CN1654058A - Medicine for treating chronic kidney failure and its preparing process - Google Patents

Medicine for treating chronic kidney failure and its preparing process Download PDF

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Publication number
CN1654058A
CN1654058A CN 200410039418 CN200410039418A CN1654058A CN 1654058 A CN1654058 A CN 1654058A CN 200410039418 CN200410039418 CN 200410039418 CN 200410039418 A CN200410039418 A CN 200410039418A CN 1654058 A CN1654058 A CN 1654058A
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relative densities
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CN100389794C (en
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叶传蕙
吴芳
冯菊农
易明娟
徐万薏
王安娜
杨永胜
李明权
刘铜华
舒惠荃
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XI'AN SHIJISHENGKANG PHARMACEUTICAL INDUSTRY CO LTD
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吴芳
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Abstract

The present invention relates to one kind of medicine suppository for treating chronic kidney failure, named Shenkangshuan suppository, and its preparation process. The medicine suppository is prepared with red sage, astragalus root and other medicine materials, and through soaking, decoction, filtering, concentration, adding ethanol, letting stand, filtering, recovering ethanol, adding matrix, molding and other steps. The present invention has the advantages of convenient rectum administration, no first pass effect in liver, no gastrointestinal reaction, high bioavailability, etc.

Description

A kind of medicine for treating chronic kidney failure and preparation technology thereof who treats chronic renal failure
The present invention relates to a kind of medicine for treating chronic kidney failure and preparation technology thereof who treats chronic renal failure.
Clinically mostly be to adopt oral medication with the treatment by Chinese herbs chronic renal failure at present, its weak point is to absorb slowly, and bioavailability is low, the course of treatment is long, and weak curative effect is especially poorer to the above curative effect of renal function injury moderate, and gastrointestinal reaction is bigger, unsuitable prolonged application.The Chinese medicine injection effect is rapid, the bioavailability height, short treating period, good effect especially has better effects to the patient more than the renal function injury moderate, and a patent " SHENKANG ZHUSHEYE and preparation technology thereof " (application number 96117626 notification numbers 1146358) of applying for as the applicant is to extract the Chinese medicine injection made from herbal mixture, its weak point is complicated process of preparation, cost height, and need hospitalization uses inconvenience to the chronic renal failure patient of need long-term prescription.The present invention is that the dosage form to the patent " SHENKANG ZHUSHEYE and preparation technology thereof " of the applicant application changes agent.
The object of the present invention is to provide a kind of SHENKANG ZHUSHEYE to be changed the preparation technology that agent becomes rectal suppository, this technology is simple, and cost is low, and is easy to use, is applicable to that the chronic renal failure patient of long-term prescription consolidates curative effect behind hospitalization.
The present invention extracts the suppository of making by Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae, the Radix Astragali, Flos Carthami, and its raw material is made up of for 10~20 parts 10~20 parts of Radix Et Rhizoma Rhei, 10~20 parts of Radix Salviae Miltiorrhizaes, 40~70 parts of the Radixs Astragali, Flos Carthami.During preparation, earlier Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are added 5~10 times of amounts of water at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate, be concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 60%~80%, stir, airtight leaving standstill 24 hours filters, and filtrate recycling ethanol is standby 70 ℃~90 ℃ relative densities 1.25~1.28 to temperature; The Radix Astragali, Flos Carthami adds 5~10 times of amounts of water at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 60%~80%, stir, airtight leaving standstill 24 hours filters, filtrate recycling ethanol to temperature 70 ℃~90 ℃ relative densities 1.25~1.28, merge with last liquid, add water and be stirred to temperature, left standstill 24 hours, filter with two layers of gauze 30 ℃~50 ℃ relative densities 1.10~1.12, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 15~25 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.
The invention has the advantages that preparation technology is simple, low, the easy operating of cost, easy to use, be easy to carry, and the distal rectal administration, avoid oral drugs to pass through the first pass effect and the reaction of critically ill patient the intestines and stomach of liver, reduce effective ingredient and destroy, bioavailability has QI invigorating and consolidates than the oral medication height, the effect of dissipating stasis and purging turbidity is applicable to that the chronic renal failure patient of long-term prescription consolidates curative effect behind hospitalization.Modern study shows that medicine for treating chronic kidney failure can alleviate the carrying out property damage of the compensatory nephron of CRF rat and the carrying out property of renal function goes down, thereby delays the process of CRF, and does not have obvious toxic-side effects.Main result of study is as follows: (1) main pharmacodynamics pedant: add the method for eating adenine with excision 5/6 nephridial tissue and excision one side kidney, duplicate rat chronic renal failure (CRF) model respectively, all produce azotemia, anemia, hypoalbuminemia and the damage of excess of the kidney matter that carrying out property increases the weight of.(every day 24,16,4g crude drug/kg) are respectively to these two kinds continuous 5 weeks of rectally of dissimilar CRF models with medicine for treating chronic kidney failure.The result shows: medicine for treating chronic kidney failure has some improvement to the azotemia of CRF rat.With the model group comparison same period, the horizontal decrease to some degree of blood BUN, Cr, be reduced to significantly (P<0.05) of high dose group BUN, Hb gos up to some extent simultaneously, and ALB slightly improves, and the kidney coefficient is not had obvious influence.The result of histopathologic examination, treatment group and model group rat are compared, and remarkable reduction that compensatory glomerule hypertrophy obviously alleviates, the glomerule stage is hardened, tubular ectasia, epithelial cell damage and interstitial fibrosis all obviously alleviate, and the epithelial cell reparation increases.Show that medicine for treating chronic kidney failure can alleviate the carrying out property damage of the compensatory nephron of CRF rat and the carrying out property of renal function goes down, thereby delay the process of CRF.In addition, medicine for treating chronic kidney failure still has immunological enhancement and improves the effect of hemorheological property, can significantly improve the non-specific phagocytic function and the tardy property of the inductive mice of the DNCB skin hypersensitivity of mononuclear phagocyte under the mouse immune inhibition situation; Significantly reduce whole blood viscosity, plasma viscosity and the erythrocyte aggregation of blood stasis due to qi deficiency rat.(2) acute toxicity and irritation test: medicine for treating chronic kidney failure (extractum) 75g crude drug/kg (be a clinical consumption per day 90 times) three rectum (with colon) administration in 4 hours respectively, perhaps with the method to rat rectum (with colon) successive administration 7 days, the overt toxicity reaction all do not occur, none is only dead; Rectum and colon do not see that local excitation reaction and histopathology change.(3) long term toxicity test: medicine for treating chronic kidney failure with every day 50g crude drug/kg and 25g crude drug/kg to the continuous rectum of rat (with colon) administration four months, its outward appearance sign, behavioral activity, body weight gain, routine blood test, liver, renal function and 12 kinds of organ coefficients all do not have obvious influence, and main organs and peritoneum, tail vein there is no tangible pathological tissue morphological change.3 weeks of drug withdrawal, do not find tardy property toxic reaction, only in the time of four months, a little medicine pigmentation occurs in the local renal tubules,convoluted epithelial cell for examination group part rat, but do not see that being deposited pigment epithelium cell has obvious damage, and obviously reduce after the drug withdrawal in administration.(4) clinical research: carried out " the clinical prerun of medicine for treating chronic kidney failure treatment chronic renal failure " August in January, 1991 to nineteen ninety-five through Chengdu TCM Universities Affiliated Hospital and observed 21 examples altogether, 8 weeks of the course of treatment, produce effects 6 examples as a result, obvious effective rate is 28.57%; Effective 10 examples, effective percentage are 47.62%, and total effective rate is 76.19%.Do not find in the clinical prerun process that medicine for treating chronic kidney failure has any untoward reaction and obvious toxic-side effects.After JIUYUE in 1999 obtained national SDA Clinical Researches of New Drugs on the 7th, adopt multicenter, the randomized controlled test is a group leader unit with Nanfang Hospital of No.1 Military Medical Univ., the collaborative Hunan Province academy of traditional Chinese medicine, Shanxi Institute of Traditional Chinese Medicine, Anhui Chinese Medicine College Affiliated Hospital, five families of Henan Province Affiliated Hospital of the college of traditional Chinese medicine carry out the II clinical trial phase, observe 200 examples altogether, the result shows: 1. medicine for treating chronic kidney failure curative effect: produce effects 37%, and effective 40%, total effective rate 77%; 2. traditional Chinese medical science disease: recovery from illness 4%, produce effects 38%, effective 38%, invalid 6%, total effective rate 94%.
With specific embodiment the present invention is elaborated below:
Embodiment 1:
During preparation, earlier 10 parts of Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are added 7 times of amounts of water for 10 parts at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate, be concentrated into 90 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters, and filtrate recycling ethanol to 80 ℃ relative density 1.25~1.28 is standby; 70 parts of the Radixs Astragali, Flos Carthami adds 7 times of amounts of water for 10 parts at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into 90 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters filtrate recycling ethanol to 80 ℃ relative density 1.25~1.28, merge with last liquid, add water and be stirred to 40 ℃ of relative densities 1.10~1.12, left standstill 24 hours, filter with two layers of gauze, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 20 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.
Embodiment 2:
During preparation, earlier 15 parts of Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are added 7 times of amounts of water for 15 parts at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate, be concentrated into 85 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters, and filtrate recycling ethanol to 75 ℃ relative density 1.25~1.28 is standby; 55 parts of the Radixs Astragali, Flos Carthami adds 7 times of amounts of water for 15 parts at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into 85 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters filtrate recycling ethanol to 75 ℃ relative density 1.25~1.28, merge with last liquid, add water and be stirred to 35 ℃ of relative densities 1.10~1.12, left standstill 24 hours, filter with two layers of gauze, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 20 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.
Embodiment 3:
During preparation, earlier 20 parts of Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are added 7 times of amounts of water for 20 parts at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate, be concentrated into 95 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters, and filtrate recycling ethanol to 80 ℃ relative density 1.25~1.28 is standby; 40 parts of the Radixs Astragali, Flos Carthami adds 7 times of amounts of water for 20 parts at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into 95 ℃ of relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 70%, stir, airtight leaving standstill 24 hours filters filtrate recycling ethanol to 80 ℃ relative density 1.25~1.28, merge with last liquid, add water and be stirred to 45 ℃ of relative densities 1.10~1.12, left standstill 24 hours, filter with two layers of gauze, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 20 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.

Claims (2)

1, a kind of medicine for treating chronic kidney failure for the treatment of chronic renal failure, its raw material is by 10~20 parts of Radix Et Rhizoma Rhei, 10~20 parts of Radix Salviae Miltiorrhizaes, 40~70 parts of the Radixs Astragali, 10~20 parts of compositions of Flos Carthami, it is characterized in that it is to make by following preparation technology: during preparation, earlier with Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae adds 6~10 times of amounts of water at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate, be concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 60%~80%, stir, airtight leaving standstill 24 hours filters, and filtrate recycling ethanol is standby 70 ℃~90 ℃ relative densities 1.25~1.28 to temperature; The Radix Astragali, Flos Carthami adds 6~10 times of amounts of water at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 60%~70%, stir, airtight leaving standstill 24 hours filters, filtrate recycling ethanol to temperature 70 ℃~90 ℃ relative densities 1.25~1.28, merge with last liquid, add water and be stirred to temperature, left standstill 24 hours, filter with two layers of gauze 30 ℃~50 ℃ relative densities 1.10~1.12, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 15~25 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.
2, the preparation technology of medicine for treating chronic kidney failure as claimed in claim 1, when it is characterized in that preparing, earlier 10~20 parts of Radix Et Rhizoma Rhei, Radix Salviae Miltiorrhizae are added 6~10 times of amounts of water for 10~20 parts at every turn, soaked 30 minutes for the first time, decoct three times, boiled 30 minutes at every turn, filter, merging filtrate is concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put cold, add ethanol and make that to contain the alcohol amount be 60%~70%, stir airtight leaving standstill 24 hours, filter, filtrate recycling ethanol is standby 70~90 ℃ of relative densities 1.25~1.28 to temperature; 40~70 parts of the Radixs Astragali, Flos Carthami adds 6~10 times of amounts of water for 10~20 parts at every turn, soaks 30 minutes for the first time, decocts three times, boiled 30 minutes at every turn, and filtered merging filtrate, be concentrated into temperature 80 ℃~95 ℃ relative densities 1.20~1.23, put coldly, add ethanol and make that to contain the alcohol amount be 60%~70%, stir, airtight leaving standstill 24 hours filters, filtrate recycling ethanol to temperature 70 ℃~90 ℃ relative densities 1.25~1.28, merge with last liquid, add water and be stirred to temperature, left standstill 24 hours, filter with two layers of gauze 30 ℃~50 ℃ relative densities 1.10~1.12, remove the resin-like thing, be concentrated into the thick paste shape, measure moisture content and be controlled at 16%~20%, weigh, seven parts of taking polyethylene glycols-6000 and Polyethylene Glycol-1000 are three parts in addition, make substrate in 80 ℃~90 ℃ heat fused mixings,, get 15~25 parts of mixed-matrixes by the displacement value calculating of measuring and calculating, be incorporated in the thick paste of 80 ℃~90 ℃ of thawings, equality of temperature heats abundant mixing, in the impouring suppository mold, puts cold while hot, take out, promptly.
CNB200410039418XA 2004-02-11 2004-02-11 Medicine for treating chronic kidney failure and its preparing process Expired - Lifetime CN100389794C (en)

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CN102475762A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang oral liquid compound preparation for treating chronic renal failure and preparation method of Shenkang oral liquid compound preparation
CN102475760A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Kidney-health compound preparation for treating chronic renal failure and preparation method thereof
CN102475761A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang oral solid compound preparation for treating chronic renal failure and preparation method of Shenkang oral solid compound preparation
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CN102475758A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang tablet for treating chronic renal failure and preparation method of Shenkang tablet
CN102475763A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang dripping pill for treating chronic renal failure and preparation method thereof
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CN102475759A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang sodium chloride injection for treating chronic renal failure and preparation method of Shenkang sodium chloride injection
CN102475757A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Kidney-strengthening externally applied compound preparation for treating chronic renal failure and preparation method of compound preparation
CN102475755A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang aerosol for treating chronic renal failure and preparation method of Shenkang aerosol
CN102475753A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Kidney-health patch for treating chronic renal failure and preparation method thereof
CN102475764A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Preparation method of Shenkang injection

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CN102475762A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang oral liquid compound preparation for treating chronic renal failure and preparation method of Shenkang oral liquid compound preparation
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CN102475759A (en) * 2010-11-30 2012-05-30 西安世纪盛康药业有限公司 Shenkang sodium chloride injection for treating chronic renal failure and preparation method of Shenkang sodium chloride injection
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CN102475756B (en) * 2010-11-30 2014-03-19 西安世纪盛康药业有限公司 Shenkang injection compound preparation for treating chronic renal failure and preparation method of Shenkang injection compound preparation

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