CN102836349A - Traditional Chinese medicine composition for treating diabetes and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating diabetes and preparation method thereof Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicine composition for treating diabetes and a preparation method thereof. The traditional Chinese medicine composition provided by the invention comprises active components prepared from the following bulk drugs: Radix rehmanniae, Radix Astragali, yam, radix puerariae, Radix trichosanthis, corn stigma, and kadsura longepedunculata. The traditional Chinese medicine composition provided by the invention has no obvious adverse reaction, and is especially suitable for treating incipient patients with mild diabetes, abnormal sugar tolerance or special patients such as children and the elderly.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to a kind of Chinese medicine composition of treating diabetes and preparation method thereof.
Background technology
Diabetes, i.e. alleged " diabetes " of the traditional Chinese medical science, be a kind of be the common incretion metabolism disease of common trait with the hyperglycemia, absolute or relative deficiency causes that its main clinical symptom is owing to insulin: polyuria, polydipsia, polyphagia, become thin.With non-diabetic physiognomy ratio, diabetes patient's cardiovascular and cerebrovascular disease, blind sickness rate and mortality rate thereof are all high 2～5 times, and ulcer of the lower limb and amputation rate exceed 20 times especially.At present, diabetes have become the third-largest non-infective disease after developed country's relaying cardiovascular disease and the tumor, are the worldwide public health problems of serious threat human health.
According to investigations, global onset diabetes number 1994 is about 1.20 hundred million, 1997 about 1.35 hundred million; 2000 about 1.75 hundred million; Estimate will reach 2.39 hundred million in 2010, and number of the infected will rise 200% in developing country, some developing country in China, India, Africa is main morbidity area.Clinical and market all presses for a kind of medicine of treating diabetes efficiently.
In Chinese invention patent application CN1562188A and CN1861176A; The Chinese medicine and western medicine compound medicament composition that is used to treat diabetes is disclosed respectively; Active component wherein is made up of Radix Puerariae, Radix Rehmanniae, the Radix Astragali, Radix Trichosanthis, Stigma Maydis, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae and glibenclamide; Both can alleviate the tcm symptom of quenching one's thirst to a certain extent, reach the purpose of blood sugar lowering again.But in the component of disclosed pharmaceutical composition, it is monarch drug that heavy dose is reused Radix Puerariae in CN1562188A; On the crude drug proportion of composing, the single medicinal material Radix Puerariae is up to 4000 weight portions, and all the other medicine summations of respectively distinguishing the flavor of only account for 1240 weight portions; This side's Radix Puerariae consumption is other all medicine in the side of being higher than far away; And be much higher than that " the clinical usual amounts of Chinese pharmacopoeia has also influenced effective performance of other each medicine effect in the side, and prescription is formed obviously unreasonable.In CN1562188A, in the disclosed pharmaceutical composition, further optimize the consumption proportion of each component in the Chinese medicine composition, can coordinate the characteristics of each component, brought into play the optimum therapeuticing effect of each medicine.But; Owing to contain the western medicine component glibenclamide in this pharmaceutical composition; Improper in the clinical practice owing to taking; Untoward reaction such as hypoglycemia possibly occur, and this pharmaceutical composition is not suitable for treating special diabeticss such as child, old people, the slight diabetics or the impaired glucose tolerance patient that send out at the beginning of should not being used for yet.
Summary of the invention
Therefore, the purpose of this invention is to provide a kind of Chinese medicine composition that is used to treat diabetes, especially be suitable for treating particular patients ' such as first slight diabetics of sending out or impaired glucose tolerance patient or child, old people.
Another object of the present invention provides the method for the above-mentioned Chinese medicine composition of preparation.
Another purpose of the present invention provides the application of above-mentioned Chinese medicine composition.
The objective of the invention is to realize through following technical scheme.On the one hand, the present invention provides a kind of Chinese medicine composition of treating diabetes, and the active component of said Chinese medicine composition is processed by the crude drug of following ratio: Radix Rehmanniae 600-1200 weight portion; Radix Astragali 200-400 weight portion; Rhizoma Dioscoreae 100-200 weight portion, Radix Puerariae 1000-2000 weight portion, Radix Trichosanthis 1000-2000 weight portion; Stigma Maydis 1000-2000 weight portion, and Fructus Schisandrae Sphenantherae 200-400 weight portion.
The active component of the preferred Chinese medicine composition of the present invention is processed by the crude drug of following ratio:
Radix Rehmanniae 600-900 weight portion, Radix Astragali 200-300 weight portion, Rhizoma Dioscoreae 100-150 weight portion, Radix Puerariae 1000-1500 weight portion, Radix Trichosanthis 1000-1500 weight portion, Stigma Maydis 1000-1500 weight portion, and Fructus Schisandrae Sphenantherae 200-300 weight portion.
The active component of the further preferred Chinese medicine composition of the present invention is processed by the crude drug of following ratio:
Radix Rehmanniae 636 weight portions, the Radix Astragali 212 weight portions, Rhizoma Dioscoreae 106 weight portions, Radix Puerariae 1060 weight portions, Radix Trichosanthis 1060 weight portions, Stigma Maydis 1060 weight portions, and Fructus Schisandrae Sphenantherae 212 weight portions.
On the other hand, the present invention provides a kind of method for preparing above-mentioned Chinese medicine composition, said method comprising the steps of:
1) get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis, the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae decocte with water once, filter, filtrating is concentrated into an amount of, puts coldly, makes concentrated solution;
2) in the concentrated solution of step 1) preparation, add ethanol, making solution contain the alcohol amount is 60% (volume), leaves standstill, and filters, and filtrating is concentrated into does not have the alcohol flavor, makes condensed cream;
3) in step 2) add 2 times of water yields in the condensed cream of preparation, stirring and dissolving fully after, through the macroporous adsorbent resin of anticipating; And with water elution to effluent colourless after, with 70% (volume) ethanol water eluting, collect eluent after colourless; Concentrate extractum, promptly get.
The present invention provides the method for the above-mentioned Chinese medicine composition of another kind of preparation, said method comprising the steps of:
1) get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis decocte with water once, filter, filtrating is concentrated into an amount of, puts coldly, makes concentrated solution;
2) get the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae pulverizing, make coarse powder;
3) with the concentrated solution and step 2 of step 1) preparation) coarse powder for preparing mixes and mixes thoroughly, and drying is ground into fine powder, promptly gets.
Another aspect, the present invention provides above-mentioned Chinese medicine composition to be used for treating the application of the Chinese medicine preparation of diabetes in preparation.
Therefore,,, the required dosage form of various clinical be can process, drop pill, pill, tablet, capsule, granule, soft capsule or powder comprised according to the galenic pharmacy specification requirement with Chinese medicine composition of the present invention.
The method for preparing that above-mentioned Chinese medicine composition provided by the invention is processed various dosage forms is following:
1, the preparation of drop pill:
Get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis, the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae decocte with water once, filter, filtrating is concentrated into an amount of, puts cold; Adding ethanol makes solution contain alcohol amount to be 60%, to leave standstill 24 hours, filter that filtrating is concentrated into does not have the alcohol flavor; Add 2 times of water yields in condensed cream, stirring and dissolving fully after, through the macroporous adsorbent resin of anticipating, and with water elution to effluent colourless after; With 70% ethanol elution, collect eluent after colourless, concentrate extractum.Taking polyethylene glycol 6000 (PEG-6000) and stearic acid to container, are heated to 100～110 ℃ in right amount, treat whole fusions after, add above-mentioned extractum, after being uniformly dispersed, be that coolant drips and processes ball with the liquid paraffin, take out drop pill, dry paraffin, promptly get drop pill.
2, the preparation of pill:
Method 1: got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, mixing.Water is general to be ball, drying, and with Black Rouge, Pulvis Talci and suitable amount of adhesive, the polishing coating, drying is processed pill.
Method 2: got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, mixing.Process ball with mechanical pellet processing machine, drying, with Black Rouge, Pulvis Talci and suitable amount of adhesive, the polishing coating, drying is processed pill.
Method 3: got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, mixing.Process granule with one-step-granulating method, be pressed into pill.
Method 4: got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into fine powder, in one-step-granulating method, process granule with concentrated solution, are pressed into pill.
3, the preparation of capsule:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder, adds an amount of dextrin; Mixing, granulation, capsule is processed in filling.
4, the preparation of tablet:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder; Add an amount of dextrin, mixing is processed granule; Drying is admixed 0.5% magnesium stearate, is pressed into tablet.
5, the preparation of granule:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, adds an amount of dextrin, mixing, processes granule.
6, the preparation of soft capsule:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of; The Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix drying thoroughly with concentrated solution; Be ground into fine powder; Add an amount of Polyethylene Glycol-400 and a spot of glycerin again, mixing is pressed into soft capsule.
7, the preparation of powder:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder and processes powder.
The consumption of pharmaceutical composition of the present invention, by active component crude drug gross weight, RD is 10.8-32.6 gram/every day, divides and takes for 2-3 time.
The present invention can be used for treating human diabetes through experiment showed, Chinese medicine composition provided by the invention in a large number, has the effect of blood sugar lowering and protection pancreas.Compare with the diabetes pill that contains the western medicine component glibenclamide, though its effect is quite or slightly, because of containing the western medicine composition glibenclamide; Diabetes pill is taken improper; Can cause the hypoglycemia untoward reaction clinically, and Chinese medicine composition of the present invention is pure Chinese medicine composition, does not contain any Western medicine; Show there is not tangible untoward reaction through experiment, be more suitable for being used to clinically treat the diabetes patients with mild of just sending out, the patient or the particular patients ' such as child, old people of impaired glucose tolerance.
The specific embodiment
The concrete embodiment of following reference explains the present invention.It will be appreciated by those skilled in the art that these embodiment only are used to explain the present invention, the scope that it does not limit the present invention in any way.
Embodiment 1: the preparation of pill
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 636 weight portions, the Radix Astragali 212 weight portions, Rhizoma Dioscoreae 106 weight portions, Radix Puerariae 1060 weight portions, Radix Trichosanthis 1060 weight portions, Stigma Maydis 1060 weight portions, Fructus Schisandrae Sphenantherae 212 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, mixing.Water is general to be ball, drying, and with Black Rouge, Pulvis Talci and suitable amount of adhesive, the polishing coating, drying is processed pill.
Embodiment 2: the preparation of pill
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 800 weight portions, the Radix Astragali 210 weight portions, Rhizoma Dioscoreae 100 weight portions, Radix Puerariae 1200 weight portions, Radix Trichosanthis 1000 weight portions, Stigma Maydis 1700 weight portions, Fructus Schisandrae Sphenantherae 330 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into fine powder, in one-step-granulating method, process granule with concentrated solution, are pressed into pill.
Embodiment 3: the preparation of pill
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 650 weight portions, the Radix Astragali 205 weight portions, Rhizoma Dioscoreae 120 weight portions, Radix Puerariae 1700 weight portions, Radix Trichosanthis 1500 weight portions, Stigma Maydis 1100 weight portions, Fructus Schisandrae Sphenantherae 220 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder, mixing; Process ball with mechanical pellet processing machine, drying is with Black Rouge, Pulvis Talci and binding agent; The polishing coating, drying is processed pill.
Embodiment 4: the preparation of pill
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 750 weight portions, the Radix Astragali 250 weight portions, Rhizoma Dioscoreae 130 weight portions, Radix Puerariae 1300 weight portions, Radix Trichosanthis 1300 weight portions, Stigma Maydis 1300 weight portions, Fructus Schisandrae Sphenantherae 250 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, and mixing is processed granule with one-step-granulating method, is pressed into pill.
Embodiment 5: the preparation of capsule
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 1200 weight portions, the Radix Astragali 400 weight portions, Rhizoma Dioscoreae 200 weight portions, Radix Puerariae 2000 weight portions, Radix Trichosanthis 2000 weight portions, Stigma Maydis 2000 weight portions, Fructus Schisandrae Sphenantherae 400 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder; Add an amount of dextrin, mixing, granulation, filling becomes capsule.
Embodiment 6: the preparation of granule
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 600 weight portions, the Radix Astragali 200 weight portions, Rhizoma Dioscoreae 100 weight portions, Radix Puerariae 1000 weight portions, Radix Trichosanthis 1000 weight portions, Stigma Maydis 1000 weight portions, Fructus Schisandrae Sphenantherae 200 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, adds an amount of dextrin, mixing, processes granule.
Embodiment 7: the preparation of powder
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 900 weight portions, the Radix Astragali 300 weight portions, Rhizoma Dioscoreae 150 weight portions, Radix Puerariae 1500 weight portions, Radix Trichosanthis 1500 weight portions, Stigma Maydis 1500 weight portions, Fructus Schisandrae Sphenantherae 300 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae are pulverized coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, and mixing is processed powder.
Embodiment 8: the preparation of tablet
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 1000 weight portions, the Radix Astragali 220 weight portions, Rhizoma Dioscoreae 110 weight portions, Radix Puerariae 1000 weight portions, Radix Trichosanthis 1700 weight portions, Stigma Maydis 1500 weight portions, Fructus Schisandrae Sphenantherae 205 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder; Add an amount of dextrin, mixing is processed granule; Drying is admixed 0.5% magnesium stearate, is pressed into tablet.
Embodiment 9: the preparation of soft capsule
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 950 weight portions, the Radix Astragali 350 weight portions, Rhizoma Dioscoreae 180 weight portions, Radix Puerariae 1500 weight portions, Radix Trichosanthis 1100 weight portions, Stigma Maydis 1200 weight portions, Fructus Schisandrae Sphenantherae 280 weight portions.
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water one time five hours, and filtered, filtrating is concentrated into an amount of; The Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix drying thoroughly with concentrated solution; Be ground into fine powder, mixing adds an amount of Polyethylene Glycol-400 and a spot of glycerin again; Mixing is processed soft capsule.
Embodiment 10: the preparation of drop pill
Take by weighing raw materials of traditional Chinese medicinal materials according to following consumption: Radix Rehmanniae 750 weight portions, the Radix Astragali 250 weight portions, Rhizoma Dioscoreae 130 weight portions, Radix Puerariae 1300 weight portions, Radix Trichosanthis 1300 weight portions, Stigma Maydis 1300 weight portions, Fructus Schisandrae Sphenantherae 250 weight portions.
Get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis, the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae decocte with water once, filter, filtrating is concentrated into an amount of, puts cold; Adding ethanol makes solution contain alcohol amount to be 60%, to leave standstill 24 hours, filter that filtrating is concentrated into does not have the alcohol flavor; Add 2 times of water yields in condensed cream, stirring and dissolving fully after, through the macroporous adsorbent resin of anticipating, and with water elution to effluent colourless after; With 70% ethanol elution, collect eluent after colourless, concentrate extractum.Taking polyethylene glycol 6000 (PEG-6000) and stearic acid to container, are heated to 100～110 ℃ in right amount, treat whole fusions after, add above-mentioned extractum, after being uniformly dispersed, be that coolant drips and processes ball with the liquid paraffin, take out drop pill, dry paraffin, promptly get drop pill.
Embodiment 11: the efficacy experiment of Chinese medicine composition of the present invention
Present embodiment has provided the efficacy experiment of traditional Chinese medicine composition for treating diabetes of the present invention.
1, laboratory sample:
1.1 sample title: diabetes pill A, be Chinese medicine composition with reference to embodiment 1 preparation, promptly, filter earlier with Radix Puerariae 1060 weight portions, Radix Rehmanniae 636 weight portions, Stigma Maydis 1060 weight portions, Radix Trichosanthis 1060 weight portion decocte with water 5 hours, filtrating is concentrated into an amount of; The Radix Astragali 212 weight portions, Fructus Schisandrae Sphenantherae 212 weight portions, Rhizoma Dioscoreae 106 parts by weight of crushed become fine powder, mix thoroughly with above-mentioned partial concentration liquid, and drying is pulverized, sieve, and mixing, with residue concentrated solution pill, drying, coating promptly gets, heavily about 2.5 grams of per 10 balls.
Tried the thing compound method: a. diabetes pill A high dose (2800mg/kg/day): take by weighing an amount of diabetes pill A powder, the limit adds the grinding of 0.5%CMC-Na limit and is dissolved to desired concn (280mg/ml), medicine preparation on the same day.B. dosage (1400mg/kg/day) among the diabetes pill A: take by weighing an amount of diabetes pill A powder, the limit add the 0.5%CMC-Na limit grind be dissolved to desired concn 140mg/ml), medicine preparation on the same day.
1.2 sample title: diabetes pill; Method for preparing the: with reference to " method for preparing of 2010 editions diabetes pilles of Chinese pharmacopoeia; With Radix Puerariae 1060 weight portions, Radix Rehmanniae 636 weight portions, Stigma Maydis 1060 weight portions, Radix Trichosanthis 1060 weight portion decocte with water 5 hours, filter, filtrating is concentrated into an amount of; The Radix Astragali 212 weight portions, Fructus Schisandrae Sphenantherae 212 weight portions, Rhizoma Dioscoreae 106 parts by weight of crushed become fine powder, mix thoroughly with above-mentioned partial concentration liquid, and drying is pulverized, sieve, and mixing, with residue concentrated solution pill, drying adds glibenclamide 1 weight portion, and coating promptly gets.Heavily about 2.5 grams of per 10 balls wherein contain glibenclamide 2.5mg.
Tried the thing compound method: a. diabetes pill high dose (2800mg/kg/day): take by weighing an amount of diabetes pill powder, the limit adds the grinding of 0.5%CMC-Na limit and is dissolved to desired concn (280mg/ml), medicine preparation on the same day.B. dosage (1400mg/kg/day) in the diabetes pill: take by weighing an amount of diabetes pill powder, the limit add the 0.5%CMC-Na limit grind be dissolved to desired concn 140mg/ml), medicine preparation on the same day.C. diabetes pill low dosage (700mg/kg/day): take by weighing an amount of diabetes pill powder, the limit add the 0.5%CMC-Na limit grind be dissolved to desired concn 70mg/ml), medicine preparation on the same day.
1.3 sample title: glibenclamide (white powder, purity: 100.8%), and available from the institute of materia medica, Tianjin, lot number: 080715.
Tried the thing compound method: a. glibenclamide high dose (2.8mg/kg): take by weighing an amount of glibenclamide powder, the limit adds the grinding of 0.5%CMC-Na limit and is dissolved to desired concn (0.28mg/ml), medicine preparation on the same day.B. dosage (1.4mg/kg) in the glibenclamide: take by weighing an amount of glibenclamide powder, the limit add the 0.5%CMC-Na limit grind be dissolved to desired concn 0.14mg/ml), medicine preparation on the same day.
1.4 feminine gender and positive reference substance
Positive reference substance: diamicron (having another name called gliclazide), available from Tianjin Hua Jin pharmaceutical factory.
The negative control article: sodium carboxymethyl cellulose (CMC-Na), available from Tianjin Da Mao chemicals factory.
2, laboratory animal:
Animal kind system: GK rat, Wistar rat
The GK rat is to cultivate the spontaneous non-obesity-related type 2 diabetes mellitus animal model that comes through the individuality that the Wistar rat is carried out oral glucose tolerance test and screen hyperglycemia by Goto etc. 1975.It is impaired that the GK rat has the insulin secretion that hypoinsulinism, glucose stimulate; The β cell number reduces; Glycogen generates too much, and typical type 2 diabetes mellitus characteristics such as muscle and fatty tissue moderate insulin resistant are a kind of comparatively ideal internationally recognized animal models of research type 2 diabetes mellitus; Portha B even think that the GK rat is a research type 2 diabetes mellitus best model, has been widely used in the various aspects of type 2 diabetes mellitus research at present.Therefore, for investigating the influence of Chinese medicine composition of the present invention to diabetes, selecting the GK rat for use is subjects.
3, experimental technique:
Choose 8 of the qualified female Wistar rats of quarantine; 80 of female GK rats; The Wistar rat is blank control group; The GK rat by blood sugar concentration at random equilibrium be divided into 9 groups, i.e. high, the middle dose groups of model group, diamicron group, the high, medium and low dose groups of diabetes pill, diabetes pill A height, middle dose groups, glibenclamide, every group of 8 GK rats.Each test group of back of dividing into groups is carried out administration by setting dosage, and the administration volume is 10ml/kg, once a day, and continuous 12 weeks.Administration carried out before the animals administer in first day and administration after the dynamic monitoring of 1h, 2h, 4h, 6h random blood sugar value (get tail blood, glucose oxidase method is with the detection of kyoto, Japan blood glucose meter); Measure random blood sugar during the administration weekly one time, minute is about 4h after the administration; Survey animal ingestion amount and amount of drinking water weekly.Detect administered dose and the surplus after 24 hours of measuring every cage feedstuff and drinking-water the same day respectively, calculate average food ration and the amount of drinking water of every animal every day.The 12nd weekend, rat was put to death in ventral aorta blood sampling back, and the blood of extraction is divided into 2 parts, and portion is used EDTA-K
2The mensuration that is used for glycolated hemoglobin after the anticoagulant, the mensuration that serum is used for insulin, BNP, FFA, GSP and biochemical indexes is got in not anticoagulant of portion in addition.Get pancreas in rat behind the sacrifice of animal and carry out the index of correlation detection.The concrete dosage of each experimental group is seen table 1.
Table 1. animal divides into groups and dosage setting
4, experimental result
4.1 rat body weight, ingest, the water uptake observed result
(1) to the influence of GK rat body weight
Visible by table 2; 1. model group administration 1-12 week body weight gain speed is obviously slow than blank control group, and statistical significance (p＜0.05 or 0.01) is arranged, and the whole experimental period body weight gain of model group rat is all slower; To the 12nd week of administration, the model group weightening finish is merely 45% of blank control group.2. compare with model group, diabetes pill high, medium and low dose groups body weight gain speed is close with model group, does not see significant difference (p＞0.05).3. diabetes pill A is high, middle dose groups body weight gain speed is close with model group, does not see significant difference (p＞0.05).4. diamicron group and glibenclamide are high, middle dose groups body weight gain speed is close with model group, do not see significant difference (p＞0.05).5. the high, medium and low dose groups of diabetes pill is compared with diabetes pill A height, middle dose groups, glibenclamide height, middle dose groups, and each dose groups GK rat body weight is close, does not see significant difference.
(2) to the influence of GK rat food ration
Visible by table 3,1. administration 1-12 week model group food ration is compared with blank control group and is not seen significant difference, but the food ration of model group has the trend of obvious increase.2. compare with model group; Diabetes pill high dose group administration the 8th all food rations are significantly less than model group (p＜0.05); The food ration of other times diabetes pill high dose group is compared with model group and is not seen significant difference, but diabetes pill high dose food ration has the effect trend that reduces gradually.3. administration 1-12 week, in the diabetes pill, the low dose group food ration compares with model group and do not see significant difference, but in the administration 1-10 week diabetes pill, low dose group all has the effect trend that reduces GK rat food ration.4. high, the middle dose groups administration 1-12 of diabetes pill A week food ration is compared with model group and is not seen significant difference (p＞0.05), but all has the effect trend that reduces GK rat food ration, and the effect of high dose is better than middle dosage.5. the diamicron group is compared with model group with high, the middle dose groups administration 1-12 of glibenclamide week food ration and is not seen significant difference (p＞0.05), but all has the effect trend that reduces GK rat food ration.6. the high, medium and low dose groups of diabetes pill is compared with the diamicron group with diabetes pill A height, middle dose groups, glibenclamide height, middle dose groups; Each dose groups GK rat food ration is close; Do not see significant difference; But it is the strongest that the diabetes pill high dose group reduces the effect of GK rat food ration, secondly is diabetes pill low dosage and diabetes pill A (pure Chinese medicine partly) high dose group.
(3) to the influence of GK rat water uptake
Visible by table 4,1. administration 1-12 week model group water uptake is compared obvious increase with blank control group, administration 5-12 week also occurs statistical significance (p＜0.05 or 0.01).2. compare with model group; Diabetes pill high dose group administration the 10th all water uptakes are significantly less than model group (p＜0.05); The water uptake of other times diabetes pill high dose group is compared with model group and is not seen significant difference; But diabetes pill high dose water uptake has the effect trend that reduces gradually, and diabetes pill high dose group water uptake reduces 1/3 approximately than model group after the administration.3. administration 1-12 is all; In the diabetes pill, the low dose group water uptake compares with model group and do not see significant difference; But in the diabetes pill, low dose group all has the effect trend that reduces GK rat water uptake, the high, medium and low dose groups of diabetes pill reduces GK rat water uptake and has tangible dose-effect relationship.4. high, the middle dose groups administration 1-12 of diabetes pill A week water uptake is compared with model group and is not seen significant difference (p＞0.05); But all have the effect trend that reduces GK rat water uptake, the effect that high, the middle dose groups of diabetes pill A reduces GK rat water uptake also has certain dose-effect relationship.5. glibenclamide high dose group administration the 10th, 11,12 all water uptakes are compared with model group and are had significant difference (p＜0.05); Other times glibenclamide high dose group water uptake is compared with model group and is not seen significant difference after the administration, but has the effect trend of obvious minimizing GK rat water uptake.Can obviously reduce the water uptake of GK rat in the glibenclamide after the dose groups administration the 11st week, after the administration in the other times glibenclamide dose groups water uptake compare with model group and do not see significant difference, but have the effect trend of obvious minimizing GK rat water uptake.6. also have after the administration of diamicron group and reduce the effect that the GK rat is taken the photograph water, but compare not statistically significant with model group.7. the high, medium and low dose groups of diabetes pill is compared with the diamicron group with diabetes pill A height, middle dose groups, glibenclamide height, middle dose groups; Each dose groups GK rat water uptake is close; Do not see significant difference; But it is the strongest that diabetes pill high dose group and glibenclamide high dose group reduce the effect of GK rat water uptake, secondly be dose groups in dosage, the glibenclamide in diabetes pill A height, the diabetes pill.
4.2 dynamic blood sugar effects after the first administration
Result of the test is seen table 5, shows that model group gives 1-6h behind the CMC-Na, and blood glucose is not seen obvious fluctuation, each time point blood glucose value all apparently higher than blank control group (＞11.0mmol/L), show that the GK rat blood sugar is more stable.1. after the administration of diabetes pill high dose group 2,4h all can significantly reduce the blood glucose (p＜0.05) of GK rat compare with model group,, 6h also has the effect trend of obvious reduction GK rat blood sugar after the administration.2. in the diabetes pill after the dose groups administration 4h can significantly reduce the blood glucose (p＜0.01) of GK rat.After the administration of diabetes pill low dose group 2,4h can significantly reduce the blood glucose (p＜0.05) of GK rat.3. 1-6h all can not significantly reduce the blood glucose of GK rat after diabetes pill A height, the middle dose groups administration, but has the effect trend of blood sugar lowering.4. 4h all can obviously reduce the blood glucose (p＜0.05) of GK rat after glibenclamide height, the middle dose groups administration.After the diamicron administration 2,4h also can significantly reduce the blood glucose (p＜0.05) of GK rat.5. the amplitude of high, the middle dose groups blood sugar lowering of diabetes pill and action time and glibenclamide height, middle dose groups, diamicron group are close, do not see significant difference.
4.3 the influence of duration of test blood glucose
Result of the test is seen table 6, shows that 1-12 week model group GK rat blood sugar is close after the administration, does not see significant difference, shows that the GK rat model is more stable.Compare with model group; 1. the 1st, 3,4,7,8,11,12 weeks of diabetes pill high dose group administration are significantly reduced the blood glucose of GK rat; Compare with model group and to have statistical significance (p＜0.05), the blood glucose and the model group of other times diabetes pill high dose group are not seen significant difference after the administration; 4h all can not significantly reduce the blood glucose of GK rat in the diabetes pill, after the low dose group administration.2. the 3rd, 4,7,8,10,11,12 weeks of diabetes pill A high dose group administration are significantly reduced the blood glucose of GK rat; Compare with model group and to have statistical significance (p＜0.05), the blood glucose and the model group of other times diabetes pill A high dose group are not seen significant difference after the administration; Among the diabetes pill A after the dose groups administration 4h all can not significantly reduce the blood glucose of GK rat.3. 4h all can significantly reduce the blood glucose of GK rat after glibenclamide administration the 1st, 3,4,7,8,12 all administrations; Compare with model group and to have statistical significance (p＜0.05); Other times glibenclamide high dose group GK rat blood sugar and model group are not seen significant difference after the administration, but the glibenclamide high dose group has the effect trend that reduces the GK rat blood sugar.Dose groups all can not significantly reduce the blood glucose of GK rat in the glibenclamide.4. can obviously reduce the random blood sugar value (p＜0.05) of GK rat in first week of diamicron group administration, other times all can not obviously reduce the blood glucose of GK rat after the administration.5. the effect of diabetes pill high dose group blood sugar lowering is the strongest, is glibenclamide high dose group and diabetes pill A high dose group secondly.
4.4 histopathology (HE) check result:
Result of the test shows: compare with blank control group, tangible morphosis has all appearred in other each test group animal pancreatic islets of langerhans to be changed.Compare with model group; Each drug group all has improvement effect in various degree to the GK pancreas in rat; Diabetes pill high dose, diabetes pill A high dose group and glibenclamide high dose group are the strongest to the improvement effect of pancreas; Secondly be dose groups in dose groups and the glibenclamide in diamicron group, the diabetes pill, and dose groups and model group comparison no significant difference in dose groups and the glibenclamide in the diabetes pill low dose group, diabetes pill A.
5. discussion of results and evaluation
5.1 rat body weight, ingest, the influence of water uptake: result of study shows; The model group rat body weight increasess slowly, food ration, water uptake and urine excretion amount (undetermined urine amount; Find through observing bedding and padding) increase obviously; The Clinical symptoms (polyphagia, polydipsia, polyuria) of similar type 2 diabetes mellitus appears in model group GK rat, shows that spontaneous type 2 diabetes mellitus model brings out successfully.The GK rat body weight increases, the water uptake of ingesting reduces and the diabetes pill high dose can make to a certain extent; In the diabetes pill, low dose group has increases the GK rat body weight and reduce the effect trend that the GK rat ingested, took the photograph water.The body weight that diabetes pill A is high, middle dose groups all can increase the GK rat, reduce the water uptake of ingesting.The body weight that glibenclamide is high, middle dose groups can increase the GK rat, reduce the water uptake of ingesting.The diabetes pill high dose group is compared with other test group, to the GK rat body weight, ingest and the improvement effect of water uptake strong slightly.
5.2 the influence to dynamic blood glucose and duration of test blood glucose after the first administration: result of the test shows.No matter the model group rat is that the administration same day or the blood glucose of whole test phase are all more stable, meets diabetes patient blood sugar's situation of change.Can obviously reduce the blood glucose of rat after the high, medium and low dose groups of diabetes pill, glibenclamide height, the middle dose groups first administration, diabetes pill A is high, middle dose groups also has tangible blood sugar reducing function trend.During 12 weeks of successive administration, the effect of diabetes pill high dose group blood sugar lowering is the strongest, is glibenclamide high dose group and diabetes pill A high dose group secondly.
5.3 histopathology (HE) check result: result of the test shows; Compare with blank control group, model group; Other are respectively organized experimental animal pancreas islets of langerhans and obvious morphosis variation all occurs; Wherein diabetes pill high dose group, diabetes pill A high dose group animal pancreatic ANOMALOUS VARIATIONS degree are lighter, be dose groups in glibenclamide, diamicron group, the diabetes pill secondly, and dose groups and model group comparison no significant difference in dose groups and the glibenclamide in the diabetes pill low dose group, diabetes pill A.Result of the test shows that also each dose groups of diabetes pill and each dose groups islets of langerhans interstitial cell hyperplasia of diabetes pill A are not obvious; And glibenclamide and diamicron group islets of langerhans interstitial cell hyperplasia are obvious; But also contain glibenclamide in the diabetes pill, supposition possibly eliminated glibenclamide with the Chinese medicine ingredients in the diabetes pill and cause the side reaction of islets of langerhans interstitial cell hyperplasia relevant.Therefore, this result shows that diabetes pill A has apparent in view influence to GK pancreas in rat tissue, can impel the islets of langerhans form of GK rat to recover towards normal morphology, also can prevent to use the side reaction that is caused behind the glibenclamide.
Therefore; Above-mentioned result of the test shows; Model group GK rat is compared with blank control group Wistar rat of the same age; Body weight gain slowly, food ration, water uptake increase, random blood sugar is stable and apparently higher than blank control group in one day or in experimental period, and serum insulin levels reduces, insulin sensitivity index reduces, and HbAlc and GSP content obviously increase; Pancreatic tissue pathology result shows that model group GK rat Langerhans islet form is irregular, and cellularity is unclear, and volume increases, and endochylema is loose, light dying.The above results shows that model group GK rat is consistent with bibliographical information in this test, possesses the characteristics of spontaneous type 2 type glycosuria rats, and spontaneous type 2 diabetes mellitus brings out successfully, and GK rat insulin opposing index reduces in this test but the result also points out.
Result of the test also shows; Diabetes pill, diabetes pill A, each dose groups of glibenclamide have following effect to the GK rat in 21-24 age in week: the effect that 1. diabetes pill is high, medium and low, diabetes pill A high, middle dose groups has to be increased the GK rat body weight, reduce food ration and water uptake, but the effect of diabetes pill high dose group is better than diabetes pill A and glibenclamide group.2. the effect that has obvious reduction GK rat blood sugar after each dose groups of diabetes pill, each dose groups of diabetes pill A and each dose groups first administration of glibenclamide; Successive administration has the effect trend of obvious reduction GK rat blood sugar in 12 weeks; The blood sugar reducing function of diabetes pill high dose group and glibenclamide high dose group is close, is diabetes pill A high dose group secondly.3. the light microscopy checking result shows that diabetes pill high dose group and diabetes pill A high dose group are apparent in view to the restitution of pancreas, and dose groups in the diabetes pill, among the diabetes pill A, glibenclamide is high, middle dose groups improvement effect is then poor slightly.
According to above experimental result, can confirm that Chinese medicine composition of the present invention can be used for treating human diabetes, have the effect of blood sugar lowering and protection pancreas.With the diabetes pill that contains the Western medicine glibenclamide relatively, though its effect is quite or slightly, diabetes pill is because of containing the Western medicine glibenclamide; It is improper to take; Can cause the hypoglycemia untoward reaction clinically, and pharmaceutical composition of the present invention does not contain Western medicine, be pure Chinese medicine pharmaceutical composition; Not finding has tangible untoward reaction, is more suitable for being used to clinically treat the diabetes patients with mild of just sending out, the patient or the particular patients ' such as child, old people of impaired glucose tolerance.
More than be to the specifying of possible embodiments of the present invention, but this embodiment is not in order to limiting claim of the present invention, does not allly break away from the equivalence that skill spirit of the present invention does and implement or change, all should be contained in the claim of the present invention
Table 2 diabetes pill A 12 weeks of successive administration are to the influence
of GK rat body weight
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01.
Table 3 diabetes pill A 12 weeks of successive administration are to the influence
of GK rat food ration
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01.
Table 4 diabetes pill A 12 weeks of successive administration are to the influence
of GK rat amount of drinking water
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01.
After the table 5 diabetes pill A first administration to the influence
of the dynamic blood glucose of GK rat
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01.
Table 6 diabetes pill A 12 weeks of successive administration are to the influence
of GK rat blood sugar
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01.
Continuous table 6 diabetes pill A 12 weeks of successive administration are to the influence
of GK rat blood sugar
Annotate: * representes to compare with model group, p＜0.05, and * * representes to compare with model group, p＜0.01
Claims (15)
1. a Chinese medicine composition of treating diabetes is characterized in that, the active component of said Chinese medicine composition is processed by the crude drug of following ratio: Radix Rehmanniae 600-1200 weight portion; Radix Astragali 200-400 weight portion; Rhizoma Dioscoreae 100-200 weight portion, Radix Puerariae 1000-2000 weight portion, Radix Trichosanthis 1000-2000 weight portion; Stigma Maydis 1000-2000 weight portion, and Fructus Schisandrae Sphenantherae 200-400 weight portion.
2. Chinese medicine composition as claimed in claim 1 is characterized in that, the active component of said Chinese medicine composition is processed by the crude drug of following ratio: Radix Rehmanniae 600-900 weight portion; Radix Astragali 200-300 weight portion; Rhizoma Dioscoreae 100-150 weight portion, Radix Puerariae 1000-1500 weight portion, Radix Trichosanthis 1000-1500 weight portion; Stigma Maydis 1000-1500 weight portion, and Fructus Schisandrae Sphenantherae 200-300 weight portion.
3. Chinese medicine composition as claimed in claim 2 is characterized in that, the active component of said Chinese medicine composition is processed by the crude drug of following ratio: Radix Rehmanniae 636 weight portions; The Radix Astragali 212 weight portions; Rhizoma Dioscoreae 106 weight portions, Radix Puerariae 1060 weight portions, Radix Trichosanthis 1060 weight portions; Stigma Maydis 1060 weight portions, and Fructus Schisandrae Sphenantherae 212 weight portions.
4. a method for preparing each said Chinese medicine composition in the claim 1 to 3 is characterized in that, said method comprising the steps of:
1) get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis, the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae decocte with water once, filter, filtrating is concentrated into an amount of, puts coldly, makes concentrated solution;
2) in the concentrated solution of step 1) preparation, add ethanol, making solution contain the alcohol amount is 60% (volume), leaves standstill, and filters, and filtrating is concentrated into does not have the alcohol flavor, makes condensed cream;
3) in step 2) add 2 times of water yields in the condensed cream of preparation, stirring and dissolving fully after, through the macroporous adsorbent resin of anticipating; And with water elution to effluent colourless after, with 70% (volume) ethanol water eluting, collect eluent after colourless; Concentrate extractum, promptly get.
5. a method for preparing each said Chinese medicine composition in the claim 1 to 3 is characterized in that, said method comprising the steps of:
1) get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis decocte with water once, filter, filtrating is concentrated into an amount of, puts coldly, makes concentrated solution;
2) get the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae pulverizing, make coarse powder;
3) with the concentrated solution and step 2 of step 1) preparation) coarse powder for preparing mixes and mixes thoroughly, and drying is ground into fine powder, promptly gets.
6. each said Chinese medicine composition is used for treating the application of the Chinese medicine preparation of diabetes in the claim 1 to 3 in preparation.
7. Chinese medicine preparation, it comprises each described Chinese medicine composition in the claim 1 to 3; Preferably, said Chinese medicine preparation is selected from: drop pill, pill, tablet, capsule, granule, soft capsule or powder.
8. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Get Radix Puerariae, Radix Rehmanniae, Stigma Maydis, Radix Trichosanthis, the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae decocte with water once, filter, filtrating is concentrated into an amount of, puts cold; Adding ethanol makes solution contain alcohol amount to be 60%, to leave standstill 24 hours, filter that filtrating is concentrated into does not have the alcohol flavor; Add 2 times of water yields in condensed cream, stirring and dissolving fully after, through the macroporous adsorbent resin of anticipating, and with water elution to effluent colourless after; With 70% ethanol elution, collect eluent after colourless, concentrate extractum; Taking polyethylene glycol 6000 and stearic acid to container, are heated to 100-110 ℃ in right amount, treat whole fusions after, add above-mentioned extractum, after being uniformly dispersed, be that coolant drips and processes ball with the liquid paraffin, take out drop pill, dry paraffin, promptly get drop pill.
9. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into fine powder, in one-step-granulating method, process granule with concentrated solution, are pressed into pill.
10. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, and mixing is selected from one of following processing again and processes pill:
A) water is general is ball, drying, and with Black Rouge, Pulvis Talci and binding agent, the polishing coating is processed pill;
B) process ball with mechanical pellet processing machine, drying, with Black Rouge, Pulvis Talci and binding agent, the polishing coating, drying is processed pill.
C) process granule with one-step-granulating method, be pressed into pill.
11. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, adds an amount of dextrin, mixing, granulation, and capsule is processed in filling.
12. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution; Drying is ground into fine powder, adds an amount of dextrin, mixing; Process granule, drying is admixed an amount of magnesium stearate, is pressed into tablet.
13. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, adds dextrin, mixing, processes granule.
14. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder; Mix thoroughly with concentrated solution, drying is ground into fine powder; Add an amount of Polyethylene Glycol-400 and a spot of glycerin, mixing is pressed into soft capsule.
15. a method for preparing the said Chinese medicine preparation of claim 7 is characterized in that, said method comprising the steps of:
Got Radix Rehmanniae, Radix Puerariae, Radix Trichosanthis, Stigma Maydis decocte with water five hours, and filtered, filtrating concentrates, and the Radix Astragali, Fructus Schisandrae Sphenantherae, Rhizoma Dioscoreae powder are broken into coarse powder, mix thoroughly with concentrated solution, and drying is ground into fine powder, processes powder.
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Address after: 510530, No. 32, Po pan Road, Guangzhou, Guangdong, Luogang District Applicant after: Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd. Address before: 510530, No. 32, Po pan Road, Guangzhou, Guangdong, Luogang District Applicant before: Guangzhou Zhongyi Pharmaceutical Co., Ltd. |
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