CN100482237C - Polysaccharid glucoside Chinese medicinal oral preparation and its making method thereof - Google Patents

Polysaccharid glucoside Chinese medicinal oral preparation and its making method thereof Download PDF

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CN100482237C
CN100482237C CNB2004100911078A CN200410091107A CN100482237C CN 100482237 C CN100482237 C CN 100482237C CN B2004100911078 A CNB2004100911078 A CN B2004100911078A CN 200410091107 A CN200410091107 A CN 200410091107A CN 100482237 C CN100482237 C CN 100482237C
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chinese medicine
chinese
ethanol
oral preparation
preparation
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CN1778311A (en
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高普
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Beijing Puhuitianyue Biotech Co.,Ltd.
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Beijing Puhuitianyue Biotech Co ltd
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Abstract

An orally taken Chinese medicine containing astragalose and ginsenoside for treating diabetes and microangium lesion (diabetic nephrosis, diabetic omentitis, etc) is prepared from astragalus root and ginseng. Its preparing process is also disclosed.

Description

Polysaccharid glucoside oral preparation of Chinese traditional medicinal and preparation method thereof
Technical field
The present invention relates to a kind of polysaccharid glucoside oral preparation of Chinese traditional medicinal and preparation method thereof, belong to medical technology.
Background technology
China has more than diabetics 4,000 ten thousand people at present, and this numeral has increased by 5 times in nearest 10 years.This disease death that causes because of blood sugar disorders has become one of Chinese's main causes of death, is only second to cardiovascular and cerebrovascular disease and cancer.The traditional Chinese medical science thinks that the cause of disease of diabetes mainly is: eating and drinking without temperance; Disorder of emotion; Deficiency of kidney-YIN.Diabetes are a kind of metabolism disturbance syndromes due to the multiple reason, causing blood glucose, glucose in urine to raise with the relative or absolute deficiency of insulin is characteristics, the diabete of traditional Chinese medical science meaning, the clinical symptoms such as polydipsia, polyphagia, polyuria, the fatigue of becoming thin that occur, especially middle age is with fatigue and weakness, nocturia is a main symptom, if long-term Western medicine control, just antibody can appear, often can cause the heart, cerebrovascular, kidney, optical fundus, retina and nervous system lesion, complication such as ketoacidosis hyperosmolar coma can take place when serious.The traditional Chinese medical science thinks that the cause of disease of diabetes mainly is: eating and drinking without temperance; Disorder of emotion; Deficiency of kidney-YIN.
Purpose of the present invention is according to motherland's Chinese medicine theory, provides a kind of blood sugar lowering oral preparation of Chinese traditional medicinal and preparation method thereof that is used in conjunction with the pharmacology of diabetes.This oral preparation of Chinese traditional medicinal is that pharmaceutically active ingredient share in two kinds, and the type of YIN-deficiency and interior-heat diabetes are had the effect of clearing away heat and nourishing YIN, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight; This medicine also has the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, and diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy; We can also increase Abwehrkraft des Koepers in addition, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors.Thereby diabetes complicated various infection all there is good effect.
Summary of the invention
1, the invention provides the polysaccharid glucoside oral preparation of Chinese traditional medicinal, it is characterized in that containing two kinds of Chinese medicines: Chinese medicine A and Chinese medicine B.Chinese medicine A is the active component astragalus polysaccharides of the Chinese crude drug Radix Astragali, and content is 50%~90%, and Chinese medicine B is the active component ginsenoside of Chinese crude drug Radix Ginseng, and content is 50%~90%.The set of dispense of Chinese medicine A and Chinese medicine B than (weight portion) in crude drug: A:B=10:90~90:10.
2, the present invention also provides the preparation method of polysaccharid glucoside oral preparation of Chinese traditional medicinal, it is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get ginseng crude drug's coarse powder, with 95% ethanol soaking at room temperature 3 times, each ethanol consumption 2000ml filters, extract 6 times with 95% alcohol heating reflux, use ethanol 2000ml at every turn, filter merging, decompression recycling ethanol, residue be with the 800ml water dissolution, as go into extracted with diethyl ether.Add saturated n-butanol extraction 16 times in (ether layer liposoluble constituent) water layer, each n-butyl alcohol consumption is 500ml, merge n-butanol layer, the reclaim under reduced pressure n-butyl alcohol, add the 300ml dissolve with ethanol in the residue, under agitation in the impouring 2000ml acetone, filtering-depositing is with washing with acetone 2 times, decompressing and extracting.
3, polysaccharid glucoside oral preparation of Chinese traditional medicinal of the present invention, confirm through clinical trial, this oral preparation of Chinese traditional medicinal can not only effectively improve subjective symptomss such as patient's polydipsia, polyphagia, polyuria, the soreness of waist, five hearts are scorching, limb cold, can also effectively control on an empty stomach and post-prandial glycemia, improves every biochemical indicator.
4, oral preparation of Chinese traditional medicinal of the present invention is that pharmaceutically active ingredient share in two kinds, and the type of YIN-deficiency and interior-heat diabetes are had the effect of clearing away heat and nourishing YIN, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight; This medicine also has the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, and diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy; We can also increase Abwehrkraft des Koepers in addition, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors; Thereby diabetes complicated various infection all there is good effect.
Drug mechanism
Oral preparation of Chinese traditional medicinal of the present invention can reduce blood glucose in diabetic rats level due to the intraperitoneal injection streptozotocin, improves its carbohydrate tolerance, reduces albumen saccharifying value and improve the diabetes rat insulin content, and these effects obviously are better than glyburide; Have the LPO content, the SOD activity improving that reduce experimental diabetic rats, improve the activity of GSH-Px in the pancreas simultaneously, thereby suppress the intravital oxygen free radical reaction of diabetes rat; Effect with disturbance state of the gonad function that improves male and female diabetes rat.
Oral preparation of Chinese traditional medicinal of the present invention has the effect of clearing away heat and nourishing YIN to the type of YIN-deficiency and interior-heat diabetes, can obviously alleviate polydipsia polyphagia polyuria symptom, makes the patient recover ideal body weight.Also have the QI invigorating effect, can effectively improve weak symptom, the while activating blood circulation to dissipate blood stasis and dredge the collateral, diabetic nephropathy, diabetic renal papillary necrosis, diabetic peripheral neuropathy that diabetic microvascular complication is caused all have good efficacy.Can increase Abwehrkraft des Koepers, improve immunity, have the merit of strengthening vital QI to eliminate pathogenic factors.Thereby diabetes complicated various infection all there is good effect.
The pharmacological research data
1. pharmacodynamics data:
Treat the effectiveness of diabetes and inquire into its mechanism of action for confirmation oral preparation of Chinese traditional medicinal of the present invention, we use the streptozotocin intraperitoneal injection and duplicate the rat diabetes model, and blood and some tissue of rat carried out a series of experiments.These experiments include: the saccharifying value of carbohydrate tolerance, serum insulin content, blood plasma fructosamine content, hemoglobin and histone, lipid peroxide (LPO) content, superoxide dismutase (SOD) activity, glutathion oxide enzyme (GSH-PX) activity, plasma testosterone and estradiol content.The result shows that oral preparation of Chinese traditional medicinal of the present invention can reduce blood glucose in diabetic rats level due to the intraperitoneal injection streptozotocin, improve its carbohydrate tolerance, reduces albumen saccharifying value and improve the diabetes rat insulin content, and these effects obviously are better than glyburide; Have the LPO content, the SOD activity improving that reduce experimental diabetic rats, improve the activity of GSH-Px in the pancreas simultaneously, thereby suppress the intravital oxygen free radical reaction of diabetes rat; Effect with disturbance state of the gonad function that improves male and female diabetes rat.
Table 1. streptozotocin lumbar injection respectively organize after 3 days rat blood sugar content and carbohydrate tolerance (X ± SD, n=10)
Figure C200410091107D00051
Annotate: nCompare P<0.0001 with the normal control group
Table 2. respectively organize rat plasma insulin content, blood plasma fructosamine and Hb saccharifying value and pancreas and kidney protein saccharifying value testing result (X ± SD, n=10)
Figure C200410091107D00052
Annotate: nCompare P<0.0001 with model control group; Compare with the normal control group, bP<0.0001, cP<0.01; Compare with the glyburide group, dP<0.01
Each organizes rat plasma LPO content, SOD and the active measurement result of GSH-Px
Table 3 respectively organize rat plasma LPO content, SOD and the active measurement result of GSH-Px (X ± SD, n=10)
Figure C200410091107D00061
Annotate: aCompare P<0.0001 with model control group; Compare with the normal control group, bP<0.0001, cP<0.01; Compare with the glyburide group, dP<0.01
2. safety testing data
Emergency toxicology research
Body weight 18-22g Kunming kind white mice each 20, male and female half and half, give maximum volume and the Cmax capsule is irritated the harmonization of the stomach intraperitoneal injection, observed continuously 7 days.Capsule filling stomach of the present invention (total dosage is 66.66g/Kg) mice any unusual performance do not occur and there is no an example death.So capsule gastric infusion LD50 of the present invention〉66.66g/Kg.Intraperitoneal injection drug (total dosage is 12.5g/Kg) was observed 7 days continuously, and writhing response appears in mice 5-10min after administration, and none example is dead.
Long-term toxicologic study
In order to study the long term toxicity effect of oral preparation of Chinese traditional medicinal of the present invention to animal, we use the capsule of the present invention of three kinds of various dose, and (dosage is respectively: 20.0g/kg, 10.0g/kg, 5.0g/kg) give Wistar rat oral gavage 3 months continuously, 6 times weekly, the normal control group gives the normal saline of same volume and irritates stomach, and the experimental session rat does not have death.Experimental result confirms, the general state of each dosage group rat and rats in normal control group, all Non Apparent Abnormality performances such as outward appearance sign, behavioral activity, feces character etc.An index such as each dosage group rat serum routine urinalysis, blood biochemical and meeting renal function is no abnormal, and compares statistics with rats in normal control group and do not have significant difference.The main organs of heavy dose of group (20.0g/kg) rat after one's own heart, internal organs such as liver, spleen, lung, adrenal gland, testis, uterus observe Non Apparent Abnormality and each organ index of each dosage group rat and normal control group no difference of science of statistics down through naked eyes and light microscopic.The dosage (this dosage is 100 times of clinical equivalent dosage) that experiment discloses 20.0g/kg.d is the safe dose scope.
3. clinical research data
The tcm syndrome integration relatively before two groups of treatments
Figure C200410091107D00071
Check through t: each organizes tcm symptom integrated value P〉0.05, comparability is arranged.
Two groups of clinical disease treatment backs relatively
Figure C200410091107D00072
Result: X 2 I-III=7.65P<0.01 X 2 II-III=4.33 P<0.05
From table as can be known: the tcm clinical practice disease of Chinese medicine I group through treatment after, treatment I group total effective rate reaches 90.5%, with Western medicine II group relatively, significance P<0.01~0.05 is arranged.
Two groups of laboratory indexes change
Figure C200410091107D00073
Annotate: compare between * P<0.05 * * P<0.01 * * * P<0.001 Δ group: P<0.05, down together
Above index shows, two groups of medicines self relatively, to blood glucose, 2h blood glucose all makes its decline effect (P<0.05~0.01) after the meal.
Relatively, I group, II organize relatively between group, are reducing fasting glucose and are having two groups of blood biochemistry index of significant difference to change on the 2h blood glucose after the meal
Figure C200410091107D00074
From table as can be known, after taking capsule of the present invention, the patient increases on blood insulin content, and relatively there were significant differences for self, decreases on the contrary before treating and take the insulin level of glyburide group.
Each content of organizing patient's fructosamine and glycolated hemoglobin all has decline after experiment, there were significant differences, and the content of the glycolated hemoglobin of capsule group wherein of the present invention approaches normally.
Each organize the Aeg treat before and after plasma estradiol and testosterone concentration change (X ± S)
Figure C200410091107D00081
Annotate: self relatively *P<0.05, *P<0.01
Each organize the aeg treat before and after plasma estradiol and testosterone concentration change (X ± S)
Figure C200410091107D00082
Respectively organize patient's male estradiol before experiment as seen from table and all be higher than normal group, testosterone all is lower than normal group, simultaneously ratio (the E of estradiol and testosterone 2/ T) also be higher than normal group; Estradiol content obviously reduces after taking capsule of the present invention, and testosterone concentration obviously raises, thereby E 2/ T also significantly reduces; Yet the patient of glyburide group, these three indexs have no significant change before and after experiment.
Four, clinical research summary
Confirm that through clinical trial oral preparation of Chinese traditional medicinal of the present invention can not only effectively improve subjective symptomss such as patient's polydipsia, polyphagia, polyuria, the soreness of waist, dysphoria with feverish sensation in the chest palms and soles, limb cold, can also effectively control on an empty stomach and post-prandial glycemia, improve every biochemical indicator.
Capsule traditional Chinese medical science disease total effective rate of the present invention is 90.5%, and wherein obvious effective rate is 42.3%.The matched group obvious effective rate is 33.3%, and total effective rate is 66.6%.Treatment I group compares with matched group, and significant difference is arranged, and single from the disease angle analysis, the treatment group is to syndrome of deficiency of both qi and yin such as weak, dysphoria with feverish sensation in the chest palms and soles better effects if.
Treatment diabetes and chronic complicating diseases clinical efficacy are reliable.The plasma insulin content of taking capsule patient of the present invention (I group) has remarkable rising.Patient's saccharification hemoglobin content approaches normal level.Take to compare on the contrary obviously before patient's insulin level and the experiment of glyburide (II group) and reduce, patient's saccharification hemoglobin content is higher than normal level.
Male blood plasma estradiol (E2) and testosterone (T) Determination on content result show, take capsule of the present invention after estradiol content obviously reduce, testosterone concentration obviously raises; Yet this index of the patient of glyburide group has no significant change before and after experiment.Each is organized women's plasma estradiol (E2) and testosterone (T) Determination on content result and shows, testosterone concentration obviously reduced after each was organized female patients and takes capsule of the present invention, and the estradiol amount obviously raises; Yet this index of the patient of glyburide group has no significant change before and after experiment.
Through the years of researches evidences, no matter still be clinical efficacy from zoopery on, its effect is all good, has no side effect.Medicine is fewer but better, and market prospect is wide, and medicament sources is convenient.
The present invention relates to a kind of hypoglycemic oral preparation of Chinese traditional medicinal, can be solution, suspensoid, tablet, capsule, granule, pill, powder, drop pill; Preferred capsule, tablet, granule; More preferably capsule.Composition A and B can be mixed in suitable carriers, in diluent or the excipient.Specific embodiment is as follows, includes but not limited to the following example.
Embodiment 1
The agent of polysaccharid glucoside Chinese medicinal capsule is characterized in that containing two kinds of Chinese medicine A and B, its set of dispense than (weight portion) in crude drug: A:B=60:40
The preparation method of polysaccharid glucoside Chinese medicinal capsule of the present invention agent is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get the ginseng crude drug, dry stem piece chopping decocts twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, recovery ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leaves standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Incapsulate by the formula proportion mix homogeneously, reinstall in the bottle and seal.
Embodiment 2
The polysaccharid glucoside Chinese medicine granules is characterized in that containing two kinds of Chinese medicine A and B, its set of dispense than (weight portion) in crude drug: A:B=60:40
The preparation method of polysaccharid glucoside Chinese medicine granules of the present invention is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get the ginseng crude drug, dry stem piece chopping decocts twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, recovery ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leaves standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Press the formula proportion mix homogeneously, add adjuvant, make soft material in right amount with ethanol, the system granule, cold drying behind the granulate, is distributed into bag.
Embodiment 3
The polysaccharid glucoside Chinese medicinal tablet is characterized in that containing two kinds of Chinese medicine A and B, its set of dispense than (weight portion) in crude drug: A:B=60:40
The preparation method of polysaccharid glucoside Chinese medicinal tablet of the present invention is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get the ginseng crude drug, dry stem piece chopping decocts twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, recovery ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leaves standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Press the formula proportion mix homogeneously, add a small amount of magnesium stearate and other adjuvants, compacting is distributed into bag in flakes.
Embodiment 4
The agent of polysaccharid glucoside Chinese medicinal soft capsule is characterized in that containing two kinds of Chinese medicine A and B, its set of dispense than (weight portion) in crude drug: A:B=60:40
The preparation method of polysaccharid glucoside Chinese medicinal soft capsule of the present invention agent is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get the ginseng crude drug, dry stem piece chopping decocts twice with little boiling water, with the liquid concentration after decocting, with 5 times 80% alcohol reflux 3 times, recovery ethanol, residue is with the distilled water heating extraction of 5 times of amounts, and filtrate stirs evenly with 0.1% active carbon, leaves standstill filtration, filtrate is 30000 ultrafilter membrane by molecular weight, is evaporated to the 1KG/ liter, adds 4 times of amount dehydrated alcohol, leave standstill filtration, get supernatant, use dehydrated alcohol, washing with acetone 4 times, 60 degrees centigrade of vacuum dryings.
Press the formula proportion mix homogeneously, add adjuvant, make soft capsule, packing.
Embodiment 5
The polysaccharid glucoside Traditional Chinese Medicine Dropping Pill is characterized in that containing two kinds of Chinese medicine A and B, its set of dispense than (weight portion) in crude drug: A:B=60:40
The preparation method of polysaccharid glucoside Traditional Chinese Medicine Dropping Pill of the present invention is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filtered, and is concentrated into relative density 1.15 ~ 1.20 (50 ℃), and adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, and gets precipitation.The precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, and filtered while hot, filtrate adds ethanol, and to make pure content be 80%, left standstill 24 hours, filters, and precipitate is with 80% washing with alcohol three times, and cold drying gets crude product.The crude product polysaccharide is put in the distilled water, added tannic acid (1%) under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness.Continued to boil 15 minutes, and added active carbon, stirred 15 minutes, filter, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitate do not contain tannic acid to the liquid with 70% washing with alcohol till.
The preparation method of Chinese medicine B: get ginseng crude drug's coarse powder, with 95% ethanol soaking at room temperature 3 times, each ethanol consumption 2000ml filters, extract 6 times with 95% alcohol heating reflux, use ethanol 2000ml at every turn, filter merging, decompression recycling ethanol, residue be with the 800ml water dissolution, as go into extracted with diethyl ether.Add saturated n-butanol extraction 16 times in (ether layer liposoluble constituent) water layer, each n-butyl alcohol consumption is 500ml, merge n-butanol layer, the reclaim under reduced pressure n-butyl alcohol, add the 300ml dissolve with ethanol in the residue, under agitation in the impouring 2000ml acetone, filtering-depositing, with washing with acetone 2 times, decompressing and extracting.
Press the formula proportion mix homogeneously, add adjuvant, make drop pill, packing.

Claims (9)

1. polysaccharid glucoside oral preparation of Chinese traditional medicinal, it is characterized in that containing two kinds of Chinese medicines: Chinese medicine A and Chinese medicine B, Chinese medicine A is the active component astragalus polysaccharides of the Chinese crude drug Radix Astragali, content is 50%~90%, Chinese medicine B is the active component ginsenoside of Chinese crude drug Radix Ginseng, content is 50%~90%, and the set of dispense of Chinese medicine A and Chinese medicine B is than counting A:B=10:90~90:10 with the weight portion of crude drug.
2, claim 1 polysaccharid glucoside oral preparation of Chinese traditional medicinal, wherein, the set of dispense of Chinese medicine A and Chinese medicine B is than counting A:B=20:80~80:20 with the weight portion of crude drug.
3, the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 1, wherein, the set of dispense of Chinese medicine A and Chinese medicine B is than counting A:B=30:70~70:30 with the weight portion of crude drug.
4, the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 1, wherein, the set of dispense of Chinese medicine A and Chinese medicine B is than counting A:B=40:60~60:40 with the weight portion of crude drug.
5, the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 1, wherein, the set of dispense of Chinese medicine A and Chinese medicine B is than counting A:B=50:50~50:50 with the weight portion of crude drug.
6. the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 1, it is characterized in that: the preparation method of Chinese medicine A and Chinese medicine B is as follows:
The preparation method of Chinese medicine A: get Milkvetch Root, decoct with water three times, each 2 hours, collecting decoction filters, and is concentrated into relative density 1.15~1.20 under 50 ℃, adding ethanol, to make pure content be 80%, left standstill 24 hours, filters, get precipitation, the precipitate cold drying is dissolved in the dry thing of gained in the distilled water, heated and boiled 10 minutes, filtered while hot, filtrate add ethanol to make pure content are 80%, leave standstill 24 hours, filter, precipitate is with 80% washing with alcohol three times, and cold drying gets crude product, and the crude product polysaccharide is put in the distilled water, add 1% tannic acid under stirring, boil the centrifugal precipitate that discards in back, add tannic acid to medicinal liquid again and do not produce till the muddiness, continued to boil 15 minutes, add active carbon, stirred 15 minutes, and filtered, filtrate adds ethanol, and to make pure content be about 70%, left standstill 24 hours, filter, precipitation, precipitation do not contain to the liquid till the tannic acid with 70% washing with alcohol;
The preparation method of Chinese medicine B: the coarse powder of getting the ginseng crude drug, with 95% ethanol soaking at room temperature 3 times, each ethanol consumption 2000ml, filter, extract 6 times, use ethanol 2000ml at every turn with 95% alcohol heating reflux, filter and merge, decompression recycling ethanol, residue add extracted with diethyl ether with the 800ml water dissolution, in water layer, add saturated n-butanol extraction 16 times, each n-butyl alcohol consumption is 500ml, merges n-butanol layer, the reclaim under reduced pressure n-butyl alcohol, in residue, add the 300ml dissolve with ethanol, under agitation in the impouring 2000ml acetone, filtering-depositing is with washing with acetone 2 times, decompressing and extracting.
7. the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 1 is solution, suspensoid, tablet, capsule, granule, pill, powder, drop pill.
8. the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 7 is capsule, tablet, granule.
9. the polysaccharid glucoside oral preparation of Chinese traditional medicinal of claim 8 is capsule.
CNB2004100911078A 2004-11-18 2004-11-18 Polysaccharid glucoside Chinese medicinal oral preparation and its making method thereof Expired - Fee Related CN100482237C (en)

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CN105616479A (en) * 2014-10-27 2016-06-01 毕京 Qilong oral-taking preparation and preparation method thereof
CN110946930A (en) * 2019-10-31 2020-04-03 贵州省兴仁市中医院 Formula for treating qi deficiency type diabetes and preparation method thereof
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