CN104147429A - Drug preparation for preventing and treating kidney failure and preparation method of drug preparation - Google Patents
Drug preparation for preventing and treating kidney failure and preparation method of drug preparation Download PDFInfo
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- CN104147429A CN104147429A CN201410433885.4A CN201410433885A CN104147429A CN 104147429 A CN104147429 A CN 104147429A CN 201410433885 A CN201410433885 A CN 201410433885A CN 104147429 A CN104147429 A CN 104147429A
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Abstract
The invention discloses a drug preparation for preventing and treating kidney failure and a preparation method of the drug preparation, and belongs to the technical field of medicines. The drug preparation is prepared from active ingredients and pharmaceutically acceptable auxiliary materials, wherein the active ingredients are prepared by performing ethanol reflux extraction on the following Chinese herb raw materials in parts by weight: 30-80 parts of bitter willow roots and 100-200 parts of reed rhizome. According to the drug preparation, the urine protein excretion and the blood BUN and Cr level can be reduced, so that the kidney function harm is prevented and improved and the purpose of preventing and treating the kidney failure is achieved.
Description
Technical field
The invention belongs to medical technical field, in particular to a kind of pharmaceutical preparation that prevents and treats renal failure and preparation method thereof.
Background technology
Chronic kidney disease (Chronic Kidney Disease, CKD) comprise clinically chronic glomerulonephritis, nephrotic syndrome, membranous nephropathy, diabetic nephropathy, hypertensive nephropathy and various Secondary cases nephropathy etc., have sickness rate high, suffer from the feature that angiopathy prevalence is high, case fatality rate is high of making up one's mind, society is not high to the awareness of chronic kidney disease in addition, control rate is low, the awareness of suffering from the angiopathy of making up one's mind is low, has become at present the open health problem in the whole world.Medically mainly whether suffer from CKD:(1 from the diagnosis of two aspects) kidney injury (showing kidney structure and function abnormal) >=3 month, can have or decline without glomerular filtration rate (GRF); (2) glomerular filtration rate (GFR) < 60ml/min/1.73m2, time >=3 month, have or not damaged foundation.Chronic kidney disease develops into middle and late stage, just likely develops into chronic kidney hypofunction, or even uremia, thereby therefore serious harm patient's health need to prevent and treat timely and effectively.
At present, to the treatment of chronic renal failure, Western medicine has love Seat (medicinal carbon); The shortcomings such as although Western medicine has certain curative effect, toxic and side effects is large, relapse rate height, as liked, Seat is effectively in the early stage, but the later stage can aggravate disease on the contrary, serum creatinine, blood urea nitrogen are high, occur unmanageable symptom, finally can develop into uremia.Chinese medicine has distinctive feature aspect preventing and curing diseases.Chronic renal failure belongs to the category such as edema, the difficulty in urination, obstruction and rejection in motherland's medical science, and pathogenesis is deficiency in origin and excess in superficiality, controls when strengthening vital QI to eliminate pathogenic factors, giving consideration to both the incidental and fundamental.Research shows, Chronic Renal Functional Failure with Chinese Traditional Medicine exhausts early, mid-term patient can effectively stop or delay the carrying out property deterioration of renal function, the development of delaying chronic kidney exhaustion.From Chinese medicine, find active strong, effect is lasting, the alleviating or the novel drugs of delaying chronic kidney exhaustion progress of low toxicity, treatment chronic renal failure exploitation is had great significance.
Summary of the invention
In view of the deficiencies in the prior art, the object of the present invention is to provide Chinese medicine preparation of a kind of novel control renal failure and preparation method thereof.This medicine is prepared from as raw material using Radix Salicis Purpureae and Rhizoma Phragmitis, can prevent and improve renal function injury, reaches the object of control renal failure.
In order to realize object of the present invention, inventor, by furtheing investigate on the basis of folk remedy and persistent exploration, has finally obtained following technical scheme:
A kind of pharmaceutical preparation that prevents and treats renal failure, be prepared from by acceptable adjuvant on active component and pharmaceutics, wherein said active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: Radix Salicis Purpureae 30-80 part, Rhizoma Phragmitis 100-200 part.
Preferably, prevent and treat as mentioned above the pharmaceutical preparation of renal failure, wherein said active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: Radix Salicis Purpureae 42-60 part, Rhizoma Phragmitis 135-170 part.
Further preferably, prevent and treat as mentioned above the pharmaceutical preparation of renal failure, wherein said active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: 50 parts of Radix Salicis Purpureaes, 150 parts of Rhizoma Phragmitiss.
The pharmaceutical preparation of control renal failure of the present invention is solid orally ingestible, comprises tablet, capsule, granule.According to the common process of formulation art, those skilled in the art is easy to adjuvant available on the active component of above-mentioned Chinese medicine extract composition and pharmaceutics to be prepared into conventional solid orally ingestible, as granule, tablet, capsule.Wherein, on pharmaceutics, available adjuvant comprises filler, disintegrating agent, binding agent, correctives, lubricant etc.
The pharmaceutical preparation of control renal failure of the present invention can be selected and is prepared as follows technique: take Radix Salicis Purpureae and Rhizoma Phragmitis, pulverize, add alcoholic solution, heating and refluxing extraction, filters, and decompression recycling ethanol is extremely without alcohol taste, continue concentrated rear lyophilizing, pulverize, obtain Chinese medicine extract; Add filler, disintegrating agent and binding agent to mix rear soft material processed Chinese medicine extract, cross 16-32 mesh sieve wet granular processed, wet granular is fully dry in 45-60 DEG C, after dry gained granule and lubricant are mixed granule, or dry gained granule and lubricant are mixed to rear tabletting or filled capsules shell, obtain tablet or capsule.
Further, in order to improve offending taste in oral formulations, in pharmaceutical preparation of the present invention, can also add appropriate correctives, or on label, wrap up sugarcoating layer.
Amycin tail vein injection is to manufacture one of kidney of rats failure model common method.Amycin causes rat chronic injury of kidney, method is easy to be controlled, it is generally acknowledged through 1 property injection amycin 7.5mg/kg of tail vein, in experiment 3 days, rat shows as hydrosarca, ascites, High-grade Proteinuria, hypoalbuminemia, under light microscopic, see that glomerule changes slight, rarely seen glomerule and endotheliocyte mild swelling, bowman's capsule chamber narrows, renal cells cavity sample becomes, in tube chamber, there is protein cast, the rarely seen kidney interstitial of immunofluorescence tunica intima has a little deposition, under Electronic Speculum, see glomerular capillary endothelium cytopathy, podocyte cavity sample becomes, mitochondrial swelling, along with the increasing of dosage, the prolongation of time, the infringement of renal function increases the weight of gradually, form typical renal failure animal model.The inventor adopts amycin tail vein injection to manufacture kidney of rats failure model, after modeling success, giving Chinese medicine extract prepared by the present invention treats, result shows that it can reduce urinary protein excretion, reduce blood BUN, Scr level, can make renal function injury alleviate, this is indicating that the Chinese medicine extract of preparing using the present invention can prevent and improve renal function injury as active component, thereby reaches the symptom of control renal failure.Based on above result of study, the present invention also provides a kind of pharmaceutical applications, that is: the purposes of the traditional Chinese medicinal material raw materials compositions being made up of Radix Salicis Purpureae and Rhizoma Phragmitis in preparation control renal failure medicine.
Compared with prior art, active component in pharmaceutical preparation of the present invention is prepared from as raw material using Radix Salicis Purpureae and Rhizoma Phragmitis, and Renal Failure Patients can reduce urinary protein excretion after taking, and reduces blood BUN, Cr level, thereby prevent and improve renal function injury, reaching the object of control renal failure.In addition, preparation method of the present invention is simple, and cost is low, for patient provides a kind of economy, effective ways for the treatment of chronic renal failure.
Detailed description of the invention
Be below the concrete preparation example of pharmaceutical preparation of the present invention and the effect test example of Chinese medicine extract, technical scheme of the present invention and technique effect are further explained and are described.It should be noted that, the traditional Chinese medicinal material raw materials that Chinese medicine preparation of the present invention adopted in the preparation has following source: Radix Salicis Purpureae is selected the dry root of Salicaceous Plants purple osier Salix sinopurpurea C.Wang et Ch.Y.Yang.; Rhizoma Phragmitis is selected the dry rhizome of grass phragmites communis Phragmites communis Trin..
the preparation of embodiment 1 Chinese medicine extract
Take Radix Salicis Purpureae 0.5kg and Rhizoma Phragmitis 1.5kg, mix, with FW135 type Chinese medicine grinder pulverizing, sieve, add 80%(v/v) alcoholic solution 8L, heating and refluxing extraction, each 2h, repeat altogether to extract merge extractive liquid,, 4 layers of filtered through gauze 3 times, decompression recycling ethanol is extremely without alcohol taste, continue to be condensed into thick paste, then lyophilization, pulverizes, cross 100 mesh sieves, obtain extract.
the preparation of embodiment 2 coated tablets
Prescription: Chinese medicine extract 100g, dextrin 100g, mannitol 50g, starch slurry are appropriate, carboxymethyl starch sodium 20g, magnesium stearate 3g.
Preparation technology: take Chinese medicine extract 100g prepared by embodiment 1, and the dextrin 100g of recipe quantity, mannitol 50g and carboxymethyl starch sodium 20g, cross respectively 100 mesh sieves, mix, add the rear soft material processed of appropriate amount of starch slurry, cross 20 mesh sieve wet granular processed, wet granular is fully dried in 55 DEG C, obtain dry granule; Dry gained granule and magnesium stearate are mixed to 1000 of rear pressures, then sugar coating.
the preparation of embodiment 3 capsules
Prescription: Chinese medicine extract 100g, dextrin 100g, mannitol 50g, starch slurry are appropriate, carboxymethyl starch sodium 20g, Pulvis Talci 2.5g.
Preparation technology: take Chinese medicine extract 100g prepared by embodiment 1, and the dextrin 100g of recipe quantity, mannitol 50g and carboxymethyl starch sodium 20g, cross respectively 100 mesh sieves, mix, add the rear soft material processed of appropriate amount of starch slurry, cross 20 mesh sieve wet granular processed, wet granular is fully dried in 55 DEG C, obtain dry granule; Dry gained granule and Pulvis Talci are mixed to rear encapsulated shell.
the treatment research of embodiment 4 Chinese medicine extract of the present invention to kidney of rats failure model
48 of male wistar rats, weight (200 ± 20) g, gives rat special solid feedstuff, freely drinks water, and adaptability is raised after 1 week and is divided at random following four groups: Normal group, model control group, extract high and low dose group, 12 every group.Except Normal group, its excess-three group rat adopts amycin to manufacture Renal Failure Model as follows: with 0.2% amycin solution, and by 7.5mg/kg tail vein injection, interval 7d, same method and dosage are administered once again.Give the activity of observing rat after amycin every day, ingest, the situation such as excretion.After administration for the second time when 7d, blood 1-2ml is got in all rat tail end 1/3 place dockings, anticoagulant heparin, censorship, mensuration serum creatinine (Scr), blood urea nitrogen (BUN) compare, when Scr, the BUN compared with normal matched group of model control group and extract group rat obviously raise, prompting modeling success.
Giving after amycin modeling success, taking rat weight as benchmark, extract high and low dose group respectively gavage gives Chinese medicine extract 1.32g/kg, 0.66g/kg prepared by the embodiment of the present invention 1, Normal group and model control group gavage give normal saline 1ml/100g, the equal administration of each group rat 2 weeks, 1 time/d.All rats all freely absorb normal diet and tap water.Observe all rats mobility, ingest, excretion, death condition; In the time giving amycin 7d the 1st time, rat is fed separately in metabolic cage, collect 24h urine, measure 24h urine protein quantitation; After 2 weeks, all rat broken ends are got to blood at gastric infusion, measure Scr, BUN by automatic biochemical analyzer and compare.
When amycin injection 7d, model control group and extract high and low dose group rat obviously occur that mobility is poor, minimizings of ingesting, the back of a bow, chaeta first rise, and pubes humidity, loses weight, and drains performance such as minimizing grade; Normal group does not change.At the 2nd injection amycin, after 1 week, model control group and the above-mentioned performance of extract high and low dose group are more obvious, dead 3 of model control group.In addition, result of the test by table 1 can be found out, four groups of rat Scr, BUN, the comparison of 24h urine protein quantitation, model control group blood Scr, BUN, urine protein quantitation raise the most obvious, and extract high and low dose group Scr, BUN, urine protein quantitation obviously decline compared with model control group.
The each group of table 1 rat Scr, BUN, the comparison of 24h urine protein quantitation
Model control group and Normal group comparison,
* p< 0.05;
* p< 0.01;
Extract group and model control group comparison,
$ p< 0.05,
$$ p< 0.01.
Claims (6)
1. prevent and treat the pharmaceutical preparation of renal failure for one kind, be prepared from by acceptable adjuvant on active component and pharmaceutics, it is characterized in that: described active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: Radix Salicis Purpureae 30-80 part, Rhizoma Phragmitis 100-200 part.
2. the pharmaceutical preparation of control renal failure according to claim 1, is characterized in that: described active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: Radix Salicis Purpureae 42-60 part, Rhizoma Phragmitis 135-170 part.
3. the pharmaceutical preparation of control renal failure according to claim 2, is characterized in that: described active component is prepared from through alcoholic solution reflux, extract, by the traditional Chinese medicinal material raw materials of following weight portion: 50 parts of Radix Salicis Purpureaes, 150 parts of Rhizoma Phragmitiss.
4. according to the pharmaceutical preparation that prevents and treats renal failure described in claim 1-3 any one, it is characterized in that: described pharmaceutical preparation is tablet, capsule or granule.
5. one kind according to the preparation method of preventing and treating the pharmaceutical preparation of renal failure described in claim 1-3 any one, it is characterized in that the method comprises the steps: to take Radix Salicis Purpureae and Rhizoma Phragmitis, pulverize, add alcoholic solution, heating and refluxing extraction, filters, decompression recycling ethanol is extremely without alcohol taste, continue concentrated rear lyophilizing, pulverize, obtain Chinese medicine extract; Add filler, disintegrating agent and binding agent to mix rear soft material processed Chinese medicine extract, cross 16-32 mesh sieve wet granular processed, wet granular is fully dry in 45-60 DEG C, after dry gained granule and lubricant are mixed granule, or dry gained granule and lubricant are mixed to rear tabletting or filled capsules shell, obtain tablet or capsule.
6. the purposes of the traditional Chinese medicinal material raw materials compositions being formed by Radix Salicis Purpureae and Rhizoma Phragmitis in preparation control renal failure medicine.
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Citations (2)
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CN101428120A (en) * | 2007-11-06 | 2009-05-13 | 天津天士力制药股份有限公司 | Effective component of phragmites communis trin, preparation method and use thereof |
WO2012159107A1 (en) * | 2011-05-19 | 2012-11-22 | Rhode Island Hospital | Inhibition of renal fibrosis |
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Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN101428120A (en) * | 2007-11-06 | 2009-05-13 | 天津天士力制药股份有限公司 | Effective component of phragmites communis trin, preparation method and use thereof |
WO2012159107A1 (en) * | 2011-05-19 | 2012-11-22 | Rhode Island Hospital | Inhibition of renal fibrosis |
Non-Patent Citations (5)
Title |
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吴玉生等: "《常见病中医处方手册》", 31 August 2011, 化学工业出版社 * |
汪美芳: "芦根中阿魏酸的提取、分离和检测", 《池州师专学报》 * |
金锋: "《中华食疗大观》", 30 April 1999, 中国青年出版社 * |
陈翔等: "《儿科药物手册》", 31 July 2002, 科学出版社 * |
颜建军等: "阿魏酸钠治疗早期糖尿病肾病的初步临床研究", 《中国中西医结合肾病杂志》 * |
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Inventor after: Liu Qian Inventor after: Fan Guangming Inventor before: Liu Xuejian |
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Application publication date: 20141119 |