CN101391009A - Medicine composition for treating diabetic nephropathy of deficiency of both qi and yin and accumulation of blood stasis and preparation method thereof - Google Patents
Medicine composition for treating diabetic nephropathy of deficiency of both qi and yin and accumulation of blood stasis and preparation method thereof Download PDFInfo
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- CN101391009A CN101391009A CNA2008102349168A CN200810234916A CN101391009A CN 101391009 A CN101391009 A CN 101391009A CN A2008102349168 A CNA2008102349168 A CN A2008102349168A CN 200810234916 A CN200810234916 A CN 200810234916A CN 101391009 A CN101391009 A CN 101391009A
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Abstract
Disclosed is a medicine combination which is derived from the Chinese traditional medicine for curing diabetes mellitus and nephropathy with deficiency of both qi and yin and stasis of blood retardarce. The medicine combination is composed of materials: Astragalus root, radix rehmanniae, rhubarb, yam, radix paeoniae alba, salvia miltiorrhiza, motherwort, red paeonia and scorpion, and is applied to curing the diabetes mellitus and nephropathy with deficiency of both qi and yin and stasis of blood retardarce; the medicine combination has the advantages of few medicine, but special medicine potency with security and effect, and the medicine can be made into various oral preparation.
Description
Technical field
The present invention relates to a kind of treatment deficiency of both QI and YIN that comes from Chinese medicine, the diabetic nephropathy drugs composition and method of making the same of stagnation of blood stasis.
Background technology
Diabetes are a kind of chronic diseases and since congenital and day after tomorrow insulin or absolute deficiency cause due to sugared concentration increases in the blood.Diabetes are a kind of lifelong diseases, are type ii diabetes (non-insulin-dependent diabetes mellitus) more than 90%, are mainly in the adult.Yet, more direct clinically harm diabetics health be not diabetes itself, but because of its complication that causes.Diabetic nephropathy is development and come on the basis of diabetes, it is microangiopathies along with the prolongation generation of diabetic duration, cause one of performance of organ injury, promptly to the infringement of renal function, its basic pathology is changed into the kidney hypertrophy, the high filtration of glomerule, urine protein, edema, hypertension can appear in glomerular basement membrane thickening, sclerosis etc. clinically, so that azotemia.The morbidity of 90% diabetics is arranged approximately after 2~10 years, it is unusual the glomerule histology to occur, has half patient to develop into diabetic nephropathy approximately.Diabetic nephropathy in early days (UAE20~200ug/min) has reversibility in various degree, but enter the clinical phase (UAE〉200ug/min or urine protein 0.5g/24h) continuous proteinuria to occur then irreversible.Discuss and in the recent period to the researching and analysing of diabetic nephropathy, the main pathogenesis of diabetic nephropathy is that the deficiency of YIN is scorching, says as " Linzheng Zhinan Yi three types of diabetes " according to the traditional Chinese medical science: " three eliminating masses, though the branch of upper, middle and lower is arranged, yin deficiency yang hyperactivity more in fact, Tianjin heat that dries up is excessive ".So it is forefathers generally get nourshing Yin and drynsessmoistening prescription method to the treatment of primary disease, how dirty and control from spleen (stomach), lung, kidney three.But " hyperactive fire wasting QI ", so diabetes still has the deficiency of vital energy for a long time, different pathogenesis such as yang deficiency, in a word, how empty the card of three types of diabetes is, and disease originally is to suffer from a deficiency of the kidney, and quenches one's thirst with the passing of time, visible deficiency of both QI and YIN, or deficiency of YIN affecting YANG or deficiency in both YIN and YANG.Kidney-yang deficiency then can not steam aquation gas, and it is entire unfavorable to open, and vital essence is solid, and kidney qi can not be received and take the photograph, thus visible frequent micturition, drinking one cup of water and running two cups of urine very then, cloudy urine, if kidney qi is lost void, QI failing to transform into body fluid then, the spleen renal failure loses, and water retention spreads unchecked skin and then becomes edema; It is weak that deficiency of both QI and YIN, the deficiency of vital energy are then transported blood, and the deficiency of YIN then blood is capable involved and abstruse, and so-called " disease is gone into deeply for a long time, and it is puckery that battalion defends trip ", the stasis of blood stagnates, and then old person can not go when going, and new person is when giving birth to and can not give birth to, the more empty and stasis of blood more of blood, more the stasis of blood is and more empty, and reciprocal causation hands over to be trouble mutually.Therefore, from the viewpoint analysis of the traditional Chinese medical science, the treatment diabetic nephropathy is still needed and logical is mended parallelly, and based on reinforcing, blood circulation promoting and blood stasis dispelling is auxilliary, or both lay equal stress on, in supplementing QI and nourishing YIN, assistant with invigorate blood circulation, methods such as blood stasis dispelling, collateral dredging.
Summary of the invention
The technical problem to be solved in the present invention is a kind of treatment deficiency of both QI and YIN of research, the diabetic nephropathy drugs compositions of stagnation of blood stasis, and with supplementing QI and nourishing YIN, disperse blood stasis and dredge collateral, and flavour of a drug are few and the efficacy of a drug is special, and toxic and side effects is littler, safe and effective than chemical medicine.But the present invention also comprises the preparation method of described pharmaceutical composition commercial Application.
The invention provides following technical proposals for addressing the above problem.
A kind of treatment deficiency of both QI and YIN, the diabetic nephropathy drugs compositions of stagnation of blood stasis is characterized in that being made by the following raw materials in part by weight medicine basically: Radix Astragali 8-12 part, Radix Rehmanniae 3-7 part, Radix Et Rhizoma Rhei 2-6 part, Rhizoma Dioscoreae 6-10 part, Radix Paeoniae Alba 3-7 part, Radix Salviae Miltiorrhizae 3-7 part, Herba Leonuri 6-10 part, Radix Paeoniae Rubra 3-7 part, Scorpio 1-3 part.The consumption of preferred feedstock medicine is counted by weight: Radix Astragali 9-11 part, Radix Rehmanniae 4-6 part, Radix Et Rhizoma Rhei 3-5 part, Rhizoma Dioscoreae 7-9 part, Radix Paeoniae Alba 4-6 part, Radix Salviae Miltiorrhizae 4-6 part, Herba Leonuri 7-9 part, Radix Paeoniae Rubra 4-6 part, Scorpio 1-3 part.
Described preparation of drug combination method comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, carry out percolation after the alcohol dipping, reclaim ethanol and become extractum;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavor alcohol reflux filter, and filtrate recycling ethanol becomes extractum;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae water decoct, and filter, and concentrate, and add above-mentioned two parts of extractum, fully stir evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, with the dry powder mixing, gets the active component of pharmaceutical composition of the present invention.
Preferred pharmaceutical composition, the consumption of its crude drug is counted by weight: Radix Astragali 9-11 part, Radix Rehmanniae 4-6 part, Radix Et Rhizoma Rhei 3-5 part, Rhizoma Dioscoreae 7-9 part, Radix Paeoniae Alba 4-6 part, Radix Salviae Miltiorrhizae 4-6 part, Herba Leonuri 7-9 part, Radix Paeoniae Rubra 4-6 part, Scorpio 1-3 part.
Most preferred pharmaceutical composition, the consumption of its crude drug is counted by weight: 10 parts of the Radixs Astragali, 5 parts of Radix Rehmanniae, 4 parts of Radix Et Rhizoma Rhei, 8 parts of Rhizoma Dioscoreaes, 5 parts of the Radix Paeoniae Albas, 5 parts of Radix Salviae Miltiorrhizaes, 8 parts of Herba Leonuris, 5 parts of Radix Paeoniae Rubra, 1 part of Scorpio.
Pharmaceutical composition of the present invention contains pharmaceutically acceptable oral formulations adjuvant.
Aforementioned preparation of drug combination method comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, carry out percolation after 70% alcohol dipping with PH9, reclaim ethanol and become extractum;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavors filter with 6 times of amount 80% alcohol reflux, and filtrate recycling ethanol becomes extractum;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae decoct with 7 times of water gagings, filter, and concentrate, and add above-mentioned two parts of extractum, fully stir evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, with the dry powder mixing, gets the active component of pharmaceutical composition of the present invention.
Most preferred preparation of drug combination method comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, make solvent with 70% ethanol of PH9, flood and carry out percolation after 48 hours, gathering speed is the 20ml/ branch, collects 10 times of amounts, reclaims ethanol and becomes extractum, about 1.10 (the 50 ℃ of surveys) of relative density;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavors were measured 80% alcohol reflux 2.5 hours with 6 times, filtered, and filtrate recycling ethanol becomes extractum, about 1.10 (the 50 ℃ of surveys) of relative density;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae decoct three times with 7 times of water gagings, and each 0.5 hour, filter, filtrate merges, and is concentrated into about 1.10 (the 50 ℃ of surveys) of relative density, adds above-mentioned two parts of extractum, fully stirs evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, and with 1 part of mixing of dry powder, it is an amount of to add 0.5 part of beta-schardinger dextrin-, 0.5 part in dextrin and sweeting agent, gets the active component of pharmaceutical composition of the present invention.
Pharmaceutical composition of the present invention is made up of 9 flavor Chinese medicines such as the Radix Astragali, Radix Rehmanniae.Radix Astragali sweet in the mouth is warm in nature in the side, can QI invigorating tonifying deficiency, the sweet Han Zhirun of the Radix Rehmanniae, abnormal smells from the patient is all thick, property is heavy and fall, Kidney-Yin in the nourishing kidney, two medicines match and are monarch, the lifting same usefulness of negative and positive that is harmonious, the QI invigorating nourishing YIN has sun to give birth to the moon and answers wonderful that sexual intercourse executes.Rhizoma Dioscoreae is sweet flat, and kind boosting qi and nourishing yin quenches the thirst, principal drug assistance Radix Astragali tonification gas, the merit of Radix Rehmanniae YIN nourishing and the production of body fluid promoting; The Radix Paeoniae Alba is good at the yin fluid astringing easing the affected liver that nourishes blood, and can help the moon of Radix Rehmanniae nourishing the liver and kidney; The Radix Et Rhizoma Rhei bitter cold is purged heat to fall and is let out, and share the pathogenic fire reducing kidney nourishing water with the Radix Rehmanniae, promoting the production of body fluid to quench thirst, so but Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Et Rhizoma Rhei principal drug assistance benefit are fostered the spirit of nobility Yin and promoting production of body liquid, be ministerial drug.The Radix Salviae Miltiorrhizae bitter in the mouth is slightly cold, and goes into the Liver Channel blood system, kind activating blood circulation to dissipate blood stasis and dredge the collateral, the Herba Leonuri toil is slightly cold, the sharp detumescence of function promoting blood flow to regulate menstruation, the Radix Paeoniae Rubra bitter in the mouth is slightly cold, the kind heresy of loosing of merit, stagnating in the promoting the circulation of blood, Herba Leonuri, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra three flavor blood circulation promoting and blood stasis dispelling, push away Chen Zhixin,, assistant is controlled the stagnation of QI-blood of quenching one's thirst and with the passing of time causing, strongly fragrant disease in the turbid poison.Scorpio is hot flat, returns Liver Channel, and merit is arrogated to oneself removing obstruction in the collateral to relieve pain, and we get its property of walking to scurry collateral dredging, with Herba Leonuri, Radix Salviae Miltiorrhizae, Radix Paeoniae Rubra etc. be adjuvant drug altogether.
The flavour of a drug of pharmaceutical composition of the present invention are few, thereby not only the efficacy of a drug is special, and are beneficial to and are prepared into modernized preparation, also are beneficial to the quality control of suitability for industrialized production.The toxic and side effects of pharmaceutical composition of the present invention is littler, safe and effective than chemical medicine.
Preparation of drug combination method of the present invention is suitable for commercial Application.Described pharmaceutical composition comprises the various oral formulations that pharmaceutically are suitable for, for example granule, capsule, tablet.The method that the present invention prepares various oral formulations is common method pharmaceutically, as conventional tabletting, granulation, encapsulated etc.The adjuvant of the various oral formulations of preparation that the present invention was suitable for has beta-schardinger dextrin-, magnesium stearate, but those of ordinary skills are the general knowledge conventional adjuvant hyprolose of also drug of choice allusion quotation as required routinely, carboxymethyl starch sodium, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose; Lactose, microcrystalline Cellulose, dextrin, starch, calcium phosphate; Pregelatinized Starch, polyvidone, sodium carboxymethyl cellulose, hypromellose; Pulvis Talci, magnesium stearate, micropowder silica gel, hydrogenated vegetable oil; Sodium lauryl sulphate, Tween 80; Hypromellose, ethyl cellulose etc.
The specific embodiment
Below further set forth the beneficial effect of pharmaceutical composition of the present invention by testing example, these are tested examples and have comprised that pharmacodynamics test and clinical observation on the therapeutic effect test.
The raw materials used medicine Radix Astragali of pharmaceutical composition of the present invention, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are commercially available, and meet standard under 2005 editions pharmacopeia continuous items.
The used oral formulations adjuvant of pharmaceutical composition of the present invention is commercially available, and meets standard under the pharmacopeia continuous item.
The pharmacodynamics result of study showed that this medicine of suitable dosage can significantly suppress the discharge of animal pattern urine protein before pharmaceutical composition of the present invention was clinical, kept the plasma albumin normal level, can alleviate the kidney pathological change, reduced the increase of renal glomerular basement membrane thickness; Animal pattern to insulin resistant still has the effect of the insulin for reducing blood sugar of assistance.Show that this medicine has certain therapeutical effect to diabetic nephropathy.
Acute experiment shows: the maximum tolerated dose of the oral pharmaceutical composition extractum of the present invention of mice is greater than 236.8g/kg (in the crude drug amount); The LD of mouse peritoneal injection pharmaceutical composition extractum of the present invention
50Be 41.1 (36.5-46.3) g/kg (in the crude drug amount).
Long term toxicity test: by the requirement of " new Chinese medicine toxicologic study guide ", choose 120 of SD rats, first 1 week of breeding observing, be divided into 4 groups by body weight then, 30 every group, male and female half and half.If high, medium and low three dosage groups give pharmaceutical composition 90.0g/kg of the present invention, 45.0g/kg, 22.5g/kg (in the crude drug amount, down together) respectively, are blank solvent matched group with distilled water in addition.Continuous irrigation stomach 6 months was irritated stomach weekly 6 days, irritated stomach every day once.It is 6.0g/ml that high dose is made into concentration, in, low two dosage two-fold dilution successively, rat administration volume is 1.5ml/100g, matched group is given the equivalent distilled water.The result shows that dosage 45.0,22.5g/kg are safe dose.
Claims (7)
1. treat deficiency of both QI and YIN for one kind, the diabetic nephropathy drugs compositions of stagnation of blood stasis is characterized in that being made by the following raw materials in part by weight medicine: Radix Astragali 8-12 part, Radix Rehmanniae 3-7 part, Radix Et Rhizoma Rhei 2-6 part, Rhizoma Dioscoreae 6-10 part, Radix Paeoniae Alba 3-7 part, Radix Salviae Miltiorrhizae 3-7 part, Herba Leonuri 6-10 part, Radix Paeoniae Rubra 3-7 part, Scorpio 1-3 part.
2. the medicine of claim 1, wherein the consumption of crude drug is: Radix Astragali 9-11 part, Radix Rehmanniae 4-6 part, Radix Et Rhizoma Rhei 3-5 part, Rhizoma Dioscoreae 7-9 part, Radix Paeoniae Alba 4-6 part, Radix Salviae Miltiorrhizae 4-6 part, Herba Leonuri 7-9 part, Radix Paeoniae Rubra 4-6 part, Scorpio 1-3 part.
3. the pharmaceutical composition of claim 2, wherein the consumption of crude drug is: 10 parts of the Radixs Astragali, 5 parts of Radix Rehmanniae, 4 parts of Radix Et Rhizoma Rhei, 8 parts of Rhizoma Dioscoreaes, 5 parts of the Radix Paeoniae Albas, 5 parts of Radix Salviae Miltiorrhizaes, 8 parts of Herba Leonuris, 5 parts of Radix Paeoniae Rubra, 1 part of Scorpio.
4. the pharmaceutical composition of claim 1-3 is characterized in that described pharmaceutical composition contains pharmaceutically acceptable oral formulations adjuvant.
5. the preparation of drug combination method of claim 1-3 comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, carry out percolation after the alcohol dipping, reclaim ethanol and become extractum;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavor alcohol reflux filter, and filtrate recycling ethanol becomes extractum;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae water decoct, and filter, and concentrate, and add above-mentioned two parts of extractum, fully stir evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, with the dry powder mixing, gets the active component of pharmaceutical composition of the present invention.
6. the preparation of drug combination method of claim 1-3 comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, carry out percolation after 70% alcohol dipping with PH9, reclaim ethanol and become extractum;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavors filter with 6 times of amount 80% alcohol reflux, and filtrate recycling ethanol becomes extractum;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae decoct with 7 times of water gagings, filter, and concentrate, and add above-mentioned two parts of extractum, fully stir evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, with the dry powder mixing, gets the active component of pharmaceutical composition of the present invention.
7. the preparation of drug combination method of claim 6 comprises the following steps:
A) the weighting raw materials Radix Astragali, Radix Rehmanniae, Radix Et Rhizoma Rhei, Rhizoma Dioscoreae, the Radix Paeoniae Alba, Radix Salviae Miltiorrhizae, Herba Leonuri, Radix Paeoniae Rubra, Scorpio are standby;
B) Radix Et Rhizoma Rhei, Radix Paeoniae Rubra, the Radix Paeoniae Alba three flavors are ground into coarse powder, make solvent with 70% ethanol of PH9, flood and carry out percolation after 48 hours, gathering speed is the 20ml/ branch, collects 10 times of amounts, reclaims ethanol and becomes extractum, about 1.10 (the 50 ℃ of surveys) of relative density;
C) Radix Astragali, Radix Salviae Miltiorrhizae two flavors were measured 80% alcohol reflux 2.5 hours with 6 times, filtered, and filtrate recycling ethanol becomes extractum, about 1.10 (the 50 ℃ of surveys) of relative density;
D) Radix Astragali, Radix Salviae Miltiorrhizae decoction dregs and Herba Leonuri, Rhizoma Dioscoreae, Radix Rehmanniae decoct three times with 7 times of water gagings, and each 0.5 hour, filter, filtrate merges, and is concentrated into about 1.10 (the 50 ℃ of surveys) of relative density, adds above-mentioned two parts of extractum, fully stirs evenly, and spray drying gets dry powder;
E) Scorpio is ground into fine powder, and with 1 part of mixing of dry powder, it is an amount of to add 0.5 part of beta-schardinger dextrin-, 0.5 part in dextrin and sweeting agent, gets the active component of pharmaceutical composition of the present invention.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102293855A (en) * | 2010-06-22 | 2011-12-28 | 天津市石天药业有限责任公司 | Chinese medicinal composition for treating speech and kidney deficiency diabetic nephropathy, and preparation method and application thereof |
CN109078150A (en) * | 2018-11-02 | 2018-12-25 | 太极集团有限公司 | A kind of composition of Chinese materia medica preparation and its preparation method and application for treating diabetes |
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2008
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN102293855A (en) * | 2010-06-22 | 2011-12-28 | 天津市石天药业有限责任公司 | Chinese medicinal composition for treating speech and kidney deficiency diabetic nephropathy, and preparation method and application thereof |
CN109078150A (en) * | 2018-11-02 | 2018-12-25 | 太极集团有限公司 | A kind of composition of Chinese materia medica preparation and its preparation method and application for treating diabetes |
CN109078150B (en) * | 2018-11-02 | 2022-02-18 | 太极集团有限公司 | Traditional Chinese medicine preparation composition for treating diabetes and preparation method and application thereof |
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