CN104971102A - Drug composition for treating diabetic nephropathy, preparation method and uses thereof - Google Patents

Drug composition for treating diabetic nephropathy, preparation method and uses thereof Download PDF

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CN104971102A
CN104971102A CN201510151713.2A CN201510151713A CN104971102A CN 104971102 A CN104971102 A CN 104971102A CN 201510151713 A CN201510151713 A CN 201510151713A CN 104971102 A CN104971102 A CN 104971102A
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parts
crude drug
diabetic nephropathy
pharmaceutical composition
semen
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CN104971102B (en
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钟森
涂翔
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Teaching Hospital of Chengdu University of TCM
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Abstract

The invention belongs to the field of medicine, and particularly relates to a drug composition for treating diabetic nephropathy, a preparation method and uses thereof. The technical problem solved by the present invention is to provide a completely-new drug composition for treating diabetic nephropathy. According to the drug composition of the present invention, caulis sinomenii, astragalus complanatus, milkvetch root and coptis chinensis are adopted as main bulk drugs to achieve the diabetic nephropathy treating purpose; and rosa laevigata michx and euryale ferox can further be added so as to further improve the treatment effect of the drug composition. According to the present invention, the most typical symptom of the diabetic nephropathy is nodular glomerulosclerosis and mainly the excretion amount of the urinary albumin is adopted as the diagnostic indicator, and after patients take the drug composition, the proteinuria excretion is significantly reduced, the 24 h urine total protein level and the urinary albumin excretion rate are reduced, the urinary albumin/creatinine ratio is reduced, the serum creatinine level is lowered, the life quality of patients is significantly improved, and the progress of the diabetic nephropathy disease is delayed.

Description

Pharmaceutical composition for the treatment of diabetic nephropathy and its production and use
Technical field
The invention belongs to field of medicaments, be specifically related to pharmaceutical composition for the treatment of diabetic nephropathy and its production and use.
Background technology
Diabetic nephropathy is one of Diabetic microvascular complication, is the important death cause of diabetics.The diabetes nephropathy of broad sense comprises infection and vascular lesions.Infection has pyelonephritis and necrosis of renal papillae.Vascular lesions divides blood capillary and macroangiopathy, and macroangiopathy comprises renal arteriosclerosis (involving trunk and branch) and renal arteriolosclerosis (involving people's ball and efferent glomerular arteriole).Microangiopathies refers to glomerular sclerosis, and point nodositas, exudative and diffusivity three kinds, three can merge existence separately, and in above-mentioned change, most typical is nodular glomerulosclerosis.The diabetic nephropathy that we say usually is glomerular sclerosis.Diabetic nephropathy there is no specific short.Treatment principle is: 1. strict glycemic control, makes blood glucose close to normal level as far as possible, prevents and delays diabetic nephropathy occurs; 2. the speed of renal hypofunction is delayed; 3. dialysis treatment and renal transplantation.
The document utilizing Chinese medical theory to treat diabetic nephropathy can be seen in " summary of experience of Li Xiaojuan Experience in Treating diabetic nephropathy " [Han Yunping, Liaoning medical pharmaceutical university, master thesis, 20090401] " a flat Experience in Treating diabetic nephropathy experience " [mountain peak, Liaoning medical pharmaceutical university, master thesis, 20100401].
The present invention for provide a kind of completely newly, the significant medicine of clear curative effect is used for the treatment of diabetic nephropathy.
Summary of the invention
Technical problem solved by the invention is to provide a kind of brand-new pharmaceutical composition and is used for the treatment of diabetic nephropathy.
Pharmaceutical composition of the present invention is with Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, and Rhizoma Coptidis is primary raw material medicine, and reach the object for the treatment of diabetic nephropathy, pharmaceutical composition of the present invention can also add Fructus Rosae Laevigatae, and Semen Euryales is to promote the curative effect of pharmaceutical composition further.
1) pharmaceutical composition of the present invention is with Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, when Rhizoma Coptidis is crude drug:
Crude drug weight proportion is as follows: Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part.
Crude drug preferred weight proportioning is as follows: Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part.
Crude drug further preferred weight proportioning is as follows: Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part.
Crude drug most preferably weight proportion is as follows: Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts.
2) pharmaceutical composition of the present invention is with Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, Rhizoma Coptidis, Fructus Rosae Laevigatae, when Semen Euryales is crude drug:
Crude drug weight proportion is as follows: Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part, Fructus Rosae Laevigatae 5-60 part, Semen Euryales 5-60 part.
Crude drug preferred weight proportioning is as follows: Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part, Fructus Rosae Laevigatae 5-30 part, Semen Euryales 5-30 part.
Crude drug further preferred weight proportioning is as follows: Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part, Fructus Rosae Laevigatae 10-20 part, Semen Euryales 10-20 part.
Crude drug most preferably weight proportion is as follows: Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts, Fructus Rosae Laevigatae 15 parts, Semen Euryales 15 parts.
The most typical symptom of diabetic nephropathy is nodular glomerulosclerosis, mainly with urinaryalbumin output how much for diagnosis index.After patient adopts pharmaceutical composition of the present invention, albuminuria output, obviously reduces, and twenty-four-hour urine total protein levels, urinary albumin excretion ratio reduce, urinary albumin-creatinine ratio ratio reduces, serum creatinine level reduces, and patients ' life quality obviously improves, and has delayed the progress of diabetic nephropathy disease.
For the ease of application, can on the basis of crude drug, conventionally or add pharmaceutically acceptable adjuvant and make conventional oral formulations.As powder, capsule, tablet, granule, capsule, oral liquid etc.For the application characteristic of medicine of the present invention, additionally provide the preparation method of this pharmaceutical composition.
As:
Method one: each crude drug is ground into fine powder, mixing powder;
Method two: each crude drug is ground into fine powder, encapsulated capsule;
Method three: each crude drug is ground into fine powder, tabletting tablet;
Method four: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, granule;
Method five: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, encapsulated capsule;
Method six: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, tabletting tablet;
Method seven: after each crude drug water boiling and extraction, make oral liquid.
Application said method all can realize the object for the treatment of diabetes, but because of the convenience of application and the easy of preparation, inventor is made into granule more and uses.
To sum up, applying medicine composite for curing diabetes provided by the invention has clear and definite effect, stable curative effect, has no side effect, controlled.
Detailed description of the invention
Illustrate below by way of specific description of embodiments of the present invention but do not limit the present invention.
The pharmaceutical composition that the present invention is used for the treatment of diabetic nephropathy is made up of the crude drug of following weight proportion:
1) pharmaceutical composition of the present invention is with Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, when Rhizoma Coptidis is crude drug:
Crude drug weight proportion is as follows: Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part.
Crude drug preferred weight proportioning is as follows: Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part.
Crude drug further preferred weight proportioning is as follows: Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part.
Crude drug most preferably weight proportion is as follows: Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts.
2) pharmaceutical composition of the present invention is with Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, Rhizoma Coptidis, Fructus Rosae Laevigatae, when Semen Euryales is crude drug:
Crude drug weight proportion is as follows: Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part, Fructus Rosae Laevigatae 5-60 part, Semen Euryales 5-60 part.
Crude drug preferred weight proportioning is as follows: Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part, Fructus Rosae Laevigatae 5-30 part, Semen Euryales 5-30 part.
Crude drug further preferred weight proportioning is as follows: Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part, Fructus Rosae Laevigatae 10-20 part, Semen Euryales 10-20 part.
Crude drug most preferably weight proportion is as follows: Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts, Fructus Rosae Laevigatae 15 parts, Semen Euryales 15 parts.
Inventor, when nearly clinical practice in 2 years, adjusts the consumption of crude drug within the scope of following weight proportion, all can realize treatment diabetic nephropathy object:
With Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, when Rhizoma Coptidis is crude drug, crude drug most preferably weight proportion is as follows:
Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts.
With Caulis Sinomenii, Semen Astragali Complanati, the Radix Astragali, Rhizoma Coptidis, Fructus Rosae Laevigatae, when Semen Euryales is crude drug, crude drug most preferably weight proportion is as follows:
Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts, Fructus Rosae Laevigatae 15 parts, Semen Euryales 15 parts.
For the ease of application, on the basis of crude drug, pharmaceutically acceptable adjuvant can be added and makes conventional oral formulations.As powder, capsule, tablet, granule, capsule, oral liquid etc.
The beneficial effect of pharmaceutical composition of the present invention is proved below by way of clinical statistics.
It is clinical that inventor adopts pharmaceutical composition of the present invention to be applied to, and gets different amounts proportioning raw material for different indication, makes following dosage form and apply,
Prescription: during practical application, crude drug can adopt following weight proportion:
1) Caulis Sinomenii 120 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 120 parts, Rhizoma Coptidis 60 parts.
2) Caulis Sinomenii 60 parts, Semen Astragali Complanati 120 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 5 parts.
3) Caulis Sinomenii 30 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 5 parts.
4) Caulis Sinomenii 40 parts, Semen Astragali Complanati 50 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 5 parts.
5) Caulis Sinomenii 30 parts, Semen Astragali Complanati 20 parts, the Radix Astragali 50 parts, Rhizoma Coptidis 30 parts.
6) Caulis Sinomenii 10 parts, Semen Astragali Complanati 40 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts.
7) Caulis Sinomenii 20 parts, Semen Astragali Complanati 120 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 5 parts, Fructus Rosae Laevigatae 5 parts, Semen Euryales 5 parts.
8) Caulis Sinomenii 120 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 15 parts, Fructus Rosae Laevigatae 10 parts, Semen Euryales 10 parts.
9) Caulis Sinomenii 30 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 120 parts, Rhizoma Coptidis 60 parts, Fructus Rosae Laevigatae 60 parts, Semen Euryales 60 parts.
10) Caulis Sinomenii 60 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 10 parts, Rhizoma Coptidis 5 parts, Fructus Rosae Laevigatae 5 parts, Semen Euryales 5 parts.
11) Caulis Sinomenii 10 parts, Semen Astragali Complanati 40 parts, the Radix Astragali 40 parts, Rhizoma Coptidis 15 parts, Fructus Rosae Laevigatae 20 parts, Semen Euryales 20 parts.
12) Caulis Sinomenii 50 parts, Semen Astragali Complanati 10 parts, the Radix Astragali 50 parts, Rhizoma Coptidis 30 parts, Fructus Rosae Laevigatae 30 parts, Semen Euryales 30 parts
13) Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts, Fructus Rosae Laevigatae 15 parts, Semen Euryales 15 parts.
During clinical practice, inventor be made into granule application, adopt above-mentioned different material medicine proportion relation to prepare granule respectively, preparation method is as follows: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, granule.
Pharmaceutical composition of the present invention: take dosage on 2nd: Caulis Sinomenii 30g, Radix Astragali 30g, Rhizoma Coptidis 10g, Semen Astragali Complanati 30g, Fructus Rosae Laevigatae 15g, Semen Euryales 15g; One day three times.
Control drug: day takes dosage: Radix Astragali 30g, Rhizoma Coptidis 10g, Semen Astragali Complanati 30g, Fructus Rosae Laevigatae 15g, Semen Euryales 15g; One day three times.
Inventor applies the 13rd group of medicine composite for curing diabetic nephropathy.Nearly 2 years treatment more than 50 people, with reference to nephropathy branch of China Association of Traditional Chinese Medicine " diabetic nephropathy diagnosis, differentiation of symptoms and signs for classification of syndrome and efficacy assessment standard " therapeutic effect of grading in 2006.About 2 weeks pharmaceutical composition onset times of the present invention, healing time about 8 weeks, recurrence about 5%.
The non-clinical statistical data applying pharmaceutical composition of the present invention and control drug is as follows:
Note:
Transference cure: represent that clinical symptoms disappears substantially, twenty-four-hour urine protein quantification <30mg/24h.
Symptom alleviates: represent that clinical symptoms significantly alleviates, the quantitative <300mg/24h of 30mg/24h<24 hours urine protein.
Total effective rate alleviates sum in transference cure and symptom.
Apply medicine composite for curing diabetic nephropathy patient of the present invention, the albuminuria discharge capacity of patient obviously reduces, thus can slow down the process of diabetic nephropathy disease progression.
To sum up, pharmaceutical composition of the present invention is through clinical statistics observation for many years, finally determine that Caulis Sinomenii, Semen Astragali Complanati, Rhizoma Coptidis, the Radix Astragali are primary raw material medicine after screening prescription, and add Fructus Rosae Laevigatae, the further consolidate curative effect of Semen Euryales, treatment diabetic nephropathy best results, for clinical treatment diabetes provide a kind of selection completely newly.

Claims (10)

1. treat the pharmaceutical composition of diabetic nephropathy, it is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part.
2. the pharmaceutical composition being used for the treatment of diabetic nephropathy according to claim 1, is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part.
3. the pharmaceutical composition being used for the treatment of diabetic nephropathy according to claim 2, is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part;
Preferably, crude drug weight proportion is as follows:
Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts.
4. treat the pharmaceutical composition of diabetic nephropathy, it is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 10-120 part, Semen Astragali Complanati 10-120 part, Radix Astragali 10-120 part, Rhizoma Coptidis 5-60 part, Fructus Rosae Laevigatae 5-60 part, Semen Euryales 5-60 part.
5. according to the pharmaceutical composition being used for the treatment of diabetic nephropathy that claim 4 is stated, it is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 10-50 part, Semen Astragali Complanati 10-50 part, Radix Astragali 10-50 part, Rhizoma Coptidis 5-30 part, Fructus Rosae Laevigatae 5-30 part, Semen Euryales 5-30 part.
6. according to the pharmaceutical composition being used for the treatment of diabetic nephropathy that claim 5 is stated, it is characterized in that: crude drug weight proportion is as follows:
Caulis Sinomenii 20-40 part, Semen Astragali Complanati 20-40 part, Radix Astragali 20-40 part, Rhizoma Coptidis 5-15 part, Fructus Rosae Laevigatae 10-20 part, Semen Euryales 10-20 part;
Preferably, crude drug weight proportion is as follows:
Caulis Sinomenii 30 parts, Semen Astragali Complanati 30 parts, the Radix Astragali 30 parts, Rhizoma Coptidis 10 parts, Fructus Rosae Laevigatae 15 parts, Semen Euryales 15 parts.
7. the pharmaceutical composition being used for the treatment of diabetic nephropathy according to any one of claim 1-6, is characterized in that: described pharmaceutical composition is on the basis of crude drug, conventionally makes oral formulations; Or add pharmaceutically acceptable adjuvant and make conventional oral formulations.
8. the pharmaceutical composition being used for the treatment of diabetic nephropathy according to claim 7, is characterized in that: described oral formulations is powder, tablet, granule, capsule or oral liquid.
9. the preparation method being used for the treatment of the pharmaceutical composition of diabetic nephropathy described in any one of claim 1-6, is characterized in that:
Method one: each crude drug is ground into fine powder, mixing powder; Or
Method two: each crude drug is ground into fine powder, encapsulated capsule; Or
Method three: each crude drug is ground into fine powder, tabletting tablet; Or
Method four: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, granule; Or
Method five: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, encapsulated capsule; Or
Method six: after each crude drug water boiling and extraction, concentrated extracting solution makes granule, tabletting tablet; Or
Method seven: after each crude drug water boiling and extraction, make oral liquid.
10. the pharmaceutical composition described in any one of claim 1-6 reduces the purposes in the medicine of albuminuria output in preparation.
CN201510151713.2A 2014-04-03 2015-04-01 The pharmaceutical composition and its preparation method and application for treating diabetic nephropathy Expired - Fee Related CN104971102B (en)

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Cited By (4)

* Cited by examiner, † Cited by third party
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CN105194458A (en) * 2015-10-21 2015-12-30 彭书磊 Traditional Chinese medicine for treating diabetic nephropathy
CN105998854A (en) * 2016-07-24 2016-10-12 刘咏梅 Medicine for treating diabetic nephropathy and preparation method
CN108114032A (en) * 2017-01-24 2018-06-05 青海春天药用资源科技利用有限公司 There is the pharmaceutical composition of invigorating the blood
CN110772607A (en) * 2019-10-21 2020-02-11 南方医科大学 Traditional Chinese medicine composition for improving diabetic nephropathy and preparation thereof

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105194458A (en) * 2015-10-21 2015-12-30 彭书磊 Traditional Chinese medicine for treating diabetic nephropathy
CN105194458B (en) * 2015-10-21 2019-12-17 薛武 Traditional Chinese medicine for treating diabetic nephropathy
CN105998854A (en) * 2016-07-24 2016-10-12 刘咏梅 Medicine for treating diabetic nephropathy and preparation method
CN108114032A (en) * 2017-01-24 2018-06-05 青海春天药用资源科技利用有限公司 There is the pharmaceutical composition of invigorating the blood
CN110772607A (en) * 2019-10-21 2020-02-11 南方医科大学 Traditional Chinese medicine composition for improving diabetic nephropathy and preparation thereof

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