CN110433204B

CN110433204B - Chinese medicine compound preparation and its preparing method and use

Info

Publication number: CN110433204B
Application number: CN201910854023.1A
Authority: CN
Inventors: 邓德强; 李崇瑞; 刘艺; 赵媛; 周江; 翁幼武; 杨明霞; 肖艳; 木太里普·吐逊; 马丹; 杨绍玮
Original assignee: Urumqi Hospital Of Traditional Chinese Medicine
Current assignee: Urumqi Hospital Of Traditional Chinese Medicine
Priority date: 2019-09-10
Filing date: 2019-09-10
Publication date: 2021-09-28
Anticipated expiration: 2039-09-10
Also published as: CN110433204A

Abstract

The invention relates to the technical field of medicine and preparation and application thereof, in particular to a traditional Chinese medicine compound preparation and a preparation method and application thereof, wherein the raw material components of the traditional Chinese medicine compound preparation comprise main materials and auxiliary materials, the main materials comprise saussurea involucrate, eucommia ulmoides, rhizoma cibotii, medicinal cyathula root, centella asiatica, cistanche, astragalus membranaceus, poria cocos, red paeony root, white paeony root, moutan bark and red-rooted salvia root, the auxiliary materials comprise starch, lactose, dextrin, mannitol and sodium carboxymethyl starch, the required amount of the main materials are extracted for 1 to 4 times by using water or ethanol, and the obtained extracting solutions are combined, filtered, concentrated and dried to obtain a mixture extract; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing the mixture into a traditional Chinese medicine compound preparation of granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation. The traditional Chinese medicine compound preparation is prepared by taking authentic traditional Chinese medicinal materials as raw materials, and clinical treatment shows that the traditional Chinese medicine compound preparation has unique curative effect in medicines for treating or preventing diabetes, nephropathy, senile deficiency syndrome and hypertension, and has no toxic or side effect.

Description

Chinese medicine compound preparation and its preparing method and use

Technical Field

The invention relates to the technical field of medicines and preparation and application thereof, in particular to a traditional Chinese medicine compound preparation and a preparation method and application thereof.

Background

Diabetes Mellitus (DM) is one of the most common chronic diseases worldwide and has become a significant social hygiene problem. Statistically, by 2010, the number of diabetics reaches 2.8 billion globally, and is expected to increase by 2.2% annually. Diabetic nephropathy is one of diabetic microvascular complications, is a specific renal complication of diabetes, is clinically characterized by proteinuria, progressive renal function damage, hypertension and edema, has severe renal failure at the late stage, often directly affects the life quality of patients, seriously threatens the lives of the patients, and is an important reason for death of the diabetic patients. At present, Diabetic Nephropathy (DN) becomes a leading cause of end-stage nephropathy, and once clinical diabetic nephropathy occurs, kidney damage develops rapidly.

The development of diabetic nephropathy is mainly divided into five stages, firstly, the first stage is the hypertrophy of the kidney and the increase of glomerular filtration rate, the tiny lesions do not change significantly in the stage and have no obvious pathological tissue damage, and the development of the nephropathy can be relieved by effectively controlling the blood sugar in the stage; the second stage is that the patient has proteinuria, the basement membrane of the glomerulus is thickened, in addition, stroma is increased in a mesentery region, the body of the patient is basically recovered to be normal when the patient is at rest, and the duration of the second stage is longer; in the third stage, the filtration rate of glomeruli of the patient is reduced, meanwhile, the glomeruli are diseased, the urine protein of the patient is very obvious after the patient moves, even microalbumin appears, the blood pressure of the patient is also increased, and the urine microalbumin level of the patient can be reduced by combining the patient with related medicines, so that the disease condition of the patient is relieved; in the fourth stage, the glomerular filtration rate of the patient is obviously reduced, the proteinuria symptoms of the patient are very obvious, and the patient also can have symptoms related to nephrotic syndrome; in the fifth stage, the patients are the renal failure diseases at the end stage, the pathological examination shows that glomerular sclerosis occurs, the serious patients show uremia diseases, the patients need dialysis treatment to relieve the diseases to a certain extent, and the clinical treatment of the patients at the fifth stage is difficult. Proteinuria, namely protein appears in urine of a patient, a small amount of small molecular protein exists in normal human urine, but the small molecular protein cannot be detected in routine examination of urine, but the small molecular protein appears along with kidney diseases, and the method is an important means for detecting the nephropathy. Microalbumin in urine is an important content for kidney detection in diabetic nephropathy and hypertensive nephropathy, microalbumin can appear in urine under the condition of abnormal kidney function, and the inherent cell structure of the kidney is changed due to the hyperglycemic environment, so that the kidney function is influenced, and the urine microalbumin disease of a patient appears.

At present, ACEI or ARB medicines are mainly taken to protect the kidney and reduce urine protein in the treatment of diabetic nephropathy in the III stage by oral administration in Western medicine, an effective treatment means is lacking clinically, the clinical dialysis creatinine value of a diabetic patient is lower than that of a non-diabetic patient, the medical cost is high, the death rate of dialysis treatment of a type 2 diabetic patient is high, the dialysis cost of the diabetic nephropathy patient is obviously higher than that of ERSD (acute respiratory syndrome) caused by non-diabetes, and the current situation causes urgent need for a new treatment means.

"supplement of compendium of materia Medica": saussurea involucrata, which is a monarch drug with strong heat in nature, can tonify essence and yang, is warm in nature, sweet and bitter in taste, enters liver, spleen and kidney meridians, and has the effects of dispelling cold, tonifying yang, regulating menstruation and stopping bleeding; the rhizoma cibotii is bitter, sweet and warm, and belongs to liver and kidney meridians, the eucommia bark is sweet, pungent and warm, and belongs to liver and kidney meridians, the radix cyathulae is sweet, bitter and sour, neutral in nature and belongs to liver and kidney meridians, the cistanche deserticola is also called desert ginseng, is sweet in taste, salty, warm in nature, and belongs to kidney and large intestine meridians, and can tonify kidney yang and replenish essence and blood, and the four medicines can tonify liver and kidney. The white peony root, radix paeoniae alba, bitter and sour, with slight cold, enters the liver channel, nourishes blood and astringes yin, increases the effect of the snow lotus on tonifying the kidney, and is a ministerial drug; astragalus root, radix astragali is sweet and warm, and enters spleen channel, poria cocos, sweet and bland, and enters spleen channel and kidney channel, the astragalus root and poria cocos are mutually matched, and the astragalus root and poria cocos are capable of strengthening spleen and replenishing qi, and the radix achyranthis bidentatae and centella asiatica are capable of inducing diuresis and reducing edema. Radix paeoniae rubrathe, root of red rooted saliva, root bark of tree peony, cyathula root, radix paeoniae rubrathe, etc. are used to activate blood, resolve stasis, dredge collaterals and eliminate mass. Red peony root, bitter in taste and slightly cold in nature, enters liver and spleen channels, clears heat and cools blood, promotes blood circulation and removes blood stasis; radix Paeoniae Rubra is scattered but not supplemented, radix Paeoniae alba is scattered but not discharged, and two herbs are used together, one scattered and one astringent, one discharged and one supplemented, and blood stasis is removed without damaging healthy qi. Moutan bark, cortex moutan is cool, pungent and bitter, enters heart, liver and kidney meridians, and has the actions of clearing heat, cooling blood, harmonizing blood and removing blood stasis, and salvia miltiorrhiza, which is bitter in taste and slightly cold in nature, enters heart and liver meridians, and has the actions of removing blood stasis and cooling blood. Centella asiatica is pungent, bitter and cold, enters lung channel, spleen channel, kidney channel and bladder channel, is an adjuvant drug, and can clear heat, promote diuresis, reduce swelling and remove toxicity.

Disclosure of Invention

The invention provides a Chinese medicinal compound preparation, a preparation method and application thereof, overcomes the defects of the prior art, and has unique curative effect in medicaments for treating or preventing diabetes, nephropathy, senile deficiency and hypertension.

One of the technical schemes of the invention is realized by the following measures: a compound Chinese medicinal preparation comprises the following raw material components in parts by weight, the main material comprises 10-30 parts of saussurea involucrate, 9-15 parts of eucommia ulmoides, 9-15 parts of rhizoma cibotii, 8-15 parts of radix cyathulae, 15-30 parts of centella asiatica, 10-15 parts of cistanche, 15-30 parts of astragalus membranaceus, 9-15 parts of poria cocos, 10-15 parts of red paeony roots, 6-15 parts of radix paeoniae alba, 6-12 parts of moutan barks and 10-15 parts of salvia miltiorrhiza, and the auxiliary material comprises 50-400 parts of starch, 50-400 parts of lactose, 50-400 parts of dextrin, 50-200 parts of mannitol and 50-200 parts of sodium carboxymethyl starch.

The following is a further optimization or/and improvement of one of the above-mentioned technical solutions of the invention:

the preparation method comprises the following steps: firstly, extracting a required amount of main materials for 1 to 4 times by using water or 30 to 80 volume percent of ethanol at the temperature of 30 to 100 ℃, combining obtained extracting solutions, filtering, concentrating and drying to obtain a mixture extract, wherein the weight ratio of the water or 30 to 80 volume percent of ethanol to the mixture extract is 8 to 20:1, and the extraction time is 0.5 to 3 hours; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing the mixture into a traditional Chinese medicine compound preparation of granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation.

The second technical scheme of the invention is realized by the following measures: a preparation method of a traditional Chinese medicine compound preparation is carried out according to the following steps: firstly, extracting a required amount of main materials for 1 to 4 times by using water or 30 to 80 volume percent of ethanol at the temperature of 30 to 100 ℃, combining obtained extracting solutions, filtering, concentrating and drying to obtain a mixture extract, wherein the weight ratio of the water or 30 to 80 volume percent of ethanol to the mixture extract is 8 to 20:1, and the extraction time is 0.5 to 3 hours; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing the mixture into a traditional Chinese medicine compound preparation of granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation.

The third technical scheme of the invention is realized by the following measures: an application of a Chinese medicinal compound preparation in preparing medicine for treating or preventing diabetes and/or nephropathy and/or chronic nephropathy is provided.

The traditional Chinese medicine compound preparation is prepared by taking authentic traditional Chinese medicinal materials as raw materials, and clinical treatment shows that the traditional Chinese medicine compound preparation has excellent curative effect in medicines for treating or preventing diabetes, nephropathy, senile deficiency and hypertension, and has no toxic or side effect.

Detailed Description

The present invention is not limited by the following examples, and specific embodiments may be determined according to the technical solutions and practical situations of the present invention. The various chemical reagents and chemical articles mentioned in the invention are all the chemical reagents and chemical articles which are well known and commonly used in the prior art, unless otherwise specified; the percentages in the invention are mass percentages unless otherwise specified; the solution in the present invention is an aqueous solution in which the solvent is water, for example, a hydrochloric acid solution is an aqueous hydrochloric acid solution, unless otherwise specified; the normal temperature and room temperature in the present invention generally mean a temperature of 15 ℃ to 25 ℃, and are generally defined as 25 ℃.

The invention is further described below with reference to the following examples:

example 1: the traditional Chinese medicine compound preparation comprises raw material components and auxiliary materials, wherein the main material comprises, by weight, 10-30 parts of saussurea involucrate, 9-15 parts of eucommia ulmoides, 9-15 parts of rhizoma cibotii, 8-15 parts of radix cyathulae, 15-30 parts of centella asiatica, 10-15 parts of cistanche, 15-30 parts of astragalus membranaceus, 9-15 parts of poria cocos, 10-15 parts of red peony roots, 6-15 parts of radix paeoniae alba, 6-12 parts of moutan barks and 10-15 parts of salvia miltiorrhiza, and the auxiliary materials comprise, by weight, 50-400 parts of starch, 50-400 parts of lactose, 50-200 parts of dextrin, 50-400 parts of mannitol and 50-200 parts of sodium carboxymethyl starch.

Example 2: the traditional Chinese medicine compound preparation comprises raw material components and auxiliary materials, wherein the main material comprises, by weight, 10 parts or 30 parts of saussurea involucrate, 9 parts or 15 parts of eucommia ulmoides, 9 parts or 15 parts of rhizoma cibotii, 8 parts or 15 parts of radix cyathulae, 15 parts or 30 parts of centella asiatica, 10 parts or 15 parts of cistanche, 15 parts or 30 parts of astragalus membranaceus, 9 parts or 15 parts of poria cocos, 10 parts or 15 parts of red paeony root, 6 parts or 15 parts of radix paeoniae alba, 6 parts or 12 parts of cortex moutan radicis and 10 parts or 15 parts of salvia miltiorrhiza, and the auxiliary materials comprise, by weight, 50 parts or 400 parts of starch, 50 parts or 400 parts of lactose, 50 parts or 400 parts of dextrin, 50 parts or 200 parts of mannitol and 50 parts or 400 parts of sodium carboxymethyl starch.

Example 3: the preparation method of the traditional Chinese medicine compound preparation is carried out according to the following steps: firstly, extracting a required amount of main materials for 1 to 4 times by using water or 30 to 80 volume percent of ethanol at the temperature of 30 to 100 ℃, combining obtained extracting solutions, filtering, concentrating and drying to obtain a mixture extract, wherein the weight ratio of the water or 30 to 80 volume percent of ethanol to the mixture extract is 8 to 20:1, and the extraction time is 0.5 to 3 hours; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing the mixture into a traditional Chinese medicine compound preparation of granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation.

Example 4: the application of the traditional Chinese medicine compound preparation in preparing the medicine for treating or preventing diabetes or/and nephropathy or/and chronic nephropathy.

The clinical test data analysis of the invention:

the research content and the method are as follows:

1. study object

Screening out diabetic nephropathy stage III between 35 and 70 years, differentiating patients with spleen-kidney deficiency in 66 cases, wherein the patients are outpatients and inpatients from 11 months in 2017 to 11 months in 2018 in the Wuluqiqi traditional Chinese medicine hospital. In the control group, 33 cases are treated, 2 cases are lost due to poor settlement and 1 case is removed without matching with random group entry, and the final number of cases is 30; in 33 patients in the treatment group, 3 patients have poor compliance and are not taken regularly, and the final number of cases is 30.

1.1 diagnostic criteria:

1.1.1 Western diagnostic criteria:

(1) diagnostic criteria for diabetes:

reference is made to 2017 edition Chinese type 2 diabetes mellitus prevention and treatment guidelines:

the traditional Chinese medicine composition has typical diabetes symptoms (three more and one less symptoms) and random blood sugar (plasma glucose in any time period after meal) which is more than or equal to 11.1 mmol/L;

② twice fasting (prohibiting the intake of heat for 8-14 hours) plasma glucose (FPG) is more than or equal to 7.0 mmol/L;

③ two sugar tolerance tests, the blood plasma glucose (2hPG) after 2 hours is more than or equal to 11.1 mmol/L.

(2) Staging criteria for diabetic nephropathy:

according to the standard proposed by international Mogensen:

stage III (recessive stage), namely stage DN, is characterized by persistent microalbuminuria, the microalbuminuria in 24 hours is 20ug/min200ug/min or 30mg/24h to 300mg/24h, and other diseases such as fever, nephritis, urinary infection and other stress states, and violent exercise can be eliminated, and the pathological examination can find that GBM is thickened and the mesenteric matrix is obviously widened.

1.1.2 Chinese medicine syndrome differentiation standard:

referring to the Chinese medicine prevention and treatment guidelines for diabetic nephropathy, the Chinese and Western integrated diagnosis and treatment standards for diabetes, and the diagnosis, syndrome differentiation and evaluation criteria for therapeutic effects of diabetic nephropathy (trial) for diabetes with deficiency of spleen and kidney: the main symptoms are: edema of both lower limbs, face and whole body, soreness and weakness of waist and knees. The secondary symptoms are as follows: aversion to cold, cold limbs, mental fatigue, turbid urine and frequent micturition. Tongue manifestation: pale tongue with swollen and large tongue coating and white tongue coating, and pulse: thready and weak pulse or deep and slow pulse.

1.2 case selection

1.2.1 inclusion criteria for subjects:

(1) those who meet the criteria for stage III diagnosis of diabetic nephropathy;

(2) those who meet the syndrome differentiation standard of spleen-kidney deficiency syndrome in traditional Chinese medicine;

(3) for group safety and balance, the age range of the tested population is 35 years to 70 years, and the exact course of diabetes is 6 years to 10 years;

(4) controlling the blood pressure of patients with hypertension to be 130mmHg to 80mmHg/80mmHg to 60 mmHg;

(5) subjects gave their informed consent and signed the consent.

1.2.2 test subject exclusion criteria:

(1) patients with non-diabetic nephropathy.

(2) It is combined with other serious primary diseases such as serious heart and brain diseases, abnormal liver function (AST and ALT are more than or equal to the upper limit of normal value by 1.5 times), hematopoietic system or malignant tumor, etc.

(3) Pregnant, lactating women, or patients with psychiatric disorders.

(4) Patients allergic to known components of the test drug.

1.2.3 knockout and shedding case criteria:

(1) patients cannot take the medicine regularly according to the research scheme, so that the curative effect cannot be accurately judged.

(2) Treatment was abandoned during the study, and the trial was automatically withdrawn or the trial was not completed as required.

(3) Those who meet the inclusion criteria but fail to complete the treatment cycle as prescribed and are withdrawn.

2. Research content and method

2.1 study design

(1) The design method comprises the following steps: using random control experiments

(2) Sample content:

PC: control group sample rate (ref. related literature, PC 71.25%); PT: test group sample rate (ref. related literature, PT — 89.77%); nT: number of test group samples; nc: number of control group samples; n: total number of samples, N ═ nT + nc; and (delta): the limit of effectiveness (after reference to the relevant literature, Δ ═ 3%); d: the difference between the two sets of rates desired to be detected, D ═ PT-PC; α: as a first type of error, α is 0.05; beta: as a second type of error, β ═ 0.20; the total sample size was estimated to be 150 cases. The total sample size was adjusted to 60 due to limited sample collection time and more limitations. Because events such as loss and sample rejection can occur in the research process, in order to meet the efficiency of statistical test, the sample size can be increased by 10 percent, 3 patients are needed in each group through preliminary calculation, at least 6 patients are added to two samples, and 66 patients are needed in total.

2.2 methods of investigation:

2.2.1 basic treatment

Each group controls and reduces blood sugar through positive diabetes knowledge learning, mental health education, proper exercise enhancement, diet intake control, and treatment of related medicines such as blood sugar reduction, blood pressure reduction, blood fat reduction (having little influence on kidney function) and the like, and possible emergency is timely treated.

(1) The blood pressure reduction treatment is selected as follows: non-ARB/ACEI antihypertensive drugs are required to be taken,

(2) the hypoglycemic therapy is selected as follows: insulin like, biguanide like drugs, alpha-glucosidase inhibitors;

(3) the lipid-lowering medicine is selected from: statins, fibrates (fenofibrate, bezafibrate), cholesterol absorption inhibition (ezetimibe).

2.2.2 clinical Observation of treatment

(1) Control group: only 50mg of losartan potassium tablets are given once on the basis of general treatment, 1 time a day and the tablets are taken orally; one treatment course is 12 weeks.

(2) Treatment groups: the kidney-tonifying granule containing herba Saussureae Involueratae is taken 5 g/time with boiled water for 2 times/day, and then losartan potassium tablet is taken 50mg each time for 1 time per day; one treatment course is 12 weeks.

2.3 Observation index

(1) General indexes are as follows: age, blood pressure, weight, course of disease

(2) The main indexes are as follows: clearance rate of microalbumin and endogenous creatinine in urine in 24 hours.

(3) Secondary indexes are as follows: traditional Chinese medicine syndrome score, kidney function, blood sugar, glycated hemoglobin, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), serum Total Cholesterol (TC), and serum triglyceride.

(4) The safety index is as follows: liver function and blood are conventional.

2.4 therapeutic efficacy assessment criteria

(1) And (3) judging the curative effect of the Western medicine: the curative effect is judged after 12 weeks of treatment. (refer to the related scheme of Chinese and Western medical treatment and treatment (second edition) for diabetes and its complications)

The effect is shown: the urinary microalbumin is reduced by more than 50 percent after 24 hours.

The method has the following advantages: the urine microalbumin is reduced by 30 to 50 percent after 24 hours.

And (4) invalidation: the urine microalbumin is reduced by less than 30 percent after 24 hours.

(2) The evaluation standard of the traditional Chinese medicine symptom curative effect is as follows:

by using the nimodipine method, the calculation formula is as follows:

the effect is shown: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the symptom integral is reduced by more than or equal to 70 percent and N is less than 90 percent.

The method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are slightly improved, and the symptom integral is reduced by more than or equal to 30 percent and less than 70 percent.

And (4) invalidation: the clinical symptoms and physical signs of the traditional Chinese medicine are not improved or aggravated, and the symptom integral is reduced by less than 30 percent.

3. Quality control

Subjects signed informed consent and followed the investigator's request to fill out the questionnaire to ensure the authenticity and validity of the test data.

Patients are diagnosed definitively by endocrinologists.

The patients are supervised and urged to take the medicine on time, and the compliance of the patients is enhanced, so that the data accuracy is increased.

4. Statistical data analysis

SPSS22.0 software is used for data statistics, and counting data are subjected to statistical analysis by chi-square test; measuring data, namely firstly checking whether the data accord with normal distribution, wherein the measuring data accord with the normal distribution is represented by a mean plus or minus standard deviation (), the data comparison among groups is checked by an independent sample t, and the data in the groups are checked and compared by a pair t; if the measured data does not conform to the normal distribution, non-parametric test is adopted. The grade data is calculated by Mann-Whitney U rank sum test, and the difference of P less than 0.05 has statistical significance.

5. Results

5.1 comparing the sex ratios of two groups of patients, and analyzing by chi-square test, wherein P is more than 0.05, and the difference has no statistical significance; the age and the disease course of two groups of patients are compared, and the difference is not statistically significant and has comparability after t test analysis of two independent samples, and the results are shown in table 1.

5.2 comparison of microalbumin in 24h urine in two groups of patients

After treatment, the urine microalbumin levels at 24 hours in both groups were lower than before treatment as analyzed by t-test, but after treatment the urine microalbumin levels were lower than in the control group (P0.007)<0.01), the differences were statistically significant, and the results are shown in table 2. It can be seen from table 2 that the treatment group and the control group both have a certain effect on reducing 24-hour urine microalbumin, but the treatment group has a better effect on improving 24-hour urine microalbumin than the control group. Wherein, in Table 2, compared to before treatment,^*P<0.05，^**P<0.01, compared with a control group^△P＜0.05，^△△P＜0.01。

5.3 comparison of creatinine clearance in two groups of patients

Prior to treatment, endogenous creatinine clearance was compared in two groups of patients and analyzed by t-test in groups, P>0.05, the difference is not statistically significant; after treatment, the endogenous creatinine clearance level of the two groups of patients is higher than that before treatment through matching t test analysis, but the endogenous creatinine clearance level of the treatment group of patients is higher than that of the control group (P is 0.01)<0.05), the difference is statistically significant,the results are shown in Table 3. It can be seen from Table 3 that the treatment group and the control group had a certain effect of increasing endogenous creatinine clearance, but the treatment group had a better effect. Wherein, in Table 3, compared to before treatment,^*P<0.05，^**P<0.01, compared with a control group^△P＜0.05，^△△P＜0.01。

5.4 comparison of blood lipid indicators for two groups of patients

Before treatment, the four blood lipids of two groups of patients are compared, P>0.05, the difference is not statistically significant; after treatment, the total cholesterol levels in the treatment group patients are lower than before treatment, P<0.05; treatment groups triglyceride, low density lipoprotein and high density lipoprotein compared to pretreatment, P>0.05, the difference is not statistically significant; control group lipid four items compared with before treatment, P>0.05, the difference was not statistically significant, and the results are shown in Table 4. From Table 4, the total cholesterol, triglyceride, low density lipoprotein and high density lipoprotein levels in the two groups of patients after treatment are compared, and P is>0.05, the difference was not statistically significant. Wherein, in Table 4, compared to before treatment,^*P<0.05, compared with the control group^△P＜0.05。

5.5 comparison of glycated hemoglobin in two groups of patients

Before treatment, the glycated hemoglobin levels of the two groups of patients were compared, P>0.05, the difference is not statistically significant; after treatment, the glycated hemoglobin levels in both groups were lower than before treatment. The level of glycated hemoglobin after treatment was lower in the patients in the treatment group than in the control group (P0.024)<0.05), the differences were statistically significant, and the results are shown in table 5. It can be seen from table 5 that the treatment group and the control group had a certain effect of reducing glycated hemoglobin, but the treatment group was more significant. Wherein, in Table 5, compared to before treatment,^*P<0.05，^**P<0.01, compared with a control group^△P＜0.05，^△△P＜0.01。

5.6 Chinese medicine syndrome integral comparison of two groups of patients

Whether the treatment group or the control group has statistical significance before and after treatment (P is less than 0.01); after treatment, the Chinese medicine syndrome integrals of the two groups of patients are analyzed by matching t test, and the Chinese medicine syndrome integrals of the treatment group are lower than those of the control group P<0.05, the differences were statistically significant, and the results are shown in Table 6. As shown in Table 6, the treatment group and the control group both improved the symptoms related to TCM, but the treatment group showed better effect. Wherein, in Table 6, compared to before treatment,^*P<0.05，^**P<0.01, compared with a control group^△P＜ 0.05，^△△P＜0.01。

5.7 clinical curative effect comparison of Chinese medicine syndrome of two groups of patients

The treatment group has 11 cases of obvious effect, 17 cases of effective effect and 2 cases of ineffective effect, and the effective rate is 93.33 percent; the control group has 5 effective cases, 18 effective cases and 7 ineffective cases, and the effective rate is 76.67 percent. The clinical efficacy of both groups was tested by Mann-Whitney U rank sum, P <0.05, the difference was statistically significant, and the results are shown in Table 7. As can be seen from Table 7, the therapeutic effect of the treatment group was significantly better than that of the control group in terms of improving clinical symptoms of TCM.

5.8 comparison of the level of the combined therapeutic effects of two groups of patients

The comprehensive curative effects of the two groups after treatment are analyzed, the curative group has 13 cases of obvious effect, 12 cases of effective effect and 5 cases of ineffective effect, and the total effective rate is 83.33 percent; the control group showed 6 cases of significant effect, 12 cases of effective effect and 12 cases of ineffective effect, the total effective rate was 60%, and the results are shown in table 8. As shown in Table 8, the rank-sum test showed that the two groups had differences, and the combined therapeutic effect of the treatment group was better than that of the control group (P ═ 0.021 < 0.05).

5.9 comparison of safety indices (ALT, AST, Cr, BUN) of two groups before and after treatment

Compared with the comparative level of the safety indexes of the two groups before treatment (P is more than 0.05), the safety indexes have no statistical difference; after treatment, ALT levels were higher than before treatment, P was <0.05, and the differences were statistically significant but within normal ranges for the control group, ALT compared to before treatment, AST compared to before treatment, and P compared to before treatment>0.05, the difference was not statistically significant, and the results are shown in Table 9. As can be seen from Table 9, the liver function and kidney function indexes of the two groups after the test are within the normal range, and have no obvious difference compared with the former. Wherein, in Table 9, compared to before treatment,^*P<0.05, compared with the control group^△P＜0.05。

In conclusion, the traditional Chinese medicine compound preparation is prepared by taking authentic traditional Chinese medicinal materials as raw materials, and clinical treatment shows that the traditional Chinese medicine compound preparation has excellent curative effect in medicines for treating or preventing diabetes, nephropathy, senile deficiency syndrome and hypertension, and has no toxic or side effect.

The technical characteristics form an embodiment of the invention, which has strong adaptability and implementation effect, and unnecessary technical characteristics can be increased or decreased according to actual needs to meet the requirements of different situations.

TABLE 1

TABLE 2

TABLE 3

TABLE 4

TABLE 5

TABLE 6

TABLE 7

Group of	Number of examples	Show effect	Is effective	Invalidation	High efficiency
						Treatment group	30	11	17	2	93.33％
Control group	30	5	18	7	76.67％

TABLE 8

Group of	Number of examples	Show effect	Is effective	Invalidation	High efficiency
						Treatment group	30	13	12	5	83.33％
Control group	30	6	12	12	60.00％

TABLE 9

。

Claims

1. The traditional Chinese medicine compound preparation for treating or preventing diabetic nephropathy is characterized by comprising raw material components and auxiliary materials, wherein the main material components comprise, by weight, 10-30 parts of snow lotus, 9-15 parts of eucommia ulmoides, 9-15 parts of rhizoma cibotii, 8-15 parts of radix cyathulae, 15-30 parts of centella asiatica, 10-15 parts of cistanche, 15-30 parts of astragalus membranaceus, 9-15 parts of poria cocos, 10-15 parts of red paeony root, 6-15 parts of radix paeoniae alba, 6-12 parts of moutan bark and 10-15 parts of salvia miltiorrhiza, and the auxiliary materials comprise, by weight, 50-400 parts of starch, 50-400 parts of lactose, 50-200 parts of dextrin, 50-400 parts of mannitol and 50-200 parts of sodium carboxymethyl starch, and are prepared according to the following method: firstly, extracting a required amount of main materials for 1 to 4 times by using water or 30 to 80 volume percent of ethanol at the temperature of 30 to 100 ℃, combining obtained extracting solutions, filtering, concentrating and drying to obtain a mixture extract, wherein the weight ratio of the water or 30 to 80 volume percent of ethanol to the mixture extract is 8 to 20:1, and the extraction time is 0.5 to 3 hours; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing into granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation.

2. A preparation method of the traditional Chinese medicine compound preparation according to claim 1 is characterized by comprising the following steps: firstly, extracting a required amount of main materials for 1 to 4 times by using water or 30 to 80 volume percent of ethanol at the temperature of 30 to 100 ℃, combining obtained extracting solutions, filtering, concentrating and drying to obtain a mixture extract, wherein the weight ratio of the water or 30 to 80 volume percent of ethanol to the mixture extract is 8 to 20:1, and the extraction time is 0.5 to 3 hours; and uniformly mixing the mixture extract with required amount of auxiliary materials, and preparing into granules, capsules or tablets according to a conventional preparation method of a pharmaceutical formulation.

3. The use of the compound Chinese medicinal preparation according to claim 1 in the preparation of a medicament for treating or preventing diabetic nephropathy.