CN1626211A - Astragalus-leech preparation of lowering blood sugar for treating diabetes and syndrome and preparation method - Google Patents
Astragalus-leech preparation of lowering blood sugar for treating diabetes and syndrome and preparation method Download PDFInfo
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Abstract
A Chinese medicinal for treating diabetes and its complications is prepared from astragalus root, rehmannia root, siberian solomonseal rhizome and leach. Its advantages are high curative effect and high safety.
Description
Technical field: the present invention is a kind of stilbene trematodiasis antihypelipidemic preparation for the treatment of diabetes and complication thereof and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: diabetes are a kind of common endocrine-metabolic diseases, absolute or the relative deficiency of insulin is the main cause that causes sugar, fat and protein metabolism disorder, serum glucose level continues to increase, the heavy absorbability that surpasses kidney, in the course of time, cause microcirculatory blood vessel, neuropathy, thereby cause a series of cardiovascular and cerebrovascular vessel of diabetics to change.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: QIZHI JIANGTANG JIAONANG, still, preparation technology in this product and drug prescription amount are not open, so can't instruct production; The necessary careful usefulness of this medical material of Hirudo that particularly uses in its prescription is if uncertain its prescription consumption can produce toxic and side effects to human body; The dosage form of existing product is relatively backward in addition, and product quality is not ideal enough: capsule is store the benefit bonding for a long time; The dosage form kind is abundant inadequately, is suitable for crowd's narrow range, and product bioavailability, medicine stability are undesirable; It is that " 97199360 ", name are called the patent application of " pharmaceutical compositions of treatment diabetes " that the Chinese patent communique discloses number of patent application, and the problem that its exists is: prescription is very complicated, and the quality of production is restive.
Summary of the invention: the objective of the invention is to: a kind of stilbene trematodiasis antihypelipidemic preparation for the treatment of diabetes and complication thereof and preparation method thereof is provided; This preparation can blood sugar lowering, improve sugar, lipid metabolism, improve blood plasma albumin level, reducing urine protein discharges, increase muscle protein and stock, necessary aminoacid is provided, improve the protein metabolism disorder of renal glomerular disease on the whole, it is synthetic to suppress renal NO, can partly correct the early stage kidney HT of diabetes, the high filtration simultaneously; Suppress the overexpression of diabetes rat renal cortex transforming growth factor-beta (TGF-β), influence the generation and the development of diabetes; Suppress the kidney hypertrophy, improve renal function, improve the clinical symptoms of diabetes, the various complication that treatment diabetes and diabetes cause.In addition, the clearer and more definite preparation formulation of preparation provided by the invention is micropill, dispersible tablet, and their disintegrative is good, and the bioavailability height is particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take; The present invention also provides the preparation method of soft capsule, drop pill, has solved medicine and has met damp and hot problem of unstable, can also cover poor taste, the abnormal smells from the patient of medicine, and plays the effect that increases stability, improves bioavailability.
The present invention constitutes like this: calculate according to components by weight percent, it mainly is to be made for 40～80 parts by 80～120 parts of the Radixs Astragali, 60～100 parts of Radix Rehmanniae, 60～100 parts of Rhizoma Polygonatis, Hirudo.Say accurately: calculate according to components by weight percent, it mainly is to be made for 67 parts by 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, Hirudo.Preparation of the present invention comprises: injection, as: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.Say accurately: described preparation is dispersible tablet, soft capsule, micropill, drop pill.Preparation method of the present invention is: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, decoct with water, filter, merging filtrate is condensed into thick paste, adds the ethanol precipitate with ethanol then, leave standstill, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, different preparations is made in dry, pulverizing then respectively.Concrete preparation method is: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, add 8 times of water gagings and decoct each 1 hour 2 times, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously, different preparations is made in dry, pulverizing then respectively.
Dispersible tablet in the preparation of the present invention prepares like this: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, add 8 times of water gagings and decoct 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, dry, pulverize, adding 2%CMS-Na, is that 12% starch slurry is a binding agent with concentration, the system soft material, crossing 20 mesh sieves granulates, 60 ℃ of oven dry, 20 order granulate add 3%CMS-Na, 1% Pulvis Talci, 4% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings, promptly.
Pellet in the preparation of the present invention prepares like this: get 90% Hirudo; the Radix Astragali of full dose; the Radix Rehmanniae of full dose; the Rhizoma Polygonati of full dose; adding 8 times of water gagings decocts 2 times; each 1 hour; filter; merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste; add 90% ethanol then; stir; make and contain alcohol amount and reach 50%; left standstill 24 hours; get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent; dry; pulverize; with extract powder and microcrystalline Cellulose mixed by 3: 2, put in the comminutor, be binding agent with 1%L-HPC solution; with water is wetting agent; at engine speed 220r/min; spray pump rotating speed 25r/min; for powder machine rotating speed 20r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 4min; round as a ball time 3min, pill, promptly.
Soft capsule in the preparation of the present invention prepares like this: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, drying, pulverize, press extract powder again: substrate=1: 1.2, add soybean oil, yellow beeswax, the mixed-matrix of soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.3: 0.5, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70～80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 3 hours, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying, promptly.
Drop pill in the preparation of the present invention prepares like this: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to most, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously, drying, pulverize, with PEG4000 is substrate, add thick paste, drug quality: substrate volume=2: 5 stirs, airtight, internal diameter 4.2mm is used in insulation, external diameter 5.2mm dropper splashes into methyl-silicone oil with the speed of 30～40 of per minutes: in the mixing liquid coolant of liquid paraffin=3: 2, the high 130cm of cooling column, rotating speed 15rmin
-1, promptly.
Among the we, monarch drug in Radix Astragali invigorating QI to consolidate the body surface resistance, the diuresis poison holding side of being; Radix Rehmanniae clearing away heat and cooling blood, YIN nourishing and the production of body fluid promoting, the Rhizoma Polygonati boosting qi and nourishing yin, spleen invigorating, lung moistening, kidney tonifying, Hirudo removing blood stasis, removing blood stasis, stimulating the menstrual flow altogether is ministerial drug; All medicines are harmonious, supplementing QI and nourishing YIN, and blood circulation promoting and blood stasis dispelling is used for the glycosuria disease and belongs to the deficiency of both QI and YIN stasis of blood person that holds concurrently, and card is seen: thirsty polydipsia, polyuria are easily hungry, and body is thin weak, spontaneous sweating, dim complexion, numb limbs and tense tendons, tongue secretly have ecchymosis etc.
Compared with prior art, the present invention is directed to prior art, blood sugar lowering improves sugar, lipid metabolism, improves blood plasma albumin level, reducing urine protein discharges, increase muscle protein and stock, necessary aminoacid is provided, improve the protein metabolism disorder of renal glomerular disease on the whole, it is synthetic to suppress renal NO, can partly correct the early stage kidney HT of diabetes, the high filtration; Suppress the overexpression of diabetes rat renal cortex transforming growth factor-beta (TGF-β), influence the generation and the development of diabetes; Suppress the kidney hypertrophy, improve renal function, improve the clinical symptoms of diabetes, the various complication that treatment diabetes and diabetes cause.The present invention writes out a prescription clearly, safe and reasonable, simple for process, and micropill provided by the invention, dispersible tablet, disintegrative are good, the bioavailability height, be particularly suitable for the old people and swallow tablet or the inconvenient patient of capsule take, dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, solved the not high problem of bioavailability; Soft capsule of the present invention, drop pill have solved medicine and have met damp and hot problem of unstable, can also cover poor taste, the abnormal smells from the patient of medicine, can play the effect that increases stability, improves bioavailability.The applicant finds in development process, dispersible tablet needs disintegrate fully in the 3min in 19 ℃～21 ℃ water, the micropill roundness is inhomogeneous, the drop pill ratio of briquetting is low, it is the key issue of this product that the soft capsule disintegrate is transfinited, by a large amount of influence factors such as adjuvant, process conditions have been carried out experiment screening, make the functional of product.Certainly, other process conditions are also feasible, but the most simple with process conditions of the present invention; The preparation that obtains has reasonable prevention effect for diabetes and complication thereof such as hypertension, nephropathy, retinopathy etc.; But and the little patients life-time service of preparation untoward reaction provided by the invention; Reached the purpose of invention.
The applicant has carried out a series of experiments, with the supplementary product kind of the prescription of selecting pharmaceutical preparation provided by the invention, preparation technology, use and consumption, ratio etc.; Guarantee its science, reasonable, feasible; The preparation that obtains has effective therapeutic effect.
Experimental example 1: Study on extraction
Group decocting time (h) decocts number of times (inferior) amount of water (doubly) astragaloside %
1 1 1 6 0.02
2 1 2 8 0.09
3 1 3 10 0.08
4 2 1 10 0.04
5 2 2 6 0.05
6 2 3 8 0.02
7 3 1 8 0.03
8 3 2 10 0.06
9 3 3 6 0.01
The result shows, extraction process of the present invention: add 8 times of water gagings and decoct 2 times, and each 1 hour, rationally feasible.
Experimental example 2: Study on Forming
Measure angle of repose: adopt the fixed funnel method, funnel is fixed on the graph paper of horizontal positioned, the funnel end opening is 3cm apart from the distance of graph paper, pour the difference pill of writing out a prescription into funnel respectively, below the cone tip that forms up to the bottom touches till the bell mouth, measure the diameter of conical base, calculate angle of repose, the bright mobility of particle of novel angle of repose is good.
Check disintegration: adopting changes the basket method, and lift disintegration tester, tablet or capsule are got 6 slices/, observes the situation by screen cloth.Percent of pass height then disintegrative is good, more pleasant bulk absorption.
Melting is checked: get granule 10g, add 20 times of hot water, stirred 5 minutes, observe immediately.
The mensuration of tablet tensile strength: behind the tabletting tablet is placed 12h,, calculate the tensile strength of tablet with the radially crushing force of tablet four-function instrument mensuration tablet.
Homogeneity be the ball between the 18-40 order heavy/total ball is heavy by * 100%, yield P%=W1/W * 100% (wherein the weight W 1 of 18-24 order ball, the gross weight that feeds intake W)
Measure angle of repose: adopt the fixed funnel method, funnel is fixed on the graph paper of horizontal positioned, the funnel end opening is 3cm apart from the distance of graph paper, pour the difference pill of writing out a prescription into funnel respectively, below the cone tip that forms up to the bottom touches till the bell mouth, measure the diameter of conical base, calculate angle of repose, the bright mobility of particle of novel angle of repose is good.
Friability: tablet four-function instrument, the radially crushing force and the friability of mensuration tablet.
1, dispersible tablet Study on Forming
Dispersible tablet meet water rapidly disintegrate form the water dispersion tablet of uniform sticky suspension, it is poor to have solved former dosage form disintegrative, stripping is shortcoming slowly, and the dispersible tablet that the applicant makes is disintegrate fully in the 3min in 19 ℃～21 ℃ water, and suspension ability is good, bioavailability is high, dispersed homogeneous degree.
1. adjuvant screening: the bigger factor (as disintegrating agent, binder concn) of dispersible tablet preparation technology influence of the present invention is carried out orthogonal test, determine best prescription.
Group CMS-Na (in add) % CMS-Na (adding) % starch slurry concentration % disintegration time (s)
1 1 3 8 122
2 1 2 10 55
3 1 1 12 124
4 2 3 12 25
5 2 2 8 84
6 2 1 10 50
7 3 3 10 40
8 3 2 12 43
9 3 1 8 36
2. compression force:
Compression force/shelves friability %
3 0.54
2 0.30
1 0.47
The result shows that optimum process condition is: adding 2%CMS-Na, is that 12% starch slurry is a binding agent with concentration, the system soft material, cross 20 mesh sieves and granulate, 60 ℃ of oven dry, 20 order granulate add 3%CMS-Na, 1% Pulvis Talci, 4% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings.
2, pellet Study on Forming
The micropill diameter is less than 2.5mm, and class is in particle properties, the bioavailability height, and the applicant finds when development product micropill of the present invention: maximum difficulty is exactly that hygroscopicity is strong and mobile poor, and poor plasticity prepares with conventional method and adjuvant and to be difficult to molding.
1. diluent ratio
Diluent extract powder: diluent angle of repose
- - 42°
38 ° of starch 5: 2
4∶2 45°
3∶2 40°
1∶2 45°
30 ° of microcrystalline Cellulose 5: 2
4∶2 28°
3∶2 26°
1∶2 29°
2. binder concn
Binder concn % angle of repose
HPMC 0.5 40°
1 35°
2 39°
L-HPC 0.5 28°
1 24°
2 27°
3. engine speed
Rotating speed (r/min) particle size distribution
200 a large amount of aggregation block and powder
220 aggregation block fragmentations, particle diameter diminishes
250 a large amount of aggregation block and powder
300 aggregation block fragmentations, particle diameter diminishes
The result shows that the selection engine speed is 250r/min.
4. the round as a ball time: this experiment is the optimization screening that index is carried out process conditions with the roundness (critical angle φ represents with the plane) and 18～24 purpose yields (f) of micropill.The mensuration of roundness: a certain amount of micropill is put on the flat board, a dull and stereotyped side is lifted, measure at micropill begin the to roll angle (φ) of top rake plane and horizontal plane, this angle is more little, and the roundness of micropill is good more.
(min) 2 φ of round as a ball time/° f/%
2 30.5 82.5
3 29.2 86.2
5 33.9 65.0
8 32.0 84.5
10 35.5 83.9
5. become the ball parameters Optimization
For powder machine rotating speed (r/min) spray revolution speed (r/min) f/%
5 10 82.0
10 15 76.3
15 20 76.5
20 25 88.5
25 30 82.6
The result shows; with extract powder and microcrystalline Cellulose mixed by 3: 2; put in the comminutor; with 1%L-HPC solution is binding agent; with water is wetting agent; at engine speed 220r/min, spray pump rotating speed 25r/min, for powder machine rotating speed 20r/min, jet flow 15L/min, whiff pressure 0.5Mpa, air blast flux 10 * 20L/min, whitewashing time 4min, round as a ball time 3min, be optimum process condition.
3, soft capsule Study on Forming
1. the adsorbing base rate is investigated
Medicated powder: substrate suspension situation
1: 1.0 inhomogeneous suspension
1: 1.2 even suspension
1: 1.5 even suspension
2. adjuvant is to the influence of composition:
Group astragaloside (%)
Medicated powder 0.022
Add after the substrate 0.020
The result shows that optimum process condition is for pressing medicated powder: substrate=1: 1.2, Astragaloside content did not have significant change after medicated powder added substrate.
4, drop pill Study on Forming
1. different substrates and coolant are to the influence of drop pill molding
Group substrate and medicine amalgamation coolant drip system situation molding situation
1 PEG4000 easily melts liquid paraffin oil droplet shape mutually and oozes fast, oblate spheroid, and the chain pearl,
The too fast ball that sinks is less
2 PEG4000 easily melt methyl-silicone oil oil droplet shape mutually and ooze fast, oblate spheroid, and the chain pearl,
The slow ball that sank is less
3 PEG4000 easily melt methyl-silicone oil mutually: liquid paraffin oil droplet shape oozes fast, and spheroidal is no stingy
3: 2 moderate holes of sinking, ball is less
4 PEG6000 melt liquid paraffin mutually than difficulty, and to drip speed slower, and oblate spheroid appears in water dropper, the chain pearl,
Stop up, the too fast ball that sinks is bigger
5 PEG6000 melt methyl-silicone oil mutually than difficulty, and to drip speed slower, water dropper oblate spheroid, chain pearl
Occur stopping up, the slow ball that sank is bigger
6 PEG6000 melt methyl-silicone oil mutually than difficulty: liquid paraffin drips that speed is slower, and oblate spheroid appears in water dropper, and is no stingy
Stop up at 3: 2, the moderate hole that sinks, ball is bigger
2. different pharmaceutical adding mode and ratio are to the influence of drop pill molding
Group substrate medicine: the substrate medicine is the molding situation in substrate
(g: ml) deployment conditions
1 PEG4000 is difficult to be uniformly dispersed rough at 3: 5, and irregular colour is even
The 2 PEG4000 spheroidal that is uniformly dispersed at 3: 7, smooth, color even, quality is harder
3 PEG4000 are uniformly dispersed rough at 2: 4, and irregular colour is even
The 4 PEG4000 spheroidal that is uniformly dispersed at 2: 5, smooth, color even, quality is better
The 5 PEG4000 spheroidal that is uniformly dispersed at 1: 3, smooth, color is not too even, and quality is softer
3. cool off liquid-column height, rotating speed and drip fast selection
Group cooling column height (cm) rotating speed (rmin
-1) a speed (min
-1) drop pill ratio of briquetting (%)
1 120 10 40～50 80.16
2 120 15 50～60 90.50
3 120 20 30～40 78.36
4 130 10 50～60 42.85
5 130 15 30～40 95.32
6 130 20 40～50 58.05
7 140 10 30～40 60.34
8 140 15 40～50 64.05
9 140 20 50～60 68.02
The result shows, optimum process condition is for being substrate with PEG4000, add thick paste, drug quality: substrate volume=2: 5 stirs, airtight, insulation with internal diameter 4.2mm, external diameter 5.2mm dropper, splashes into methyl-silicone oil with the speed of 30～40 of per minutes: in the mixing liquid coolant of liquid paraffin=3: 2, the high 130cm of cooling column, rotating speed 15rmin
-1
Experimental example 3: contrast experiment
1. dissolution is investigated: adopt the little slurry method of cuvette to measure dissolution in vitro, get in the little stripping rotor of 0.05mol/L phosphate sodium dihydrogen buffer solution that 12 in tablet is equipped with 37 ℃ ± 0.5 ℃ of 100ml, put 2 for every glass, totally 6 glasss of (micropills, drop pill then every glass put 1 ball), start little slurry immediately and pick up counting, rotating speed is 50 rev/mins, respectively at 5min, 10min, 30min, 45min, the 60min sampling, sampling amount 10ml (replenishing 10ml37 ℃ ± 0.5 ℃ 0.05mol/L phosphate sodium dihydrogen buffer solution after each sampling simultaneously), and through the 0.45um membrane filtration, inject high performance liquid chromatograph, measure the content of astragaloside.
Average stripping quantity (%)
Time (min) conventional tablet drop pill pellet
5 29.0 44.2 56.4
10 50.4 85.5 89.0
30 81.2 99.0 99.8
45 87.0 99.5 100.0
60 89.5 100.0 98.9
2. disintegration time is investigated
The group disintegration time
Capsule 30min
Soft capsule 24min
Dispersible tablet 30sec
The result shows that preparation of the present invention is functional.
Experimental example 4: to type ii diabetes rat insulin and the excretory influence of C peptide
Healthy 3 monthly age Wistar pure lines male rat (closed colony) 40, body weight 200～250g is divided into two groups at random.One group, 20 tail vein injection 25mg/kg body weight streptozotocin only.2 weeks back survey carbohydrate tolerance selects 20 unusual persons to add and feeds high fat, high sugar, high heat feedstuff, is the type ii diabetes model group.20 rats of another group are not injected STZ, and the arm's length basis diet is the normal control group.Test the 8th all model group and normal group animal respectively vein get hematometry on an empty stomach triglyceride and cholesterol level, and carry out the glucose tolerance experiment.Remarkable with body weight change in the model group, impaired glucose tolerance, 2h blood glucose value 〉=11.1mmol/L behind the glucose load, triglyceride, cholesterol concentration raise, and the person is successful model to have the significant difference with normal group.The model group animal is divided into two groups at random: model administration group (A group), model control group (B group): the normal group animal is divided into two groups at random: normal control group (C group), normal administration group (D group): 10 of every treated animals.A group and D organize and give soft capsule 30mg/kg of the present invention every day; B group and C group are irritated stomach with distilled water every day: irritate measure respectively on an empty stomach behind the stomach 20d, behind the oral glucose 30,60, insulin and the C peptide level of 120min.Collection of specimens and insulin and C peptide are measured: the 15ml test tube is preset in 0 ℃ of frozen water.The light anaesthesia of rat ether, tail vein are got blood 12ml and are added mixing in the ice-cold test tube that 40000U/ml aprotinin 20 μ l are housed, 4 ℃ of centrifugal 10min of following 4000rpm, and separation of serum is preserved in-25 ℃ of refrigerators.
1. model group and normal group cholesterol, triglyceride, and blood glucose value on an empty stomach and behind the oral glucose (x ± s)
Grouping model group matched group
Body weight (kg) 0.40 ± 0.12 0.38 ± 0.25
Triglyceride (mmol/L) 1.97 ± 0.15 0.56 ± 0.10
Cholesterol (mmol/L) 1.91 ± 1.01 1.49 ± 0.12
Fasting glucose (mmol/L) 8.40 ± 1.05 7.15 ± 0.96
Oral glucose 2h blood glucose (mmol/L) 14.43 ± 2.73 7.63 ± 1.50
2. to the influence of insulin, C peptide concentration behind normal group rat limosis and the oral glucose: C group and D group do not have significant difference at insulin C on an empty stomach and behind the oral glucose 30min.
3. model administration group and model control group insulin concentration (μ IU/ml) on an empty stomach and behind the oral glucose
Grouping model administration group (A group) model control group (B group)
Empty stomach 64.67 ± 8.10 58.60 ± 11.25
30min 69.31±9.45 64.56±14.13
60min 83.10±10.02 66.15±17.50
120min 68.52±6.03 88.40±12.13
The result shows that preparation of the present invention has the effect of good recovery islet function.
Experimental example 5: the experimentation of treatment rat diabetes nephropathy
Select 30 of the healthy male Wistar rats of 150～190g for use, be divided into normal control group, diabetic groups and micropill treatment group of the present invention at random, every group 10, divide cage to feed, arbitrarily drink water, with diabetes rats, fasting 10h, be dissolved in 0.1mol/L citric acid sodium citrate buffer solution (pH4.5) with streptozotocin, be made into 1% solution, press the 50mg/kg single intraperitoneal injection, get tail vein behind the 5d, measure blood glucose with blood glucose meter, blood glucose 〉=16.7mmol/L is diabetes rat (becoming mould rate 100%).The citric acid citrate buffer solution of normal control group injection respective volume.Drop pill of the present invention, capsule group are become 0.5g/L solution with physiological saline solution, and the treatment group is pressed 70mgkg morning every day
-1D
-1Dosage is irritated stomach, and the diabetic groups stomach is raised the normal saline of equivalent, continues to feed to 12 all backs collect specimens, and metabolic cage is collected 24h urine, surveys 24h excretion quantity of urinary protein (UPE).Claim to anaesthetize after the quality, right atrium is got blood and is surveyed Endothelin, puts the method for exempting from and measures insulin, surveys blood urea nitrogen (BUN) with the CX7 automatic biochemistry analyzer, and calculates endogenous creatinine clearance rate (Ccr), and the result proofreaies and correct with the body constitution amount.Get two kidneys, right kidney part is fixed with 4% paraformaldehyde, conventional film-making, and light microscopy checking is measured MGPA and MGV with image analyzer, and left kidney is used to organize the ET assay.
Normal control group diabetic groups drop pill group of the present invention capsule group
MGPA 51.14±3.56 65.26±4.25 52.10±2.12 59.24±1.09
MGV 430.4±36.5 648.2±23.2 459.5±36.8 501.2±15.0
BUN 7.26±0.65 11.30±1.43 8.12±1.02 10.17±1.22
Ccr 5.10±0.75 2.62±0.12 4.23±0.24 4.83±0.71
UPE 9.24±1.20 42.78±10.10 18.35±1.47 19.09±1.05
The result shows that MGPA, MGV, BUN, Ccr and 24h excretion quantity of urinary protein are all significantly improved than the diabetic nephropathy rat, and effect is not less than the capsule group.
Concrete embodiment:
Embodiments of the invention 1: 80 parts of the Radixs Astragali, 60 parts of Radix Rehmanniae, 60 parts of Rhizoma Polygonatis, 40 parts of Hirudos, get 36 portions of Hirudos, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to most, be condensed into thick paste, get 4 portions of Hirudos of residue and pulverize the same thick paste mix homogeneously, the drying stated, pulverize, add 2%CMS-Na, with concentration is that 12% starch slurry is a binding agent, and the system soft material is crossed 20 mesh sieves and granulated, 60 ℃ of oven dry, 20 order granulate add 3%CMS-Na, 1% Pulvis Talci, 4% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings promptly get dispersible tablet, this product oral, three times on the one, each 2.
Embodiments of the invention 2: 120 parts of the Radixs Astragali; 100 parts of Radix Rehmanniae; 100 parts of Rhizoma Polygonatis; 80 parts of Hirudos; get 72 parts Hirudo; the Radix Astragali of full dose; the Radix Rehmanniae of full dose; the Rhizoma Polygonati of full dose; adding 8 times of water gagings decocts 2 times; each 1 hour; filter; merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste; add 90% ethanol then; stir; make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent; be condensed into thick paste; get 8 portions of Hirudos of residue and pulverize the same thick paste mix homogeneously, the drying stated; pulverize, extract powder and microcrystalline Cellulose are pressed 3: 2 mixed; put in the comminutor; with 1%L-HPC solution is binding agent, is wetting agent with water, at engine speed 220r/min; spray pump rotating speed 25r/min; for powder machine rotating speed 20r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 4min; round as a ball time 3min; pill promptly gets micropill.
Embodiments of the invention 3: 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, 67 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, dry, pulverize, press extract powder again: substrate=1: 1.2 adds soybean oil, yellow beeswax, the mixed-matrix of soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.3: 0.5, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70～80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 3 hours, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying promptly gets soft capsule.
Embodiments of the invention 4: 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, 67 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stirs, make and contain alcohol amount and reach 50%, left standstill 24 hours, and got supernatant and reclaim ethanol, be condensed into thick paste to the greatest extent, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, dry, pulverizing, is substrate with PEG4000, adds thick paste, drug quality: substrate volume=2: 5, stir, airtight, insulation, use internal diameter 4.2mm, external diameter 5.2mm dropper, speed with 30～40 of per minutes splashes into methyl-silicone oil: in the mixing liquid coolant of liquid paraffin=3: 2, and the high 130cm of cooling column, rotating speed 15rmin
-1, promptly get drop pill.
Embodiments of the invention 5: 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, 67 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 6 times of water gagings decocted 2 hours, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 60% ethanol then, stir, make to contain alcohol amount and reach 70%, left standstill 24 hours, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, dry, pulverizing, granulate, tabletting promptly gets tablet.
Embodiments of the invention 6: 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, 67 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 2 hours, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 70% ethanol then, stir, make to contain alcohol amount and reach 80%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, drying, pulverize, get extract powder, add alcohol granulation, promptly get granule.
Embodiments of the invention 7: 80 parts of the Radixs Astragali, 60 parts of Radix Rehmanniae, 60 parts of Rhizoma Polygonatis, 40 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 10 times of water gagings decocts 2 times, each 2 hours, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 80% ethanol then, stir, make to contain alcohol amount and reach 90%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, drying, pulverize, add alcohol granulation, encapsulated, promptly get capsule.
Embodiments of the invention 8: 80 parts of the Radixs Astragali, 60 parts of Radix Rehmanniae, 60 parts of Rhizoma Polygonatis, 40 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 12 times of water gagings decocted 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 40% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, get the residue Hirudo and pulverize, add water for injection, syrup, promptly get oral liquid with above-mentioned thick paste mix homogeneously.
Embodiments of the invention 9: 120 parts of the Radixs Astragali, 100 parts of Radix Rehmanniae, 100 parts of Rhizoma Polygonatis, 80 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 12 times of water gagings decocts 3 times, each 3 hours, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stirs, make and contain alcohol amount and reach 50%, left standstill 24 hours, and got supernatant and reclaim ethanol, be condensed into thick paste to the greatest extent, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, add carbomer, stir evenly, promptly get gel.
Embodiments of the invention 10: 120 parts of the Radixs Astragali, 100 parts of Radix Rehmanniae, 100 parts of Rhizoma Polygonatis, 80 parts of Hirudos, get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 4 times of water gagings decocted 3 hours, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stirs, make and contain alcohol amount and reach 50%, left standstill 24 hours, and got supernatant and reclaim ethanol, be condensed into thick paste to the greatest extent, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, dry, pulverize, add microcrystalline Cellulose, granulate, tabletting promptly gets oral cavity disintegration tablet.
Claims (10)
1, a kind of stilbene trematodiasis antihypelipidemic preparation for the treatment of diabetes and complication thereof, it is characterized in that: calculate according to components by weight percent, it mainly is made by 80～120 parts of the Radixs Astragali, 60～100 parts of Radix Rehmanniae, 60～100 parts of Rhizoma Polygonatis, 40～80 parts of Hirudos or their extract of corresponding weight portion.
2, according to the stilbene trematodiasis antihypelipidemic preparation of described treatment diabetes of claim 1 and complication thereof, it is characterized in that: calculate according to components by weight percent, it mainly is made by 100 parts of the Radixs Astragali, 83 parts of Radix Rehmanniae, 83 parts of Rhizoma Polygonatis, 67 parts of Hirudos or their extract of corresponding weight portion.
3, according to the stilbene trematodiasis antihypelipidemic preparation of claim 1 or 2 described treatment diabetes and complication thereof, it is characterized in that: described preparation comprises: injection comprises: all acceptable dosage forms on injection, powder pin, freeze-dried powder, gel, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, micropill, powder, drop pill, slow releasing preparation, controlled release preparation, gel, oral liquid, soft extract, extractum and the membrane pharmaceutics.
4, according to the stilbene trematodiasis antihypelipidemic preparation of described treatment diabetes of claim 3 and complication thereof, it is characterized in that: described preparation is dispersible tablet, soft capsule, micropill or drop pill.
5, as the preparation method of the stilbene trematodiasis antihypelipidemic preparation of any described treatment diabetes and complication thereof in the claim 1～4, it is characterized in that: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, decoct with water, filter, merging filtrate is condensed into thick paste, add the ethanol precipitate with ethanol then, leave standstill, get supernatant and reclaim ethanol to most, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously, different preparations is made in dry, pulverizing then respectively.
6, preparation method according to the stilbene trematodiasis antihypelipidemic preparation of described treatment diabetes of claim 5 and complication thereof, it is characterized in that: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, dry, pulverize, make different preparations then respectively.
7, preparation method according to the stilbene trematodiasis antihypelipidemic preparation of claim 5 or 6 described treatment diabetes and complication thereof, it is characterized in that: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent, be condensed into thick paste, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, drying, pulverize, add 2%CMS-Na, with concentration is that 12% starch slurry is a binding agent, the system soft material is crossed 20 mesh sieves and is granulated 60 ℃ of oven dry, 20 order granulate, add 3%CMS-Na, 1% Pulvis Talci, 4% micropowder silica gel, mix homogeneously, one-shot formula tablet machine, 2 grades of compression force tablettings promptly get dispersible tablet.
8; preparation method according to the stilbene trematodiasis antihypelipidemic preparation of claim 5 or 6 described treatment diabetes and complication thereof; it is characterized in that: get 90% Hirudo; the Radix Astragali of full dose; the Radix Rehmanniae of full dose; the Rhizoma Polygonati of full dose; adding 8 times of water gagings decocts 2 times; each 1 hour; filter; merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste; add 90% ethanol then; stir; make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol to the greatest extent; be condensed into thick paste; getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, drying; pulverize, extract powder and microcrystalline Cellulose are pressed 3: 2 mixed; put in the comminutor; with 1%L-HPC solution is binding agent, is wetting agent with water, at engine speed 220r/min; spray pump rotating speed 25r/min; for powder machine rotating speed 20r/min; jet flow 15L/min; whiff pressure 0.5Mpa; air blast flux 10 * 20L/min; whitewashing time 4min; round as a ball time 3min; pill promptly gets pellet.
9, preparation method according to the stilbene trematodiasis antihypelipidemic preparation of claim 5 or 6 described treatment diabetes and complication thereof, it is characterized in that: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, add 90% ethanol then, stir, make to contain alcohol amount and reach 50%, left standstill 24 hours, get supernatant and reclaim ethanol, be condensed into thick paste, get the residue Hirudo and pulverize with above-mentioned thick paste mix homogeneously to the greatest extent, dry, pulverize, press extract powder again: substrate=1: 1.2 adds soybean oil, yellow beeswax, the mixed-matrix of soybean lecithin, heating and melting, mixing gets soft capsule content; The preparation of glue: with gelatin: glycerol: water=1: 0.3: 0.5, get gelatin and add an amount of distilled water and make its imbibition, glycerol and remaining water are put be heated to 70～80 ℃ in the glue pot in addition, mix homogeneously adds expansible gelatin and stirs, and makes it to dissolve into uniform glue, in 70 ℃ of insulations 3 hours, leave standstill, remove the come-up foam, filter with cloth bag, in encapsulating machine, be pressed into soft capsule, be pressed into soft capsule, put in the drum drying machine and finalize the design, whole ball, drying promptly gets soft capsule.
10, preparation method according to the stilbene trematodiasis antihypelipidemic preparation of claim 5 or 6 described treatment diabetes and complication thereof, it is characterized in that: get 90% Hirudo, the Radix Astragali of full dose, the Radix Rehmanniae of full dose, the Rhizoma Polygonati of full dose, adding 8 times of water gagings decocts 2 times, each 1 hour, filter, merging filtrate is condensed into and measures proportions at 90 ℃ is 1.2～1.5 thick paste, adds 90% ethanol then, stirs, make and contain alcohol amount and reach 50%, left standstill 24 hours, and got supernatant and reclaim ethanol, be condensed into thick paste to the greatest extent, getting the residue Hirudo pulverizes with above-mentioned thick paste mix homogeneously, dry, pulverizing, is substrate with PEG4000, adds thick paste, drug quality: substrate volume=2: 5, stir, airtight, insulation, use internal diameter 4.2mm, external diameter 5.2mm dropper, speed with 30～40 of per minutes splashes into methyl-silicone oil: in the mixing liquid coolant of liquid paraffin=3: 2, and the high 130cm of cooling column, rotating speed 15rmin
-1, promptly get drop pill.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410040465 CN1626211A (en) | 2004-08-13 | 2004-08-13 | Astragalus-leech preparation of lowering blood sugar for treating diabetes and syndrome and preparation method |
| CN 200510200470 CN1733251A (en) | 2004-08-13 | 2005-08-12 | Sugar reducing preparation for curing diabetes and its complication comprising astragalus root and leech and process for preparing the same |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410040465 CN1626211A (en) | 2004-08-13 | 2004-08-13 | Astragalus-leech preparation of lowering blood sugar for treating diabetes and syndrome and preparation method |
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| CN1626211A true CN1626211A (en) | 2005-06-15 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101953852A (en) * | 2010-09-16 | 2011-01-26 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
| CN101406619B (en) * | 2007-10-08 | 2011-02-16 | 吉林一正药业集团有限公司 | Hypoglycemic capsules containing astragalus and leech, and preparation method thereof |
| CN101890098B (en) * | 2009-05-21 | 2012-03-14 | 中国中医科学院广安门医院 | Medicament for treating type II diabetic cardiopathy and preparation method thereof |
| CN101745028B (en) * | 2010-01-19 | 2012-03-14 | 吉林一正药业集团有限公司 | Drug for treatment of diabetes and complications thereof and preparation method thereof |
| CN107802789A (en) * | 2017-11-24 | 2018-03-16 | 海城市中医院 | A kind of Chinese medicine preparation and its instructions of taking for preventing and treating diabetes |
-
2004
- 2004-08-13 CN CN 200410040465 patent/CN1626211A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101406619B (en) * | 2007-10-08 | 2011-02-16 | 吉林一正药业集团有限公司 | Hypoglycemic capsules containing astragalus and leech, and preparation method thereof |
| CN101890098B (en) * | 2009-05-21 | 2012-03-14 | 中国中医科学院广安门医院 | Medicament for treating type II diabetic cardiopathy and preparation method thereof |
| CN101745028B (en) * | 2010-01-19 | 2012-03-14 | 吉林一正药业集团有限公司 | Drug for treatment of diabetes and complications thereof and preparation method thereof |
| CN101953852A (en) * | 2010-09-16 | 2011-01-26 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
| CN101953852B (en) * | 2010-09-16 | 2014-09-24 | 贵州信邦制药股份有限公司 | Antithrombin preparation and preparation method thereof |
| CN107802789A (en) * | 2017-11-24 | 2018-03-16 | 海城市中医院 | A kind of Chinese medicine preparation and its instructions of taking for preventing and treating diabetes |
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