CN101167862B - Traditional Chinese medicine compound preparation for treating diabetes and nephrosis and preparing method thereof - Google Patents
Traditional Chinese medicine compound preparation for treating diabetes and nephrosis and preparing method thereof Download PDFInfo
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- CN101167862B CN101167862B CN2007100481779A CN200710048177A CN101167862B CN 101167862 B CN101167862 B CN 101167862B CN 2007100481779 A CN2007100481779 A CN 2007100481779A CN 200710048177 A CN200710048177 A CN 200710048177A CN 101167862 B CN101167862 B CN 101167862B
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Abstract
The invention relates to a traditional Chinese medicine compound medicament for treating diabetic nephropathy and process for preparation, belonging to the traditional Chinese medicine field. The invention is prepared into various solid dosage forms which are suitable to oral administration and is made from the following traditional Chinese medicine, raw glutinous rehmannia, salvia miltiorrhizae, epimedium, prepared rhubarb, and raspberry and appropriate amount of excipient. The invention is showed through animal experiments that fasting plasma glucose of diabetic nephropathy model rat is significantly reduced, plasma glucagons is lowered, the contents of urinary albumin and urine beta 2 microglobulin are decreased, and the level of pituitary growth hormone is reduced. The invention has the effects of lowering hyperglycemia, reducing urinary albumin, and protecting kidney functions, which has important significance and applicable value for the treatment of diabetic nephropathy.
Description
Technical field
The invention belongs to the field of Chinese medicines, relate to a kind of compound Chinese medicinal preparation for the treatment of diabetic nephropathy and preparation method thereof.
Background technology
Diabetic nephropathy is the common microvascular complications of diabetes, is one of main cause of death of diabetes, the onset concealment, and usual earlier is asymptomatic.In case proceed to clinical albuminuria, edema occurs, hypertension, enter the clinical diabetes nephropathy phase, renal function injury is irreversible, develops into renal failure in whole latter stage at last.In recent years, the research work of Chinese medicine prevention diabetic nephropathy is carried out more, but lacks the perspective study of system, particularly in early days (the urinary albumin excretion rate is between 20～200 μ g/min), stop albuminuretic progress with Chinese medicine, great clinical meaning is arranged.Chinese medicine is included into different categories with diabetic nephropathy, is that main person can be included into categories such as " letting out under the vital essence ", " deficient " with albuminuria; Accompany typical polydipsia, polyphagia, polyuria, belong to " quenching one's thirst ", " diabetes involving the kidney " category when becoming thin; Mainly show as edema, renal insufficiency person, belong to categories such as " edema ", " obstruction and rejection ".It is generally acknowledged deficient five internal organs, eating and drinking without temperance, overstrain internal injury be main diseases because of; Sick position is at kidney, and is relevant with internal organs such as spleen, lung, livers; Blood stasis, water wet, expectorant is turbid is its mainly double heresy of holding under the arm.Each family adopts method of treatment to be not quite similar, and has to carry out dialectical opinion and control, and the explanation deficiency of spleen-YANG and kidneyYANG and the hepatic and renal YIN deficiency are controlled with warming the kidney and strengthening the spleen QI invigorating astringency inducing or strong water system fire, the method for activating blood and promoting diuresis.Or according to clinical four diagnostic methods gained, with primary disease be divided into spleen kidney qi Yin bivacuity type, spleen kidney qi sun deficiency, heart kidney qi sun deficiency is treated.In a word, still do not have unified pathogenesis about diabetic nephropathy and summarize, at present clinical effectively method of treatment and the square medicine of still lacking really.
Summary of the invention
The object of the present invention is to provide compound Chinese medicinal preparation of a kind of treatment diabetic nephropathy that good efficacy arranged and preparation method thereof.
The present invention has used 8 batches of zooperies repeatedly on the basis of theory of Chinese medical science and clinical practice: the orthogonal test drug screening, craft screening and pharmacodynamics test provide the present invention to treat compound Chinese medicinal preparation of diabetic nephropathy and preparation method thereof.
The present invention is a compound preparation of being made the treatment diabetic nephropathy by effective ingredient and pharmaceutical carrier.
Effective ingredient of the present invention is made up of the extract of following bulk drugs: Radix Rehmanniae, Radix Salviae Miltiorrhizae, Fructus Rubi, Radix et Rhizoma Rhei (processed), Herba Epimedii.
The weight proportion of extracts of bulk drugs component of the present invention is: Radix Rehmanniae 26%～38% Radix Salviae Miltiorrhizae 14%～23% Herba Epimedii 14%～23% Radix et Rhizoma Rhei (processed) 14%～23% Fructus Rubi 14%～23%.
The preferred weight proportioning of described extracts of bulk drugs component is Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 23% Fructus Rubi 23%.
The proportioning of preferred weight again of described extracts of bulk drugs component is: Radix Rehmanniae 38% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%.
The preferred weight proportioning in addition of described extracts of bulk drugs component is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 23% Herba Epimedii 23% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%.
The present invention adopts the extract of above-mentioned raw materials medicine to add the medicine adjuvant and makes oral solid formulations such as granule, tablet, capsule, effervescent tablet.
The used adjuvant of preparations shaping of the present invention comprise dextrin, lactose,, sodium bicarbonate, citric acid, Sodium Hydroxymethyl Stalcs, micropowder silica gel, starch, soluble starch and magnesium stearate, be medicinal specification adjuvant.
Chinese medicine quality of medicinal material used in the present invention should meet each pertinent regulations under corresponding medical material item of Chinese Pharmacopoeia version in 2005.
1. Radix Rehmanniae is the dry rhizome of goatweed bosom celebrating Radix Rehmanniae Rehmannia glutinosa Libosch.f.hueichingensis (Chaoet Schih) Hsiao or R.glutinosa (Gaertn.) Libosch..
2. Radix Salviae Miltiorrhizae is the dry rhizome of labiate Radix Salviae Miltiorrhizae Saluia miltiorrhiza Bge..
3. Herba Epimedii is the dry herb of Berberidaceae plant Herba Epimedii Epimedium grandiflorum Morr..
4. Radix et Rhizoma Rhei (processed) is the dry rhizome of polygonum rheum palmatum Rheum palmatum 1., Rheum tanguticum R.tanguticumMaxim.ex Reg., makes ripe usefulness.
5. Fructus Rubi is the dry immature fruit of Rosaceae Fructus Rubi Rubus chingii Hu..
The present invention prepares by following method
Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines add ethanol extraction 3 times, extract 1 ~ 2 hour at every turn.Fructus Rubi, Herba Epimedii adopt and close the extraction process of frying in shallow oil, be that Fructus Rubi, Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), carry out purification process, purification process adopts ethanol precipitation, centrifuging or chitosan fining process, the preferred alcohol sedimentation method.Other flavour of a drug extracts of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction merge mixing, drying, add suitable adjuvant, make solid oral dosage form: after comprising that extract merges, add dextrin, spray drying makes into fine powder, makes granule through dry granulation; Or add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, and lactose, magnesium stearate, mix homogeneously is with 95% ethanol system granule; 80 ℃ of dry back tablet agents; Add an amount of micropowder silica gel, behind the mixing, incapsulate; Or the part fine powder adds citric acid, starch is made granule; All the other fine powders add sodium bicarbonate, starch is made granule.After two kinds of granules add magnesium stearate, mix homogeneously, tabletting.
Compound preparation of the present invention shows through animal test results: the diabetic nephropathy model rat fasting blood-glucose is significantly reduced, and the blood plasma glucagon reduces; Microdose urine protein content, urine β2Wei Qiudanbai content reduce; The pituitary growth hormone level descends.Result of the test shows, the present invention has the hyperglycemia of reduction, reduces microdose urine protein, and the effect of renal function protecting is of great significance and value to the treatment of diabetic nephropathy.
Table 1 is the comparison of respectively organizing fasting glucose, serum insulin, blood plasma glucagon
Table 2 is comparisons of respectively organizing rat microdose urine protein, blood and urine β 2-MG (ng/L)
Table 3 is comparisons of respectively organizing rat blood serum growth hormone, pituitary growth hormone
Table 1
| Group | Number of animals | Blood glucose (mmol/L) | Insulin (ng/ml) | Glucagon (ng/ml) |
| Model of the present invention is normal | 15 16 20 | 20.14±0.89** 22.02±1.2 △△ 6.34±0.45 | 4.57±2.39 4.50±1.36 △ 6.94±3.49 | 197.06±41.21** 398.60±200.74 △△ 191.69±37.40 |
Compare with normal group
△P＜0.05
△ △P＜0.01; Compare * P＜0.05 * * P＜0.01 with model group
Table 2
| Group | Number of animals | The white egg (mg/ml) of urine trace | Blood β 2-MG | Urine β 2-MG |
| Model of the present invention is normal | 15 16 20 | 0.545±0.275** 0.941±0.173 △△ 0.421±0.167 | 2.90±1.11 3.37±0.78 △ 2.48±0.77 | 1.52±0.98** 3.32±1.25 △△ 1.46±0.69 |
Compare with normal group
△P＜0.05
△ △P＜0.01; Compare * * P＜0.01 with model group
Table 3
| Group | Number of animals | Growth hormone of serum (ng/ml) | Pituitary growth hormone (ng/mg hypophysis) |
| Model of the present invention is normal | 15 16 20 | 0.514±0.142 0.654±0.179 △△ 0.386±0.055 | 6.72±0.83** 10.44±1.28 △△ 4.40±0.83 |
Compare with normal group
△ △P＜0.01; With model group than * * P＜0.01
The specific embodiment
Embodiment 1
Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines add ethanol extraction 3 times, extract 1～2 hour at every turn.Fructus Rubi, Herba Epimedii adopt and close the extraction process of frying in shallow oil, be that Fructus Rubi, Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), carry out purification process, purification process adopts ethanol precipitation, centrifuging or chitosan fining process.Other flavour of a drug extracts of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction, merge mixing, each components by weight is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%, dry, add suitable adjuvant, make solid oral dosage form.
Described dosage form preparation method can adopt: after extract merges, add dextrin, spray drying makes into fine powder, makes granule through dry granulation.Or add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, and lactose, magnesium stearate, mix homogeneously is with 95% ethanol system granule or 80 ℃ of dry back tablet agents; Or add an amount of micropowder silica gel, behind the mixing, incapsulate; Or the part fine powder adds citric acid, starch is made granule, and all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, and mix homogeneously, tabletting.
Embodiment 2
Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines add ethanol extraction 3 times, extract 1～2 hour at every turn.Fructus Rubi, Herba Epimedii adopt and close the extraction process of frying in shallow oil, be that Fructus Rubi, Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), carry out purification process, purification process can be ethanol precipitation, centrifuging or chitosan fining process.Other flavour of a drug extracts of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction, merge mixing, each components by weight is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 23% Fructus Rubi 23%, dry, add suitable adjuvant, make solid oral dosage form.
Described dosage form preparation method can adopt: after extract merges, add dextrin, spray drying makes into fine powder, makes granule through dry granulation.Or add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, and lactose, magnesium stearate, mix homogeneously is with 95% ethanol system granule or 80 ℃ of dry back tablet agents; Or add an amount of micropowder silica gel, behind the mixing, incapsulate; Or the part fine powder adds citric acid, starch is made granule, and all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, and mix homogeneously, tabletting.
Embodiment 3
Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines add ethanol extraction 3 times, extract 1～2 hour at every turn.Fructus Rubi, Herba Epimedii adopt and close the extraction process of frying in shallow oil, be that Fructus Rubi, Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), carry out purification process, purification process can be ethanol precipitation, centrifuging or chitosan fining process.Other flavour of a drug extracts of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction, merge mixing, described each components by weight is: Radix Rehmanniae 38% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%, dry, add suitable adjuvant, make solid oral dosage form.
Described dosage form preparation method can adopt: after extract merges, add dextrin, spray drying makes into fine powder, makes granule through dry granulation.Or add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, and lactose, magnesium stearate, mix homogeneously is with 95% ethanol system granule or 80 ℃ of dry back tablet agents; Or add an amount of micropowder silica gel, behind the mixing, incapsulate; Or the part fine powder adds citric acid, starch is made granule, and all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, and mix homogeneously, tabletting.
Embodiment 4
Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines add ethanol extraction 3 times, extract 1～2 hour at every turn.Fructus Rubi, Herba Epimedii adopt and close the extraction process of frying in shallow oil, be that Fructus Rubi, Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, after aqueous extract is concentrated into relative density 1.08～1.12 (80 ℃), carry out purification process, purification process can be ethanol precipitation, centrifuging or chitosan fining process.Other flavour of a drug extracts of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction, merge mixing, each components by weight is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 23% Herba Epimedii 23% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%, dry, add suitable adjuvant, make solid oral dosage form.
Described dosage form preparation method can adopt: after extract merges, add dextrin, spray drying makes into fine powder, makes granule through dry granulation.Or add Sodium Hydroxymethyl Stalcs, micropowder silica gel, soluble starch, and lactose, magnesium stearate, mix homogeneously is with 95% ethanol system granule or 80 ℃ of dry back tablet agents; Or add an amount of micropowder silica gel, behind the mixing, incapsulate; Or the part fine powder adds citric acid, starch is made granule, and all the other fine powders add sodium bicarbonate, starch is made granule, after two kinds of granules add magnesium stearate, and mix homogeneously, tabletting.
Claims (7)
1. compound Chinese medicinal preparation for the treatment of diabetic nephropathy, be to make, it is characterized in that described effective ingredient is made up of the extract of following materials of weight proportions medicine: Radix Rehmanniae 26～38% Radix Salviae Miltiorrhizaes 14～23% Herba Epimedii 14～23% Radix et Rhizoma Rhei (processed) 14～23% Fructus Rubies 14～23% by effective ingredient and pharmaceutical carrier; Prepare by following step: Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) three flavor medicines, add ethanol extraction 3 times, each 1～2 hour, Fructus Rubi and Herba Epimedii were soaked 1 hour, add 8～10 times in water, extract three times, aqueous extract is concentrated into relative density 1.08～1.12 80 ℃, adopt ethanol precipitation, centrifuging or chitosan fining process purification process, the other drug extract of above-mentioned Radix Rehmanniae, Radix Salviae Miltiorrhizae, Radix et Rhizoma Rhei (processed) ethanol extraction and the purified processing of water extraction merges mixing, drying, add excipient substance, make compound preparation.
2. by the compound Chinese medicinal preparation of the described treatment diabetic nephropathy of claim 1, it is characterized in that the weight proportion of wherein said each crude drug is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 14% Herba Epimedii 14% Radix et Rhizoma Rhei (processed) 23% Fructus Rubi 23%.
3. by the described compound Chinese medicinal preparation that is used for the treatment of diabetic nephropathy of claim 1, it is characterized in that the weight proportion of wherein said each crude drug is: Radix Rehmanniae 26% Radix Salviae Miltiorrhizae 23% Herba Epimedii 23% Radix et Rhizoma Rhei (processed) 14% Fructus Rubi 14%.
4. by the compound Chinese medicinal preparation of the described treatment diabetic nephropathy of claim 1, it is characterized in that described compound preparation makes solid oral dosage form.
5. by the compound Chinese medicinal preparation of the described treatment diabetic nephropathy of claim 6, it is characterized in that described solid oral dosage form is granule, tablet or capsule.
6. by the compound Chinese medicinal preparation of the described treatment diabetic nephropathy of claim 1, it is characterized in that described excipient substance is selected from dextrin, lactose, sodium bicarbonate, citric acid, Sodium Hydroxymethyl Stalcs, micropowder silica gel, starch, soluble starch and/or magnesium stearate.
7. by the compound Chinese medicinal preparation of the described treatment diabetic nephropathy of claim 1, it is characterized in that described purification process selects ethanol precipitation for use.
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| CN101167862B true CN101167862B (en) | 2011-05-25 |
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| CN105596935B (en) * | 2015-11-27 | 2020-10-27 | 内蒙古自治区蒙医药研究所 | Mongolian medicine compound preparation for intervening or improving diabetic nephropathy and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1951480A (en) * | 2006-09-30 | 2007-04-25 | 郭更雄 | Medicament for treating type 2 diabetes |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1951480A (en) * | 2006-09-30 | 2007-04-25 | 郭更雄 | Medicament for treating type 2 diabetes |
Non-Patent Citations (2)
| Title |
|---|
| 董丽芳.中药治疗糖尿病经验体会.吉林中医药26 3.2006,26(3),11-12. |
| 董丽芳.中药治疗糖尿病经验体会.吉林中医药26 3.2006,26(3),11-12. * |
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