CN1586598A - Wuqi fat regulation oral liquid - Google Patents

Abstract

The present invention relates to one kind of blood fat regulating Wuqi oral liquid for treating hyperlipemia and its preparation process and quality control method. The said medicine preparation is prepared with fleeceflower root, wolfberry fruit, cassia seed, chrysanthemum, safflower, haw, dried orange peel and other Chinese medicinal materials.

Description

Wuqi fat regulation oral liquid

Technical field:

The present invention relates to a kind of Chinese medicine preparation for the treatment of hyperlipidemia and preparation method thereof, method of quality control, particularly relate to the pharmaceutical preparation made from Chinese medicines such as Radix Polygoni Multiflori Preparata, Fructus Lycii, Semen Cassiae, Flos Chrysanthemi, Flos Carthami, Fructus Crataegi, Pericarpium Citri Reticulataes.

Background technology:

(Hypelipidemia is a kind of common and multiple metabolic disease HLP) to hyperlipemia, sees middle-aged and elderly people more.The result shows according to Epidemiological study, existing 80,000,000 people of China suffer from cardiovascular and cerebrovascular disease, and every day is with 10,000 patients' speed increase, cardiovascular and cerebrovascular disease has become the leading killer of health risk in China, and hyperlipemia is the initiating agent of cardiovascular and cerebrovascular disease, and preventing and treating HLP effectively is the important channel of control cardiovascular and cerebrovascular disease.

As if the medicine that can be used in hyperlipemia in clinical a lot, Western medicine such as fenofibrate, cholestyramine, gemfibrozil, bezalip, nicotinic acid, lovastatin, general Liprevil, Max EPA etc., Chinese medicine such as xinqingning tablet, fat can be clearly, Radix Polygoni Multiflori tablet, the smart tablets of reducing blood fat of Fructus Crataegi, fat-reducing health sheet, xinmaitong tablet, JIANGZHILINGPIAN, public region tablets of reducing blood fat etc., but the Western medicine oral formulations mostly has side effect and some to cost an arm and a leg, few in the Chinese medicine preparation at the middle-aged and elderly people deficiency of the liver and kindey blood stasis syndrome person that holds concurrently, therefore need in clinical a kind of can nourishing the liver and kidney, again can promoting blood circulation to remove obstruction in the collateral; Fat can be transferred, the medicine of clinical symptoms can be improved again.

Say in " element is asked non-wind " book: ", just being to say also " with the deficiency of YIN through cloud man-year 40 half of YIN QI consumed.Illustrate more than 40 years old middle-aged and elderly people essence in kidney, liver blood gradually void decline, easily cause the hepatic and renal YIN deficiency, with advancing age, the hyperlipemia prevalence goes out to improve, and influence among many pathogenic factor that hyperlipemia takes place to develop, the effect of blood stasis can not be ignored.This be because the morbidity of middle-aged and elderly people diseases caused by exogenous pathogenic factor and internal injury to cause evil probability more than between twenty and fifty people, thereby evil choke stagnates and the approach of giving birth to blood stasis also increases.Or exopathogen is kept the pent-up of feelings will, stagnation of pathogen inside the body; Or the labour feels frustrated the blood trouble of working with one's mind; Or interior-heat caused by deficiency of YIN, the refining blood that burns can both produce blood stasis, and simultaneously many old people Xing Ju are idle, and often both work less are few again movable, escape for a long time and cause obstruction of QI, and blood is unpopular, stagnates and give birth to the stasis of blood.So blood stasis is considered to the main pathological factor (the meeting 1992:124 of teaching material traditional Chinese medical science presbyatrics Science and Technology of Shanghai publishing house on probation of universities and colleges of high hospital) of hyperlipemia.

It is generally acknowledged now: how with age hyperlipemia asthenia, and obstinate disease is had a liking for tobacco and wine delicious food etc., the hepatic and renal YIN deficiency that causes of a specified duration, and the essence and blood loss, hyperlipidemia, hematogenous blockage forms the card of deficiency in origin and excess in superficiality.This is the hepatic and renal YIN deficiency, is designated as the venation stasis of blood and stagnates.Answer nourishing the liver and kidney to consolidate it in the treatment, promoting blood circulation to remove obstruction in the collateral is controlled its mark, and the present invention writes out a prescription just in view of the above.Hyperlipemia is a kind of micro index, though the name of disease of motherland's medical science ahyperlipoidemia has relevant argumentation.As " a Ling Shu Miraculous Pivot or Divine Axis disorder of defensive QI piece of writing " day: " gas is sliding few for fat person, its serum "." element is asked and can be commented the deficiency and excess opinion " day: " fertile high official, and disease due to addiction to eating greasy food is also "; " a vital QI of the body connecting with natural QI opinion piece of writing " pointed out the cause of disease, pathology and the symptom of hyperlipemia, and day, " it was too sweet to distinguish the flavor of, obstruction of heart-QI with dyspnea, darkish complexion, imbalance of kidney-QI." and that the mechanism of the clinical symptoms of relevant hyperlipemia and control are discussed is a lot of, is dispersed in the relevant book more, as " the dizzy fortune of Jing Yue's complete work ": " Dan Xi then day no expectorant have can do dizzy, when controlling expectorant, and his medicine of dual-purpose, Yu Zeri does not have void and can not do dizzy, when controlling void, and drink its mark of holding concurrently.”

Most scholars is thought the sick position of primary disease at blood vessels, and and liver, spleen, kidney three are dirty relevant, and main pathogenesis deficiency of spleen and stomach causes the stagnation of phlegm blood stasis and with the passing of time then gives birth to its card from cold the change from heat.Think that as Shao Shi primary disease is worn with age, obstinate disease is had a liking for food tobacco and wine, delicious food etc., the hepatic and renal YIN deficiency that causes of a specified duration, the essence and blood loss, the turbid strongly fragrant resistance of expectorant, disorder of QI movement, the body lipid Metabolic disorder, contamination with the passing of time, hematogenous blockage, blood-vessel obstructive forms the card of deficiency in origin and excess in superficiality.Chen Shi etc. think insufficiency of the spleen failing of the spleen to transport, or the deficiency of the liver catharsis is unable, or the gasification of suffering from a deficiency of the kidney is unable, and this dirtyly loses emptyly for liver spleen kidney is all to cause the turbid blood stasis of expectorant, is designated as the turbid blood block up of expectorant.Liao Shi thinks that the gasification of kidney dominating the metabolism of whole health, and easily to give birth to expectorant turbid so suffer from a deficiency of the kidney; Yi and Kui are derived from the same origin, the kidney failing to nourish the liver then causes yang hyperactivity.Therefore this is Liver and kidney two void, is designated as the phlegm-damp yang hyperactivity.(journal of shanghai Chinese medicine 1999; 12 32-33)

Wu Songying etc. studies show that, the easy trouble factor of suffer from a deficiency of the kidney, expectorant is turbid, blood stasis is old lipid metabolic disorder.Suffer from a deficiency of the kidney be in old individual the intrinsic factor of lipid metabolic disorder take place.(Wu Songying, Lin Qiucheng, Yang Chi etc., old lipid look for thank to the disorderly traditional Chinese medical science easily suffer from clinical investigation China Chinese and Western of factor) in conjunction with magazine 1,993 13 (5) 273.The many handles of modern medicine " kidney " belong to hypothalamus-hypophysis-target gland axle, and some hypothalamic and pituitary hormone has the interior environment pay-as-you-go operation of combined regulating blood fat directly or indirectly, and it is lowly relevant with hypothalamus-hypophysis-target gland s function to suffer from a deficiency of the kidney.

The essence of blood stasis is in particular in microcirculation disturbance, and abnormal hemodynamics and blood become learns aspects such as unusual.The microcirculation (nail fold and the tip of the tongue) that Jia Yuhua etc. discover presenium HLP patient than the same period healthy old men poor, with spleen kidney both deficiency type and blood stasis type integration the highest (the high more microcirculation of integration is poor more), the insufficiency of the spleen phlegm stagnation syndrome type of spleen takes second place, caused by hepatic stagnation qi stagnation is lower.(Jia Yuhua, the differential diagnosis in tcm of the flat presenium hyperlipemia of Lv Zhi and microcirculation improve become and traditional Chinese medical science typing concern Liaoning Journal of Traditional Chinese Medicine 1992 (4): but 3 Huang youngsters etc.s have obvious change in indexs such as the whole blood contrast viscosity of studying HLP patient, plasma viscosity, erythrocyte aggregation index, reduced viscosities.(hyperlipemia velocity of blood flow such as Huang Keer, Fang Yongqi, Li Xiaobing improve the new traditional Chinese medical science 1993 of relation that reaches with traditional Chinese medical science typing, (2): 6).

Expectorant is turbid to be both the pathological product of body zang-fu disharmony with blood stasis, and the domination of pathogen excessive phlegm stasis of blood of HLP is with sick.Jin Shi thinks expectorant stasis of blood homology, expectorant stagnates can be converted into blood stasis, thereby blood stasis expectorant to stagnate be to cause one of major reason that blood fat raises, the phlegm-damp that practical first aid 1,997 4 (11): the 499 Yu Ya qins of the combination of Chinese and Western medicine etc. are inquired into HLP from hemorheology changes, the bloody sputum blood stasis syndrome positive rate of finding the phlegm-damp group is higher than non-phlegm-damp group significantly, and whole blood contrast viscosity, whole blood reduced viscosity, Fibrinogen and erythrocyte electrophoresis are apparently higher than non-phlegm-damp group.Further verified the theory that expectorant with fixed attention must blood stasis, shown that the expectorant blood coagulation stasis of blood is the main cause that HLP causes atherosclerosis and other complication.(the journal 1999:19 of Hunan College of Traditional Chinese Medicine (1): 62-63)

Adding up according to the square medicine for the treatment of hyperlipemia over nearly 10 years, mainly is liver and kidney tonifying, invigorating the spleen for eliminating dampness, blood circulation promoting and blood stasis dispelling, clearing away heat and loosing the bowels, the Chinese medicine that eliminates indigestion and phlegm.As liver and kidney tonifying Radix Polygoni Multiflori, Fructus Ligustri Lucidi, Fructus Lycii, Ganoderma, Cordyceps, Folium Acanthopanacis Senticosi, Semen Astragali Complanati etc. are arranged; Spleen invigorating is regulated the flow of vital energy Radix Ginseng, Herb Gynostemmae Pentaphylli, Pericarpium Citri Reticulatae, Radix Glycyrrhizae, Fructus Crataegi etc.; Blood circulation promoting and blood stasis dispelling Pollen Typhae, Hirudo, Radix Angelicae Sinensis, Rhizoma Polygoni Cuspidati, Radix Notoginseng, Folium Ginkgo etc. are arranged; Heat-clearing and toxic substances removing Herba Portulacae, Radix Scutellariae, yellow limit, Radix Bupleuri, Radix Rhapontici, Flos Chrysanthemi, Flos Nelumbinis, Folium Nelumbinis etc. are arranged; Relieving constipation Radix Et Rhizoma Rhei, Semen Cassiae, Rhizoma Polygoni Cuspidati etc. are arranged.(CHINA JOURNAL OF CHINESE MATERIA MEDICA 1999; 24 (3): 184-185)

The mechanism research of Chinese medicine blood fat reducing as yet not deeply, its effect for reducing fat more complicated is often by multicomponent, multipath and the shaft raising cooperation is used.

Reduce the absorption of exogenous lipid:

Mainly be meant the absorption that reduces cholesterol.Contain anthraquinone analog compound in Radix Polygoni Multiflori, the Semen Cassiae, can promote enterokinesia, increase the drainage of cholesterol.Radix Polygoni Multiflori can combine with cholesterol and reduce cholesterol at intestinal absorption or cut-out enterohepatic circulation.

Reduce the synthetic of endogenous lipid:

The endogenous lipid is mainly derived from the synthetic of lipid and discharges.Rhizoma Alismatis contains triterpenoid compound, can reduce the generation of the raw material acetyl-CoA of synthetic cholesterol.Cell culture shows that the free fatty that Herb Gynostemmae Pentaphylli total glycosides can make adipose tissue's cell decompose and produce reduces about 28%, makes the glucose that enters the synthetic middle fat of cell reduce about 50%.Biochemical pharmacology studies show that ferulic acid can suppress rat liver mevalonate-5-pyrophosphate glue hydroxyl enzyme, thereby suppresses liver synthesis cholesterol.

The transhipment and the drainage of lipid when short:

Intravital lipid is with the form transhipment of lipoprotein and drains.Fructus Lycii, Fructus Crataegi etc. have the report of rising HDL-C or ApoAl.

Regulate lipid metabolism:

Biochemical Radix Polygoni Multiflori, Fructus Crataegi, the Flos Chrysanthemis etc. of studies show that are by reversible phosphorylation and dephosphorylation, realization is to the inhibition of the little material body of hepatocyte 3-hydroxy-3-methylglutaryl coenzyme A reductase (HMGR) vigor, the inhibition degree is equivalent to 50mmol/L NaF, plays the effect of regulating lipid metabolism.

The Chinese patent medicine of treatment hyperlipemia treatment is more at present, mainly contains following several:

(1) Yunnan pollen four or seven oral liquids: the syndrome of static blood blocking collaterals of forming, be used for hyperlipemia by shepherd's purse wheat pollen, four Radix Notoginseng, Mel.

(2) xinqingning tablet: form by Radix Et Rhizoma Rhei.The pyretic toxicity inner product card that is used for hyperlipemia.

(3) fat can be clear: be made up of Semen Lepidii, Radix Scutellariae, Fructus Crataegi, Rhizoma Alismatis, Radix Et Rhizoma Rhei, the Radix Aucklandiae, be used for accumulateing card in the phlegm-damp of hyperlipemia.

(4) Radix Polygoni Multiflori tablet: form by the Radix Polygoni Multiflori.The interior card that stagnates of the food stasis of blood that is used for hyperlipemia.

(5) SHANZHAJING JIANGZHI PIAN: form by Fructus Crataegi.The interior card that stagnates of the food stasis of blood that is used for hyperlipemia.

(6) fat-reducing health sheet: form by Rhizoma Alismatis, be used for the insufficiency of the spleen leading to overabundance of dampness card of hyperlipemia.

(7) xinmaitong tablet: form by Radix Angelicae Sinensis, Semen Cassiae, Ramulus Uncariae Cum Uncis, Radix Achyranthis Bidentatae, Radix Salviae Miltiorrhizae, Radix Puerariae, Flos Sophorae, Radix Ilicis Pubescentis, Spica Prunellae, Radix Notoginseng, be used for the syndrome of static blood blocking collaterals of hyperlipemia.

(8) JIANGZHILINGPIAN: form by Radix Polygoni Multiflori Preparata, Fructus Lycii, Rhizoma Polygonati, Fructus Crataegi, Semen Cassiae, be used for the syndrome of yin deficiency of liver and kidney of hyperlipemia.

(9) red four fat reducing pills: form by Radix Salviae Miltiorrhizae, the Radix Polygoni Multiflori, Radix Ginseng, Rhizoma Polygonati, four or seven, Rhizoma Chuanxiong, Radix Angelicae Sinensis, Rhizoma Alismatis, Herba Epimedii, Cortex Acanthopancis, Cortex Cinnamomi.The deficiency of YIN stasis of blood resistance card that is used for hyperlipemia.

Hyperlipidemia patient sees with person in middle and old age more, so it is very big the hold concurrently probability of syndrome of blood stasis of deficiency of the liver and kindey to occur, and the medicine that therefore needs a kind of genus deficiency of the liver and kindey of hyperlipemia to hold concurrently the syndrome of blood stasis person.The medicine of existing treatment hyperlipemia belongs to a bit cures the symptoms, not the disease, and some uses expensive material, and some interrupts use because uncertain therapeutic efficacy is cut in application process.

For this reason, the invention provides a kind of determined curative effect, safe ready, little, the cheap pure traditional Chinese compound medicine of side effect.Pharmaceutical preparation of the present invention is by Radix Polygoni Multiflori, Semen Cassiae, Fructus Lycii, Flos Chrysanthemi, Flos Carthami, Fructus Crataegi, Pericarpium Citri Reticulatae is made, this prescription has following two big characteristics: the one, and be many at hyperlipemia with person in middle and old age, and the many deficiency of the liver and kindey of person in middle and old age, the pathological characteristic prescription medication that the stagnant stasis of blood of again venation stasis of bloods of holding concurrently stagnates more, pathogenesis links closely, silk silk as button, treating both the principal and the secondary aspects of a disease at the same time, medicine letter power is special: the 2nd, and compatibility is precise and appropriate, has both used Radix Polygoni Multiflori, the Fructus Lycii nourishing the liver and kidney is used Semen Cassiae again, the liver heat removing of Flos Chrysanthemi YIN nourishing, suppressing the hyperactive liver, it is done in order to clear benefit is main, mend and oiliness, assistant is with Fructus Crataegi, the Pericarpium Citri Reticulatae invigorating the spleen and stomach had not both had and had grown the greasy fraud that hinders stomach, did not have the void of living expectorant again; Adapted Flos Carthami, the unobstructed venation of Fructus Crataegi, and the property that tool flows.

Preparation of the present invention is respectively formed drug introduction:

Radix Polygoni Multiflori: 1. Compendium of Material Medica: " foot faint the moon, few cloudy " 2. " medicine justice " " the liver benefiting is held back blood, YIN nourishing; control waist knee joint weakness, and the dish bone is ached ... " 3. " herbal political affairs ": " Radix Polygoni Multiflori is specially gone into Liver and kidney; take a tonic or nourishing food to build up one's health Kidney-Yinly, and flavor is solid very thick, and it is pained to hold concurrently slightly; property is then gentle, and all the reason with part of the body cavity below the umbilicus, housing the bladder, kidneys and bowels envelope Tibetans meets, so can fill out beneficial vital essence; have negative and positive and put down secret effect, non-relatively the moon as Radix Rehmanniae is comparable with fixed attention ... good ancient meaning eliminating pathogen in the liver wind is that the moon is not contained sun, and water is not supported wood, be to cause edema with the liver involved to give birth to wind, this can mend wind, and this energy nourishing YIN is then controlled wind and controlled blood earlier, the blood sector-style is gone out, also it is declared, but this to be tonic relieve dizziness, high fever, infantile convulsions, epilepsy, etc., must take for eliminating pathogen in the liver ".4. " Chongqing hall random notes ": " Radix Polygoni Multiflori, interior QI and blood regulating, the skin ulcer of loosing outward pain, the nearly Radix Angelicae Sinensis of merit also is the medicine in the blood ".5. " book on Chinese herbal medicine is looked for the truth ": " Radix Polygoni Multiflori goes into to lead in liver, is the yang aspect of yin medicine, thus do not go into the usefulness that Liver Channel thinks that beneficial blood dispels the wind, its double the kidney invigorating person, also holding concurrently because of tonifying liver reaches also.”

Semen Cassiae: 1. " property of medicine opinion ": " sharp the five internal organs remove liver man heat ".2. " order China son book on Chinese herbal medicine ": " helping irritability, beneficial smart water ".3. " Bencao Jingshu ": " the salty not gas that gets, rusticly sweet, hardship can expel the heat-evil, the flat gastric qi of closing, cold can expelling the heat-evil by tonifying YIN, the positive medicine of liver channel of foot-Jueyin is also ".

Fructus Lycii: 1. TAO Hong-Jing: " nourishing the essence and strengthening QI, prosperous and powerful vagina ".2. " property of medicine opinion " " the smart various symptoms and signs of deficiency of energy tonification ".3. Compendium of Material Medica " nourishing kidney, lung moistening make eye bright ".4. " book on Chinese herbal medicine " states " it is dizzy to control apoplexy, asthenia ".Flos Chrysanthemi: 1. " Amplification on Materia Medica is mended deficient ": " Flos Chrysanthemi, energy nourishing YIN "; 2. Compendium of Material Medica: " Flos Chrysanthemi, the former times people calls it can remove wind heat, the liver benefiting nourishing YIN, lid does not know that its outstanding multipotency benefit gold, water two are also dirty, thus moisturizing system fire, thus the flat wood of benefit gold, flat MUZE wind breath, then evanescence of heat falls in fire, with controlling all public attention orders, its purport is profound and subtle ".3. " Bencao Jingshu ": " the autocratic wind wood of Flos Chrysanthemi is so the key medicine of dispeling the wind also.Hardship can expel the heat-evil, the beneficial blood of sweet energy, and sweet the detoxifcation, flat then hold concurrently hot so also eliminating stagnation, bitter in taste acting on the heart, small intestinal, sweet flavour enters the spleen, stomach, flat suffering is walked liver." 4. " book on Chinese herbal medicine justice ": " and all flowers are all main advocates catharsis, and solely Flos Chrysanthemi is then taken the photograph and received declines, can the suppressing the hyperactive liver fire, put out endogenous wind, but the perverse and unreasonable manner of wood gas.

Flos Carthami: 1.＜the Amplification on Materia Medica benefit is deficient 〉: " broken stagnant blood nourishes blood.The then removing blood stasis of using more, few with then nourishing blood ".2.＜book on Chinese herbal medicine converges speech " Flos Carthami, removing blood stasis, promoting the circulation of blood and blood, accent blood also.3.＜medicine justice 〉: " the sharp passages through which vital energy circulates of the kind energy of Flos Carthami ".

Fructus Crataegi: 1.＜daily book on Chinese herbal medicine 〉: " relieving dyspepsia is long-pending, the row stagnation of QI, it is wide every, the blood mass at the hypochondrium that disappears piece to be good for the stomach ".2.＜food mirror book on Chinese herbal medicine 〉: " change clot, air parcel is invigorated blood circulation ".3.＜book on Chinese herbal medicine is new again 〉: " control insufficiency of the spleen damp and hot, the food mill that helps digestion is long-pending, sharp defecation ".

Pericarpium Citri Reticulatae: 1.＜herbal classic〉" main abdominal mass heat in the heart, contrary gas, diuretic paddy.Clothes are deodorized for a long time, and the therapeutic method to keep the adverse QI flowing downwards is logical refreshing ".2.＜property of medicine opinion 〉: " control gas between septum pectorale, appetizing, main diarrhea due to disorder of qi, expectorant saliva is controlled gas and is coughed and gargle." 3.＜Bencao Shiyi〉" degassing, in the accent ".4. " solar corona ": " broken lump in the abdomen mass beside the umbilicus ".

Summary of the invention:

The invention provides a kind of traditional Chinese compound medicine preparation for the treatment of hyperlipidemia, said preparation is made by following Chinese medicinal raw materials.

Radix Polygoni Multiflori Preparata 133-533g Fructus Lycii 133-533g

Semen Cassiae 133-533g Flos Chrysanthemi 83-333g

Flos Carthami 50-200g Fructus Crataegi 133-533g

Pericarpium Citri Reticulatae 50-200g

Preferably:

Radix Polygoni Multiflori Preparata 200-399g Fructus Lycii 200-399g

Semen Cassiae 200-399g Flos Chrysanthemi 124-250g

Flos Carthami 75-150g Fructus Crataegi 200-399g

Pericarpium Citri Reticulatae 75-150g

More preferably

Radix Polygoni Multiflori Preparata 266.5g Fructus Lycii 266.5g

Semen Cassiae 266.5g Flos Chrysanthemi 166.5g

Flos Carthami 100g Fructus Crataegi 266.5g

Pericarpium Citri Reticulatae 100g

In more than forming, weight is calculated with crude drug, and this prescription composition can be made into 1000 doses of pharmaceutical preparatioies, described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000g, oral liquid 1000ml etc., as oral liquid, can pack with big bottle, as the bottle of 10-500ml, if be the bottle of 10ml, more than prescription can be made 100 bottles of oral liquids, if be the bottle packing of 500ml, more than prescription can be made into 2 bottles of oral liquids.For granule, can adorn 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.

More than form, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As oral liquid, make 10ml 100 bottles, take the 1-2 bottle at every turn, can take 50-100 time altogether.

More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.

The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.

Raw material of Chinese medicine, especially ministerial drug and adjuvant drug in more than forming also can be replaced by the suitable Chinese medicine with identical property of medicine, and its drug effect of the Chinese medicine preparation after the replacement is constant.

Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.

Pharmaceutically active substance in the pharmaceutical preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.As oral liquid, preferred carrier is water, cyclamate and potassium sorbate.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every bottle of oral liquid etc., in the unit dose, the amount that contains active substance is 5-800mg, preferably 20-500mg.

Pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation.

Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.

The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant comprises, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.

Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.

The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.

For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.

Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.

Preparation of the present invention is determined usage and dosage according to patient's situation in use, but obeys 1-4 time every day, each 1-20 agent, as: 1-20 bottle or sheet.

Preparation of the present invention can be according to following prepared:

Radix Polygoni Multiflori Preparata 266.5g Fructus Lycii 266.5g

Semen Cassiae 266.5g Flos Chrysanthemi 166.5g

Flos Carthami 100g Fructus Crataegi 266.5g

Pericarpium Citri Reticulatae 100g cyclamate 3g

Potassium sorbate 2g

Method for making:

More than seven flavors, depend on that pine torch is broken into coarse powder, add 50% alcohol reflux secondary, add 7 times of amount ethanol for the first time, extracted 2 hours, add 6 times for the second time and measure ethanol, extracted 1.5 hours, merge alcohol extract twice, standby behind the decompression recycling ethanol.With the coarse powder of Radix Polygoni Multiflori Preparata, Six-element medical materials such as Fructus Lycii mix with medicinal residues after the Semen Cassiae alcohol extraction, and extracting in water three times adds 8 times of water gagings for the first time and extracted 2 hours, collects the about 300ml of Aromatic water earlier, and is standby; Adding for the second time 7 times of water gagings extracted 1.5 hours; Add 6 times of water gagings for the third time, extracted 1.0 hours, merge three times the water extract, filter, being evaporated to relative density is 1.10-1.15 (60 ℃ of heat are surveyed), under agitation, slowly adding ethanol makes and contains alcohol amount and reach 60%, left standstill 16 hours, and filtered decompression filtrate recycling ethanol, be evaporated to about 1.15 (60 ℃ of heat are surveyed) of relative density, add above-mentioned Semen Cassiae alcohol extraction concentrated solution and Aromatic water, cyclamate 3g, potassium sorbate 2g, distilled water is adjusted total amount to 1000ml, stir evenly, cold preservation was left standstill 24 hours, filtered, fill is in brown oral liquid bottle under aseptic or half aseptic condition, roll the cap seal mouth, sterilization, promptly.Prescription of the present invention, component for reducing blood fat in the flavour of a drug is water soluble ingredients such as flavonoid glycoside, anthraquinone glycoside, pharmacological testing shows that the improving blood circulation and reducing fat composition of each flavour of a drug is a decocting liquid part, consider that Chinese medicine oral liquid is a kind of dosage form of developing on the decoction basis, have easy absorption, little, the taking convenience of dosage, and be suitable for characteristics such as industrialized great production, and by drug effect, its oral liquid formulation good effect of clinical trial.Therefore, preferably decide the dosage form of oral solutions as this medicine.The present invention also provides the method for quality control of the method for quality control of Chinese medicine preparation of the present invention, particularly oral liquid, and this method comprises following content:

[character] this product is the rufous clear liquid; Feeble QI, it is little sweet to distinguish the flavor of.Can there be the small amount of precipitate thing to separate out in the placement, can be uniformly dispersed after the jolting.

[discriminating]

(1) get this product 10ml, put in the separatory funnel, add water 50ml, shake up, reuse ethyl acetate extraction 3 times, each 20ml merges ethyl acetate solution, adds water 20ml and washes once, and ethyl acetate solution water bath method, residue add methanol 2ml dissolving as need testing solution.Other gets Radix Polygoni Multiflori control medicinal material fine powder 1g, puts in the conical beaker, adds methanol 25ml supersound extraction 30 minutes, takes out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the preparation of need testing solution preparation method again, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10～15ul of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (4: 4: 1.2: 0.2) be developing solvent, expansion was taken out with toluene-ethyl acetate-methanol-water, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were toasted 5～10 minutes, and is clear to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color.

(2) get the need testing solution under (1) item, as need testing solution.Other gets Fructus Lycii control medicinal material fine powder 2g, puts in the conical flask, adds methanol 25ml supersound extraction 30 minutes, takes out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the need testing solution preparation method, make control medicinal material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned two kinds of each 10-15ul of solution, put respectively on same silica gel g thin-layer plate, (4: 3: 0.8: 0.2) be developing solvent, expansion was taken out with toluene-ethyl acetate-methanol-water, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sapphirine fluorescence speckle.

(3) get this product 5ml, put in the evaporating dish, add 5% hydrochloric acid solution 25ml again, boiling water bath hydrolysis 30 minutes, residue add water 50ml gradation dissolving, change in the separatory funnel, add chloroform extraction 3 times, each 25ml, combined chloroform solution, leave standstill and make layering, chloroformic solution water bath method, residue add chloroform 5ml makes dissolving, as need testing solution, other depends on pine torch control medicinal material 1g, shines medical material solution in pairs with legal system.Get the chrysophanol reference substance again and add the chloroform dissolving, be mixed with the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned three kinds of each 1-2ul of solution respectively, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃) one ethyl acetate-formic acid (15: 5: 1) upper solution is developing solvent, launch, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on show the fluorescence speckle of same color.

(4) get need testing solution under (1) as need testing solution, other gets Pericarpium Citri Reticulatae control medicinal material fine powder 1g, put in the conical flask, add methanol 25ml supersound extraction 30 minutes, take out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the need testing solution preparation method, make control medicinal material solution.Get the hesperidin reference substance again, add 70% dissolve with methanol, make the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5-10ul of need testing solution, control medicinal material solution 2ul, reference substance solution 4ul, put respectively on same 0.5% sodium hydroxide silica gel g thin-layer plate, with ethyl acetate-methanol-water (100: 17: 13) is developing solvent, launch, take out, dry, spray is with 2% aluminum chloride test solution, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of identical color.

[inspection]

Relative density should be not less than 1.03 (with reference to pycnometric methods under an appendix VII of Chinese Pharmacopoeia version in 2000 the A relative density algoscopy item).

PH value should be 4.0-6.0 (with reference to an appendix VII of Chinese Pharmacopoeia version in 2000 G pH value algoscopy).

Other should meet relevant every regulation under Chinese Pharmacopoeia version appendix in 2000 the I J mixture item.

[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D).

System suitability test: with octadecylsilane chemically bonded silica is filler, and acetonitrile-water (0.2: 0.8) is mobile phase, detects wavelength 320nm, according to 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D glycoside peak theory of computation plate number is greater than 2000, separating degree＞1.5.

The preparation of reference substance solution: get be dried to constant weight 2,3,5, the 4 '-tetrahydroxystilbene-2-O-β-about 5mg of D glycoside reference substance, the accurate title, decide, put in the 50ml volumetric flask, add 80% dissolve with methanol and be diluted to scale, shake up, the accurate again 5ml that draws, put in the 25ml volumetric flask, add 80% methanol and be diluted to scale, shake up, promptly.(lucifuge operation)

The preparation of need testing solution: accurate this product 1ml that draws, put in the 100ml measuring bottle, add 80% methanol and be diluted to scale, shake up, filter, discard the about 25ml of filtrate just, collect subsequent filtrate as need testing solution.(lucifuge operation).

Algoscopy: the accurate reference substance solution 10ul that draws, need testing solution 10ul injects high performance liquid chromatograph respectively, measures peak area, calculates, promptly.

This product contains 2,3,5,4 '-tetrahydroxystilbene 2-O-β-D glycoside (C20H2209) must not be less than 1.0mg/ml.

[function with cure mainly] nourishing the liver and kidney, promoting blood circulation to remove obstruction in the collateral.Be used for the hepatic and renal YIN deficiency hyperlipemia of syndrome of blood stasis of holding concurrently.

[usage and consumption] is oral, a 10ml, 3 times on the one.

[specification] 10ml/ props up.

[storage] sealing is put shady and cool lucifuge place and is preserved.

Below by pharmacodynamic experiment data declaration beneficial effect of the present invention:

Oral liquid of the present invention (transferring the fat oral liquid at this called after) with the preparation of the method for embodiment 1 experimentizes, and transfers the fat oral liquids to carry out the preliminarily stabilised test to three batches.

One, test method

Adopt the reserved sample observing method, with sample in clinical trial with under the terms of packing, under the room temperature natural conditions, place, and according to " transferring fat oral liquid end product quality draft standard " and " specification requirement of new Chinese medicine steady quality Journal of Sex Research ", except that investigating this month once, sampling in every month detects once, investigates three months continuously, and has investigated the stability of placing again 3 months.Test item and test method thereof are as follows:

1, character: outward appearance is investigated color and luster, abnormal smells from the patient, the clarity of content.

2, differentiate: (1) Radix Polygoni Multiflori Preparata: adopt thin layer chromatography to identify (seeing the method under No. 7 data end product quality standard discriminatings (1) item for details).(2) Fructus Lycii: adopt thin layer chromatography to identify (see No. 7 data end product quality draft standards for details and differentiate (2) item method down).(3) Semen Cassiae: adopt thin layer chromatography to identify (see No. 7 data end product quality standards for details and differentiate (3) item method down).(4) Pericarpium Citri Reticulatae: adopt thin layer chromatography to identify (see No. 7 material end product quality standards for details and differentiate (4) item method down).

3, check: (1) relative density: by " pycnometric method is measured under an appendix VII of the Chinese pharmacopoeia nineteen ninety-five version A relative density algoscopy item, should be not less than 1.03.

(2) pH value: by " an appendix VII of Chinese pharmacopoeia nineteen ninety-five version G pH value assay method is measured, and should be 4.0-6.0.

4, assay: the content (seeing the method under the data end product quality draft standard assay item for details No. 7) that adopts four hydroxyl stilbene glycosides in the high effective liquid chromatography for measuring finished product.

5, health examination: by " medicine sanitary standard promulgated by the ministries or commissions of the Central Government " mix respectively bacterium, mycete, escherichia coli, the demodicid mite inspection of living.

Two, result of the test: according to said method to three batch samples (lot number: 991006,991009,991012) investigate respectively, conclusion is: reserved sample observing is the result show: three batch samples are (6 months) in probation, every detection index is all up to specification, and do not have obvious variation, can think that therefore it is more stable transferring the fat oral liquid.Below for to cure mainly relevant Pharmacodynamic test of active extract with function:

To the research of hyperlipemia rabbit prevention medicine-feeding test

[summary] this experimentation the influence of transferring the fat oral liquid that the influence and the atherosclerotic plaque of rabbit hyperlipidemia model blood fat formed.The result shows:

1, rabbit is irritated stomach and transfers the fat oral liquid, dosage is 2.15,4.3,8.6g crude drug/kg, can obviously reduce serum total cholesterol, triglyceride, the high density lipoprotein increasing cholesterol reduces low-density lipoprotein cholesterol, rising serum aPoA-I reduces serum apolipoprotein B and serum lipoprotein a.The hyperlipemia rabbit had preventive effect.

2, rabbit gavages and transfers the fat oral liquid, and dosage is the same.Through perusal, om observation, electron microscopic observation, find to transfer the fat oral liquid to have tangible anti-aorta and coronary artery atheromatous plaque

Electron microscopic observation finds to transfer the fat oral liquid to have the effect of tangible anti-aorta and the formation of coronary artery atheromatous plaque.

3, rabbit gavages and transfers the fat oral liquid, and dosage is the same, can obviously reduce whole blood viscosity and plasma viscosity, has the effect of blood circulation promoting and blood stasis dispelling.

4, the superoxide dismutase that can raise, and liver had protective effect.

[purpose] observed and transferred the fat oral liquid to the influence of rabbit hyperlipidemia model blood fat and the influence of atherosclerotic plaque formation.

[test material]

1, animal

Japan's white big ear rabbit, 72, about body weight 2Kg, the male and female dual-purpose, Hunan College of Traditional Chinese Medicine's Experimental Animal Center provides.Animal rank: one-level.The quality certification number: moving word 20-003 number of doctor.

2, medicine and reagent

Transfer the fat oral liquid, provide by the Hunan Inst of Traditional Chinese Medicine.Lot number: 991006.Specification: 10ml * 10, content: 1.43g crude drug/ml.Xuezhikang: the Beijing WBL Peking University Biotech Co., Ltd produces, lot number: 990102.Cholesterol: BP level, Shanghai biological chemical reagent company, lot number: 9302190.Transfer fat oral liquid and XUEZHIKANG JIAONANG to be mixed with desired concn in order to irritating stomach with distilled water.

[test method and result]

One, modeling method

Japan's white big ear rabbit, is divided into 6 groups, 12 every group at random by 72.Wherein 60 give high lipid food.(adding 15% egg yolk, 0.5% cholesterol and 5% Adeps Sus domestica in the normal feedstuff), after 3 weeks, serum cholesterol is elevated to certain level, no longer adds the feedstuff that cholesterol only is fed with yolk powder and Adeps Sus domestica in the feedstuff, continues for 9 weeks, totally 12 weeks.Raise with common foodstuff for 12 in addition.

Two, animal grouping

12 raised to divide with the rabbit of common foodstuff organize at A.All the other 60 rabbit are divided into 5 groups, give high lipid food.

The A group is (on the normal control tissue: irritate stomach distilled water (10ml/kg) every day

B organizes (hyperlipidemia model group): irritate stomach distilled water (10ml/kg) every day

C organizes (Xuezhikang group): irritate stomach 0.12g/kg (be equivalent to clinical equivalent dosage 2 times) every day

D group (transferring fat oral liquid small dose group): irritate stomach 2.15g crude drug/kg (be equivalent to clinical equivalent dosage 1 times) every day.The administration capacity is 10ml/kg.

E group (transferring dosage group in the fat oral liquid): irritate stomach 4.3g crude drug/kg (being equivalent to clinical isodose 2 times) every day.The administration capacity is 10ml/kg.

F group (transferring the heavy dose of group of fat oral liquid): irritate stomach 8.6g crude drug/kg (be equivalent to clinical equivalent dosage 4 times) every day.The administration capacity is 10ml/kg.

Three, observation index and result

During on-test, survey blood fat biochemical indicator normal value in the animal hearts blood sampling.(except the normal control group) carried out in animal modeling and administration simultaneously, be administered once every day, (model forms the back) promptly put to death animal in 90 days; get specimen and detect, and observed and transferred the influence of fat oral liquid to rabbit high blood lipid model lipid metabolism, SOD, aorta speckle, coronary plaque, liver wet weights etc.

1, to the influence of lipid metabolism

Instrument: day island proper Tianjin CL-7200 type automatic clinical chemistry analyzer

Reagent: cholesterol, triglyceride test kit provide (990803,990717 by Shanghai Ke Hua-Dong Pedicellus et Pericarpium Trapae company.The HDL-C test kit provides (AUF8504) by Japanese first KCC.Low-density lipoprotein cholesterol, ApoA 1, apolipoprotein B test kit provide (990810,990811,990812) by Ningbo of Zhejiang Ci Cheng.Lipoprotein a test box provides (990731) animal hearts blood sampling when the on-test by Shandong 3V Inc., measure blood lipids index, the result shows, A, B, C, D, E, F six treated animal T-CHO (T-CHOL), TG (triglyceride), HDL-C (HDL-C), HDL ₂HDL ₃, LDL-C (low-density lipoprotein cholesterol), apoA-1 (serum ApoA ₁) (serum lipoprotein a) does not all have a bright significant difference for apoB (serum apolipoprotein B), LP (a).Give experimental animal (B, C, D, E, F group) modeling and administration simultaneously, the A group is only irritated stomach with the volume distilled water, gets the every index of hematometry blood fat in animal hearts after 90 days, and the result shows: 1. animal hyperlipidemia model is set up (seeing Table 1,2); 2. transfer the fat oral liquid that the big ear rabbit of hyperlipidemia Japan is had T-CHO, the TG of reduction, rising HDL, HDL ₂, stablize HDL ₃, reduce LDL, rising APOA-1, the good action (seeing Table 1) of reduction APOB, LP (a); 3. transfer the fat oral liquid to hyperlipidemia animal model T-CHO, TG, HDL ₂, LDL, apoA-1 the effect of apoB LP (a) be better than contrasting medicine Xuezhikang (seeing Table 1).

Table 1a transfers the influence of fat oral liquid to blood fat

2, to hemorheological influence

Determining instrument is LBY-N ₇Type hemorheology instrument, Tianjin Puli company product.

After the last administration, heart extracting blood is used anticoagulant heparin, measure the whole blood viscosity height cut, in cut, low cutting, and plasma viscosity.Hyperlipidemia model group whole blood viscosity and plasma viscosity all increase as a result.And transfer fat oral liquid, Xuezhikang and plasma viscosity that reduction is in various degree arranged, prompting transfers the fat oral liquid can improve hemorheological property, has the effect (seeing Table 2) of blood circulation promoting and blood stasis dispelling.

3, to the influence of superoxide dismutase (SOD)

Test kit builds up biological study by Nanjing and is provided, and adopts xanthine oxidase to measure.SOD can remove superoxide anion (O ₂), the protection cell is avoided damage.Result of the test shows: 1. to organize this enzyme content minimum for B, with A, C, D, E group highly significant difference arranged relatively, and the model group establishment be described.2. C, D, three groups of SOD content of E all are higher than the B group, illustrate to transfer all energy increased SOD content of fat oral liquid and Xuezhikang.3. transfer the effect and the Xuezhikang of fat oral liquid small dose group increased SOD suitable, and in, heavy dose of group is not as good as Xuezhikang (seeing Table 3).

4, the influence that the aorta speckle is formed

1. perusal was put to death animal after 90 days, separate aorta (from aortic valve to the iliac artery crotch), cut open in the dorsal surface stringer, directly with perusal aorta speckle situation, according to the classification of following atheromatous plaque grade scale: 0 grade: intimal surface is smooth, do not have cream-colored the variation, promptly do not have speckle; 0.5 level: inner membrance has cream-colored widely and milky changes, but does not have the speckle that protrudes from the surface; 1 grade: sure cream-colored speckle is arranged, and area is less than 3mm ²2 grades: plaque area is greater than 3mm ²3 grades: many specklees that vary in size are arranged, and the fusion that has is in blocks, the super 3mm of area of big speckle ²4 grades: the surface of endarterium almost covers for the speckle that merges entirely.Count 1,2,3,4 fens respectively, and statistical procedures is carried out in the t check.

The result shows: the no speckle of A group (normal control group) forms, B group (model group) speckle is maximum, and D group and E group speckle significantly are less than model group, illustrate that transferring little, the middle dosage group of fat oral liquid to have prevents and treat the effect (seeing Table 4) that the aorta speckle forms preferably.

2. om observation formalin fixed, paraffin embedding, HE dyeing, light microscopic is observed down and is had or not speckle to form, and the no speckle of result: A group forms, and B group speckle forms 100%, C group 70%, D group 33.3%, E group 28.6%, F organizes 71.4%.Through the X2 check, the difference of the number that low, middle dosage group speckle forms has the significance meaning, shows the effect of transferring fat mouth liquid to have anti-preferably aorta speckle to form.(seeing Table 5).

3. electron microscopic examination: inspect 12 of aorta samples altogether by ready samples and be respectively A ₂, A ₇, B ₃₅, B ₄₇, C ₁₅, C ₁₇, D ₂, D ₂₅, E ₃₁, E ₃₄, F ₃₈, F ₄₁Specimen is through 2.5% glutaraldehyde (0.1MPBS) fixedly more than the 2h, after cleaning up, and 1% osmic acid (OSO ₄) fix 1 hour again, acetone dehydration step by step, Epon812 soaks, embedding, Sweden produces the section of LKB ultramicrotome, plumbi nitras one acetic acid uranium is dual dye after, H-600 transmission electron microscope (daily output) is observed, newspaper sheet, analysis.

Observed result: elastic force inner membrance and smooth muscle cell.The B group: the lipid infiltration appears in film in endarterium and the part, as seen is rich in the foam cell of lipid in a large number, and this foam cell can be that the macrophage phagocytic lipid forms or smooth muscle cell is transformed.Arterial endothelial cell is impaired, even downright bad, and inner membrance tube chamber face has cellulose to soak into and lymphocyte is assembled, also the attached wall of visible red cell.Internal elastic membrane is impaired, interruption even complete obiteration, occur a large amount of foam cells in the middle film, and the smooth muscle cell of normal morphology as seen.The C group: a small amount of lipid granule in the accidental smooth muscle cell, inner membrance and middle film are roughly normal.The D group; As seen endotheliocyte necrosis has foam cell to soak into, but greatly reduces than B group number, but interior elastic force film is normal, does not see destruction.A small amount of lipid granule in the visible intercalation sliding myocyte of minority in subendothelial layer and the middle film.The E group: endotheliocyte is impaired, and necrosis is arranged, and visible cellulose sample material soaks into inner membrance, the visible lipid granule of subendothelial layer (few than the B group).The F group: see that a small amount of lipid of subendothelial layer soaks into, also visible lipid is infiltrated on a matter in the middle film, visible a small amount of lipid granule in the smooth muscle cell.But endothelium, interior elastic force film are all normal, do not see that foam cell soaks into.

It is normal to observe conclusion: A group.It is serious that B group fat becomes, formed atherosis, and the structure of destroyed blood vessel wall.C, D, E, F group have bigger improvement than B group ultra micro pathomorphism.But the degree varies that each group is improved.Better with C, D group, and the E group is poorer slightly.More than change explanation C, D, E, F group medication treatment effectively.

5, the coronary artery speckle is taken out, after 10% formaldehyde fixed, its crosscut is become three, get 2 in tissue for every, frozen section, with soudan III and haematoxylin dyeing, 10 sections of each sections observation.Carry out light microscopy checking, and, counted 1 fen for every grade with following standard grading score statistics): 0 grade: endarterium does not have lipid and soaks into; 0.5 level: inner membrance has slight lipid to soak into; 1 grade: the inner membrance speckle accounts for 1/4 of lumen of vessels area; 2 grades: speckle accounts for 1/2 of tube chamber area; 3 grades: plaque area is greater than 1/2 of the tube chamber area; 4 grades: speckle almost stops up whole tube chamber.

The result shows: a, model group coronary plaque scoring value are apparently higher than other 5 groups, model establishment: b is described, transfers three dosage groups of fat oral liquid speckle scoring value type group that significant difference is arranged, illustrate and transfer the fat oral liquid to have formation of better prevention hyperlipemia coronary plaque and effect to be better than Xuezhikang.(see Table 6)

6, to the influence of liver wet weights

After six treated animals are put to death; contain liver according to animal per 100 grams and heavily restrain number calculating organ coefficient; to observe the influence of medicine to liver; the result shows; B, C, the heavy coefficient of E, F group liver increase; and D group and A group there was no significant difference, prompting transfers fat oral liquid (small dose group) that liver is had protective effect (seeing Table 7).

[conclusion]

Experimental result shows, transfers the fat oral liquid that the hyperlipemia model animal is had following pharmacological action:

1, can reduce T-CHO, TG, rising HDL-C, HDL ₂Stablize HDL ₃, reducing LDL-C, rising apoA-1 reduces apoB, LP (a).

2, can effectively prevent and treat aorta and crown tremulous pulse medicated porridge magnetic hardening.

3, can improve hemorheological property, have the effect of blood circulation promoting and blood stasis dispelling.

4, can increased SOD, and liver had the certain protection effect.

Table 1a transfers the influence of fat oral liquid to blood fat

Group T-CHO mmol/L) TG (mmol/L)

Before the n administration after the administration before the administration after the administration

A organizes (normal control) 8 2.075 ± 0.534 2.094 ± 0.438 0.804 ± 0.181 1.033 ± 0.354

B organizes (hyperlipidemia model) 7 2.194 ± 0.427 13.926 ± 2.181 ^*0.826 ± 0.199 2.090 ± 0.397 ^*

C organizes (Xuezhikang) 10 2.279 ± 0.371 8.894 ± 1.984 △ △ 0.825 ± 0.234 1.254 ± 0.490 △ △

D organizes (low dose) 9 2.404 ± 0.459 6.580 ± 1.045 ^{△ △ △ △}0.941 ± 0.416 1.176 ± 0.343 △ △

E organizes (middle dosage) 7 2.264 ± 0.575 8.447 ± 1.788 △ △ 0.889 ± 0.323 0.863 ± 0.114 △ △ △

F organizes (heavy dose) 7 2.296 ± 0.704 6.831 ± 2.136 △ △ 0.823 ± 0.181 1.206 ± 0.358 △ △

Compare with A group (normal control) ^*△ △ P＜0.01 is compared with B group (hyperlipidemia model) in P＜0.01, compares △ P＜0.05 △ △ P＜0.01 with C group (Xuezhikang)

Table 1b transfers the influence of fat oral liquid to blood fat

Group HDL (MML/L) HDL ₂(mml/L) HDL ₃(mmol/L) mmol/L)

Before the n administration after the administration before the administration after the administration before the administration after the administration before the administration after the administration

A organizes (matched group) 8 0.863 ± 0.257 0.765 ± 0.481 ^{△ △}0.528 ± 0.073 0.522 ± 0.097 ^{△ △}0.249 ± 0.067 0.242 ± 0.047 0.906 ± 0.262 1.001 ± 0.455 ^{△ △}

B organizes (model group) 7 0.893 ± 0.085 0.964 ± 0.065 ^*0.554 ± 0.069 0.410 ± 0.065 ^*0.253 ± 0.080 0.554 ± 0.182 0.911 ± 0.211 12000 ± 2334 ^*

C organizes (Xuezhikang) 10 0.771 ± 0.107 1.315 ± 0.182 ^{△ △}0.520 ± 0.083 0.672 ± 0.140 ^{△ △}0.203 ± 0.063 0.630 ± 0.263 0.902 ± 0.367 7.592 ± 1.652 ^{△ △}

D organizes (low dose) 9 0.768 ± 0.081 1.263 ± 0.124 ^{△ △ ▲ ▲}0.512 ± 0.097 0.836 ± 0.135 ^{△ △ ▲}0.201 ± 0.069 0.422 ± 0.123 ^▲1.147 ± 0.277 5.322 ± 1.764 ^{△ △ ▲}

E organizes (middle dosage) 7 0.830 ± 0.126 1.221 ± 0.120 ^{△ △}0.579 ± 0.058 0.809 ± 0.125 ^{△ △}0.151 ± 0.064 0.409 ± 0.115 ^▲1.066 ± 0.416 7.234 ± 1.706 ^{△ △}

F organizes (heavy dose) 7 0.771 ± 0.161 1.279 ± 0.084 ^{△ △}0.537 ± 0.066 0.851 ± 0.138 ^{△ △ ▲}0.212 ± 0.070 0.434 ± 0.106 1.111 ± 0.664 5.539 ± 1.704 ^{△ △}

Compare * * P＜0.01 with A group (normal control), compare with B group (hyperlipidemia model) ^{△ △}P＜0.05 P＜0.01 is compared with C group (Xuezhikang) in P＜0.01

Table 1c transfers the fat oral liquid that blood fat is influenced

Group apoA-1 (g/L) apoB (b/L) Lp (a) (mg/L)

Before the n administration after the administration before the administration after the administration before the administration after the administration

A (matched group) 8 0.195 ± 0.033 0.100 ± 0.001 ^{△ △}0.111 ± 0.035 0.133 ± 0.027 ^{△ △}220.1 ± 21.1 221.9 ± 9.1 ^{△ △}

B (model group) 7 0.190 ± 0.047 0.063 ± 0.014 ^*0.144 ± 0.018 1.856 ± 0.500 ^*216.0 ± 20.2 1037.1 ± 219.1 ^*

C (Xuezhikang) 10 0.200 ± 0.037 0.143 ± 0.039 ^{△ △}0.138 ± 0.035 1.250 ± 0.229 ^△220.2 ± 21.2 478.9 ± 110.1 ^{△ △}

D (low dose) 9 0.194 ± 0.034 0.161 ± 0.045 ^{△ △}0.116 ± 0.052 1.202 ± 0.171 ^△224.2 ± 25.8 249.8 ± 44.6 ^{△ △ ▲ ▲}

E (middle dosage) 7 0.197 ± 0.046 0.167 ± 0.039 ^{△ △}0.117 ± 0.061 0.946 ± 0.233 ^{△ △ ▲}201.3 ± 12.4 369.6 ± 56.5 ^{△ △ ▲}

F (heavy dose) 7 0.176 ± 0.024 0.180 ± 0.026 ^{△ △ ▲}0.156 ± 0.040 1.317 ± 0.154 ^△213.5 ± 23.4 348.5 ± 53.8 ^{△ △ ▲ ▲}

Compare with A group (normal control) ^*Compare with B group (hyperlipidemia model) P＜0.01 ^△P＜0.05 ^{△ △}P＜0.01, with C group (Xuezhikang) comparison ▲ P＜0.05 ▲ ▲ P＜0.01

Table 2 transfers the fat oral liquid to hemorheological influence

Whole blood viscosity

Plasma viscosity

The low Qie Gaoqie that hits

Group n

A organizes (matched group) 8 10.413 ± 0.947 7.332 ± 0.628 3.420 ± 0.219 1.579 ± 0.126

B organizes (model group) 7 13.870 ± 2.396 ^*9.343 ± 1.221 ^*3.957 ± 0.356 2.022 ± 0.111

C organizes (Xuezhikang) 10 11.178 ± 0.619 ^{△ △}7.650 ± 0.429 ^{△ △}3.571 ± 0.199 ^△1.734 ± 0.157 ^{△ △}

D organizes (low dose) 9 12.101 ± 1.069 8.126 ± 0.564 ^△3.553 ± 0.145 ^△1.869 ± 0.132

E organizes (middle dosage) 7 11.206 ± 1.934 ^△7.809 ± 1.111 ^△3.556 ± 0.271 ^△1.795 ± 0.169 ^{△ △}

F organizes (heavy dose) 7 10.273 ± 2.229 ^△6.952 ± 0.522 ^{▲ △}3.514 ± 0.337 ^△1.595 ± 0.148 ^{△ △}

Compare with matched group ^*Compare with model group P＜0.01 ^{△ △}P＜0.05, ^{△ △}P＜0.01 is with Xuezhikang group comparison ▲ P＜0.05

Table 3 is transferred the influence of fat oral liquid to superoxide dismutase

Group n SOD (nitrite unit/ml)

A (normal control) 8 149.394 ± 22.075

B (hyperlipidemia model) 7 114.559 ± 7.623**

C (Xuezhikang) 10 168.388 ± 23.581 ^{△ △}

D (low dose) 9 164.315 ± 19.089 ^{△ △}

E (middle dosage) 7 139.783 ± 14.999 ^{△ △ ▲ ▲}

F (heavy dose) 7 135.764 ± 26.193 ^▲

Compare with A group (normal control) ^*Compare with B group (hyperlipidemia model) P＜0.01 ^△P＜0.05 ^{△ △}Compare with C group (Xuezhikang) P＜0.01 ^▲P＜0.05 ^{▲ ▲}P＜0.05

Table 4 transfers the fat oral liquid that the aorta speckle is formed influences perusal relatively

Group n X ± SD

A (normal control) 80 ± 0

B (hyperlipidemia model) 7 2.286 ± 1.380**

C (Xuezhikang group) 10 1.600 ± 1.506

D (low dose) 9 0.778 ± 0.972 ^△

E (middle dosage) 7 0.714 ± 0.756 ^△

F (heavy dose) 7 1.667 ± 1.367

Compare with the A group ^*Compare with B P＜0.01 ^△P＜0.05

Table 5 transfers the fat oral liquid that the aorta speckle is formed influences the light microscopic detection relatively

The group speckle forms the animal number of elements

Number of animals

(only)-+

A (normal control) 88

B (hyperlipidemia model) 707

C (Xuezhikang) 10 37

D (low dose) 96 ^※3

E (middle dosage) 75 ^※2

F (heavy dose) 725

Compare with model group ^※Compare with the B group P＜0.05 ^△P＜0.05

Table 7 is transferred the influence of fat oral liquid to liver wet weights

Group n liver weight/100g body weight (X ± SD)

A (normal control) 8 0.029 ± 0.008

B (hyperlipidemia model) 7 0.043 ± 0.007**

C (Xuezhikang group) 10 0.039 ± 0.009*

D (low dose) 9 0.036 ± 0.011

E (middle dosage) 7 0.042 ± 0.005**

F (heavy dose) 7 0.045 ± 0.008**

Compare * P＜0.05 * * P＜0.01 with the A group

The specific embodiment:

Further specify the present invention by the following examples.

Embodiment 1

[prescription]

Radix Polygoni Multiflori Preparata 266.5g Fructus Lycii 266.5g

Semen Cassiae 266.5g Flos Chrysanthemi 166.5g

Flos Carthami 100g Fructus Crataegi 266.5g

The sweet close plain 3g of Pericarpium Citri Reticulatae 100g

Potassium sorbate 2g

[method for making] above seven flavors depend on that pine torch is broken into coarse powder, add 50% alcohol reflux secondary, add 7 times of amount ethanol for the first time, extract 2 hours; Add for the second time 6 times of amount ethanol, extracted 1.5 hours, merge alcohol extract twice, filter, standby behind the decompression recycling ethanol.Six-element medical materials such as the coarse powder of Radix Polygoni Multiflori Preparata, Fructus Lycii are mixed with medicinal residues after the Semen Cassiae alcohol extraction, and extracting in water three times adds 8 times of water gagings for the first time to extract 2 hours, collects the about 300ml of Aromatic water simultaneously, and is standby; Adding for the second time 7 times of water gagings extracted 1.5 hours; Adding 6 times of water gagings for the third time extracted 1.0 hours, merge three times the water extract, filter, being evaporated to relative density is 1.10-1.15 (60 ℃ of heat are surveyed), under agitation, slowly add ethanol and make and contain alcohol amount and reach 60%, left standstill 16 hours, filter, filtrate recycling ethanol, be evaporated to about 1.15 (60 ℃ of heat are surveyed) of relative density, add above-mentioned Semen Cassiae alcohol extraction concentrated solution and Aromatic water, cyclamate 3g, potassium sorbate 2g, adding distil water is adjusted total amount to 1000ml again, stirs evenly, and cold preservation was left standstill 24 hours, filter, totally 100 bottles of fill 10ml bottles, sterilization, promptly.

Embodiment 2

[prescription]

Radix Polygoni Multiflori Preparata 133g Fructus Lycii 133g

Semen Cassiae 133g Flos Chrysanthemi 83g

Flos Carthami 50g Fructus Crataegi 133g

The sweet close plain 3g of Pericarpium Citri Reticulatae 50g

Potassium sorbate 2g

[method for making] above seven flavors depend on that pine torch is broken into coarse powder, add 50% alcohol reflux secondary, add 7 times of amount ethanol for the first time, extract 2 hours; Add for the second time 6 times of amount ethanol, extracted 1.5 hours, merge alcohol extract twice, filter, standby behind the decompression recycling ethanol.Six-element medical materials such as the coarse powder of Radix Polygoni Multiflori Preparata, Fructus Lycii are mixed with medicinal residues after the Semen Cassiae alcohol extraction, and extracting in water three times adds 8 times of water gagings for the first time to extract 2 hours, collects the about 300ml of Aromatic water simultaneously, and is standby; Adding for the second time 7 times of water gagings extracted 1.5 hours; Adding 6 times of water gagings for the third time extracted 1.0 hours, merge three times the water extract, filter, being evaporated to relative density is 1.10-1.15 (60 ℃ of heat are surveyed), under agitation, slowly add ethanol and make and contain alcohol amount and reach 60%, left standstill 16 hours, filter, filtrate recycling ethanol, be evaporated to about 1.15 (60 ℃ of heat are surveyed) of relative density, add above-mentioned Semen Cassiae alcohol extraction concentrated solution and Aromatic water, cyclamate 3g, potassium sorbate 2g, adding distil water is adjusted total amount to 1000ml again, stirs evenly, and cold preservation was left standstill 24 hours, filter, totally 100 bottles of fill 10ml bottles, sterilization, promptly.

Embodiment 3

[prescription]

Radix Polygoni Multiflori Preparata 533g Fructus Lycii 533g

Semen Cassiae 533g Flos Chrysanthemi 333g

Flos Carthami 200g Fructus Crataegi 533g

The sweet close plain 3g of Pericarpium Citri Reticulatae 200g

Potassium sorbate 2g

[method for making] above seven flavors depend on that pine torch is broken into coarse powder, add 50% alcohol reflux secondary, add 7 times of amount ethanol for the first time, extract 2 hours; Add for the second time 6 times of amount ethanol, extracted 1.5 hours, merge alcohol extract twice, filter, standby behind the decompression recycling ethanol.Six-element medical materials such as the coarse powder of Radix Polygoni Multiflori Preparata, Fructus Lycii are mixed with medicinal residues after the Semen Cassiae alcohol extraction, and extracting in water three times adds 8 times of water gagings for the first time to extract 2 hours, collects the about 300ml of Aromatic water simultaneously, and is standby; Adding for the second time 7 times of water gagings extracted 1.5 hours; Adding 6 times of water gagings for the third time extracted 1.0 hours, merge three times the water extract, filter, being evaporated to relative density is 1.10-1.15 (60 ℃ of heat are surveyed), under agitation, slowly add ethanol and make and contain alcohol amount and reach 60%, left standstill 16 hours, filter, filtrate recycling ethanol, be evaporated to about 1.15 (60 ℃ of heat are surveyed) of relative density, add above-mentioned Semen Cassiae alcohol extraction concentrated solution and Aromatic water, cyclamate 3g, potassium sorbate 2g, adding distil water is adjusted total amount to 1000ml again, stirs evenly, and cold preservation was left standstill 24 hours, filter, totally 100 bottles of fill 10ml bottles, sterilization, promptly.

Claims (10)

1. a Chinese medicine preparation for the treatment of hyperlipidemia is characterized in that, per 1000 dosage units are made by following Chinese medicinal raw materials,

Radix Polygoni Multiflori Preparata 133-533g Fructus Lycii 133-533g

Semen Cassiae 133-533g Flos Chrysanthemi 83-333g

Flos Carthami 50-200g Fructus Crataegi 133-533g

Pericarpium Citri Reticulatae 50-200g.

2. the Chinese medicine preparation of claim 1 is characterized in that, per 1000 dosage units are made by following Chinese medicinal raw materials,

Radix Polygoni Multiflori Preparata 200-399g Fructus Lycii 200-399g

Semen Cassiae 200-399g Flos Chrysanthemi 124-250g

Flos Carthami 75-150g Fructus Crataegi 200-399g

Pericarpium Citri Reticulatae 75-150g.

3. the Chinese medicine preparation of claim 1 is characterized in that, per 1000 dosage units are made by following Chinese medicinal raw materials,

Radix Polygoni Multiflori Preparata 266.5g Fructus Lycii 266.5g

Semen Cassiae 266.5g Flos Chrysanthemi 166.5g

Flos Carthami 100g Fructus Crataegi 266.5g

Pericarpium Citri Reticulatae 100g.

4. the Chinese medicine preparation of claim 1-3 is to be fit to medicinal various dosage forms.

5. the Chinese medicine preparation of claim 4 is oral liquids.

6. the Chinese medicine preparation of claim 5 wherein also comprises the medicine acceptable carrier.

7. the Chinese medicine preparation of claim 1 prevents and/or treats application in the medicine of hyperlipidemia in preparation.

8, the preparation method of the Chinese medicine preparation of claim 1, it is characterized in that, through following steps, depend on that pine torch is broken into coarse powder, adds 50% alcohol reflux secondary, add for the first time 7 times of amount ethanol, extracted 2 hours, and added 6 times of amount ethanol for the second time, extracted 1.5 hours, merge alcohol extract twice, standby behind the decompression recycling ethanol.With the coarse powder of Radix Polygoni Multiflori Preparata, Six-element medical materials such as Fructus Lycii mix with medicinal residues after the Semen Cassiae alcohol extraction, and extracting in water three times adds 8 times of water gagings for the first time and extracted 2 hours, collects the about 300ml of Aromatic water earlier, and is standby; Adding for the second time 7 times of water gagings extracted 1.5 hours; Add 6 times of water gagings for the third time, extracted 1.0 hours, merge three times the water extract, filter, be evaporated to relative density and be 1.10-1.15 (60 ℃ of heat are surveyed), under agitation, slowly add ethanol and make and contain the alcohol amount and reach 60%, left standstill 16 hours, filter, decompression filtrate recycling ethanol is evaporated to about 1.15 (60 ℃ of heat are surveyed) of relative density, add above-mentioned Semen Cassiae alcohol extraction concentrated solution and Aromatic water, obtain pharmaceutically active substance.

9, preparation method according to Claim 8 is characterized in that, the pharmaceutically active substance that the method for claim 8 obtains is pressed pharmaceutical dosage form and added adjuvant, makes preparation with the galenic pharmacy routine techniques.

10, a kind of detection method is characterized in that, is a kind of detection method to tablet in the pharmaceutical preparation of claim 5, may further comprise the steps,

[character] this product is the rufous clear liquid; Feeble QI, it is little sweet to distinguish the flavor of.Can there be the small amount of precipitate thing to separate out in the placement, can be uniformly dispersed after the jolting;

This product 10ml is got in [discriminating] (1), puts in the separatory funnel, adds water 50ml, shakes up, reuse ethyl acetate extraction 3 times, each 20ml merges ethyl acetate solution, add water 20ml and wash once, ethyl acetate solution water bath method, residue add methanol 2ml dissolving as need testing solution.Other gets Radix Polygoni Multiflori control medicinal material fine powder 1g, puts in the conical beaker, adds methanol 25ml supersound extraction 30 minutes, takes out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the preparation of need testing solution preparation method again, in contrast medical material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 10～15ul of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, (4: 4: 1.2: 0.2) be developing solvent, expansion was taken out with toluene-ethyl acetate-methanol-water, dry, spray is with 10% ethanol solution of sulfuric acid, and 105 ℃ were toasted 5～10 minutes, and is clear to the speckle colour developing.In the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on, show the speckle of same color;

(2) get the need testing solution under (1) item, as need testing solution.Other gets Fructus Lycii control medicinal material fine powder 2g, puts in the conical flask, adds methanol 25ml supersound extraction 30 minutes, takes out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the need testing solution preparation method, make control medicinal material solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned two kinds of each 10-15ul of solution, put respectively on same silica gel g thin-layer plate, (4: 3: 0.8: 0.2) be developing solvent, expansion was taken out with toluene-ethyl acetate-methanol-water, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with the corresponding position of control medicinal material chromatograph on show identical sapphirine fluorescence speckle;

(3) get this product 5ml, put in the evaporating dish, add 5% hydrochloric acid solution 25ml again, boiling water bath hydrolysis 30 minutes, residue add water 50ml gradation dissolving, change in the separatory funnel, add chloroform extraction 3 times, each 25ml, combined chloroform solution, leave standstill and make layering, chloroformic solution water bath method, residue add chloroform 5ml makes dissolving, as need testing solution, other depends on pine torch control medicinal material 1g, shines medical material solution in pairs with legal system.Get the chrysophanol reference substance again and add the chloroform dissolving, be mixed with the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw above-mentioned three kinds of each 1-2ul of solution respectively, put respectively on same silica gel g thin-layer plate, with petroleum ether (30-60 ℃)-ethyl acetate-formic acid (15: 5: 1) upper solution is developing solvent, launch, dry, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on show the fluorescence speckle of same color;

(4) get need testing solution under (1) as need testing solution, other gets Pericarpium Citri Reticulatae control medicinal material fine powder 1g, put in the conical flask, add methanol 25ml supersound extraction 30 minutes, take out, filter, filtrate water bath method, residue add water 50ml gradation dissolving, change in the separatory funnel, press the need testing solution preparation method, make control medicinal material solution.Get the hesperidin reference substance again, add 70% dissolve with methanol, make the solution that every 1ml contains 1mg, in contrast product solution.Test according to thin layer chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 B), draw each 5-10ul of need testing solution, control medicinal material solution 2ul, reference substance solution 4ul, put respectively on same-0.5% sodium hydroxide silica gel g thin-layer plate, with ethyl acetate-methanol-water (100: 17: 13) is developing solvent, launch, take out, dry, spray is with 2% aluminum chloride test solution, put under the ultra-violet lamp (365nm) and inspect, in the test sample chromatograph, with reference substance and the corresponding position of control medicinal material chromatograph on, show the fluorescence speckle of identical color;

[inspection]

Relative density should be not less than 1.03 (with reference to pycnometric methods under an appendix VII of Chinese Pharmacopoeia version in 2000 the A relative density algoscopy item);

PH value should be 4.0-6.0 (with reference to an appendix VII of Chinese Pharmacopoeia version in 2000 G pH value algoscopy).

Other should meet relevant every regulation under Chinese Pharmacopoeia version appendix in 2000 the I J mixture item;

[assay] measured according to high performance liquid chromatography (an appendix VI of Chinese Pharmacopoeia version in 2000 D);

System suitability test: with octadecylsilane chemically bonded silica is filler, and acetonitrile-water (0.2: 0.8) is a mobile phase, detects wavelength 320nm, according to 2,3,5,4 '-tetrahydroxystilbene-2-O-β-D glycoside peak theory of computation plate number is greater than 2000, separating degree＞1.5;

The preparation of reference substance solution: get be dried to constant weight 2,3,5, the 4 '-tetrahydroxystilbene-2-O-β-about 5mg of D glycoside reference substance, the accurate title, decide, put in the 50ml volumetric flask, add 80% dissolve with methanol and be diluted to scale, shake up, the accurate again 5ml that draws, put in the 25ml volumetric flask, add 80% methanol and be diluted to scale, shake up, promptly get (lucifuge operation);

The preparation of need testing solution: accurate this product 1ml that draws, put in the 100ml measuring bottle, add 80% methanol and be diluted to scale, shake up, filter, discard the about 25ml of filtrate just, collect subsequent filtrate as need testing solution.(lucifuge operation);

Algoscopy: the accurate reference substance solution 10ul that draws, need testing solution 10ul injects high performance liquid chromatograph respectively, measures peak area, calculates, promptly;

This product contains 2,3,5,4 '-tetrahydroxystilbene 2-O-β-D glycoside (C20H22O9) must not be less than 1.0mg/ml.