CN102697910B - Chinese medicinal extract dripping pill for treating diabetes and hyperlipidemia - Google Patents

Abstract

The invention relates to a Chinese medicinal extract dripping pill for treating diabetes and hyperlipidemia, which can effectively solve the problems of long dissolving time, low dissolubility and bio-availability of existing Chinese medicinal oral preparations after administration. A technical proposal provided by the invention comprises the steps of mixing polyethylene glycol (PEG) 4000 and PEG 6000, or PEG 4000 and sodium carboxymethyl starch or Poloxamer, or PEG 6000 and sodium carboxymethyl starch or Poloxamer at weight ratio of 1:(1-10), and heating and melting to obtain matrix; mixing 10-30 wt% of Fructus Rosae Laevigatae extract, 5-25 wt% of Fructus Mori extract, 10-30 wt% of Rhizoma Coptidis extract, 5-20 wt% of Radix Astragali extract, 5-20 wt% of Polygoni Multiflori Radix extract, and 5-20 wt% of Fructus Corni extract, wherein the total amount of the Chinese medicinal extracts is 100%; and mixing the Chinese medicinal extracts with the matrix at weight ratio of 1:(1.5-5). The inventive dripping pill has the advantages of abundant and easily-accessible materials, simple production, and good treatment effect, and is an innovation in aspect of medicines for treating diabetes and hyperlipidemia.

Description

A kind of Chinese medicine extraction composition dropping pills for the treatment of diabetes and hyperlipidemia

Technical field

The present invention relates to medicine, particularly a kind of Chinese medicine extraction composition dropping pills for the treatment of diabetes and hyperlipidemia.

Background technology

Raising along with people's living standard, diet is too greasy mostly, sugar content also increases to some extent in the food, this has just caused the diabetes incidence rate to increase year by year, at present increasing people recognize the seriousness of diabetes, and begin to pay attention to diabetes, the patient actively seeks treatment, diabetes are by inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, the free radical toxin, the various virulence factors of Nervous and Mental Factors etc. act on body and cause hypoinsulinism, insulin resistant etc. and the sugar that causes, protein, fat, a series of metabolism disorder syndromes such as power and water Xie Zhi, be main feature clinically with the hyperglycemia, polyuria can appear in model case, polydipsia, polyphagia, performance such as become thin, i.e. " three-many-one-little " symptom, diabetes (blood glucose) cause complication in case control bad meeting, cause kidney, eye, the depleted pathological changes at positions such as foot, and can't cure.Through discovering that the traditional Chinese medical herbal treatment diabetes have extraordinary effect, many Chinese herbal medicine have the effect of good blood sugar lowering, and are helpful to the treatment diabetes.

Because making one or more lipids of blood plasma be higher than unusually, lipid metabolism or running normally be called hyperlipemia.Lipid is insoluble or be slightly soluble in water and must exist with the lipoprotein form with protein bound, and therefore, hyperlipemia is hyperlipoproteinemia often, shows as hypercholesterolemia, hypertriglyceridemia or both have concurrently.Chinese medicine is a kind of good effect to the treatment of hyperlipidemia, but steadily, effective method, have no side effect again simultaneously, this is the advantage place that Western medicine can't be accomplished, China's influence of various Chinese medicines to hyperlipidemia that just begin one's study from the fifties, so far progressively ripe and perfect, have been found that the Chinese herbal medicine with effect for reducing fat have 90 surplus kind, from effect, except the blood fat effect shows that mainly cholesterol reducing and triglyceride reducing use.

In Chinese medicine preparation, drop pill has become a kind of important novel form, the Chinese medicine dripping pills preparation be by solid drugs with after the substrate heating and melting becomes solution, splash in the immiscible condensed fluid and form through the suitable water dropper of bore.It has the title of solid solution, and dissolution rate is fast, bioavailability is high, and consumption is little, the effect of having immediate effect.The medicine stability height that adopts drops to make, not facile hydrolysis, be difficult for oxidation owing to operate under liquid state, no dust pollution is easy to guarantee the quality of medicine, is a kind of advanced person's dosage form.State is because drop pill has the outstanding characteristic that other dosage forms do not possess, meet people ＂ three little ＂, ＂ triple effect ＂, the ＂ five of modern medicines preparation made things convenient for basic demands such as ＂, thereby meet growing clinical needs more, be widely used in clinical treatment, along with the maturation gradually of dropping pill formulation Technology, drop pill will have more vast potential for future development and application space.Have shortcomings such as long, dissolution of molten diffusing time and bioavailability are low after taking and present most of oral preparation of Chinese traditional medicinal has, therefore, the improvement of the Chinese medicine for the treatment of diabetes and hyperlipidemia is the problem of needing solution at present badly.

Summary of the invention

At above-mentioned situation, for solving the defective of prior art, the present invention's purpose just provides a kind of Chinese medicine extraction composition dropping pills for the treatment of diabetes and hyperlipidemia, can effectively solve most of oral preparation of Chinese traditional medicinal and take the molten diffusing time length in back, dissolution and the low problem of bioavailability.

The technical scheme that the present invention solves is: this drop pill is with Macrogol 4000 and polyethylene glycol 6000, or Macrogol 4000 and carboxymethyl starch sodium or poloxamer, or polyethylene glycol 6000 mixes the post-heating fusion with carboxymethyl starch sodium or poloxamer according to weight ratio 1:1 ~ 10, gets mixed-matrix; Press Chinese medicine extract and mixed-matrix weight ratio 1:1.5 ~ 5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract and mixed-matrix proportioning can be preferably as follows: the proportioning of Chinese medicine extract and mixed-matrix is by weight being 1:3 ~ 5;

Wherein:

Described Chinese medicine extract, following material by weight percentage is formed: Smallfruit Rose Root extract 10～30%, Fructus Mori extract 5～25%, Rhizoma Coptidis extract 10～30%, Radix Astragali extract 5～20%, Radix Polygoni Multiflori extract 5～20%, Fructus Corni extract 5～20%;

The Chinese medicine extract weight percentage can be preferably as follows: Smallfruit Rose Root extract 15～25%, Fructus Mori extract 15～20%, Rhizoma Coptidis extract 15～20%, Radix Astragali extract 12～18%, Radix Polygoni Multiflori extract 10～18%, Fructus Corni extract 10～13%;

The Chinese medicine extract weight percentage can continue to be preferably as follows: Smallfruit Rose Root extract 10～16% or 17～25% or 26～30%, Fructus Mori extract 5～10% or 11～18% or 19～25%, Rhizoma Coptidis extract 10～16% or 17～25% or 26～30%, Radix Astragali extract 5～10% or 11～15% or 16～20%, Radix Polygoni Multiflori extract 5～10% or 11～15% or 16～20%, Fructus Corni extract 5～10% or 11～15% or 16～20%;

Described Smallfruit Rose Root method for preparing extractive is: the root of getting dry Smallfruit Rose Root is pulverized, cross the 40-60 mesh sieve and become coarse powder, add distilled water and decoct extraction, extraction time is 1～3h, if medical material weight be 1kg then the consumption of distilled water be 7～11L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge the extracting solution that obtains, below 70 ℃, carry out flash concentration with Reduced Pressure Concentration Device, be concentrated into 1/10～15 of original volume, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, namely get Smallfruit Rose Root extract dry powder; The Smallfruit Rose Root extract yield reaches 22.4～43.7%;

Described Fructus Mori extract preparation method is: after the Fructus Mori fruit of thawing again after freezing is smashed with tissue mashing machine, squeeze out fruit juice, fruit juice is standby; Extruding pulp volumetric concentration after the fruit juice and be 40%～70% ethanol merceration extracts 2～5 times, each 6～14h, extrude that the volume ratio of pulp and ethanol consumption is 1:1～3 after the fruit juice, pulp is again by extruding behind the ethanol merceration, obtain the sarcocarp extracting solution, discard marc, fruit juice and sarcocarp extracting solution are merged, below 70 ℃, carry out flash concentration to 1/10～15 of original volume with Reduced Pressure Concentration Device, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, be ground into powder with mortar then, by 80～120 order sub-sieves, namely get Fructus Mori extract dry powder; The Fructus Mori extract yield reaches 12.5～25.6%.Adopt pH differential method to measure the content of total anthocyanidin in the Fructus Mori extract, content reaches 18.5～29.6%;

Described Rhizoma Coptidis extract preparation method is: the Rhizoma Coptidis of drying is pulverized, cross the 40-60 mesh sieve and become coarse powder, pack in the percolation device, be that 1% sulphuric acid is solvent soaking medical material 6～12h with the mass concentration of volume ratio 1:1, be that 1% sulphuric acid is that solvent carries out percolation and extracts with mass concentration then, if medical material weight be 1kg then mass concentration be that the consumption of 1% sulphuric acid is 12～18L, be that the speed of 10～20 ml/min is collected percolate by flow velocity, the percolate that obtains is added concentrated hydrochloric acid, transfer to PH 2～3, add 10% Sal again, namely separate out a large amount of yellow mercury oxides, placement is spent the night, sucking filtration, obtain Rhizoma Coptidis (berberine hydrochloride) extract, precipitation is put in the baking oven in dry below 70 ℃, get Rhizoma Coptidis extract; Extract yield is 2.5～6.6%, and the content through adopting the HPLC method to measure berberine hydrochloride (berberine) in the extract is 78.4～95.6%;

Described Radix Astragali extract preparation method is: the Radix Astragali of drying is put in certain container, add volumetric concentration and be 40～80% ethanol and carry out supersound extraction, extraction time is 20～60min, if medical material weight be 1kg then consumption of ethanol be 6～10L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge the extracting solution that obtains, carrying out flash concentration to 1/8～12 of original volume with Reduced Pressure Concentration Device below 70 ℃, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, be ground into powder with mortar then, by 80～120 order sub-sieves, namely get Radix Astragali extract dry powder; The Radix Astragali extract yield reaches 10.8～26.4%;

Described Radix Polygoni Multiflori extract preparation method is: the Radix Polygoni Multiflori of drying is put in certain container, add volumetric concentration and be 40～70% ethanol and carry out supersound extraction, extraction time is 30～80min, if medical material weight be 1kg then consumption of ethanol be 7～10L, extract 2～4 times.With the extracting solution sucking filtration, discard filtering residue, merge the extracting solution that obtains, carrying out flash concentration to 1/8～10 of original volume with Reduced Pressure Concentration Device below 70 ℃, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, namely get Radix Polygoni Multiflori extract dry powder; The Radix Polygoni Multiflori extract yield reaches 12.1～22.4%;

Described Fructus Corni extract preparation method is: the Fructus Corni sarcocarp of drying is put in certain container, add volumetric concentration and be 40～80% ethanol and carry out supersound extraction, extraction time is 20～60min, if medical material weight be 1kg then consumption of ethanol be 6～10L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge the extracting solution that obtains, carrying out flash concentration to 1/10～12 of original volume with Reduced Pressure Concentration Device below 70 ℃, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, be ground into powder with mortar then, by 80～120 order sub-sieves, namely get Fructus Corni extract dry powder; The Fructus Corni extract yield reaches 18.4～26.2%;

Described Smallfruit Rose Root method for preparing extractive can be preferably: the consumption of distilled water is 8～10 times of amounts of medical material weight; Extraction time is 2～2.5h; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/12 ~ 13 of original volume;

Described Fructus Mori extract preparation method can be preferably: the volumetric concentration of the ethanol of pH=4 is 50～60%; The volume ratio of sarcocarp and ethanol consumption is 1:1～2; Merceration extraction time is 10～12h; Extraction time is 3～4 times; When carrying out flash concentration, be concentrated into 1/12 ~ 13 of original volume;

Described Rhizoma Coptidis extract preparation method can be preferably: be that 1% sulphuric acid is solvent soaking medical material 8～10h with mass concentration; The consumption of percolate 1% sulphuric acid is 15～18 times of amounts of medical material weight; The flow velocity of collecting percolate is 10～16ml/min;

Described Radix Astragali extract preparation method can be preferably: the volumetric concentration of ethanol is 60～70%; Consumption of ethanol is 7～8 times of amounts; Extraction time is 30～50min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/10 ~ 12 of original volume;

Described Radix Polygoni Multiflori extract preparation method can be preferably: the volumetric concentration of ethanol is 55～65%; Consumption of ethanol is 8～9 times of amounts; Extraction time is 30～40min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/9 ~ 10 of original volume;

Described Fructus Corni extract preparation method can be preferably: the volumetric concentration of ethanol is 55～70%; Consumption of ethanol is 6～8 times of amounts; Extraction time is 20～40min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/10 ~ 11 of original volume.

The glass column that described percolation device is used with column chromatography replaces, and flash concentration device (Reduced Pressure Concentration Device) can be and designs assembling customized voluntarily, or directly buys (prior art, no longer Ao Shu) from the market.

Chinese medicine extraction composition dropping pills of the present invention, abundant raw material, easily purchase, expense is low, method is simple, easily produce, the product good effect, is the innovation on treatment diabetes and the high blood cholesterol drug.

The specific embodiment

Be described in further detail below in conjunction with the specific embodiment of the present invention of embodiment.

Embodiment 1

This drop pill be with Macrogol 4000 and polyethylene glycol 6000 according to the fusion of weight ratio 1:1 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:2.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 20%, Fructus Mori extract 20%, Rhizoma Coptidis extract 20%, Radix Astragali extract 20%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

Embodiment 2

This drop pill be with Macrogol 4000 and polyethylene glycol 6000 according to the fusion of weight ratio 1:3 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:3, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 15%, Rhizoma Coptidis extract 30%, Radix Astragali extract 5%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

Embodiment 3

This drop pill be with Macrogol 4000 and carboxymethyl starch sodium according to the fusion of weight ratio 1:5 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:3.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 20%, Rhizoma Coptidis extract 25%, Radix Astragali extract 5%, Radix Polygoni Multiflori extract 15%, Fructus Corni extract 5%.

Embodiment 4

This drop pill be with Macrogol 4000 and poloxamer according to the fusion of weight ratio 1:7 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:4, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 25%, Fructus Mori extract 20%, Rhizoma Coptidis extract 25%, Radix Astragali extract 10%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

Embodiment 5

This drop pill be with polyethylene glycol 6000 and carboxymethyl starch sodium according to the fusion of weight ratio 1:9 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:4.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 20%, Rhizoma Coptidis extract 20%, Radix Astragali extract 20%, Radix Polygoni Multiflori extract 5%, Fructus Corni extract 5%.

Embodiment 6

This drop pill be with polyethylene glycol 6000 and poloxamer according to the fusion of weight ratio 1:10 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 20%, Fructus Mori extract 25%, Rhizoma Coptidis extract 30%, Radix Astragali extract 10%, Radix Polygoni Multiflori extract 5%, Fructus Corni extract 10%.

In said medicine, wherein, Smallfruit Rose Root is called Radix Rosae Cymosae, fishing rod, Radix Rosae Cymosae, is spent Aesculus chinensis Bunge, seven sisters in vain, root and tender leaf for Rosaceae gul Smallfruit Rose Root, mainly be distributed in ground such as Henan, Jiangsu, Anhui, Zhejiang, Fujian, Taiwan, Jiangxi, Hunan, Hubei, Sichuan, Yunnan, Guizhou, Guangdong, Guangxi, aboundresources, can adopt the whole year, and with 10～November for the most suitable.Be used as medicine with root and leaf.The four seasons can be adopted root, leaf, and clean chopping is dried.Its root hardship, puckery, flat.Leaf: hardship, flat.

The root of Smallfruit Rose Root has expelling wind and removing dampness, and the effect that convergence is taken off admittedly is used for rheumatic arthritis, traumatic injury, diarrhoea, proctoptosis, uterine prolapse.Leaf: removing toxic substances and promoting subsidence of swelling is used for controlling carbuncle furuncle infections, burn and scald.The Smallfruit Rose Root root bark is rich in tannin, wherein may contain ellagic acid, catechuic acid, epicatechin.Triterpenes is as Alpha-hydroxy ursolic acid, euscaphic acid Jacaric acid, Herba Astragali Melilotoidis (Herba Astragali Sinici) glycosides, Folium potentillae velutinae (Radix Potentillae Fulgentis), rosamultin etc.The Smallfruit Rose Root root bark is rich in tannin triterpenes and flavones ingredient, is active component important in the gul.The research report is arranged in recent years, and the decocting liquid of Smallfruit Rose Root has stronger hypoglycemic activity.

Fructus Mori is the mature fruit of perennial moraceae plants Mulberry, ovalize atropurpureus or beautiful white.Mulberry is a kind of perennial woody plant, wide adaptability, is easy to cultivation, and all there is cultivation in the most of area of China.Fructus Mori is enjoyed " holy fruit among the people ", " China fruit king's " laudatory title from ancient times.Modern study shows, contain compositions such as abundant flavonoid (mainly being anthocyan), sugar, organic acid, lipid, multivitamin, aminoacid, trace element in the sorosis, the tradition traditional Chinese medical science thinks, Fructus Mori has YIN nourishing, tonifying liver, the kidney invigorating, enriches blood, item, blacking hair and nourishing face, Cure for insomnia and neurasthenia, resisting fatigue, anti-effect such as treat constipation.Have the immunity of adjusting, promote hematopoietic cell to grow, prevent effects such as human body artery sclerosis, antimutagenic, defying age, blood sugar lowering, blood fat reducing, hepatoprotective, antiviral, antioxidation and continuity aging.

Fructus Mori has higher medicinal and nutritive value and multiple functional active components, is subjected to extensive concern both domestic and external.Along with the continuous lifting of international market to China's herbal health care function degree of recognition, Fructus Mori is as the Chinese herbal medicine resource of dietotherapeutic, and the Application and Development of its functional components will have good development prospect.

Rhizoma Coptidis is the dry rhizome of Ranunculaceae herbaceos perennial Rhizoma Coptidis, Coptis Beltoidea C.Y.CHENG et HSIAO or Coptis Teeta Wall.Rhizoma Coptidis is time-honored Chinese medicine simply, namely records in Shennong's Herbal.Rhizoma Coptidis nature and flavor hardship, cold.GUIXIN, stomach, liver, large intestine channel.Effects such as heat clearing away, pathogenic fire purging, dampness, detoxifcation are arranged.Contain alkaloids such as berberine (being berberine), coptisine, 13-methyl-.psi.-coptisine., palmatine, Columbamine and jateorhizine in the Rhizoma Coptidis, Rhizoma Coptidis also contains phenoloid and township's kind trace element such as magnoline.

Modern study shows, Rhizoma Coptidis has hypoglycemic activity, pharmacological experiment study is found, but the oral right to use normal mouse of Rhizoma Coptidis decocting liquid blood glucose descends, and be dose-effect relationship, berberine can reduce normal mouse blood glucose, behind the single administration in the 2-4h, hypoglycemic activity is the strongest, and effect weakens behind the 6h, and gastric infusion of berberine all has the reduction effect to the blood sugar increasing that glucose and epinephrine cause, berberine continuous irrigation stomach 15 days, spontaneous diabetes KK mice is had hypoglycemic activity, and can improve carbohydrate tolerance, alloxan is caused diabetic mice also hypoglycemic activity.Modern medicine study further discloses, and berberine (being berberine) does not influence insulin secretion and release, does not influence number and the Shou Heli of liver plasma membrane Insulin receptor INSR yet, may be by suppressing gluconeogenesis and promoting glycolysis to produce hypoglycemic activity.Simultaneously, multinational scientist's joint study proves that the Chinese medicine Rhizoma Coptidis makes insulin work better, can help type 2 diabetes mellitus patient blood sugar lowering.Experiment shows: inject the berberine mouse in three weeks continuously, blood glucose descends 50%.If this research is achieved success, the product that Rhizoma Coptidis is made will become the alternative medicine of present diabetes oral medicine.

The Radix Astragali is the root of leguminous herbaceous plant's Radix Astragali, Radix Astragali.Originate in ground such as the Inner Mongol, Shanxi, Gansu, Heilungkiang.Excavate spring and autumn, removes fibrous root, root head, dries.Section is given birth to and is used or processed with honey usefulness.Radix Astragali sweet in the mouth, slightly warm in nature.The energy invigorating the spleen and replenishing QI, tonifying the lung consolidating superficial resistance, inducing diuresis to remove edema.Mainly contain compositions such as Saponin, sucrose, polysaccharide, aminoacid, folic acid, also contain various trace elements such as selenium, zinc, copper.Enhancing human body immunity function, enhancing body anoxia enduring and stress ability, promotion organism metabolism arranged, protect the liver, diuresis, defying age, anti-stress, blood pressure lowering, adjusting blood glucose and antibacterial action more widely.

Radix Polygoni Multiflori is the dried root of polygonum multiflorum thunb, its slightly warm in nature, bitter in the mouth, sweet, puckery.Radix Polygoni Multiflori mainly contains anthraquinone analog compound, stilbene glycosides compound and polymerization procyanidin etc., also contains a large amount of lecithin and various trace elements in addition in the Radix Polygoni Multiflori, and stilbene glucoside is the main active of Radix Polygoni Multiflori.Clinical practice has Radix Polygoni Multiflori and Radix Polygoni Multiflori Preparata not.The invigorating the liver and kidney of Radix Polygoni Multiflori Preparata function, benefiting essence-blood, black beard and hair, bone and muscle strengthening, the anti-ageing effect of waiting for a long time.Cure mainly blood deficiency and yellow complexion, vertigo and tinnitus, early whitening of beard and hair, soreness of the waist and knees, numb limbs and tense tendons, bleeding not during menses, chronic malaria body void, modern Chinese medicine is usually used in treating hyperlipemia clinically.Experimentation shows, Radix Polygoni Multiflori Preparata ethanol extract gastric infusion can significantly reduce plasma triglyceride (TG) and free cholesterol (FC) level of old Carnis Coturnicis japonicae in 6 weeks, suppress the rising of total plasma cholesterol (TC) and cholesteryl ester.The water extract of Radix Polygoni Multiflori Preparata can obviously improve mice serum HDL-C (HDL-C) content, reduce the TC level, significantly raise in conjunction with HDL-C/TC ratio, the prompting Radix Polygoni Multiflori can improve the body running and remove the ability of cholesterol, the blood fat reducing level delays development of atherosclerosis.

Fructus Corni is the fruit of Cornaceae plant Fructus Corni, another name Fructus Corni, Fructus Corni, meat Fructus Jujubae, Fructus Jujubae skin, chicken foot, real Fructus Jujubae, medicine Fructus Jujubae, another name for Sichuan Province Fructus Jujubae.Fructus Corni nature and flavor acid, puckery, tepor.Return liver, kidney channel.Cure mainly liver and kidney tonifying, essence astringing and desertion stemming.Be used for vertigo and tinnitus, soreness of waist and knee joint, impotence and seminal emission, enuresis frequent micturition, bleeding not during menses, profuse sweating collapse.Interior-heat is quenched one's thirst.The anti-stress ability of Fructus Corni energy enhancing body improves mice anoxia enduring, anti-fatigue ability, memory reinforcing.Fructus Corni can improve SOD activity in the erythrocyte, to anti peroxidation of lipid.Fructus Corni alcohol extraction thing also has effect for reducing blood fat, can reduce serum triglycerides, content of cholesterol, arteriosclerosis.Fructus Corni alcohol extraction thing can reduce normal mouse blood glucose, also can reduce the alloxan hyperglycemia.Studies show that Fructus Corni has hypoglycemic activity to the diabetes rat due to the streptozocin, and effectively main component is ursolic acid.Fructus Corni alcohol extraction thing does not have obvious influence to the blood glucose of normal rat, and the diabetes model animal by epinephrine or model induced by alloxan is had the obvious functions of blood sugar effect, and can reduce whole blood viscosity and the platelet aggregation of hyperglycemia animal, think that Fructus Corni may have therapeutical effect to type.The ether extract of Fructus Corni and effective ingredient thereof have the effect of tangible reduction glucose in urine, and have confirmed that further ursolic acid (ursolic acid) is Fructus Corni diabetes active component.Fructus Corni also has cardiotonic, and the intravenous injection of Fructus Corni injection can improve cardiac function, increases myocardial contractility and cardiac output, improves heart working efficient.After the dog injection, systolic arterial pressure, diastolic pressure and mean blood pressure, left ventricular pressure all raise.The Fructus Corni injection can resist rabbit, rat hemorrhagic shock in late period, makes the shock animals hypertension, and renal blood flow increases, and prolongs the animals survived time.

Relevant experimental data is as follows:

1, the drop pill moulding process is investigated

(1) proportioning test of the screening of substrate and material and substrate

Adopt Polyethylene Glycol (PEG) and surfactant (carboxymethyl starch sodium and poloxamer) to be the matrix optimization test.Substrate is selected: two kinds of mixed-matrixes of PEG-4000 and PEG-6000 or PEG-4000 and two kinds of mixed-matrixes of surfactant, or PEG-6000 and two kinds of mixed-matrixes of surfactant, proportioning is 1:1～10.Material (Chinese medicine extract)-substrate composition is 1:1.5～5.Melt temperature: 78 ℃ ± 1 ℃.Investigate index: drop pill forming degree, dissolve scattered time limit, drop pill hardness and drop pill shape.Under similarity condition, PEG-4000 and PEG-6000 according to certain mixed and PEG-4000 or PEG-6000 and carboxymethyl starch sodium or poloxamer according to the latter made drop pill effect of certain mixed see Table 1, table 2 and table 3.

The test effect of table 1 material-mixed-matrix (1:2)

The test effect of table 2 material-mixed-matrix (1:3)

The test effect of table 3 material-mixed-matrix (1:4)

By table 1～3 as can be seen, other conditions are constant, when the ratio of Chinese medicine extract and mixed-matrix is 1:2, because the proportion of Chinese medicine extract is bigger, makes fused solution viscosity bigger, should not drip and make ball, roundness, the forming degree of its drop pill are undesirable, and hardness is softer; When the ratio of material and mixed-matrix is 1:3 or 1:4, it is 1:10 that mixed-matrix is selected Macrogol 4000 and polyethylene glycol 6000, or polyethylene glycol 6000 and carboxymethyl starch sodium are 5～10:1, or polyethylene glycol 6000 and poloxamer be when being 5～10:1, and prepared drop pill is all more satisfactory aspect drop pill forming degree, hardness and the outward appearance uniformity.In order to guarantee that dose is little and curative effect is obvious, substrates quantity is unsuitable excessive when proportioning, so Chinese medicine extract and the preferred 1:3 of substrate ratio.When carrying out proportioning between the different molecular weight polyethylene glycol, be that 1:10 is best proportioning with Macrogol 4000 and polyethylene glycol 6000 ratio; During the mixing match that carries out between the different substrates, be 10:1 with polyethylene glycol 6000 and carboxymethyl starch sodium, or polyethylene glycol 6000 and poloxamer are that 10:1 is best proportioning.

(2) selection of coolant and drop pill specification

The coolant commonly used that Chinese Pharmacopoeia version in 2010 is recorded has liquid paraffin, Oleum Glycines, dimethicone is done the condensed fluid of drop pill, among the present invention respectively with liquid paraffin, silicone oil and Oleum Glycines are coolant, by material: the finely dispersed medicinal liquid of mixed-matrix 1:3 proportioning fusion splashes into (10 ℃) in three kinds of different coolants respectively, by investigating the shape with drop pill after the above-mentioned different coolant cools, roundness and surface flatness, factors such as hardness, the result is moderate with the dimethicone decrease speed, pill roundness and hardness are good, and therefore preferred dimethicone is as the coolant in the present invention's preparation.

Test and Selection the drop pill of different size (200 mg, 36mg), because large dripping pillar needs the big coolant of viscosity, it is slow to drip drop pill sedimentation velocity in coolant of making, the drop pill color and luster of formation is inhomogeneous, downside often has white point.Comparatively speaking, less drop pill, appearance luster, forming degree, brightness, glossiness are all better, therefore design and produce the little drop pill of 36 mg.According to dropping-pill machine head size and trial test result, the drop pill ball that drips system heavily is 36 mg ± 10%.

(3) coolant temperature is preferred

It is an amount of to take by weighing mixed-matrix polyethylene glycol 6000 and carboxymethyl starch sodium (10:1), behind 80 ℃ of heating and meltings of water-bath, add material according to material and mixed-matrix 1:3, stirring makes it molten and looses evenly, other conditions processed are constant, and coolant temperature is selected 15 ℃ respectively, 12 ℃, 10 ℃, 8 ℃ drip by the examination of shelves temperature from high to low.As a result the temperature of coolant when 10 ℃ and 8 ℃ the drop pill cooling fully, pill shaped circle is whole, hardness is moderate, 8～10 ℃ of the temperature of therefore preferred coolant.

2, blood pressure lowering and blood fat reducing result of the test

Drop pill blood sugar lowering result of the test of the present invention

Drop pill blood fat reducing result of the test of the present invention

3, conclusion

Chinese medicine extraction composition dropping pills of the present invention compared with prior art has following beneficial effect:

1, has stronger blood sugar lowering and effect for reducing blood fat by the prepared drop pill of the present invention, have therapeutical effect and using value preferably.

2, have buccal by the prepared drop pill of the present invention and absorb soon, the characteristics that bioavailability is high have efficient quick-acting effect.

3, the volume by the prepared drop pill of the present invention is little, active constituent content is high, quality is convenient to control, and easy to operate, working condition is controlled easily, the production efficiency height, and is easy to use and carry.

4, all adopt Reduced Pressure Concentration Device to carry out flash concentration to various extracting solution among the present invention; this device and method has following advantage: it is low to carry out the flash concentration heating temperature; compole is short when being concentrated heated liquid; effectively protection thermal sensitivity composition is not destroyed; effective ingredient can keep to greatest extent; the solvent recovering yield height, the concentrated speed of this device is fast, efficient is high, simple to operate, easy to use, energy-conserving and environment-protective.

Claims (10)

1. Chinese medicine extraction composition dropping pills for the treatment of diabetes and hyperlipidemia, it is characterized in that, this drop pill is with Macrogol 4000 and polyethylene glycol 6000, or Macrogol 4000 and carboxymethyl starch sodium or poloxamer, or polyethylene glycol 6000 mixes the post-heating fusion with carboxymethyl starch sodium or poloxamer according to weight ratio 1:1 ~ 10, gets mixed-matrix; Press Chinese medicine extract and mixed-matrix weight ratio 1:1.5 ~ 5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, at 75～80 ℃ of following insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Wherein:

Described Chinese medicine extract, following material by percentage by weight is formed: Smallfruit Rose Root extract 10～30%, Fructus Mori extract 5～25%, Rhizoma Coptidis extract 10～30%, Radix Astragali extract 5～20%, Radix Polygoni Multiflori extract 5～20%, Fructus Corni extract 5～20%;

Described Smallfruit Rose Root extract is: the root of the Smallfruit Rose Root of drying is pulverized, cross the 40-60 mesh sieve and become coarse powder, add distilled water and decoct extraction, extraction time is 1～3h, every 1kg Smallfruit Rose Root coarse powder adds distilled water 7～11L, extracts 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge extractive liquid, below 70 ℃, carries out flash concentration with Reduced Pressure Concentration Device, be concentrated into 1/10～15 of original volume, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, get Smallfruit Rose Root extract dry powder;

Described Fructus Mori extract is: after the Fructus Mori fruit of thawing again after freezing is smashed with tissue mashing machine, squeeze out fruit juice, fruit juice is standby; Extruding pulp volumetric concentration after the fruit juice and be 40～70% ethanol merceration extracts 2～5 times, each 6～14h, extrude that the volume ratio of pulp and ethanol consumption is 1:1～3 after the fruit juice, pulp is again by extruding behind the ethanol merceration, obtain the sarcocarp extracting solution, discard marc, fruit juice and sarcocarp extracting solution are merged, below 70 ℃, carry out flash concentration to 1/10～15 of original volume with Reduced Pressure Concentration Device, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, be ground into powder with mortar then, by 80～120 order sub-sieves, get Fructus Mori extract dry powder;

Described Rhizoma Coptidis extract is: the Rhizoma Coptidis of drying is pulverized, cross the 40-60 mesh sieve and become coarse powder, pack in the percolation device, be that 1% sulphuric acid is solvent soaking medical material 6～12h with the mass concentration of weight ratio 1:1, be that 1% sulphuric acid is that solvent carries out percolation and extracts with mass concentration then, every 1kg Rhizoma Coptidis coarse powder adding mass concentration is sulphuric acid 12～18L of 1%, is the speed collection percolate of 10～20 ml/min by flow velocity, and the percolate that obtains is added concentrated hydrochloric acid, transfer to PH 2～3, add 10% Sal again, namely separate out a large amount of yellow mercury oxides, placement is spent the night, sucking filtration, obtain Rhizoma Coptidis extract, precipitation is put in the baking oven in dry below 70 ℃, get Rhizoma Coptidis extract;

Described Radix Astragali extract is: the Radix Astragali of drying is put in certain container, add volumetric concentration and be 40～80% ethanol and carry out supersound extraction, extraction time is 20～60min, every 1kg Radix Astragali adds ethanol 6～10L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge extractive liquid, is below 70 ℃, carry out flash concentration to 1/8～12 of original volume with Reduced Pressure Concentration Device, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, get Radix Astragali extract dry powder;

Described Radix Polygoni Multiflori extract is: the Radix Polygoni Multiflori of drying is put in certain container, add volumetric concentration and be 40～70% ethanol and carry out supersound extraction, extraction time is 30～80min, every 1kg Radix Polygoni Multiflori adds ethanol 7～10L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge extractive liquid, is below 70 ℃, carry out flash concentration to 1/8～10 of original volume with Reduced Pressure Concentration Device, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, get Radix Polygoni Multiflori extract dry powder;

Described Fructus Corni extract is: the Fructus Corni sarcocarp of drying is put in certain container, add volumetric concentration and be 40～80% ethanol and carry out supersound extraction, extraction time is 20～60min, every 1kg Fructus Corni sarcocarp adds ethanol 6～10L, extract 2～4 times, with the extracting solution sucking filtration, discard filtering residue, merge extractive liquid, is below 70 ℃, carry out flash concentration to 1/10～12 of original volume with Reduced Pressure Concentration Device, concentrated solution is proceeded rotating thin film concentrate, vacuum drying becomes dry powder, is ground into powder with mortar then, by 80～120 order sub-sieves, get Fructus Corni extract dry powder.

2. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, the weight ratio of Chinese medicine extract and mixed-matrix is 1:3 ~ 5.

3. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia, it is characterized in that, described Chinese medicine extract is made up of the following material of percentage by weight: Smallfruit Rose Root extract 15～25%, Fructus Mori extract 15～20%, Rhizoma Coptidis extract 15～20%, Radix Astragali extract 12～18%, Radix Polygoni Multiflori extract 10～18%, Fructus Corni extract 10～13%.

4. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, in the described Smallfruit Rose Root extract preparation, the consumption of distilled water is 8～10 times of amounts of medical material weight; Extraction time is 2～2.5h; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/12 ~ 13 of original volume;

In the described Fructus Mori extract preparation, the volumetric concentration of the ethanol of pH=4 is 50～60%; The volume ratio of sarcocarp and ethanol consumption is 1:1～2; Merceration extraction time is 10～12h; Extraction time is 3～4 times; When carrying out flash concentration, be concentrated into 1/12 ~ 13 of original volume;

In the preparation of described Rhizoma Coptidis extract, be that 1% sulphuric acid is solvent soaking medical material 8～10h with mass concentration; The consumption of percolate 1% sulphuric acid is 15～18 times of amounts of medical material weight; The flow velocity of collecting percolate is 10～16ml/min;

In the described Radix Astragali extract preparation, the volumetric concentration of ethanol is 60～70%; Consumption of ethanol is 7～8 times of amounts; Extraction time is 30～50min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/10 ~ 12 of original volume;

In the described Radix Polygoni Multiflori extract preparation, the volumetric concentration of ethanol is 55～65%; Consumption of ethanol is 8～9 times of amounts; Extraction time is 30～40min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/9 ~ 10 of original volume;

In the described Fructus Corni extract preparation, the volumetric concentration of ethanol is 55～70%; Consumption of ethanol is 6～8 times of amounts; Extraction time is 20～40min; Extraction time is 2～3 times; When carrying out flash concentration, be concentrated into 1/10 ~ 11 of original volume.

5. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with Macrogol 4000 and polyethylene glycol 6000 according to the fusion of weight ratio 1:1 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:2.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 20%, Fructus Mori extract 20%, Rhizoma Coptidis extract 20%, Radix Astragali extract 20%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

6. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with Macrogol 4000 and polyethylene glycol 6000 according to the fusion of weight ratio 1:3 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:3, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 15%, Rhizoma Coptidis extract 30%, Radix Astragali extract 5%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

7. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with Macrogol 4000 and carboxymethyl starch sodium according to the fusion of weight ratio 1:5 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:3.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 20%, Rhizoma Coptidis extract 25%, Radix Astragali extract 5%, Radix Polygoni Multiflori extract 15%, Fructus Corni extract 5%.

8. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with Macrogol 4000 and poloxamer according to the fusion of weight ratio 1:7 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:4, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 25%, Fructus Mori extract 20%, Rhizoma Coptidis extract 25%, Radix Astragali extract 10%, Radix Polygoni Multiflori extract 10%, Fructus Corni extract 10%.

9. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with polyethylene glycol 6000 and carboxymethyl starch sodium according to the fusion of weight ratio 1:9 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:4.5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 30%, Fructus Mori extract 20%, Rhizoma Coptidis extract 20%, Radix Astragali extract 20%, Radix Polygoni Multiflori extract 5%, Fructus Corni extract 5%.

10. the Chinese medicine extraction composition dropping pills for the treatment of diabetes according to claim 1 and hyperlipidemia is characterized in that, this drop pill be with polyethylene glycol 6000 and poloxamer according to the fusion of weight ratio 1:10 mixed post-heating, get mixed-matrix; According to the proportioning of Chinese medicine extract and mixed-matrix weight ratio 1:5, under 80 ℃, with Chinese medicine extract join stir in the mixed-matrix after, 75～80 ℃ the insulation 20～30min, get fused solution, standby; Adjust the temperature-controlling system of drop pill machine, make the water dropper temperature at 76～80 ℃, the temperature of condensed fluid remains on 8～10 ℃, and the fluid reservoir that above-mentioned fused solution is placed the drop pill machine is to splash into condensed fluid under 20～60 droplets/minute the condition dripping speed, be condensed into ball, ball weighs 35～40 mg; Taken out by the drop pill of drop pill machine exit with molding, get rid of the condensing agent on surface by drier, namely;

Chinese medicine extract in this drop pill is made up of the following material of percentage by weight: Smallfruit Rose Root extract 20%, Fructus Mori extract 25%, Rhizoma Coptidis extract 30%, Radix Astragali extract 10%, Radix Polygoni Multiflori extract 5%, Fructus Corni extract 10%.