbred strain result (mean ± standard deviation)

^▲Other deformities: include tail folding, double end, double tail etc.；^*Compare with negative control group, p ＜ 0.05.

Conclusion: compare with negative control group, the acute incidence rate of positive controls mouse sperm has significant difference (p ＜ 0.05)；And given the test agent each dosage group difference there are no significant (p ＞ 0.05), and within this experimental determination value normal range, Show that this given the test agent sperm malformation test result is feminine gender.

1.5.3 30 days feeding trials

1.5.3.1 in process of the test, animal is no dead, and hair is normal, behavior expression without exception.

1.5.3.2 body weight, food-intake and food utilization

The impact to rat body weight for the present invention, is shown in Table 16；The impact to rats eating amount for the present invention, is shown in Table 17；The present invention Impact to rat chow utilization rate is shown in Table 18；The impact to rat weightening and total foodstuff utilization rate for the present invention, is shown in Table 19.

The impact (mean ± standard deviation) to rat body weight for table 16 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: body weight is compared given the test agent each dosage group rat with negative control group weekly, no significant difference (p ＞ 0.05).

The impact (mean ± standard deviation) to rats eating amount for table 17 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: food-intake is compared given the test agent each dosage group rat with negative control group weekly, no significant difference (p ＞ 0.05).

The impact (mean ± standard deviation) to rat chow utilization rate for table 18 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: food utilization is compared given the test agent each dosage group rat with negative control group weekly, no significant difference (p ＞ 0.05).

The impact (mean ± standard deviation) to rat weightening and total foodstuff utilization rate for table 19 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: given the test agent each dosage group rat total foodstuff utilization rate and weightening are compared with negative control group, and difference is all no Significance p ＞ 0.05.

1.5.3.3 hematological examination

The impact to rat blood routine examination result for the present invention, is shown in Table 20；The impact that the present invention classifies to rat leukocyte, It is shown in Table 21.

The impact (mean ± standard deviation) to rat blood routine examination result for table 20 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: with negative control group numeric ratio relatively, there are no significant for difference (p ＞ 0.05) for each dosage group of given the test agent, and All in range of normal value.

The impact (mean ± standard deviation) that table 21 present invention classifies to rat leukocyte

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: with negative control group numeric ratio relatively, there are no significant for difference (p ＞ 0.05) for each dosage group of given the test agent, and All in range of normal value.

1.5.3.4 blood biochemistry checking

The present invention, to the biochemical impact of rat blood, is shown in Table 22.

Table 22 present invention is to the biochemical impact (mean ± standard deviation) of rat blood

Each dosage group is compared with negative control group, p ＞ 0.05.

Continued 22 present invention is to the biochemical impact (mean ± standard deviation) of rat blood

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: given the test agent each dosage group rat blood serum alt, ast, bun, tch, tg, cr, glu, alb, tp measurement result With negative control group numeric ratio relatively, there are no significant for difference (p ＞ 0.05), and all in range of normal value.

1.5.3.5 organ weights and dirty/body ratio (for the body weight after fasting, that is, cut open and kill weight)

The impact to Rats Organs and Tissues weight and dirty/body ratio for the present invention, is shown in Table 23.

The impact (mean ± standard deviation) to Rats Organs and Tissues weight and dirty/body ratio for table 23 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

The impact (mean ± standard deviation) to Rats Organs and Tissues weight and dirty/body ratio for continued 23 present invention

Each dosage group is compared with negative control group, p ＞ 0.05.

Conclusion: given the test agent each dosage group organ weights and dirty/body ratio are compared with negative control group, difference is all no notable Property (p ＞ 0.05), and all in range of normal value.

1.5.3.6 histopathologic examination

Gross anatomy finding of naked eye: the splanchnocoel such as the heart of the female male rat of each test dose group, liver, spleen, lung, kidney, gastrointestinal It is normal that interior organ compares its appearance color and Organ size with negative control group, is showed no and substantially oozes out, hypertrophy, edema, withers The pathological changes such as contracting.

Finding under mirror, is shown in Table 24-27.

Table 24 present invention is to rat liver histopathologic examination result (n=10)

Table 25 present invention is to rat kidney histopathologic examination result (n=10)

Table 26 present invention is to Rats Spleen histopathologic examination result (n=10)

Table 27 present invention is to rat each internal organs histopathologic examination's result (n=10)

Conclusion: negative control group: a small amount of inflammatory cell infiltration (1/20, female 0/10, male 1/ in individual animal liver 10)；Internal organs such as kidney, spleen, gastrointestinal, ovary, testis etc. show no obvious abnormalities.

High dose group: a small amount of inflammatory cell infiltration (1/20, female 1/10, male 0/10) in individual animal liver；Individually The a small amount of inflammatory cell infiltration of animal kidney interstitial (1/20, female 0/10, male 1/10)；Spleen, gastrointestinal, ovary, testis etc. Internal organs show no obvious abnormalities.

2 function assessment animal experiments

2.1 materials and method

2.1.1 experimental animal: get spf level sd male rat 160-180g, carried by Hubei Province Animal Experimental Study center For.Adaptability is fed 7 days, and body weight is 180-220g.Animal feeding room temperature is 20-35 DEG C, and humidity is 40-70%.

2.1.2 sample source and process: take the sample crowd of the removal adjuvant of the embodiment of the present invention one to recommend daily intaking amount It is subject to test product/person/day (0.098g is subject to test product/kgbw) for 5.88g.

2.1.3 sample preparation accurately weighs sample 9.8g, 19.6g, 39.2g of the removal adjuvant of the embodiment of the present invention one, It is settled to 200ml with distilled water respectively, do basic, normal, high dosage group rat oral gavage and use.

2.1.4 feedstuff

Conventional foundation feedstuff: provided by Hubei Province Animal Experimental Study center.

Combined hyperlipidemia familial animal model high lipid food prepare: add in conventional foundation feedstuff 20.0% sucrose, 15.0% Adeps Sus domestica, 1.2% cholesterol, 0.2% sodium cholate, appropriate casein, calcium hydrogen phosphate, stone powder etc..In addition to crude fat, The moisture of model feedstuff, crude protein, crude fat, crude fibre, coarse ash, calcium, phosphorus are intended to reach the national standard maintaining feedstuff.

2.1.5 dosage packet: recommend daily intaking amount 5.88g/ by the sample crowd of the removal adjuvant of the embodiment of the present invention one Person/day, i.e. 0.098g/kgbw, expand 5,10,20 times of basic, normal, high three dosage groups of setting, i.e. 0.49g/kgbw, 0.98g/ Kgbw, 1.96g/kgbw, set blank control group and model control group (all giving distilled water) simultaneously.

2.1.6 test method: rat is randomly divided into 2 groups by body weight, 10 rats give conventional foundation feedstuff as blank Matched group, 40 are only given model feedstuff as model control group.After model control group gives model feedstuff two weeks, blank control group With the blood sampling of model control group rat non-fasting, separate determination of serum serum total cholesterol (tc), triglyceride (tg), high density fat Protein cholesterol (hdl-c), low-density lipoprotein cholesterol level (ldl-c) level.According to tc level by model control group with Machine is divided into 4 groups, i.e. hyperlipidemia model group and basic, normal, high three dosage groups of tested material；Model control group and three dosage groups after packet Relatively there are no significant for tc, tg, hdl-c, ldl-c difference.After packet, blank control group continues to give conventional foundation feedstuff, mould Type matched group and three dosage groups continue to give model feedstuff.The daily gavage of three dosage groups gives given the test agent, blank Group and model control group give distilled water.Each test group is all given by the capacity gavage of 1ml/100gbw, respectively tests during this period Group rat free water feed.After gavage 30 days, non-fasting is taken a blood sample, tc, tg, hdl-c, ldl-c level in detection serum.

2.2. result

2.2.1 the impact to rat total cholesterol level

The impact to rat total cholesterol level for the present invention, is shown in Table 28.

The impact to rat total cholesterol level for table 28 present invention (mmol/l,)

P is represented and is compared with model control group

Conclusion: before test (before giving tested material), compared with blank control group line, model control group total cholesterol level Significantly raised, difference has significance (p ＜ 0.05), illustrates that high blood lipid model is successfully prepared.Give the sample of the embodiment of the present invention one After product 30 days, compare with model control group, the serum total cholesterol level of middle and high dosage group rat substantially reduces, and difference has aobvious Work property (p ＞ 0.05).

2.2.2 the impact to rat content of triglyceride

The impact to rat content of triglyceride for the present invention, is shown in Table 29.

The impact to rat content of triglyceride for table 29 present invention (mmol/l,)

P is represented and is compared with model control group

Conclusion: before test (before giving tested material), compared with blank control group, model control group content of triglyceride is bright Aobvious rising, difference has significance (p ＜ 0.01), illustrates that high blood lipid model is successfully prepared.Give the sample of the embodiment of the present invention one After 30 days, compare with model control group, the content of triglyceride of middle dose group rat substantially reduces, difference has significance (p ＜ 0.05).

2.2.3 the impact to rat HDL-C

The impact to rat HDL-C for the present invention, is shown in Table 30.

The impact to rat HDL-C for table 30 present invention (mmol/l,)

P is represented and is compared with model control group

Conclusion: before test (before giving tested material), compared with blank control group, model control group high density lipoprotein gallbladder Sterin content no substantially changes, no significant difference (p ＞ 0.05).The sample giving the embodiment of the present invention one is after 30 days, with mould Type matched group compares, and each dosage group rat blood serum HDL-C content no substantially changes, no significant difference (p ＞ 0.05).

2.2.4 the impact to rat low-density lipoprotein cholesterol

The impact to rat low-density lipoprotein cholesterol for the present invention, is shown in Table 31.

The impact to rat low-density lipoprotein cholesterol for table 31 present invention (mmol/l,)

P is represented and is compared with model control group

Conclusion: before test (before giving tested material), compared with blank control group, model control group low density lipoprotein, LDL gallbladder Sterin content is significantly raised, and difference has significance (p ＜ 0.05).The sample giving the embodiment of the present invention one is after 30 days, with model Matched group compares, and middle and high dosage group rat blood serum low-density lipoprotein cholesterol content substantially reduces, and difference has significance (p ＜ 0.05).

2.2.5 the impact to high blood lipid model rat body weight

The impact to high blood lipid model rat body weight for the present invention, is shown in Table 32.

The impact to high blood lipid model rat body weight for table 32 present invention (mmol/l,)

^*Compare with blank control group

Conclusion: compare with blank control group, model control group rat substantially increases in detection 4th week body weight, and difference has aobvious Work property (p ＜ 0.05).Compare with model control group, each dosage group each week body weight all no substantially changes, no significant difference (p ＞ 0.05).

3 function assessment human experiments

3.1 materials and method

3.1.1 sample: character of the present invention: brown tablet, content is light brown to sepia label.Net content 0.927g/ piece.Human body recommended amounts are oral, and 2 times a day, and 4 tablets once.Dose is 7.416g/ day.

3.1.2 study subject: select to meet following standard persons as experimenter's participation human experiment by the principle of voluntariness in the know Test.

Experimenter's inclusive criteria: (1), in the case of normal diet, detects the blood lipid level after fasting 12-14h, in half a year At least lipids detection twice, serum total cholesterol is in 5.18-6.21mmol/l, and serum triglycerides are in 1.70- 2.25mmol/l, can be used as auxiliary lipid-lowering function alternative objects；Serum triglycerides are in 1.70-2.25mmol/l, and blood Clear T-CHOL≤6.21mmol/l, can reduce triglyceride function alternative objects as auxiliary；Serum total cholesterol is in 5.18- 6.21mmol/l, and serum triglycerides≤2.25mmol/l, can reduce cholesterol function alternative objects as auxiliary, in ginseng On the basis of examining zoopery, selection corresponding index person is study subject；(2) In Patients With Primary Hyperlipoidemia；(3) obtain informed consent Book, voluntary participation experimenter.

Subject Exclusion Criteria: (1) age is in under-18s or over-65s person；(2) gestation or women breast-feeding their children, allergy Body constitution or to this given the test agent allergy sufferers；(3) merge intentionally, liver, the serious disease such as kidney and hemopoietic system, psychotic；(4) Once take lipid-regulation medicine within nearly two weeks, have influence on the judgement person to result；(5) the hyperlipidemia person being in hospital；(6) do not press fixing eating Given the test agent, or data is not complete, affects effect or safety judgement person.

3.1.3 EXPERIMENTAL DESIGN and packet: using itself and between group two groups of control design.Requirement according to random blind is carried out Packet.It is randomly divided into test-meal group and matched group by experimenter's blood lipid level, consider the principal element such as year of impact structure as far as possible Age, sex, diet etc., carry out harmonious inspection, to ensure the comparability between group.Every group of experimenter is no less than 50.Test-meal group Take given the test agent, matched group adopts blank.

3.1.4 dosage and time are eaten: experimenter keeps life at ordinary times and dietary habit in tested period.Test-meal group takes Use product of the present invention, 2 times a day, 4 tablets once, continuously take 90 days.Matched group blank, Time of Administration is 90 days.

3.1.5 key instrument and reagent: Hitachi 7180 automatic clinical chemistry analyzer (German centronic)；dirui h- 300 eight analysers (Changchun Di Rui company) of urine；Sysmex-k21 three-classification blood analyzer (sysmex company)；Sysmex blood Cell analysis diluent (sysmex company)；Dirui urinalysis reagent strip (Changchun Di Rui company)；Li Deman biochemical reagents box (Beijing Leaderman Biochemistry Co., Ltd)；Japan's consonance biochemical reagents box (the medical Co., Ltd. of Japan's consonance)；Japan one Metaplasia test kit (Japanese Daiichi Pure Chemicals Co., Ltd.).

3.1.6 observation index

3.1.6.1 ordinary circumstance: include spirit, sleep, defecation, blood pressure etc..

3.1.6.2 safety observations

Blood, urine, feces routine examination: red blood cell count(RBC) (rbc), hemoglobin (hb), numeration of leukocyte (wbc), urine, stool Routine examination.

Liver and kidney function checks: serum albumin (alb), total protein (tp), glutamic oxaloacetic transaminase, GOT (ast), glutamate pyruvate transaminase (alt), carbamide (urea), creatinine (cre), glucose (glu) etc..

Chest X-rays, electrocardiogram, abdominal part b surpass inspection (carrying out only before on-test).

3.1.6.3 efficiency observation

Functional parameter: serum total cholesterol (tc) level and reduction percentage rate, triglyceride (tg) level and reduction percentage Rate, HDL-C (hdl-c) level and ascensional range, low-density lipoprotein cholesterol (ldl-c) level.

Effect criterion: effectively: tc reduces ＞ 10%；Tg reduces ＞ 15%；Hdl-c rises ＞ 0.104mmol.No Effect: not up to effective standard person.

Observe serum total cholesterol (tc) effective percentage, triglyceride (tg) effective percentage, HDL-C (hdl- C) effective percentage and total effective rate.

Tc reduces tc value × 100% before percentage rate=(tc value after tc value-individuality test before individual test)/individual test

Number of cases/tc that tc effective percentage=individuality tc is reduced more than 10% observes number of cases × 100%

Tg reduces tg value × 100% before percentage rate=(tg value after the individual test of tg- before individual test)/individual test

Number of cases/tg that tg effective percentage=individuality tg is reduced more than 15% observes number of cases × 100%

Total effective rate=tc be reduced more than 10% simultaneously tg be reduced more than 15% number of cases/experimental observation number × 100%

3.1.7 data processing

All own control data can adopt paired t-test, and two groups of means compare using composition t inspection, and the latter need to be carried out Homogeneity test of variance, carries out suitable variable conversion to the data of nonnormal distribution or heterogeneity of variance, normal state variance to be met is neat Afterwards, carry out t inspection with the data of conversion；If change data still can not meet normal state variance requiring together, use t, inspection or sum of ranks instead Inspection；Variance side but too big (as cv ＞ 50%) the logging data application rank test of the coefficient of variation together.Effective percentage and total effective rate are adopted Use x²Inspection is tested.Four form total number of cases are less than 40, or total number of cases equal to or more than 40 but theoretical value and are equal to or little When 1, exact method method should be used instead.

3.2 result

3.2.1 test-meal group is compared with matched group harmony

Include experimenter 114 people, remove matched group depigmentation 1 people in process of the test, actual experimenter is 113 people, and male 36 People, women 77 people, it is serum total cholesterol, triglyceride exception crowd.Test front two groups of blood fat, age, sex harmony Relatively, it is shown in Table 33.

Front two groups of blood fat tested by table 33, age, sex harmony compare

Project	Test-meal group (n=57)	Matched group (n=56)	Statistic	P value
					Sex (male/female)	15/42	21/35	1.628	0.202
Age (year)	54.65±7.23	55.86±7.82	-0.853	0.396
					T-CHOL (mmol/l)	5.50±0.22	5.47±0.22	0.556	0.5793
Triglyceride (mmol/l)	1.83±0.10	1.86±0.13	-1.150	0.253
					HDL-C (mmol/l)	1.42±0.20	1.38±0.21	0.935	0.352

Note: p is to compare between group；Sex is x²Inspection.

Conclusion: before test, test-meal group blood lipid level, age, sex are compared with matched group, no significant difference (p ＞ 0.05) before, showing two groups of tests, age, sex, blood lipid level have equilibrium comparability.

3.2.2 the impact of property index safe to the human body

3.2.2.1 ordinary circumstance compares

Inquiring investigation is carried out to experimenter's spirit, sleep, diet, defecation situation, by good, differential levels statistics. Before and after test, two groups of ordinary circumstances compare, and are shown in Table 34.

Before and after table 34 test, two groups of ordinary circumstances compare

Conclusion: most subjects general status are good, after test-meal group test, the mental status, diet situation are normal, show Test has no adverse effects to experimenter's ordinary circumstance.

3.2.1.2 two groups of experimenter's blood pressures, analyses of heart rate before and after testing

Before and after test, two groups of experimenter's blood pressures, test results of heart rate, are shown in Table 35.

Two groups of experimenter's blood pressures, test results of heart rate before and after table 35 test

Conclusion: before and after experimenter's test, the blood pressure of two groups of experimenters, heart rate inspection result are showed no significant change and (are p ＞ 0.05).

3.2.1.3 routine blood test and blood biochemistry index before and after test

Before and after test, routine blood test and blood biochemistry index, are shown in Table 36.

Routine blood test and blood biochemistry index before and after table 36 test

Conclusion: before and after experimenter's test, the routine blood test of two groups of experimenters and blood biochemistry index inspection result are substantially in normal model In enclosing.

3.2.3.4 Chest X-rays, electrocardiogram, abdominal part b surpass and urine, stool routine inspection

Conclusion: experimenter tests the Chest X-rays of front two groups of experimenters, electrocardiogram, abdominal part b surpasses and urinates, stool routine inspection is showed no Substantially abnormal.

3.2.3 the impact to people with hyperlipidemia efficacy measures

3.2.3.1 the impact to serum total cholesterol

The impact to serum total cholesterol for the tested material, is shown in Table 37.

The impact to serum total cholesterol for table 37 tested material (mmol/l)

Project	Test-meal group (n=57)	Matched group (n=56)	T value	P value
					Before test	5.50±0.22	5.47±0.22	0.556	0.579
After test	4.86±0.57	5.50±0.23	-7.897	0.000
					Difference	0.64±0.54	-0.03±0.12	9.003	0.000
Reduction rate	11.59±9.78	-0.53±2.15	9.065	0.000
					Compare (t, p) in group	8.898,0.000	- 1.797,0.078	-	-

Conclusion: before and after test-meal group test, self pair compares, statistically significant (the p ＜ of serum total cholesterol content difference 0.01) before, being less than test after test；Before and after matched group test, self pair compares, and serum total cholesterol content difference no counts Learn meaning (p ＞ 0.05)；After test, test-meal group serum total cholesterol content is compared with matched group, statistically significant (the p ＜ of difference 0.01).

3.2.3.2 the impact to serum triglycerides

The impact to serum total cholesterol for the tested material, is shown in Table 38.

The impact to serum triglycerides for table 38 tested material (mmol/l)

Project	Test-meal group (n=57)	Matched group (n=56)	T value	P value
					Before test	1.83±0.10	1.86±0.13	-1.150	0.253
After test	1.23±0.34	1.84±0.25	-10.876	0.000
					Difference	0.60±0.32	0.02±0.22	11.288	0.000
Reduction rate	33.04±17.68	1.00±12.01	11.247	0.000
					Compare (t, p) in group	14.137,0.000	0.665,0.509	-	-

Conclusion: before and after test-meal group test, self pair compares, statistically significant (the p ＜ of serum triglycerides content difference 0.01) before, being less than test after test；Before and after matched group test, self pair compares, and serum triglycerides content difference no counts Learn meaning (p ＞ 0.05)；After test, test-meal group serum triglycerides content is compared with matched group, statistically significant (the p ＜ of difference 0.01).

3.2.3.3 the impact to serum High Density Lipoprotein Cholesterol

The impact to serum High Density Lipoprotein Cholesterol for the tested material, is shown in Table 39.

The impact to serum High Density Lipoprotein Cholesterol for table 39 tested material (mmol/l)

Project	Test-meal group (n=57)	Matched group (n=56)	T value	P value
					Before test	1.42±0.20	1.38±0.21	0.935	0.352
After test	1.40±0.18	1.36±0.20	1.049	0.297
					Lift-off value	0.02±0.15	0.02±0.19	-0.067	0.947
Compare (t, p) in group	0.946,0.348	0.827,0.412	-	-

Conclusion: before and after test-meal group test, self pair compares, and serum High Density Lipoprotein Cholesterol content difference no counts Learn meaning (p ＞ 0.05), before being higher than test after test；After test test-meal group serum High Density Lipoprotein Cholesterol content with compare Group compares, no significant difference (p ＞ 0.05).

3.2.3.4 the impact to serum LDL cholesterol

The impact to serum LDL cholesterol for the tested material, is shown in Table 40.

The impact to serum LDL cholesterol for table 40 tested material (mmol/l)

Project	Test-meal group (n=57)	Matched group (n=56)	T value	P value
					Before test	2.79±0.47	2.73±0.56	0.568	0.571
After test	2.51±0.41	2.74±0.51	-2.662	0.009
					Lift-off value	0.28±0.42	-0.01±0.54	3.178	0.002
Compare (t, p) in group	5.077,0.000	- 0.109,0.914	-	-

Conclusion: before and after test-meal group test, self pair compares, and serum LDL cholesterol content difference has statistics Learn meaning (p ＜ 0.01), before being less than test after test；Before and after matched group test, self pair compares, serum low-density LP Cholesterol level no significant difference (p ＞ 0.05)；After test test-meal group serum LDL cholesterol content with Matched group compares, difference statistically significant (p ＜ 0.01).

3.2.3.5 cardinal symptom improves situation

After experimenter's test, test-meal group cardinal symptom is improved situation and is substantially better than matched group, is shown in Table 41, table 42.

Table 41 cardinal symptom improves situation

Cardinal symptom	Number of cases)	Effectively number of cases	Invalid number of cases	Improve green (%)
					Dizzy	43(51)	21(14)	22(37)	48.8(27.5)
Dizziness	32(28)	16(7)	16(21)	50.0(25.0)
					Cardiopalmus	44(46)	21(18)	23(28)	47.7(39.1)
Irritated	51(29)	17(6)	34(23)	33.3(20.7)
					Shortness of breath	31(26)	16(9)	15(17)	51.6(34.6)
Weak	42(42)	22(19)	20(23)	52.4(45.2)

Note: test-meal group (matched group)

Positive symptom integral change before and after table 42 test

Group	Test-meal group (n=57)	Matched group (n=56)	T value	P value
					Before test	4.67±1.23	4.30±1.13	1.636	0.105
After test	3.39±1.70	4.34±1.00	-3.632	0.000
					Compare (t, p) in group	6.358,0.000	-0.227.0.821	-	-

3.2.3.6 effective percentage compares

Effective percentage situation compares, and is shown in Table 43.

Table 43 effective percentage situation compares

Conclusion: test-meal group tc, tg effective percentage and total effective rate are respectively 33.3%, 87.7% and 29.8%, with matched group Relatively, difference all statistically significant (p ＜ 0.01).Test-meal group hdl-c effective percentage is compared with matched group, and no statistical difference is anticipated Adopted (p ＞ 0.05).

3.2.3.7 untoward reaction is observed

Two groups of allergy and other untoward reaction situations during testing, are shown in Table 44.

44 liang of groups of table allergy and other untoward reaction situations during testing

Group	Number of cases	Anaphylaxiss	Other untoward reaction (nausea, flatulence, diarrhoea, stomachache etc.)
				Test-meal group	57	0	0
Matched group	56	0	0

The foregoing is only presently preferred embodiments of the present invention, not in order to limit the present invention, all essences in the present invention Within god and principle, any modification, equivalent substitution and improvement made etc., should be included within the scope of the present invention.

Claims (10)

1. a kind of auxiliary blood fat reducing piece it is characterised in that: meter by weight includes the following raw material component: Radix Salviae Miltiorrhizae 500-700 part, Radix Puerariae 500-700 part, Monas cuspurpureus Went 150-300 part, propolis 10-50 part, green tea extract 10-50 part, xylitol 80-120 part, hydroxypropyl Cellulose 30-60 part, silicon dioxide 5-15 part, magnesium stearate 2-10 part.

2. according to claim 1 auxiliary blood fat reducing piece it is characterised in that: also include film coating agent 20-50 part.

3. according to claim 2 auxiliary blood fat reducing piece it is characterised in that: by weight meter include the following raw material group Point: Radix Salviae Miltiorrhizae 600-700 part, Radix Puerariae 600-700 part, Monas cuspurpureus Went 150-200 part, propolis 20-50 part, green tea extract 20-50 part, wood Sugar alcohol 80-120 part, Hydroxypropyl Cellulose 30-50 part, silicon dioxide 5-10 part, magnesium stearate 2-6 part, film coating agent 30-45 Part.

4. a kind of prepare as described in any one of claim 1-3 auxiliary blood fat reducing piece method it is characterised in that: include as follows Step:

(1) pre-treatment: by Radix Salviae Miltiorrhizae, Radix Puerariae respectively net system, broken standby；Monas cuspurpureus Went, propolis co-grinding are sieved, obtains mixed powder i； Xylitol, Hydroxypropyl Cellulose, silicon dioxide, magnesium stearate and green tea extract are sieved respectively；

(2) extract, concentrate: weigh Radix Salviae Miltiorrhizae, Radix Puerariae by weight, add decocting to boil, filter, merging filtrate, by filtrate decompression Concentrate, obtain extractum；

(3) it is dried: extractum is spray-dried, sieves, obtain extract powder；

(4) mix: weigh xylitol, Hydroxypropyl Cellulose, mixed powder i, green tea extract and extract powder by weight, mixing, Obtain mixed powder ii.

(5) pelletize: appropriate 80%-90% ethanol will be added in mixed powder ii to make soft material, pelletize, be dried, granulate, and must do Grain；

(6) total mixing: the silicon dioxide weighing by weight and magnesium stearate will be added in dry particl, mixing, obtain and always mix Thing；

(7) tabletting is carried out to always mixed thing, add film coating agent that coated tablet is obtained.

5. auxiliary blood fat reducing piece according to claim 4 preparation method it is characterised in that: add in described step (2) The decocting of 10 times amount boils 2 times, each 1.5h.

6. auxiliary blood fat reducing piece according to claim 4 preparation method it is characterised in that: decompression in described step (2) The condition concentrating is 60-80 DEG C, -0.06--0.1mpa.

7. according to claim 4 auxiliary blood fat reducing piece preparation method it is characterised in that: will filter in described step (2) When liquid is concentrated under reduced pressure to give 70 DEG C, relative density is 1.05-1.15g/cm³Extractum.

8. auxiliary blood fat reducing piece according to claim 4 preparation method it is characterised in that: spraying in described step (3) Inlet temperature 170-180 DEG C is dried.

9. auxiliary blood fat reducing piece according to claim 4 preparation method it is characterised in that: mixed in described step (4) The conjunction time is 20-50min.

10. auxiliary blood fat reducing piece according to claim 4 preparation method it is characterised in that: mixed in described step (6) The conjunction time is 10-30min.