CN104258320B

CN104258320B - A kind ofly treat Chinese medicine preparation of hypertensive renal damage edema and preparation method thereof

Info

Publication number: CN104258320B
Application number: CN201410462022.XA
Authority: CN
Inventors: 巴元明
Original assignee: HUBEI PROVINCIAL HOSPITAL OF TCM
Current assignee: HUBEI PROVINCIAL HOSPITAL OF TCM
Priority date: 2014-09-11
Filing date: 2014-09-11
Publication date: 2016-01-20
Anticipated expiration: 2034-09-11
Also published as: CN104258320A

Abstract

A kind of Chinese medicine preparation for the treatment of hypertensive renal damage edema, the raw material composition of this Chinese medicine preparation and weight part ratio thereof are: Poria 15 30, Semen Plantaginis 10 15, Semen Phaseoli 10 15, Herba Leonuri 10 15, the Radix Aucklandiae 4 6, the Rhizoma Atractylodis Macrocephalae 5 10, Pericarpium Citri Reticulatae 5 10, Ramulus Cinnamomi 3 5, Polyporus 5 10, Rhizoma Alismatis 5 10, Pericarpium Arecae 5 10, Cortex Zingiberis 5 10, Cortex Mori 5 10, during preparation, first by pulverize after each raw material add water or ethanol extraction to obtain extract, in extract, add pharmaceutically acceptable adjuvant or complementary composition be again prepared into pharmaceutically conventional preparation.The design has effect of invigorating spleen and kidney, unobstructed QI and blood, elimination edema, and has no side effect.

Description

A kind ofly treat Chinese medicine preparation of hypertensive renal damage edema and preparation method thereof

Technical field

The invention belongs to tcm field, be specifically related to a kind ofly treat Chinese medicine preparation of the edema that hypertensive renal damage causes and preparation method thereof, especially card belongs to deficiency of spleen-YANG and kidneyYANG water of holding concurrently and to wet the edema of syndrome of blood stasis, is applicable to invigorating spleen and kidney, unobstructed QI and blood, eliminates edema.

Background technology

The theme of World Hygiene Day in 2013 is decided to be " control hypertension " by WHO, is intended to improve the attention degree of society of countries in the world government to hypertension problem, and proposes the outbreak that its ultimate aim is minimizing heart disease and stroke.And hypertension except can cause cardiovascular and cerebrovascular vessel damage except, its to another important organ one by one kidney also there is obvious damaging action.The renal damage that hypertension causes has become second or the 3rd cause of disease that developed country causes end stagerenaldisease (ESRD), the report display of U.S.'s kidney data system (USRDS), since 1981, the patient of the ESRD caused due to hypertension with renal injury comparatively added 8 times before 30 years.According to statistics, in Beijing's dialysis patients in 2006, hypertensive renal damage is the 3rd cause of disease of ESRD.But less to the correlational study of hypertensive renal damage at present, the also analysis document of rare Chinese and western medicine diagnosis and treatment present situation aspect.

Edema is the modal clinical manifestation of hypertensive renal damage.Early discovery edema is conducive to the control of nephropathy, is conducive to the awareness improving nephropathy, prevents aggravation.Meanwhile, edema usually occurs repeatedly, mostly comparatively obstinate, heavy then accompany ascites, hydrothorax, even because causing heart failure pulmonary edema threat to life, alleviating and controlling edema, improving patients ' life quality, seeming very necessary clinically.

Hypertensive renal damage edema belongs to the category such as " water ", " aqueous vapor ", " edema " of the traditional Chinese medical science.Chinese medicine prevention hypertensive renal damage edema is better with its curative effect, toxic and side effects is little, s' approve by doctor more and more, become the focus of research both at home and abroad in recent years, carried out a large amount of Clinical and experimental studies, comprise Chinese medicine compound and single medicinal material, and achieve larger achievement.

Hypertensive renal damage edema exopathogenic factor mostly is exopathogen, evil poison, endogenous cause of ill duty unfavorable in lung, spleen, kidney and qiactivity of triple energizer, diet and overwork.Its pathogenesis always belongs to the simulataneous insufficiency and excessive of polyphyly deficiency in origin and excess in superficiality, and the clinical deficiency and excess that mostly is is interlocked, and disease is complicated.Mainly lung, spleen, gas, blood, the water three metabolism that kidney three is dirty caused of the pathogenesis of edema, transit link is abnormal forms, the deficiency of the lung then vital QI failing to transform into essence and change water, insufficiency of the spleen then the spleen failing to restrict the kidney and anti-gram, suffer from a deficiency of the kidney then water without main and absurd row.Deficiency in origin influences each other with mark is real, and common pathogenetic form vicious cycle, so that the course of disease is touching, sees disease multiterminal, therefore treats edema when strengthening vital QI to eliminate pathogenic factors to take into account.

Chinese patent: Patent publication No is CN103800736A, date of publication is that the patent of invention on May 21st, 2014 discloses a kind of pharmaceutical composition and application thereof for the treatment of hypertensive nephropathy, said composition is prepared from by the traditional Chinese medicinal material raw materials of following weight portion: Radix Platycodonis 23 ?28 parts, Stigma Maydis 8 ?13 parts, the Radix Astragali 27 ?34 parts, Semen Coicis 13 ?17 parts, Radix Oryzae Glutinosae 10 ?15 parts, Radix Glycyrrhizae uralensis 18 ?23 parts, Radix Rubiae 8 ?13 parts, Rhizoma Phragmitis 18 ?23 parts, Rhizoma Imperatae 8 ?13 parts, Placenta Hominis 13 ?17 parts, Radix Salviae Miltiorrhizae 18 ?23 parts, Bulbus Fritillariae Thunbergii 27 ?34 parts, Radix Scutellariae 13 ?17 parts, Semen Pharbitidis 6 ?10 parts, Fructus Foeniculi 13 ?17 parts, Semen Phaseoli 27 ?35 parts.Although this invention effectively can improve the renal function of hypertensive renal patient, eliminate the symptom such as edema, urine protein and sign, improve the curative effect of primary disease, toxic and side effects is low, but still there is following defect:

In the party, Semen Pharbitidis is toxicant, and take improper meeting and have side effects even poisoning, cardinal symptom is vomiting, stomachache, diarrhoea etc.; Placenta Hominis and Placenta Hominis, because Placenta Hominis is connected with parent, if anemia of pregnant woman itself has some can by the disease of blood born, pathogen such as acquired immune deficiency syndrome (AIDS), syphilis, hepatitis B, measles etc. probably also can pollute Placenta Hominis.

Summary of the invention

The object of the invention is to overcome that the side effect that existing medicine exists is large, the problem of fast spreading disease, provide a kind of and to have no side effect and can not the Chinese medicine preparation and preparation method thereof of pathophorous treatment hypertensive renal damage edema.

For realizing above object, the invention provides following technical scheme:

Treat a Chinese medicine preparation for hypertensive renal damage edema, the raw material of this Chinese medicine preparation composition and weight part ratio thereof are: Poria 15 ?30, Semen Plantaginis 10 ?15, Semen Phaseoli 10 ?15, Herba Leonuri 10 ?15, the Radix Aucklandiae 4 ?6, the Rhizoma Atractylodis Macrocephalae 5 ?10, Pericarpium Citri Reticulatae 5 ?10, Ramulus Cinnamomi 3 ?5, Polyporus 5 ?10, Rhizoma Alismatis 5 ?10, Pericarpium Arecae 5 ?10, Cortex Zingiberis 5 ?10, Cortex Mori 5 ?10.

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 30, Semen Plantaginis 5, Semen Phaseoli 15, Herba Leonuri 15, the Radix Aucklandiae 6, the Rhizoma Atractylodis Macrocephalae 10, Pericarpium Citri Reticulatae 10, Ramulus Cinnamomi 5, Polyporus 10, Rhizoma Alismatis 10, Pericarpium Arecae 10, Cortex Zingiberis 10, Cortex Mori 10.

A kind of preparation method of Chinese medicine preparation of described treatment hypertensive renal damage edema, this preparation method refers to: first each raw material after pulverizing is added water or ethanol extraction to obtain extract, then in extract, add pharmaceutically acceptable adjuvant or complementary composition be prepared into pharmaceutically conventional preparation.

Described preparation method comprises the following steps successively:

Decoct: each raw material after pulverizing is decocted with water 2 times in the desired amount to obtain decocting liquid, wherein, the interpolation weight of described water be each raw material weight 8 ?10 times, each time decocted be 1 ?2h;

Prepared by dosage form: after first being merged by described decocting liquid, concentrating under reduced pressure is to obtain concentrate, then in concentrate, adds adjuvant and is prepared into oral formulations.

Compared with prior art, beneficial effect of the present invention is:

1, the present invention is a kind of treats the raw material composition of the Chinese medicine preparation of hypertensive renal damage edema and weight part ratio is: Poria 15 ?30, Semen Plantaginis 10 ?15, Semen Phaseoli 10 ?15, Herba Leonuri 10 ?15, the Radix Aucklandiae 4 ?6, the Rhizoma Atractylodis Macrocephalae 5 ?10, Pericarpium Citri Reticulatae 5 ?10, Ramulus Cinnamomi 3 ?5, Polyporus 5 ?10, Rhizoma Alismatis 5 ?10, Pericarpium Arecae 5 ?10, Cortex Zingiberis 5 ?10, Cortex Mori 5 ?10, Poria in this formula, the Rhizoma Atractylodis Macrocephalae is sweet, light, flat, GUIXIN, spleen, kidney channel, has inducing diuresis to remove edema, the merit of eliminating dampness by diuresis spleen invigorating, Semen Plantaginis diuretic and do not consume gas, and to share then diuretic effect stronger with Polyporus, and Rhizoma Alismatis goes directly kidney and wing skin with promoting diuresis with drugs of tasteless flavour, joins Poria, Polyporus can strengthen diuretic effect, and Herba Leonuri is good at promoting blood circulation, Radix Aucklandiae promoting the circulation of QI to induce diuresis, Ramulus Cinnamomi warming YANG and promoting the functioning of QI to circulate body fluid, can the gas of temperatureization wing skin and diuresis, again can relieving the exterior syndrome loose evil, joining Poria can activating YANG for promoting diuresis, Pericarpium Arecae pungent temperature therapeutic method to keep the adverse QI flowing downwards alleviating distention in middle-JIAO, inducing diuresis to remove edema, Semen Phaseoli can be ventilated, strengthening the spleen and stomach, we invigorate blood circulation at activating QI, while inducing diuresis to remove edema takes stopgap measures, tonifying speen and tonifying kidney effects a permanent cure, thus reaches invigorating spleen and kidney, unobstructed QI and blood, eliminate effect of edema, and do not contain the medical material of toxicity and fast spreading disease, have no side effect, can not spread disease.Therefore, the present invention not only invigorating spleen and kidney, unobstructed QI and blood, eliminate edema, and have no side effect, can not spread disease.

Detailed description of the invention

Essentiality content of the present invention is further illustrated below in conjunction with embodiment.

Described preparation method comprises the following steps successively:

Decoct: each raw material after pulverizing is decocted with water 3 times in the desired amount to obtain decocting liquid, wherein, the interpolation weight of described water be each raw material weight 8 ?10 times, each time decocted be 1 ?2h;

Principle of the present invention is described as follows:

Chinese medicine preparation of the present invention comprises Poria, Semen Plantaginis, Semen Phaseoli, Herba Leonuri, the Radix Aucklandiae, the Rhizoma Atractylodis Macrocephalae, Pericarpium Citri Reticulatae, Ramulus Cinnamomi, Polyporus, Rhizoma Alismatis, Pericarpium Arecae, Cortex Zingiberis, Cortex Mori.This formula adopts that tonifying speen and tonifying kidney, activating QI are invigorated blood circulation, the Therapeutic Principle of inducing diuresis to remove edema, and the Rhizoma Atractylodis Macrocephalae both can air making-up and spleen enlivening, again can dampness diuretic, and can play the effect for the treatment of both the principal and secondary aspects of a disease, be monarch drug, Semen Plantaginis diuretic and do not consume gas, to share then diuretic effect stronger with Polyporus, and Rhizoma Alismatis goes directly kidney and wing skin with promoting diuresis with drugs of tasteless flavour, and join Poria, Polyporus can strengthen diuretic effect, this three medicine is ministerial drug altogether, Herba Leonuri, the Radix Aucklandiae, Poria, Pericarpium Citri Reticulatae, Ramulus Cinnamomi, Pericarpium Arecae, Cortex Zingiberis, Cortex Mori is adjuvant drug, Herba Leonuri enters blood system, be good at promoting blood circulation, the product of invigorating blood circulation are assisted a ruler in governing a country in diuretic agent, meet " the not all right then suffering from edema of blood ", that " harnesses the river when controlling blood " says, Radix Aucklandiae promoting the circulation of QI to induce diuresis, the Rhizoma Atractylodis Macrocephalae joined by Poria can tonifying the spleen diuretic, Ramulus Cinnamomi warming YANG and promoting the functioning of QI to circulate body fluid, can the gas of temperatureization wing skin and diuresis, can fall apart evil by relieving the exterior syndrome again, to remove the exterior syndrome of the sun, one medicine dual-purpose, treating both the exterior and interior at the same time, join Poria with resolving fluid-retention with drugs of warm nature, can activating YANG for promoting diuresis, pungent cool dismission a surname of CORTEX ZINGIBERIS RHIZOMAE sends out stomach sun aproll, Pericarpium Arecae pungent temperature therapeutic method to keep the adverse QI flowing downwards alleviating distention in middle-JIAO, inducing diuresis to remove edema, during Pericarpium Citri Reticulatae is regulated the flow of vital energy and is adjusted, to be amusing removing dampness, Cortex Mori eliminating the pathogens from the lung sending down the abnormal ascending QI is with clear water source, become under making water certainly, source clear stream is clean, descending not only tonneau water channel is apt to by Semen Phaseoli, inducing diuresis to remove edema, and can ventilate, strengthening the spleen and stomach.We have the effect for the treatment of both the principal and secondary aspects of a disease, strengthening vital QI to eliminate pathogenic factors.

Embodiment 1:

Treat a Chinese medicine preparation for hypertensive renal damage edema, the raw material composition of this Chinese medicine preparation and weight part ratio thereof are: Poria 30, Semen Plantaginis 15, Semen Phaseoli 15, Herba Leonuri 15, the Radix Aucklandiae 6, the Rhizoma Atractylodis Macrocephalae 10, Pericarpium Citri Reticulatae 10, Ramulus Cinnamomi 5, Polyporus 10, Rhizoma Alismatis 10, Pericarpium Arecae 10, Cortex Zingiberis 10, Cortex Mori 10;

During preparation, carry out according to following steps successively:

Decoct: each raw material after pulverizing is decocted with water 2 times in the desired amount to obtain decocting liquid, and wherein, the interpolation weight of described water is 8 times of each raw material weight, each time decocted is 1.5h;

Embodiment 2:

Step with embodiment 1, unlike:

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 15, Semen Plantaginis 15, Semen Phaseoli 15, Herba Leonuri 15, the Radix Aucklandiae 6, the Rhizoma Atractylodis Macrocephalae 10, Pericarpium Citri Reticulatae 10, Ramulus Cinnamomi 5, Polyporus 10, Rhizoma Alismatis 10, Pericarpium Arecae 10, Cortex Zingiberis 10, Cortex Mori 10;

In described decoction step, the interpolation weight of water is 9 times of each raw material weight.

Embodiment 3:

Step with embodiment 1, unlike:

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 30, Semen Plantaginis 10, Semen Phaseoli 10, Herba Leonuri 15, the Radix Aucklandiae 6, the Rhizoma Atractylodis Macrocephalae 10, Pericarpium Citri Reticulatae 10, Ramulus Cinnamomi 5, Polyporus 10, Rhizoma Alismatis 10, Pericarpium Arecae 10, Cortex Zingiberis 10, Cortex Mori 10;

In described decoction step, each time decocted is 2h.

Embodiment 4:

Step with embodiment 1, unlike:

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 20, Semen Plantaginis 13, Semen Phaseoli 10, Herba Leonuri 10, the Radix Aucklandiae 5, the Rhizoma Atractylodis Macrocephalae 5, Pericarpium Citri Reticulatae 5, Ramulus Cinnamomi 3, Polyporus 5, Rhizoma Alismatis 5, Pericarpium Arecae 5, Cortex Zingiberis 5, Cortex Mori 5.

Embodiment 5:

Step with embodiment 1, unlike:

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 30, Semen Plantaginis 10, Semen Phaseoli 12, Herba Leonuri 12, the Radix Aucklandiae 4, the Rhizoma Atractylodis Macrocephalae 10, Pericarpium Citri Reticulatae 10, Ramulus Cinnamomi 5, Polyporus 10, Rhizoma Alismatis 10, Pericarpium Arecae 10, Cortex Zingiberis 10, Cortex Mori 10.

In described decoction step, the interpolation weight of water is 10 times of each raw material weight, and each time decocted is 2h.

Embodiment 6:

Step with embodiment 1, unlike:

The raw material composition of described Chinese medicine preparation and weight part ratio thereof are: Poria 15, Semen Plantaginis 15, Semen Phaseoli 15, Herba Leonuri 15, the Radix Aucklandiae 4, the Rhizoma Atractylodis Macrocephalae 7, Pericarpium Citri Reticulatae 7, Ramulus Cinnamomi 4, Polyporus 7, Rhizoma Alismatis 7, Pericarpium Arecae 7, Cortex Zingiberis 7, Cortex Mori 7.

In described decoction step, each time decocted is 1h.

Beneficial effect of the present invention is proved below by way of clinical trial or concrete pharmacodynamics test.

Data and method

1. physical data

Case is originated: the hypertensive renal damage edematous patient that this research case history is accepted for medical treatment from Hubei Provincial Hospital of TCM's outpatient service and ward of being in hospital, totally 120 examples, is divided into matched group 60 example, treatment group 60 example at random.Treatment group man 27 example, female 33 example, 43.28 ± 15.58 years old age, the course of disease 3.48 ± 3.17 months, treatment foreset is divided into 17.23 ± 2.87; Matched group man 29 example, female 31 example, at 47.63 ± 13.76 years old age, the course of disease 4.12 ± 2.68 months, treatment foreset is divided into 17.06 ± 2.79.

Two groups of patients before age, sex, treatment in tcm symptom total mark and the course of disease etc. situation similar, there was no significant difference (P > 0.05), has comparability.

2. Therapeutic Method

Matched group:

Do not use the medicine impairing kidney, in erstricted diet, albumen and phosphorus enter amount, adopt less salt low fat high-quality protein diet;

Use ACEI or ARB medicine to reduce albuminuria, control blood pressure, urine protein >=1g/d, blood pressure should control at below 125/75mmHg; Urine protein <1g/d, blood pressure can be loosened to 130/80mmHg;

For the patient of Severe edema, add with diuretic furosemide or spironolactone.

Treatment group:

Treatment of control group basis gives Drug therapy of the present invention.

The course for the treatment of is 1 month, and follow-up period is 3 months, observes relapse rate.

3. diagnostic criteria

Western medicine diagnose standard edits " nephrology " (second edition) with reference to " Chinese hypertension guideline of prevention and treatment (revised edition in 2005) ", Wang Haiyan.

Tcm diagnosis standard is issued with reference to State Administration of Traditional Chinese Medicine 1994, nineteen ninety-five implements " People's Republic of China's traditional Chinese medicine industry standard---Chinese medical disease Standardization of diagnosis and curative effect ", differential diagnosis in tcm standard to be held concurrently water damp syndrome, syndrome of blood stasis and curative effect determinate standard with reference to the chronic nephritis spleen deficiency of kidney-QI in 2002 version " new Chinese medicine guideline of clinical investigations ".

4. observation index

4.1. safety observations

Inquiring and general physical examination project;

Promoting the circulation of blood, urine, feces routine examination;

Electrocardiogram, Liver and kidney function detect.

Untoward reaction, record symptom degree, occurrence frequency, persistent period analyze reason, records the corresponding measure taked.

4.2. health giving quality is observed

Clinical symptoms, sign, tongue, pulse condition;

Edema degree: heavy in light;

Urine volume and body weight: record urine amount and body weight every day;

Auxiliary examination: uroscopy, urine protein quantitation etc.

5. statistical procedures data

All data medical statistics software Spss19.0 process, measurement data data with mean ± standard deviation ( ± s) represent, adopt t inspection; Enumeration data adopts X ²inspection; Ranked data adopt R to analyze.P < 0.05 is for there being significant difference; P < 0.01 is for there being significant differences; P > 0.05 is there was no significant difference.

Result

1. a liang group case total effects compares

Treatment group recovery from illness 18 example, effective 36 examples, invalid 6 examples, total effective rate 90%; Matched group recovery from illness 11 example, effective 28 examples, invalid 21 examples, total effective rate 65%.

There is significant difference (P < 0.05) in two groups of comparitive study, and the curative effect for the treatment of group is obviously better than matched group.

2. liang group case traditional Chinese medical science cardinal symptom comparitive study (see table 1)

Rear two groups of case main hypertensive TCM cardinal symptom comparitive study treated by table 1

After treatment, two groups of case traditional Chinese medical science cardinal symptoms are all improved, and two groups are compared and have significant difference (P < 0.05 or P < 0.01), and treatment group is improved amplitude and is better than matched group.

3. liang forward and backward integral contrast of group treatment

Before treatment group treatment, symptom integral is 17.23 ± 2.87, and after treatment, symptom integral is 6.00 ± 3.06; Before treatment of control group, symptom integral is 17.06 ± 2.79, and after treatment, symptom integral is 9.87 ± 3.68.

Two groups of treatments have significant difference (P < 0.05) forward and backward comparison, and the curative effect for the treatment of group is obviously better than matched group.

4. liang forward and backward urine RBC count ratio of group treatment comparatively

Before treatment group treatment, urine RBC is 26.36 ± 8.51/HP, and after treatment, urine RBC is 7.67 ± 2.5/HP; Before treatment of control group, urine RBC is 27.63 ± 7.93/HP, and after treatment, urine RBC is 12.87 ± 5.69/HP.

Treatment group and matched group after the treatment urine RBC counting decline before all comparatively treating to some extent, and after two groups of treatments, urine RBC count ratio comparatively have significant differences (P < 0.01), and the curative effect for the treatment of group is better than matched group.

5. liang forward and backward uric acid of group treatment compares

Treatment group uric acid concentration is before the treatment 416.64 ± 111.78, and the uric acid concentration after treatment is 326.77 ± 52.91; Matched group uric acid concentration is before the treatment 386.77 ± 52.91, and the uric acid concentration after treatment is 350.38 ± 53.5.

Treat front two groups of uric acid concentrations to compare, there was no significant difference (P > 0.05), has comparability.After two groups of treatments, uric acid concentration declines all to some extent, but there was no significant difference (P > 0.05), and treat forward and backward uric acid concentration within normal range, not there is statistical significance.

6. untoward reaction

Two groups are showed no untoward reaction.

In sum: Chinese medicine preparation of the present invention has good curative effect to hypertensive renal damage edema, and clinical practice is safe and effective, has no side effect, be a kind of effective ways for the treatment of hypertensive renal damage edema.

Claims

1. treat a Chinese medicine preparation for hypertensive renal damage edema, it is characterized in that:

The raw material composition of this Chinese medicine preparation and weight part ratio thereof are: Poria 15 ?30, Semen Plantaginis 10 ?15, Semen Phaseoli 10 ?15, Herba Leonuri 10 ?15, the Radix Aucklandiae 4 ?6, the Rhizoma Atractylodis Macrocephalae 5 ?10, Pericarpium Citri Reticulatae 5 ?10, Ramulus Cinnamomi 3 ?5, Polyporus 5 ?10, Rhizoma Alismatis 5 ?10, Pericarpium Arecae 5 ?10, Cortex Zingiberis 5 ?10, Cortex Mori 5 ?10.

2. a kind of Chinese medicine preparation for the treatment of hypertensive renal damage edema according to claim 1, is characterized in that:

3. a preparation method for the Chinese medicine preparation for the treatment of hypertensive renal damage edema according to claim 1, is characterized in that:

This preparation method refers to: first each raw material after pulverizing is added water or ethanol extraction to obtain extract, then in extract, add pharmaceutically acceptable adjuvant or complementary composition be prepared into pharmaceutically conventional preparation.

4. a kind of preparation method for the treatment of the Chinese medicine preparation of hypertensive renal damage edema according to claim 3, is characterized in that:

Described preparation method comprises the following steps successively: