CN1524543A - Medicament formulation for preventing and treating diabetes complication and preparation method therefor - Google Patents
Medicament formulation for preventing and treating diabetes complication and preparation method therefor Download PDFInfo
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- CN1524543A CN1524543A CNA031052754A CN03105275A CN1524543A CN 1524543 A CN1524543 A CN 1524543A CN A031052754 A CNA031052754 A CN A031052754A CN 03105275 A CN03105275 A CN 03105275A CN 1524543 A CN1524543 A CN 1524543A
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Abstract
The invention relates to a pharmaceutical preparation for preventing and treating diabetic complication and method for making same, wherein a set of traditional Chinese herbal medicines are extracted and chemically mixed with the assistance of nutrient. The medicine can substantially eliminate the insulin opposing, increase the insulin sensitivity, and prevent and treat diabetic complication.
Description
Technical field
The invention belongs to field of pharmaceutical technology, be specifically related to one group and be used to prevent and treat medicine prescription of diabetic complication and preparation method thereof.
Technical background
For a long time, some important pathological changes, for example hypertension, coronary heart disease, apoplexy, diabetes etc. all are considered to the disease cut apart each other at large.Particularly the hypertension that diabetics took place, coronary heart disease, nephropathy, retinopathy, neuropathy all are considered to cause owing to diabetes, are diagnosed as diabetic complication, and explain with the pathological change of advanced diabetes.But this says and is difficult to explain that blood glucose is in the non-diabetic level, even the fact of cardiovascular event also takes place the patient of normal level.
According to document Stern MP.Diabetes and cardiovascular diseaseThe " Common sail " hypothesis.Diabetes nineteen ninety-five 44 (4): 369-374.
Reach Reaven GM.Role of insulin in human diseaseDiabetes 1988,37 (12): the X-syndrome that 1595-1607 is at first proposed by Reaven, it comprises following content:
(1) Insulin receptor INSR is resisted insulin on Skeletal Muscle Cell, adipose cell, the hepatocyte;
(2) impaired glucose tolerance (IGT);
(3) hyperinsulinemia;
(4) very low density lipoprotein (VLDL) (VLDL)-triglyceride (TG) raises;
(5) HDL-C (HDL-C) reduces;
(6) hypertension.
Discovering afterwards, except that above-mentioned disease, below some diseases also should be included in the X-syndrome: low density lipoprotein, LDL (LDL) and intermediated-density lipoprotein (IDL) granule small and dense in abdominal part or internal organs obesity, the dyslipidemia increases, atherosclerosis, coronary heart disease, polycystic ovary syndrome, women's estrogen increases, microalbuminuria, hyperuricemia, plasminogen activator inhibitor increase, cancer cachexia, chronic alcoholism, hypomagnesemia, intracellular calcium concentration rising, LBW, high leptin mass formed by blood stasis.This is one group of disease that internal relation is arranged, and their common pathogenic factor is exactly an insulin resistant, causes hyperinsulinemia, brings out multiple risk factor, and atherosclerosis takes place, and develops into the disease that the form of expression has nothing in common with each other.
Some has had the individuality of insulin resistant, though hyperinsulinemia has been arranged, but the B emiocytosis of its insulin is powerful, still can be with glycemic control at normal level, can not produce the clinical manifestation of diabetes, but other diseases can take place, as hypertension, coronary heart disease, apoplexy, some cancer.If the B cell function is strong inadequately, its compensatory capacity is limited, and the generation of its diabetes so, development are exactly inevitable.
By above argumentation as can be seen, the many diseases that are diagnosed as diabetic complication are in the past given birth to by diabetes, but the twin sisters of diabetes, they are born on the same block of soil jointly, promptly insulin resistant and due to carbohydrate metabolism, disorders of lipid metabolism.Therefore must start with from eliminating insulin resistant if will prevent and treat diabetic complication.
Equally, for a long time, as of late, people will prevent and treat the eye of diabetes and complication thereof and dig-in blood sugar lowering, think that hyperglycemia is the cause of all kinds of wickedness, the source of all kinds of diseases and ailments, all be because insulin resistant takes place earlier body in fact in most cases, then produce hyperglycemia.Develop into diabetes, the complication of existing varying degree in the diabetics of the new diagnosis of half often, these complication are multifactor property, but not only are due to the hyperglycemia toxicity.Hence one can see that, want to prevent and treat effectively coronary heart disease, apoplexy, hypertension, must be core to eliminate insulin resistant, want to prevent and treat effectively the complication of advanced diabetes, follow two measures: (one) is main forwarding to eliminate insulin resistant from blood sugar lowering, thinks that insulin sensitivity enhancing is main; (2) pharmaceutical intervention should be implemented as early as possible, should eliminate the soil that the X-syndrome produces as early as possible, one, the dyslipidemia person is carried out pharmaceutical intervention, its two, IGT crowd is carried out pharmaceutical intervention, to prevent the generation of diabetic complication, the patient that diabetic complication takes place is effectively treated.
We know that prior art is to be core with the blood sugar lowering to treatment of diabetes.The result shows that it is very difficult to want to allow diabetic keep blood glucose well to control (HbAlc＜7%) for a long time, and antidiabetic drug is eaten more and more, and hypoglycemic effect worse and worse; Insulin injection also is that injection volume is big more more, and final insulin is also ineffective, and hypertension, coronary heart disease, apoplexy reduce patient's quality of life, even seizes patient's life.
One of Britain studies show that, adopts monotherapy after 3 years, and what glycemic control was good only then reduces to 25% after 50%, nine year.
Summary of the invention
Purpose control insulin resistant of the present invention is a target, selects medicine prescription of prevention and treatment diabetic complication and preparation method thereof, belongs to field of pharmaceutical technology.
A kind ofly be used to prevent and treat medicine prescription of diabetic complication and preparation method thereof, it is characterized in that: the medicine prescription comprise by: the Chinese herbal medicine with effect of eliminating insulin resistant with have the chemical medicine compatibility that makes insulin-sensitizing effect, form down the auxiliary of nutrient, its preparation method is: extraction, substep through Chinese herbal medicine add nutrition enhancer, the medicinal microcapsule parcel of chemistry is made microcapsule, the mixture of above-mentioned medicine is added different carriers, be prepared into hard capsule, soft capsule, tablets and other formulations.
The present invention realizes by following steps, Figure of description is a process chart of the present invention, in conjunction with Figure of description, particularly prepares the process chart of hard capsule, when the present invention was prepared into dosage forms such as tablet, soft capsule, the different its preparation method of process chart was:
1, the extraction of Chinese herbal medicine:
With Rhizoma Coptidis, Radix Ginseng, Radix Puerariae, the Radix Astragali in 8: 10: 15: the combination of 18 ratio.Earlier with Radix Ginseng, Radix Puerariae, the Radix Astragali is in 10 parts: 15 parts: 18 parts ratio roguing, take by weighing, being immersed in 8-10 after pulverize separately mixes doubly measures 70% ethanol and spends the night, water-bath reflux, extract, secondary, each 3 hours, for the second time with 8 times of amount 70% alcohol reflux, after the filtration, secondary filtrate is merged, solvent is removed in distilling under reduced pressure in water-bath, reclaims ethanol, the concentrate that obtains defat with petroleum ether secondary, aqueous solution is concentrated into about 1/10th of original volume, and reuse 20% ethanol suspension filtering solution distilling under reduced pressure gets serosity shape concentrate, at vacuum drying below 60 ℃ (or spray drying), pulverized 80 mesh sieves.
Then with above-mentioned medicinal residues with 8 portions of Rhizoma Coptidis, with conventional water extract-alcohol precipitation method processing, dry powder is crossed 80 mesh sieves, with above-mentioned three flavor medicament extracts, mix Chinese herbal medicine extract.Every day, consumption was 300～3000mg.
2, substep adds nutrition enhancer
＜1〉folic acid and B12 are mixed with a spot of Chinese medicine extract respectively, make pre-mixing agent.
＜2〉with magnesium chloride or magnesium gluconate, vanadium oxysulfate or connection wheat vanadyl, nicotinic acid chromium or pyridine acid chromium salt, yeast chromium, glutamic acid chromium, half film propylhomoserin chromium, aspartic acid chromium, chromium methionine, anti-bad blood ammonia acid chromium, rutin chromium, battalion's ketone chromium pulverize separately are crossed 120 orders, are mixed and made into pre-mixing agent with a small amount of Chinese herbal medicine extract respectively again.
Every day, consumption was: folic acid 0-600 μ g, B12 6-60 μ g, magnesium chloride 0-400mg, vanadium oxysulfate 0-100mg, nicotinic acid chromium 0-15mg.
3, share with chemical drugs biguanides, sulphanylureas and/or thiazole ketone.Make hard, soft capsule, tablets and other formulations.
Biguanides class medicine can be selected metformin (metformin) for use, and the using dosage scope is in 0-2.5g/ day; Sulfonylurea drugs can be selected glibenclamide (glibenclamide) for use, and the using dosage scope is in 0-20mg/ day; Gliclazide (gliclazide), the using dosage scope is in 0-320mg/ day; Gliquidone (glurenorm) 0-180mg/ day; Class choice of drug rosiglitazone (Rosiglitazone) dosage range also can be selected pioglitazone (Pioglitazone) dosage range 0-6mg/ day for use in 0-8mg/ day; Glipizide (glipizide), gram sugar sharp (glibornuride), acarbose (Acarbose), troglitazone (troglitazone) etc., chemical medicine and capsule material are mixed and made into microcapsule, the medicinal microcapsule of chemistry is wrapped up, the chemical medicinal soluble capsule material parcel that water solublity is bad, available gelatin, arabic gum, sodium alginate, hetastarch, hydroxymethyl starch, Carboxymethyl cellulose sodium etc., with the insoluble capsule material parcel of the chemical medicine available water of good water solubility, as paraffin, Cera Flava, stearic acid, palmitic acid etc., the microcapsule chemistry medicine behind the parcel, with the carrier dilution, mixing is standby.
4, mix.
With the 80 purpose Chinese medicine fine powders that prepare, take out a part and nutrient premixing, remaining part is put into mixer, with the nutrient pre-mixing agent, vitamin premix, the mineral pre-mixing agent, the trace element premix agent, chemical medicine pre-mixing agent adds abundant mixing respectively.
5, packing prepares various dosage forms.
The mixture of above-mentioned medicine adds different carriers, the assembly of the invention described above can be prepared into hard capsule, soft capsule, tablets and other formulations.
Select diabetics, 2 hours after the meal blood glucose＞11.1mmol/L, check newly that by the mydriasis optical fundus discovery has the diffusion-type macular edema, retina microangioma, point-like and/or rigid the oozing out of fire temperature, vein beading, soft ooze out and/or retina has unusual person 10 people by blood capillary, on the basis of original dietary habit and motor habit, before the meal or meal in take this product, every day secondary, each 1-3 grain, two months is a course of treatment, observes six courses of treatment, and the result shows that 10 routine patients are taking this product after course of treatment, blood glucose all significantly reduced in two hours, wherein 5 examples all are lower than below the 8.2mmol/L, and 5 examples are lower than 7.8mmol/L in addition, to recover normal.The patient continue to take six the course of treatment find that retinal abnormalities all has remarkable improvement even disappearance, effective percentage 100% as a result the time.
The outstanding feature of the present invention is the basic reason-insulin resistant that produces at diabetic complication, various diseases to complication when treating is treated, this product can be eliminated the X-syndrome effectively, obviously eliminate insulin resistant, improved hypoglycemic effect, eliminated " common soil " of X-syndrome thus diabetic complication is effectively prevented in early days, obtain the effective treatment late period, and reduced the toxic and side effects of Western medicine, prolong patient's life-span, improved its quality of life.
Description of drawings
Figure of description is a process chart of the present invention, particularly prepares the process chart of hard capsule.
The specific embodiment
In conjunction with Figure of description, the present invention in conjunction with the embodiments 1 is described:
Prevention and treatment diabetic complication hard capsule prescription
Radix Ginseng 3000g
Radix Puerariae 4500g
Radix Astragali 5400g
Rhizoma Coptidis 2400g
Nicotinic acid chromium 6g
Sulphuric acid oxygen vitriol 288g
Magnesium chloride 900g
Folic acid 1.2g
B12 30mg
Glibenclamide 15g
Carrier makes total amount reach 5400g in right amount
18000 of packing (every 0.3g)
1. the extraction of Chinese herbal medicine
With Radix Ginseng 3.0kg, Radix Puerariae 4.5kg, Radix Astragali 5.4kg pulverize the back mixing and are immersed in 103.2L, spend the night in 70% ethanol, water-bath adds 103.2L70% ethanol again with medicinal residues after refluxing and filtering in 3 hours, the filtration in 3 hours that refluxes merges secondary filtrate, distilling under reduced pressure in water-bath, desolvates, reclaim ethanol, obtain concentrate, use defat with petroleum ether 2 times, remove the liposoluble part, aqueous solution is concentrated into about 1/10 of original volume, reuse 20% ethanol suspends, filter, with filtrate distilling under reduced pressure on water-soluble.
Get serosity shape concentrate and pulverize, cross 80 mesh sieves at vacuum drying below 60 ℃ (or spray drying), standby.
With the 2.4kg Rhizoma Coptidis, the water extract-alcohol precipitation method processing with routine gets dried powder, crosses 80 mesh sieves with above-mentioned medicinal residues, and with above-mentioned three flavor medicament extract fine powder mixings, getting the fine powder gross weight is 1.548kg.
2. nutritional labeling premix: will cross 200 purpose nicotinic acid chromium 6g, vanadium oxysulfate 288g, magnesium chloride 900g successively respectively with a small amount of Chinese medicine extract fine powder mixing, standby; With folic acid 1.2g and B12 30mg and a small amount of Chinese medicine extract mixing, standby again.
3. the medicinal microcapsule of chemistry is wrapped up:
(1) prescription
Glibenclamide 200 order 15g
Gumwater 3% 180ml
Gelatin solution 3% 180ml
Formalin 36% is an amount of
(2) method for making: glibenclamide is suspended in the arabic gum aqueous solution, under 38 ℃ of constant temperature, stir, again 38 ℃ of aqueous gelatin solutions are slowly added, stir evenly, with 37 ℃ of distilled water dilutings, when treating that the suspension temperature drops to below 10 ℃, solidified 35 minutes with formaldehyde (36%), the lyophilization of centrifugal flush away formaldehyde gets glibenclamide dry powder, adds a small amount of carrier mixing, and is standby.
4. mix: earlier remaining Chinese medicine extract fine powder is added in the mixer, respectively B12, folic acid, nicotinic acid chromium, vanadium oxysulfate, magnesium chloride pre-mixing agent are added in the mixer in order, each mixed 5 minutes; Then the glibenclamide microcapsule is added, add an amount of carrier again, make mixed medicated powder total amount reach 5400g, mixed continuously 30 minutes, mixing is standby.
5. packing: with the medicated powder packing of mix homogeneously, the hard capsule of packing into: the 0.3g/ grain makes 18000 altogether.
Select diabetics, 2 hours after the meal blood glucose＞11.1mmol/L, find to have the diffusion-type macular edema by the mydriasis ophthalmofundoscopy, retina microangioma, point-like and/or flamboyancy are rigid to ooze out, and vein is beading sample, soft ooze out and/or retina has unusual person 10 people by blood capillary, on the basis of original dietary habit and motor habit, before the meal or meal in take this product, every day secondary, each 2, two months is a course of treatment, observes six courses of treatment, and the result shows that 10 routine patients are taking this product after course of treatment, blood glucose all significantly reduced in two hours after the meal, wherein 5 examples all are lower than below the 8.2mmol/L, and 5 examples are lower than 7.8mmol/L in addition, have recovered normal.The patient continue to take six the course of treatment find that retinal abnormalities all has remarkable improvement even disappearance, effective percentage 100% as a result the time.
Claims (6)
1. one kind is used to prevent and treat medicine prescription of diabetic complication and preparation method thereof, it is characterized in that: the medicine prescription comprise by: the Chinese herbal medicine with effect of eliminating insulin resistant with have the chemical medicine compatibility that makes insulin-sensitizing effect, form down the auxiliary of nutrient, its preparation method is: extraction, substep through Chinese herbal medicine add nutrition enhancer, the medicinal microcapsule parcel of chemistry is made microcapsule, the mixture of above-mentioned medicine is added different carriers, be prepared into hard capsule, soft capsule, tablets and other formulations.
2. it is characterized in that according to the described Chinese herbal medicine of claim 1: except that can selecting Radix Ginseng, Radix Puerariae, the Radix Astragali, Rhizoma Coptidis for use, can also select Radix Salviae Miltiorrhizae, Radix Scrophulariae, Radix Pseudostellariae, Flos Lonicerae, Rhizoma Polygonati Odorati, Radix Bupleuri etc. for use.
3. according to the described chemical medicine of claim 1, it is characterized in that with insulin-sensitizing effect: can select for use glibenclamide, diamicron, gliquidone, glipizide, gram sugar sharp; Also can select metformin, acarbose for use; Can also select troglitazone, rosiglitazone, pioglitazone etc. for use.
4. nutrient according to claim 1 is characterized in that referring to various vitamin, necessary mineral, the trace element of human body, and wherein more desirable nutrient is folic acid, B12, chromium, vanadium, magnesium, its optimum quantum of utilization scope (every day):
Folic acid 0-600 μ g
B12 0-60μg
Magnesium chloride 0-400mg
Vanadium oxysulfate 0-100mg
Nicotinic acid chromium 0-15mg
5. according to claim 4,, contain the chemical compound of chromium, except that nicotinic acid chromium, still can use pyridine acid chromium salt, chromium glycine, yeast chromium, chromium methionine, glutamic acid chromium, ascorbic acid chromium, rutin chromium, flavone chromium; The described chemical compound that contains vanadium, except that the sulphuric acid vanadyl, still can be with joining the wheat vanadyl; Magniferous chemical compound, except that magnesium chloride, still available magnesium gluconate.
6. the preparation method of medicine according to claim 1, it is characterized in that: the medicinal microcapsule of chemistry is wrapped up, the chemical medicinal soluble capsule material parcel that water solublity is bad, available gelatin, arabic gum, sodium alginate, hetastarch, hydroxymethyl starch, Carboxymethyl cellulose sodium etc., with the insoluble capsule material parcel of the chemical medicine available water of good water solubility, as paraffin, Cera Flava, stearic acid, palmitic acid etc.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA031052754A CN1524543A (en) | 2003-02-26 | 2003-02-26 | Medicament formulation for preventing and treating diabetes complication and preparation method therefor |
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| CNA031052754A CN1524543A (en) | 2003-02-26 | 2003-02-26 | Medicament formulation for preventing and treating diabetes complication and preparation method therefor |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106974951A (en) * | 2017-03-20 | 2017-07-25 | 李忠 | Treat the pharmaceutical composition of diabetes |
| CN107648596A (en) * | 2017-10-26 | 2018-02-02 | 叶宁 | A kind of fruit stem cell drugs and preparation method thereof |
| CN108404048A (en) * | 2018-04-28 | 2018-08-17 | 李太平 | A kind of formula of hypoglycemic body health ball |
-
2003
- 2003-02-26 CN CNA031052754A patent/CN1524543A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106974951A (en) * | 2017-03-20 | 2017-07-25 | 李忠 | Treat the pharmaceutical composition of diabetes |
| CN107648596A (en) * | 2017-10-26 | 2018-02-02 | 叶宁 | A kind of fruit stem cell drugs and preparation method thereof |
| CN108404048A (en) * | 2018-04-28 | 2018-08-17 | 李太平 | A kind of formula of hypoglycemic body health ball |
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