CN102225082A - Medicament for preventing and treating diabetes and complications thereof and preparation method thereof - Google Patents
Medicament for preventing and treating diabetes and complications thereof and preparation method thereof Download PDFInfo
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Abstract
The invention relates to a single-herb Chinese medicine of common four-o'clock roots for preventing and treating diabetes and complications thereof, and a preparation method thereof. The single-herb Chinese medicine contains the active components which are extracted from common four-o'clock roots by means of ethanol reflux extraction, reduced pressure concentration and vacuum drying treatment. The pharmacological studies show that the single-herb Chinese medicine has the effects of reducing blood sugar and lipid levels, reducing triglyceride levels in the liver and the skeletal muscles and increasing glycogen levels in the liver and the skeletal muscles, produces hypoglycemic and hypolipidemic effects in both preventative and therapeutic applications, causes no adverse effect on glucose and lipid metabolisms in healthy mice, and can be used for preventing and treating type II diabetes and complications caused thereby. The invention provides a pure natural medicament for the patients suffering from type II diabetes and complications thereof.
Description
Technical field
The present invention relates to a kind of non-synthetic drug of preventing and treating type 2 diabetes mellitus and complication thereof, it is that feedstock production forms with the Chinese herbal medicine.
Background technology
Diabetes have become the third-largest disease of the serious harm human health after tumor, cardiovascular and cerebrovascular disease.World Health Organization (WHO) and IDF's data show that expecting whole world diabetics total number of persons in 2025 will reach 3.33 hundred million.19 provinces and cities' diabetes findings of the survey of announcing according to China show along with crowd's average life prolongs, the increase of income and the change of life style (, psychentonia moving less as polyphagia, smoking drink etc.), the diabetics sum will increase with the quantity in every year 100 ten thousand at least.China over nearly 20 years the onset diabetes rate increased more than 5 times, be one of global fastest-rising country, wherein type 2 diabetes mellitus accounts for more than 90% of whole patients.
Diabetic complication is the lethal major reason of diabetics, at present the pathogenesis of diabetic complication is not illustrated as yet fully, also lacks the effectively preventing medicine.The control of diabetes and complication thereof has consumed a large amount of medical resources, has brought huge medical pressure and heavy financial burden to countries in the world, and medical circle also feels very thorny to the control of this disease.Existing studies show that, western modern medicine still lack safely and effectively means and improve diabetic complication from every side, and medicament categories is on the low side, holds at high price, and the life-time service drug effect descends, and produces multiple side effect.And Chinese medicine is from the angle of differential diagnosis of diseases determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs, and according to the disease characteristics of diabetes and complication thereof, comprehensively regulating in addition on the integral level can make the sx of diabetes and complication thereof.Therefore, screen and study effective Chinese medicine to prevent and treat diabetes and complication thereof from natural drug, this is for the life-span that prolongs the patient, and improving the quality of living has important social and economic implications, has been subjected to global common concern.
Radix Mirabilis (
Mirabilis jalapaL.) be the dried root of Nyctaginaceae plant Mirabilis jalapa, have another name called into DILAOSHU, pollen head, pigment head, powder head, Radix primulae maximowiczii first-class.Cold nature, sweet in the mouth, nontoxic, have the effect of inducing diuresis for treating stranguria syndrome, heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling, in Chinese the greater part cultivation is arranged.Radix Mirabilis contains flavonoid, pigment, terpenoid, sterol, volatile oil, resin, aminoacid, organic acid and a large amount of starch, and its pharmacological action is extensive.At present for the research of Radix Mirabilis more be effects such as it is anticancer, antibiotic, contraception, resisting HIV, anti-diabetic, parasite killing.
The oral antidiabetic drug that China's approval is at present used has Drugs Promoting Insulin Secretion (sulfonylurea, meglitinide) and non-Drugs Promoting Insulin Secretion (alpha-glucosidase inhibitor, biguanides, thiazolidinedione euglycemic agent), but all can not fundamentally solve reducing and keep long-term efficacy aspect the hyperglycemia and, therefore seek new medicine and be always the research focus in this field at this two the most significant greatly problem of the effective mitigate the disease of the cause of disease.Though existing report single medicinal material Radix Mirabilis can reduce the blood glucose in diabetic mice value, but its extracting method is coarse, the diabetes model preparation is not classical, only detects this single index of blood glucose value, and the effect and the mechanism thereof of control type 2 diabetes mellitus and complication thereof be there is no report both at home and abroad.For further being applied to prevent and treat Radix Mirabilis on type 2 diabetes mellitus and the complication thereof, remain in many technical problems, comprise that effect is cheap, the Radix Mirabilis extracting method of process stabilizing, to the type 2 diabetes mellitus patient often with blood fat raise, organize related indication influences such as glycolipid metabolism disorder, and to the influence of normal person's glycolipid metabolism.Finishing of these technical methods and functional parameter will provide solid theory for Radix Mirabilis is applied to prevent and treat diabetes and complication and its preparation method thereof.
In order further to illustrate the pharmacological action of Radix Mirabilis, the present invention extracts Radix Mirabilis, and it is prevented and treated diabetes and the complication effect is studied, find that Radix Mirabilis has the effect of obvious functions of blood sugar, reduction serum total cholesterol (TC), serum triglycerides (TG), reduction tissue T G content and increase glycogen content, preventative hypoglycemic effect with the therapeutic administration is similar, and does not influence the glycolipid metabolism of normal mouse.
Summary of the invention
The objective of the invention is to propose the application of Radix Mirabilis extract in preparation control type 2 diabetes mellitus and complication medicine thereof.
Have in blood sugar lowering, blood fat reducing, reduction liver and the skeletal muscle content of triglyceride and increase in liver and the skeletal muscle new medical usage such as glycogen content by pharmacological evaluation proof Radix Mirabilis extract, can be used in particular for preparation control type 2 diabetes mellitus and complication medicine thereof.
Wherein the Radix Mirabilis preparation method of extract is as follows:
(1) extract: with the Radix Mirabilis crushed after being dried, 5-12 doubly measures the 50%-95% alcohol reflux 1-3 time, each 0.5-2 h, and merging filtrate filters;
(2) concentrate: utilize the Rotary Evaporators concentrating under reduced pressure;
(3) vacuum drying concentrating under reduced pressure thing obtains the Radix Mirabilis extract.
Utilize the medicine of Radix Mirabilis extract preparation control type 2 diabetes mellitus and complication thereof, include Radix Mirabilis extract 1%-99.5% in the medicine, all the other are the adjuvant of preparation capsule, soft capsule, granule, tablet or pill
Beneficial effect of the present invention: the present invention has TG content in blood sugar lowering, blood fat reducing, reduction liver and the skeletal muscle and increases the effect of glycogen content in liver and the skeletal muscle by the multinomial Chinese medicine Radix Mirabilis extract that experimental results show that, preventative hypoglycemic effect with the therapeutic administration is similar, and the glycolipid metabolism of normal mouse is not had influence.The present invention provides a kind of non-synthetic antidiabetic drug for type 2 diabetes mellitus and complication thereof, and its definite functions, effect be lasting, have no side effect, and has widened the scope of Radix Mirabilis disease preventing and treating.
Effect experiment example: to the experiment normal and influence of type 2 diabetes mellitus mice glycolipid metabolism.
Experiment is observed its influence to glycogen and TG content in normal and type 2 diabetes mellitus mouse blood sugar, blood fat, liver and the skeletal muscle by medicine of the present invention is carried out pharmacodynamic study.
Experiment material
1.1 animal: cleaning level male KM mice, body weight 18-22 g is provided by Field Surgery Inst. of The Third Military Medical Univ.'s Experimental Animal Center.Freely drink water and ingest, a cleaning level Animal House adaptability raised for 1 week, temperature (20 ± 2) ℃, humidity (60 ± 5) %, 12 h periodicity of illuminations.
1.2 reagent: Radix Mirabilis, pick up from the Chongqing City, and be accredited as Radix Mirabilis through Traditional Chinese Medicine experts and " China's Chinese herbal medicine commonly used ", " China's Chinese herbal medicine color atlas commonly used " contrast; Glibenclamide (No. 20100224, purity 99.56%) is purchased to Wuhan Yuancheng Technology Development Co., Ltd.; Streptozotocin, U.S. Sigma company product; TC, TG, creatinine glycogen test kit are Nanjing and build up bio-engineering research institute product; Blood sugar test paper is Johnson Co.'s product.
Experimental technique
2.1 the preparation of Radix Mirabilis ethanol extract (EEM)
(1) extract: with the Radix Mirabilis crushed after being dried, with 5-12(as 10 times) doubly measure 50%-95%(as 70%) alcohol reflux 1-3(is as 3 times) inferior, each 0.5-2 h(such as 1h), merging filtrate filters;
(2) concentrate: utilize the Rotary Evaporators concentrating under reduced pressure;
(3) vacuum drying obtains EEM.
2.2 EEM is to the influence of normal mouse glycolipid metabolism
The normal KM mice that is used for single-dose and multiple dosing all is divided into 5 groups at random, every group of 10 animals, and normal administration group is irritated stomach respectively and is given 2,4,8 g/kg EEM and 0.76 mg/kg glibenclamide, and the normal control group is irritated stomach and is given distilled water.
The single-dose process is as follows: 0.2 ml/10g body weight administration, anesthetized mice behind the single-dose 2h, eyeball are got blood and are used for blood glucose, serum TC, serum TG detection, get quick liver and skeletal muscle liquid nitrogen cryopreservation, are used for the detection of glycogen and TG.
The successive administration process is as follows: every day is with 0.2 ml/10 g body weight administration, continuous 28 days, surveys 1 body weight in per 14 days.At the 14th day, get fasting 16 h mousetail blood and be used for blood sugar test; At the 28th day, anesthesia fasting 16 h mices, eyeball is got blood and is used for blood glucose, serum TC, serum TG detection, gets liver and skeletal muscle liquid nitrogen cryopreservation fast, is used for the detection of glycogen and TG.
2.3 EEM is to building up the influence of type 2 diabetes mellitus mice glycolipid metabolism
Fasting 16 h mouse peritoneals are injected 160 mg/kg streptozotocins, detect fasting glucose after 3 days, are diabetes modeling success index with fasting glucose greater than 11.1 mmol/L, and are divided into 5 groups at random, every group of 10 animals.Model administration group is irritated stomach 2,4,8 g/kg EEM and 0.76 mg/kg glibenclamide respectively, and model control group is irritated stomach equal-volume distilled water.Single-dose and multiple dosing process are with " EEM is to the influence of normal mouse glycolipid metabolism ".
2.4 preventatively give EEM influence to type 2 diabetes mellitus mice glycolipid metabolism
Mice is divided into 6 groups at random, every group of 10 animals.Wherein irritate stomach 2,4,8 g/kg EEM and 0.76 mg/kg glibenclamide respectively for 4 groups, remain 2 groups and give the equal-volume distilled water, continuous 14 days.All mice fasting 16 h after 14 days wherein give 1 group of lumbar injection, the 0.1 mol/L citrate buffer solution of distilled water, all the other 4 groups equal lumbar injection 160 mg/kg streptozotocins.All animals continued to give distilled water or EEM 28 days again, claimed a body weight in per 14 days.The 17th day (promptly injecting streptozotocin after 3 days) with cut the Mus tail in 28 days and get the detection that blood is used for blood glucose.The 42nd day anesthesia fasting mice, eyeball is got the detection that blood is used for blood glucose, serum TC and TG level, gets the detection that liver and skeletal muscle are used for glycogen and TG content.
2.5 the detection of serum TC and TG level
With Nanjing build up bio-engineering research TC and TG test kit detect TC and TG level in the mice serum, carry out in strict accordance with description.
2.6 the detection of glycogen and TG content in liver and the skeletal muscle
With Nanjing build up bio-engineering research glycogen and TG test kit detect glycogen and TG content in mouse liver and the skeletal muscle, carry out in strict accordance with description.
2.7 statistical analysis
All data with mean ± standard deviation (
± s) expression, use SPSS 13.0 statistical softwares and carry out statistical analysis, relatively adopt one factor analysis of variance (ANOVA) between group, multiple comparisons LSD method.The result with
P＜0.05 has statistical significance for difference.
The result
3.1 EEM is to the influence of normal and type 2 diabetes mellitus mice glycolipid metabolism
3.1.1 EEM is to the influence of blood sugar level
Single-dose
The fasting blood glucose level of the inductive diabetes model control group mice of streptozotocin apparently higher than the blood sugar level that gives the normal mouse before and after the EEM (
P＜0.01), but single gives the fasting blood glucose level that 2,4,8 g/kg EEM all do not influence normal and diabetic mice, single gives the blood sugar level that the positive control drug glibenclamide can significantly reduce diabetic mice, but does not influence the blood sugar level (table 1) of normal mouse.
Multiple dosing
Continuous irrigation stomach 2,4,8 g/kg EEM and positive control drug glibenclamide 14 days and 28 days all do not have influence to normal mouse blood sugar level.With before the administration and the model control group mice relatively, gave in continuous 14 days 4,8 g/kg EEM and glibenclamide can reduce the blood glucose in diabetic mice level (
P＜0.01), EEM and can be in 14 days subsequently further the blood sugar lowering level (
P＜0.01), low dosage (2g/kg) EEM does not influence the blood sugar level of diabetic mice.On the contrary, the blood sugar level of diabetes model control group mice continues raise (table 1) in the experimentation.
Table 1 single and repeatedly irritate the influence of stomach Radix Mirabilis ethanol extract (EEM) to normal and blood glucose in diabetic mice level
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
P＜0.01, with comparison before the administration.
3.1.2 EEM is to the influence of serum TC and TG level
Single-dose
With normal control group mice relatively, the injection streptozotocin cause serum TC and TG level significantly raise (
P＜0.01).But single gives 2,4,8 g/kg EEM and glibenclamide fails to reduce normal TC and the TG level (table 2) that reaches diabetic mice.
Multiple dosing
Gave 2,4,8 g/kg EEM in continuous 28 days and glibenclamide does not all influence normal mouse serum TC and TG level.Gave 2 g/kg EEM in continuous 28 days and glibenclamide does not influence diabetic mice serum TC and TG level yet, but 4,8 g/kg EEM can significantly reduce diabetic mice serum TC and TG level (
P＜0.01) (table 2).
Table 2. single and repeatedly irritate the influence of stomach Radix Mirabilis ethanol extract (EEM) to normal and diabetic mice serum TC and TG level
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
3.1.3 EEM is to the influence of glycogen in liver and the skeletal muscle and TG content
Single-dose
Single gives 2,4,8 g/kg EEM and glibenclamide does not all exert an influence to TG and glycogen content in normal and diabetic mice liver and the skeletal muscle.With normal control group mice relatively, TG content obviously increases in diabetes model control group mice liver and the skeletal muscle, and glycogen content obviously reduce (
P＜0.01) (table 3).
Table 3. single is irritated the influence of stomach Radix Mirabilis ethanol extract (EEM) to glycogen and TG content in normal and diabetic mice liver and the skeletal muscle
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
Multiple dosing
Irritate stomach 2,4,8 g/kg EEM and glibenclamide in continuous 28 days and all do not influence TG and glycogen content in normal mouse liver and the skeletal muscle.With normal control group mice relatively, TG content obviously increases in diabetes model control group mice liver and the skeletal muscle, and glycogen content obviously reduce (
P＜0.01).Giving 2 g/kg EEM in continuous 28 days does not influence TG and glycogen content in diabetic mice liver and the skeletal muscle yet, but 4,8 g/kg EEM can significantly reduce in diabetic mice liver and the skeletal muscle TG content and increase glycogen content (
P＜0.01); The positive control drug glibenclamide can significantly increase glycogen content in diabetic mice liver and the skeletal muscle, but does not influence TG content (table 4).
Table 4. is irritated the influence of stomach Radix Mirabilis ethanol extract (EEM) to glycogen and TG content in normal and diabetic mice liver and the skeletal muscle for many times
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
3.2 preventatively give EEM influence to type 2 diabetes mellitus mice glycolipid metabolism
3.2.1 preventatively give EEM influence to type 2 diabetes mellitus mouse blood sugar level
The lumbar injection streptozotocin is induced before the diabetes, gives 2,4,8 g/kg EEM in preventative continuous 14 days and glibenclamide does not influence the normal mouse blood sugar level.Behind the lumbar injection streptozotocin 3 days (be continuous 17 days give EEM), the blood sugar level of diabetes model control group mice is still apparently higher than normal control group mice.With the diabetes model control group mice relatively, irritated in continuous 28 days stomach 4,8 g/kg EEM and glibenclamide can obviously reduce diabetic mice blood sugar level (
P＜0.01), and EEM after administration in continuous 42 days further the blood sugar lowering level (
P＜0.01).At the 28th day and the 42nd day, 2 g/kg EEM did not all influence the blood sugar level of diabetic mice.On the contrary, in experimentation, the blood sugar level of diabetes model control group mice continues raise (table 5).
The preventative filling stomach of table 5. Radix Mirabilis ethanol extract (EEM) is to the influence of blood glucose in diabetic mice level
| Group | Before the administration | Administration 14 days | Administration 17 days | Administration 18 days | Administration 42 days |
| The normal control group | 6.24 ± 0.55 | 6.27 ± 0.62 | 6.40 ± 0.42 | 6.25 ± 0.65 | 6.30 ±0.48 |
| The diabetes matched group | 6.18 ± 0.61 | 6.26 ± 0.62 | 16.14 ± 1.54 # | 18.32 ± 1.62 # | 19.76 ± 1.29 # |
| Diabetes+2 g/kg EEM | 6.25 ± 0.50 | 6.16 ± 0.58 | 15.29 ± 1.29 | 18.21 ± 1.34 | 19.75 ± 1.22 |
| Diabetes+4 g/kg EEM | 6.22 ± 0.58 | 6.16 ± 0.53 | 15.12 ± 1.58 | 13.12 ± 1.66 * | 10.07 ± 1.05 * |
| Diabetes+8 g/kg EEM | 6.23 ± 0.64 | 6.20 ± 0.60 | 15.16 ± 1.28 | 12.81 ± 1.44 * | 10.01 ± 0.84 * |
| Diabetes+glibenclamide | 6.21 ± 0.60 | 6.17 ± 0.58 | 6.87 ± 0.75 * | 6.45 ± 0.68 * | 6.17 ± 0.48 * |
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
3.2.2 preventatively give EEM influence to type 2 diabetes mellitus mice serum TC and TG level
With normal control group mice relatively, diabetes model control group mice serum TC and TG level obviously raise (
P＜0.01).Gave in preventative continuous 42 days 4,8 g/kg EEM can obviously reduce diabetic mice serum TC and TG level (
P＜0.01), but 2 g/kg EEM and glibenclamide do not influence diabetic mice serum TC and TG level (table 6).
3.2.3 preventatively give EEM influence to glycogen in type 2 diabetes mellitus mouse liver and the skeletal muscle and TG content
Compare with normal control group mice, streptozotocin is induced and can obviously be caused TG content rising in mouse liver and the skeletal muscle, the glycogen content reduction (
P＜0.01).With the diabetes model control group mice relatively, giving 4,8 g/kg EEM in preventative continuous 42 days can obviously reduce TG content in diabetic mice liver and the skeletal muscle, increase glycogen content (
P＜0.01), glibenclamide can significantly increase glycogen content in diabetic mice liver and the skeletal muscle, but does not influence TG content, and 2 g/kg EEM do not influence glycogen and TG content (table 6) in diabetic mice liver and the skeletal muscle.
The preventative filling stomach of table 6. Radix Mirabilis ethanol extract (EEM) is to the influence of glycogen, TG content in diabetic mice serum TC, TG level and liver and the skeletal muscle
Data with mean ± standard deviation (
± s) expression,
n=10.
* P＜0.01, compare with the diabetes matched group.
# P＜0.01, compare with the normal control group.
Conclusion
Set up before the diabetes model and to irritate stomach EEM and to continue administration 28 days in preventative continuous 14 days, to the influence of glycogen, TG content in blood glucose, serum TC, TG level and the liver of diabetic mice and the skeletal muscle with set up diabetes after successive administration 28 days identical.Radix Mirabilis has therapeutic and preventative hypoglycemic lipid-lowering effect to diabetic mice, but the glycolipid metabolism of normal mouse is not had influence, illustrates that this medicine can be used for the control of type 2 diabetes mellitus and complication thereof, and does not influence normal glycolipid metabolism.
The present invention can be prepared into capsule, soft capsule, granule, tablet or pill according to practical situation clinical practice is provided, and can add appropriate amount of starch or other adjuvant as additive when the above-mentioned preparation of preparation.
The specific embodiment
Embodiment one]
The acquisition of Radix Mirabilis ethanol extract
After Radix Mirabilis is ground into coarse powder, with 5 times of amounts, 50% ethanol room temperature lixiviate 3 times, each 24h, merging filtrate filters; Utilize the Rotary Evaporators concentrating under reduced pressure; Vacuum drying obtains the Radix Mirabilis ethanol extract, and extraction ratio is 12.5%.
Embodiment two]
The acquisition of Radix Mirabilis ethanol extract
After Radix Mirabilis is ground into coarse powder, with 10 times of amounts with 95% ethanol room temperature lixiviate 3 times, each 48h, merging filtrate filters; Utilize the Rotary Evaporators concentrating under reduced pressure; Vacuum drying obtains the Radix Mirabilis ethanol extract, and extraction ratio is 13.0%.
Embodiment three]
The acquisition of Radix Mirabilis ethanol extract
After Radix Mirabilis is ground into coarse powder, with 12 times of amounts with 70% alcohol reflux 3 times, each 2h, merging filtrate filters; Utilize the Rotary Evaporators concentrating under reduced pressure; Vacuum drying obtains the Radix Mirabilis ethanol extract, and extraction ratio is 14.1%.
Embodiment four]
The acquisition of Radix Mirabilis ethanol extract
After Radix Mirabilis is ground into coarse powder, with 8 times of amounts with 80% alcohol reflux 3 times, each 2h, merging filtrate filters; Utilize the Rotary Evaporators concentrating under reduced pressure; Vacuum drying obtains the Radix Mirabilis ethanol extract, and extraction ratio is 13.7%.
Embodiment five]
The acquisition of Radix Mirabilis ethanol extract
After Radix Mirabilis is ground into coarse powder, with 5 times of amounts with 95% alcohol reflux 3 times, each 1h, merging filtrate filters; Utilize the Rotary Evaporators concentrating under reduced pressure; Vacuum drying obtains the Radix Mirabilis ethanol extract, and extraction ratio is 12.4%.
Embodiment six]
The capsular preparation of Radix Mirabilis ethanol extract
A kind of Chinese herbal medicine, it is to be the made medicament of raw material with the Chinese herbal medicine Radix Mirabilis, is used for the treatment of diabetes and complication thereof.
Prescription: Radix Mirabilis ethanol extract (effective ingredient) 200g, lactose (excipient) 80g, starch (excipient) 70g, magnesium stearate (antiplastering aid) 2.5g makes 1000 capsules altogether.
Preparation method: effective ingredient and pharmaceutic adjuvant are all crossed 100 mesh sieves,, in mixer, mix 10-15min, add magnesium stearate 2.5g by prescription accurate weighing respectively, mix 2min after, pack 1000 capsules into promptly.
Embodiment seven]
Radix Mirabilis ethanol extract preparation of soft capsule
A kind of Chinese herbal medicine, it is to be the made medicament of raw material with the Chinese herbal medicine Radix Mirabilis, is used for the treatment of diabetes and complication thereof.
Prescription: Radix Mirabilis ethanol extract (effective ingredient) 200g, vegetable oil (excipient) 70g, Cera Flava (excipient) 30g, methyl parahydroxybenzoate (antiseptic) 1g makes 1000 soft capsules altogether.
Preparation method: effective ingredient is crossed 100 mesh sieves, accurately take by weighing principal agent and adjuvant, place colloid mill to be ground into ointment shape suspended matter, make 1000 soft capsules, promptly according to preparation prescription.
Embodiment eight]
The preparation of Radix Mirabilis ethanol extract granule
A kind of Chinese herbal medicine, it is to be the made medicament of raw material with the Chinese herbal medicine Radix Mirabilis, is used for the treatment of diabetes and complication thereof.
Prescription: Radix Mirabilis ethanol extract (effective ingredient) 250g, dextrin (excipient) 100g, steviosin (correctives) is an amount of.
Preparation method: effective ingredient and pharmaceutic adjuvant are all crossed 100 mesh sieves, by prescription accurate weighing respectively, mix homogeneously in mixer, by dry granulation, packing is promptly.
Embodiment nine]
The preparation of Radix Mirabilis ethanol extract tablet or pill
A kind of Chinese herbal medicine, it is to be the made medicament of raw material with the Chinese herbal medicine Radix Mirabilis, is used for the treatment of diabetes and complication thereof.
Label prescription: Radix Mirabilis ethanol extract (effective ingredient) 200g, dextrin (excipient) 112.5g, lactose (excipient) 87.5g, low-substituted hydroxypropyl cellulose (binding agent) 18.75g, 50% ethanol (binding agent) 112.5ml of 4% hydroxypropyl cellulose, Pulvis Talci (antiplastering aid) 3.75g, magnesium stearate (antiplastering aid) 3.75g makes 1250 altogether.
The coating solution prescription: coating pre-mixing agent (Opadry OY-C-7000A) 4.37g, distilled water 30g is used to prepare 1250.
Preparation method: effective ingredient and other pharmaceutic adjuvants are all crossed 100 mesh sieves, take by weighing Radix Mirabilis ethanol extract, lactose, the dextrin of recipe quantity and account for half low-substituted hydroxypropyl cellulose of recipe quantity, by the equivalent method mix homogeneously that progressively increases, 50% ethanol with 4% hydroxypropyl cellulose is wetting agent system soft material, 18 mesh sieves are granulated, wet granular is in 45-50 ℃ of drying, 20 mesh sieve granulate, add the low-substituted hydroxypropyl cellulose of surplus and Pulvis Talci, the magnesium stearate mixing of recipe quantity, after measuring active constituent content, determine that sheet is heavy, in 10.0mm shallow concave punch tabletting.Wrap with the white film clothing coating weightening finish 1-2% according to a conventional method.
The preparation of coating solution: under agitation coating pre-mixing agent (Opadry OY-C-7000A) is added in the distilled water, add in the 5min, continue to stir 45min promptly.
Described the present invention thus in detail, to those skilled in the art, obviously also various changes can have been arranged within the scope of the invention, the present invention is not subjected to the described restriction of description.
Claims (4)
1. the application of Radix Mirabilis extract in preparation control type 2 diabetes mellitus and complication medicine thereof.
2. a medicine of preventing and treating type 2 diabetes mellitus and complication thereof is characterized in that, it is the Radix Mirabilis extract of 1-99.5% that described medicine also has weight ratio, and all the other are acceptable accessories.
3. the medicine of control type 2 diabetes mellitus according to claim 1 and complication thereof is characterized in that, described medicine is tablet, capsule, pill, granule.
4. according to claim 2 or 3 described medicines, it is characterized in that described Radix Mirabilis extract adopts following method to prepare:
(1) extract: with the Radix Mirabilis crushed after being dried, doubly measure the 50%-95% alcohol reflux 1-3 time with 5-12, each 0.5-2 h, merging filtrate filters;
(2) concentrate: utilize the Rotary Evaporators concentrating under reduced pressure;
(3) vacuum drying obtains the Radix Mirabilis extract.
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| CN103585202A (en) * | 2012-08-13 | 2014-02-19 | 资元堂生物科技股份有限公司 | Plant extract for treating diabetes and preparation method thereof |
| CN117679485A (en) * | 2024-01-30 | 2024-03-12 | 烟台优达生物技术开发有限公司 | Pueraria peptide and application thereof |
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| CN103585202A (en) * | 2012-08-13 | 2014-02-19 | 资元堂生物科技股份有限公司 | Plant extract for treating diabetes and preparation method thereof |
| CN117679485A (en) * | 2024-01-30 | 2024-03-12 | 烟台优达生物技术开发有限公司 | Pueraria peptide and application thereof |
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