KR20100020461A - A new use of traditional chinese medical composition - Google Patents

Abstract

The use of traditional Chinese medical composition in manufacturing pharmaceutical for treating dilated cardiomyopathy. The said composition can treat dilated cardiomyopathy by efficiently improving cardiofuction and in some measure improving ventricular re-structure.

Description

New Uses of Chinese Medicine Compositions {A NEW USE OF TRADITIONAL CHINESE MEDICAL COMPOSITION}

TECHNICAL FIELD The present invention relates to a new use of a kind of Chinese medicine composition, and more particularly, to the application of a kind of Chinese medicine composition in the manufacture of a dilated cardiomyopathy therapeutic drug and an application in the treatment of dilated cardiomyopathy.

Dilated Cardiomyopathy (DCM) refers to the expansion of the left and right ventricles or both ventricles, accompanied by symptoms of myocardial hypertrophy. Since congestive cardiomyopathy occurs mainly, it was conventionally called congestive cardiomyopathy. Dilated cardiomyopathy is the most common of cardiomyopathy, accounting for about 70-80% of cardiomyopathy. Common symptoms include loss of ventricular contraction, heartbeat abnormalities, and myocardial weakness. The condition is progressively weighted and death can occur at any stage of the disease. Clinically, the disease can be spread evenly at each age, but middle-aged adults have been the majority. (Jin Ho-Ju << Practical Internal Medicine >> 10th Edition. P1329-1333.

Dilated cardiomyopathy is on the rise worldwide, and until now, the cause of the disease has not been fully understood and there is no specific treatment, leading to high disability and mortality. Medication is still a universal best choice for improving cardiac breakdown symptoms and controlling prognosis in patients with dilated cardiomyopathy. In some cases, however, conventional anti-heart failure treatment and the use of β receptor blockers and angiotensin converting enzyme inhibitors (ACEI) still do not achieve good effects.

Dilated cardiomyopathy is currently the most common cause of myocardial weakness, clinically characterized by heart enlargement, myocardial weakness, embolism, heart rhythm abnormalities, and sudden death. Pathological changes include diminished cardiomyocytes, enlargement of residual cardiomyocytes, proliferation of interstitial collagen, thinning of the ventricular wall, and enlargement of the heart cavity. The cause of the disease is unclear, there are no specific treatments, the prognosis is poor, the disease has a high mortality and mortality rate, the cost of heart transplantation is high, and the use of large amounts of immunosuppressants is required. Other therapeutic drugs are constantly being used to improve clinical symptoms and long-term prognosis in patients with dilated cardiomyopathy.

The herbal composition of the present invention improves blood flow dynamics, relieves cardiac weakness, and relieves left ventricular remodeling through cardiac, diuretic, vasodilatation and renin-angiotelisin system (RAS). I want to get the effect.

The present invention has been made on the basis of Chinese patent ZL 02146573.8. Chinese patent ZL 02146573.8 discloses a drug composition used in the treatment of cardiac weakness, and the present invention has unexpectedly demonstrated a new treatment for treating dilated cardiomyopathy, which is unexpectedly unknown in its cause, and for treating dilated cardiomyopathy. It was discovered that the drug provides.

It is an object of the present invention to provide an application in the manufacture of a kind of Chinese medicine for treating myocardial diseases and an application in the treatment of cardiomyopathy.

It is also an object of the present invention to provide an application in the manufacture of a drug for the treatment of dilated cardiomyopathy of a kind of Chinese herbal composition and for the treatment of dilated cardiomyopathy.

It is also an object of the present invention to provide an application in the manufacture of a medicament for the treatment of chronic myocardial weakness caused by dilated cardiomyopathy of a kind of Chinese herbal composition and in the treatment of chronic myocardial weakness due to dilated myocardial disease. There is.

를 저하시키는 약물 제조에 있어서의 응용 및 확장성 심근병 중 혈청 뇌나트륨이뇨 펩타이드를 저하시키는데 있어서의 응용을 제공하고자 하는 데 있다. An object of the present invention is also a serum cerebral natriuretic peptide in the treatment of dilated cardiomyopathy of a kind of Chinese herbal composition.

It is an object of the present invention to provide an application in the manufacture of a drug that lowers the serum cerebral natriuretic peptide in dilated cardiomyopathy.

It is also an object of the present invention to provide an application in the manufacture of a drug for reducing myocardial necrosis during the treatment of dilatant myocardial disease of a kind of Chinese herbal composition and an application in the reduction of myocardial necrosis in dilatable myocardial disease.

It is also an object of the present invention to provide an application in the manufacture of a drug for reducing myocardial fibrosis in dilated cardiomyopathy of a kind of Chinese herbal composition and an application in reducing myocardial fibrosis in dilated cardiomyopathy.

It is also an object of the present invention to provide a method for the preparation of a kind of drug composition for treating cardiomyopathy.

The technical means of the present invention for realizing the above technical objects are as follows.

150~450 중량분, 부자(附子) 40~120 중량분, 인삼(人蔘) 또는 당삼(黨蔘) 75~225 중량분, 단삼(丹蔘) 75~225 중량분, 정력자

(재쑥) 50~150 중량분, 향가피(香加皮) 또는 남오가피(南五加皮) 60~180 중량분, 택사(澤瀉) 75~225 중량분, 옥죽(玉竹) 25~75 중량분, 계지(桂枝) 30~90 중량분, 홍화(紅花) 30~90 중량분, 진피(陳皮) 25~75 중량분의 원료 약재로 제조된다. In application of a kind of Chinese medicine composition for the treatment of cardiomyopathy, the Chinese medicine composition is Astragalus

150 to 450 parts by weight, rich man 40 to 120 parts by weight, 75 to 225 parts by weight of ginseng or sugar ginseng, 75 to 225 parts by weight of sweet ginseng, energetic

50 to 150 parts by weight, 60 to 180 parts by weight of incense or Namogapi, 75 to 225 parts by weight of tajik, 25 to 75 of jade bamboo It is manufactured from the raw material medicine of 30 to 90 weight part of the weight part, gyeji, 30 to 90 weight part of safflower, and 25 to 75 weight part of the dermis.

In the application of a kind of Chinese medicine composition for the treatment of dilated cardiomyopathy and in the treatment of dilated cardiomyopathy, the Chinese medicine composition is 150-450 parts by weight, 40-120 parts by weight, ginseng or Ginseng 75 ~ 225 weight part, Dansam 75 ~ 225 weight part, sperm 50 ~ 150 weight part, scented or Namgapi 60 ~ 180 weight part, Taxa 75 ~ 225 weight part, Jade porridge 25 ~ 75 weight part, Cage 30 ~ It is prepared from raw materials of 90 weight parts, safflower 30-90 weight parts, dermis 25-75 weight parts.

In the application of the drug in the treatment of chronic myocardial weakness due to a diminished myocardial disease of a kind of Chinese medicine composition and in the treatment of chronic myocardial weakness due to dilated cardiomyopathy, the Chinese herbal composition is described in Astragalus 150-450 Weight, Rich 40-120 Weight, 75-225 weight of Ginseng or Ginseng, 75-225 weight of Sweet Ginseng, 50-150 weight of Energizer, 60-180 weight of Scented Skin or Namgapi, 75-225 Weight of Taxa It is prepared from raw materials of powder, 25-75 weight parts of jade, 30-90 weight parts of cinnamon, 30-90 weight parts of safflower, and 25-75 weight parts of dermis.

The herbicidal composition is preferably used in the preparation of drugs for lowering the serum cerebral natriuretic peptide in the treatment of dilated cardiomyopathy, and in the application of the lowering serum cerebral natriuretic peptide in the treatment of dilated cardiomyopathy.

The herbal composition is preferably used in the manufacture of drugs to reduce myocardial necrosis during the treatment of dilated cardiomyopathy and in the application of the myocardial necrosis during the treatment of dilated cardiomyopathy.

The herbal composition is preferably used in the manufacture of drugs to reduce myocardial fibrosis in the treatment of dilated cardiomyopathy and in the application of the myocardial fibrosis in the treatment of dilated cardiomyopathy.

The Chinese herbal composition is 450 parts by weight of Astragalus, 112.5 parts by weight, rich in ginseng or sugar ginseng 225 parts by weight, 225 parts by weight of sweet ginseng, 150 parts by weight of sperm (woodwort), 180 parts by weight of scented skin or Namgapi, 225 parts by weight of tack, It is preferable to be prepared from the raw material medicine of 75 parts by weight, 90 parts by weight of cinnamon, 90 parts by weight of safflower, and 75 parts by weight of dermis.

The Latin names of the herbal medicines in the Chinese herbal composition of the present invention and the processing method thereof are << Chinese Herbal Dictionary >> (July 1977, first edition, Shanghai Science and Technology Press) and <Chinese Pharmacopoeia> (2005 edition, Chemical Industry) Publisher).

The Chinese medicine composition active ingredient of the present invention can be prepared by the general extraction process [for example, pan-wall tablet << Chinese medicine pharmaceutical company (first edition of Shanghai, 1997, December 1997)] to prepare the composition of the present invention, The active ingredient of the composition is more preferably composed of the active ingredient obtained by the following process.

1) Extract Astragalus, Energizer, Taxa, Ginseng or Ginseng, Persimmon or South Ogapi with 70% ethanol, and after filtering, the extract will be a thin paste with a relative density of 1.25-1.30 at 50-70 ℃. Concentrate until

2) Extract the volatile oil from the skin and dermis with water to obtain volatile oil A, aqueous solution B and medicinal waste C.

3) After adding water, sweetened ginseng, jade and safflower to water, the obtained aqueous solution is filtered to obtain filtrate D.

4) Filter the aqueous solution B after extraction of volatile oil from the basal and dermis, collect the aqueous solution filtrate E, add water, add medicinal dregs C, and filter to obtain filtrate F.

5) The filtrate D, the filtrate E, and the filtrate F are mixed and concentrated to a thin paste having a relative density of 1.25 to 1.30. Then, ethanol is added while stirring. When the alcohol concentration reaches 60 to 80%, It is left to stand and filtered, and it concentrates by filtration at 60-70 degreeC so that it may become thin paste G with a relative density of 1.25-1.30.

6) The thin paste obtained in step 1), the volatile oil A and the thin paste G obtained in step 5) constitute the active ingredient which is the drug of the present invention.

The active ingredient of the inventive herbal composition may also be composed of the active ingredient obtained by the following process.

1) Extract Astragalus, Energizer, Taxa, Ginseng or Dried Ginseng, Scented Ginseng or Southern Oysters with an appropriate amount of 70% ethanol and filter, and extract the dilute paste with a relative density of 1.25 ~ 1.30 (measured by 60 ℃ heat). Concentrate until

2) Extract the volatile oil of gyeji and dermis.

3) After adding a suitable amount of water to decoction rich, sweet ginseng, jade and safflower, the obtained aqueous solution is filtered.

The aqueous solution after extracting the oil from the gage and the dermis is filtered, and the collected aqueous solution is filtered, and then a suitable amount of water is added to sweeten the residue, followed by filtration to mix the aqueous solution. The various aqueous solutions obtained above were mixed and concentrated so as to be a thin paste having a relative density of 1.25 to 1.30, and ethanol was added during the stirring process, and when the concentration of alcohol reached 70%, the solution was left still and filtered, and the relative density was 60 ° C. Filter and concentrate until a thin paste of 1.25 to 1.30 (measured by heat).

The herbal compositions of the invention may also be in accordance with the general formulation process. According to the preparation process described, for example, in Pan-Wall Tablet <First Chinese Medicine> (1st December 1997, Shanghai Scientific Publication), any of the general pharmaceutical forms that are pharmaceutically acceptable, such as capsules, tablets, granules, It can also be prepared by preparations such as powder, oral solution, pills.

In the application of the present invention, the herbal composition is one of the preparations such as capsules, tablets, granules, powders, oral solution, pills, etc., so that the formulation can be realized, a pharmaceutically acceptable adjuvant when preparing such a formulation, For example, fillers, disintegrants, lubricants, suspending agents, thickeners, sweeteners, copulating agents, preservatives, ground substances and the like can be added. Fillers include starch, pregelatinized starch, lactose, mannitol, chitosan, microcrystalline fiber and sucrose, and disintegrants include starch, pregelatinized starch, microcrystalline fiber, sodium carboxymethyl starch and crosslinked polyvinylpi Ralidone, low-substituted hydroxypropyl cellulose, crosslinked sodium carboxymethyl cellulose, and the like. Lubricants include magnesium stearate, sodium dodecyl sulfate, talc powder, silicon dioxide, and the like, and suspending agents include polyvinyl pyrrolidone, microcrystalline fiber, sucrose, agar, hydroxypropylmethyl cellulose, and the like. Examples of the binder include starch paste, polyvinyl pyrrolidone, hydroxypropylmethyl cellulose, and the like, and saccharin sodium, aspartame, sucrose, molasses and glycyrrhetinic acid. Mating agents include sweetening agents and various essences, and preservatives include parabens, benzoic acid, sodium benzoate, sorbic acid and salts thereof, benzalkonib bromide, chlorhexidine acetate, eucalyptus and the like. Substrates include PEG6000, PEG4000, insect wax, and the like. In order to enable the formulation to realize Chinese herbal pharmaceuticals, it is necessary to add other pharmaceutically acceptable auxiliary ingredients when preparing such formulations. Auxiliary materials described in each formulation in the first edition).

Chinese medicine composition dose of the present invention is calculated by the total weight of the active ingredient raw material medicine, can be taken once daily, 4-20g / day, it is preferable to take divided into 2 to 4 times, and also the amount of 6 ~ 12g / day It is preferred to take 2 to 4 divided doses, and more preferably, divided by three times the amount of 7.59g / day.

According to pharmacological experiments, the drug compositions and formulations of the present invention can both improve the contractile function of DCM cardiovascular rats, improve nutritional status and improve ventricular remodeling of cardiac cardiac rats, and expand dilated cardiomyopathy and It has been shown that it can cure myocardial weakness. In order to prove that the herbal composition of the present invention treats the activity of dilated cardiomyopathy, the following animal experiment was conducted using the capsule contents dry powder (hereinafter referred to as drug of the present invention) obtained in Example 1.

Experimental Example 1) Drug Test

1. Materials and Methods

1.1 Study Subject and Group Classification

Eighteen Wistar rats (Beijing Vital River Laboratory Animal Center, Permit No. SCXK (R) 2002-0003) randomly 6 normal groups (Group A), dilated cardiomyopathy (hereinafter abbreviated as DCM) heart 6 groups of debilitating group (group B) and 6 groups of drug group (group C) of the present invention. Among them, rats of Group B and Group C produced Adriamycin (Shenzhen Manlak Pharmaceutical Co., Ltd., lot number: 0407E1) every 2.5mg / kg, 3 times / week, 1 Two weeks at weekly intervals were injected, and a total of six doses of 15 mg / kg was injected using a week. After the last injection was completed, a DCM cardiac breakdown model was constructed by observing for four weeks. After model success, the group C drug of the present invention (1g powder drug / kg, once / day) was gastrointestinal irrigation for 1 month, group A and B was observed by gastrointestinal irrigation for 1 month.

2. Observation Indicators and Statistical Methods

2.1 Observational Indicators

2.1.1 Determination of Serum Brain Natriuretic Peptides (BNP, abbreviated as BNP):

All rats were placed in fasting venous blood 1-1.5ml in the early morning before and after treatment, left for 30 minutes or more, and then serum was extracted by centrifugation at 3000 r / min for 15 minutes and stored at -20 ° C. The BNP measurement was performed using a double-antibody sandwich ELISA method, and KIT was purchased from Shanghai Huanhu Science and Technology Co., Ltd. (上海 軒 昊 科技 發展 有限公司).

2.1.2 Measurement of Cardiac Function in Rats:

All animals were anesthetized with 20% urethane after treatment, filled with heparinized saline in the catheter, and inserted the tube from the right cervical common artery to the left ventricle, and a hemodynamic microcomputer analysis system泰 盟)) to measure the function of the left ventricle. Indices representing contractile function include left ventricular systolic pressure (LVSP) and maximum intraventricular pressure ascending speed (dp / dt max), and indices representing relaxation function include left ventricular diastolic pressure (LVEDP) and left ventricular pressure maximum descending velocity ( -dp / dt max).

2.1.3 Detection of Myocardial Remodeling:

① After measurement of hemodynamics, the rat's weight (BW) is weighed, and then killed and the heart is extracted. The total heart mass (HW) and left ventricular mass (LW) are measured, and the total heart mass index (HW / BW) and left ventricular mass index (LW / BW) are calculated, respectively.

② A portion of the left ventricular myocardial tissue is taken and normal hematoxylin-iosin staining (HE staining) and collagen fiber staining (V _G staining) are performed to observe the degree of myocardial necrosis and fibrosis, respectively. Myocardial necrosis is classified as Level 4 according to the standard (Blasing LE, et al. Absolute and relative cardiomyopathy due to overdose of norepinephrine. Biomedical Student Chemistry, 1985; 44: 1641). Class I: Point necrosis, confined to the lower endocardium. Class II: There is no connection between micronecrosis and lesions. Class III: Extensive plaque necrosis, connection between lesions, spread across floors. Class IV: Confluent necrosis throughout the heart. The degree of interstitial fibrosis was observed by V _G staining. Scoring standard: "-" no interstitial collagen visible in multiple visual field; Occasional visible interstitial short interstitial fibers; "++" interstitial fibers take the form of long ropes; "+++" interstitial fibers are connected to each other in a net form.

2.2 Statistical Methods:

Quantitative data such as BNP and cardiac function are expressed as X ± S. Data were analyzed using statistical software SPSS 12.0, and P <0.05 was judged to have a significant difference. Single element analysis was used for the comparison between groups, and rank sum test was used to compare myocardial necrosis and interstitial fibrosis.

3. Results

3.1 Comparison of BNP results for each group (see Table 1)

Table 1 below is a comparison ( X ± S ) of the BNP results of each group.

  A group (n = 6)  B group (n = 6)  C group (n = 6) Before treatment  1128.35 ± 256.32 1410.75 ± 97.09 ^★ 1462.44 ± 242.87 ^★ After treatment  1024.19 ± 204.29 1660.18 ± 210.87 ^{■ ▲} 1270.72 ± 203.72 ^{■ ▲}  Note: In the comparison of each group before and after treatment, ■ indicates P <0.05. ★ indicates P <0.05 compared to groups B and C before treatment. In the comparison between each group after treatment, ▲ represents P <0.05.

As a result of BNP measurement, in comparison of each group before treatment, both groups B and C were higher than group A, which had statistical significance, and group B and C had no statistical significance. In the pre and post treatment comparisons of each group, group B was higher than post-treatment treatment, and group C was lower than post-treatment treatment, all having statistical significance. Group A before and after treatment had no statistical significance, and in comparison of each group after treatment, group B and C were both higher than group A, group C was lower than group B, and group C was higher than group A. All of these have statistical significance.

3.2 Comparison of cardiac function results for each group (see Table 2):

Table 2 below compares the cardiac function results of each group ( X ± S ).

 LVSP (Kpa) dp / dt _max (Kpa / s) LVDEP (Kpa) -dp / dt _max (Kpa / s) A group (n = 6)  19.58 ± 1.87  842.60 ± 86.18  -0.82 ± 1.24  550.00 ± 89.53 B group (n = 6) 13.62 ± 1.44 ^▲ 564.00 ± 72.77 ^▲ 0.34 ± 1.15  449.80 ± 59.90 C group (n = 6) 16.76 ± 3.17 ^{● ■} 721.40 ± 115.10 ^{● ■}  -0.04 ± 0.82  542.40 ± 76.92  Note: In the comparison of group B and A, ▲ indicates P <0.05, in the comparison of group C and B, ● indicates P≤0.05, and in the comparison of group C and A, ■ indicates P> 0.05 Indicates.

After treatment, LVSP and dp / dt _max of systolic function index were lower in group B than group A, and group C was higher than group B, all of which have statistical significance. No scientific significance was found. LVDEP and -dp / dt _{max, which} are indicative of relaxation function, did not show any significant difference in the comparison between the three groups.

3.3 Comparison of body weight, total heart mass index and left ventricular mass index for each group (see Table 3):

Table 3 below compares ( X ± S ) the body weight, total heart mass index and left ventricular mass index of each group.

 BW (g)  HW / BW (g / kg)  LW / BW (g / kg) A group (n = 6)  359.43 ± 22.56  2.71 ± 0.17  2.14 ± 0.19 B group (n = 6) 272.57 ± 16.54 ^▲ 2.17 ± 0.17 ^▲ 1.77 ± 0.15 ^▲ C group (n = 6)  308.80 ± 6.30 2.66 ± 0.40 ^■ 2.07 ± 0.20 ^■  Note: In the comparison of group B and A, ▲ indicates P <0.05, and in the comparison of group C and B, ■ indicates P <0.05.

In the post-treatment results, the BW of group B was significantly reduced than that of group A, which was statistically significant, and group C was higher than group B, but there was no statistical significance, and comparison between group C and group A had no statistical significance. Appeared. In HW / BW and LW / BW, group B is lower than group A, group C is higher than group B, and both have statistical significance, and comparison between group C and group A has no statistical significance.

3.4 Results of myocardial necrosis and fibrosis in each group (see Table 4):

Table 4 below compares the degree of myocardial necrosis and fibrosis in each group.

 Average Rank Sum of Myocardial Necrosis  Average Rank Sum of Myocardial Fibrosis A group (n = 6)  21   21 B group (n = 6) 72.5 ^▲ 78.5 ^▲ C group (n = 6) 50.5 ^{▲ △} 51.5 ^{▲ △}  Note: In the comparison between Group B, Group C and Group A, P denotes P <0.01, and in the comparison of Group C and Group B, Δ represents P <0.05.

In the post-treatment results, myocardial necrosis: Groups B and C were more severe than Group A, and statistically significant, Group C was less than Group B, and statistically significant. Myocardial fibrosis: Groups B and C All of the groups had higher statistical significance than the A group, and the C group had lower statistical significance than the B group.

In the accompanying drawings, Fig. 1 is a microscopic view of group A rat myocardium stained with a general HE staining method (HE × 100), showing that the myocardial cells and myofibrillar array are neat, and that myofibrils are intact and unbroken. Can be. FIG. 2 is a microscopic view of group B rat myocardium stained with normal HE staining (HE × 100). The myocardial cell array is disturbed, the cell nuclei of some cells are lost, and the cytosol is lightly stained. can see. Figure 3 is a microscopic view of the myocardium of group C rats stained with normal HE staining (HE × 100), showing that myocardial cells and myofibrillar arrays are more orderly than the cardiac breakdown group, and myofibrils are still complete. Fig. 4 is a micrograph showing the myocardium of group B rats stained with normal HE staining (HE × 100), where large portions of myocardial cells are necrotic. FIG. 5 is a microscopic diagram of normal B staining of myocardium of group B (HE × 100), showing that large portions of myocardial cells are necrotic and myofibrils are broken. 1 to 5 after the drug treatment of the present invention, it can be seen that myocardial necrosis and myocardial fibrosis were significantly reduced than the cardiac breakdown group. Figure 6 is a microscopic view of the myocardium of group B rats stained by a general V _G staining method (V _G × 100), a large number of rope-like interstitial collagen fibers can be seen, denoted by ++. FIG. 7 is a micrograph of the myocardium of group C rats stained by a general V _G staining method (V _G × 100), where interspersed short interstitial collagen fibers are visible and denoted with +. 6 to 7, after the drug treatment of the present invention, it can be seen that myocardial cell interstitial collagen fibers are significantly reduced.

The present invention employs a method of injecting adriamycin into the abdominal cavity to produce a cardiac breakdown model of DCM rats. After one month of gastrointestinal irrigation treatment of the drug of the present invention, LVSP and dp / dt _max rises above the cardiac breakdown group and has statistical significance. LVDEP and -dp / dt _max , representing relaxation functions, had no statistical significance compared to the cardiac breakdown group, demonstrating that the drug of the present invention significantly improves the contractile function of DCM rats but does not improve the relaxation function. do. BNP is a polypeptide with 32 amino acids secreted mainly from the ventricles and represents a response to ventricular volumetric expansion and pressure loading. A large number of studies at home and abroad have already demonstrated that BNP serves as a serum / plasma marker of myocardial weakness and is used for diagnosis, treatment and prognosis of myocardial weakness. In the results of the body, the serum BNP of the cardiac breakdown group was significantly higher than that of the normal group, and after the gastrointestinal irrigation treatment of the drug of the present invention, the BNP level was clearly lowered and it was statistically significant. The successful construction of a cardiac breakdown model of the study demonstrates that the drug of the present invention can significantly improve the cardiac function of DCM rats. HW / BW and LW / BW in the cardiac breakdown group are significantly lower than in the normal group, corresponding to changes in DCM. After treatment, HW / BW and LW / BW increased, and also had statistical significance, demonstrating that the drug of the present invention can improve ventricular remodeling. Myocardial necrosis and interstitial collagen fibrosis in the drug group of the present invention were significantly reduced than the cardiac breakdown group, which explains that the drug of the present invention can suppress myocardial necrosis and prevent ventricular remodeling due to myocardial interstitial fibrosis.

Experimental Example 2) Clinical Trial:

1. Clinical data

1.1 General data: All 60 cases of selected pathology were outpatient care cases of Hebei Yiling Hospital between 2005 and 2006, including 38 cases of males and 22 cases of females. 28 cases of 56-65 years and 20 cases of 66-74 years.

1.2 Screening Standards: All meet WHO diagnostic standards. ① On the ECG, the heart was enlarged, the ventricular wall was thinned, and myocardial diminished heartbeat was demonstrated. ② Coronary heart disease, rheumatic heart disease, congenital heart disease, viral myocarditis and other definite heart disease were excluded.

1.3 Standard for Determination of Therapeutic Effect: Clinical symptoms such as palpitations, edema, loss of cardiac shade, and reduction of heart failure are considered clinical healing. After treatment, edema is lost, palpitations are alleviated, and a slight reduction in cardiac shade is considered effective.

2. Treatment method: All cases are taken three times a day, three capsules each time the capsules prepared by the method according to Example 1 of the present invention, the medication cycle is a course of 1-3 treatments, every treatment course is 1 month There is a one week interval between treatments.

3. Results: Clinically, 42 cases were cured, 17 cases were improved, 1 case was invalid, and total efficiency was 98%. Patients with non-critical cardiac echocardiography lost edema after medication during one course of treatment, diminished palpitations and shortness of breath, and were able to cure clinically if taken during four course of treatment. Severe patients with wide spread heart murmurs lost edema after medication for two treatments, reduced palpitations, shortness of breath, and reduced liver and spleen. During the four treatment sessions, cardiac breakdown was controlled after the medication and all clinical symptoms were alleviated.

4. Conclusion: The drug of the present invention has a clear effect on the treatment of dilated cardiomyopathy.

Example 1

Capsule

Prescription:

Astragalus 450g, Rich 112.5g, Ginseng 225g, Salvia 225g, Energetic 150g, Scented Skin 180g, Taxa 225g, Safflower 90g, Jade porridge 75g, Dermis 75g

Formulation Method:

(1) 8 times amount (weight ratio) of Astragalus, sperm, taxa, ginseng, and scented skin were added in an amount of 8 times (weight ratio), and returned to 70% ethanol and extracted twice for the first 3 hours and the second 2 hours. The mixture is extracted, filtered, and filtered. The filtrate is reduced in pressure to recover ethanol, and then concentrated to prepare a thin paste having a relative density of 1.25 to 1.30 (measured at 60 ° C. heat).

(2) The distillate and dermis are distilled at a ratio to extract volatile oil, and the aqueous solution after extraction is prepared by filtration. The debris is decanted for 8 hours by adding 8 times the amount of water and then filtered and mixed with the aqueous solution. .

(3) Add 9 times the amount (weight ratio) of water to the rich, sweet ginseng, jade bamboo, and safflower and add twice. After 2 hours of decoction each time, extracts were mixed and filtered, and the solution of the basal and dermal solution in step 2) was concentrated, and then concentrated to a thin paste having a relative density of 1.25 to 1.30 (measured by 60 ° C heat), followed by mixing. Ethanol was added in the process, and when the alcohol concentration reached 70%, the solution was left still at 4 ° C. or lower for 24 hours, filtered, and the filtration was decompressed to recover ethanol, and the relative density reached 1.25 to 1.30 (measured by 60 ° C. heat). Concentrate to a thin paste, mix with alcohol extraction dilute paste of step (1), and dry at 65 ~ 70 ℃.

(4) The dried paste is mixed and pulverized into 100 mesh powder, and 70% of ethanol is added to prepare granules. .

Dosage: 4 tablets each time, 3 times daily, used to treat dilated cardiomyopathy.

Example 2

Preparation of Active Ingredients

Prescription:

Astragalus 450g, Rich 112.5g, Ginseng 225g, Salvia 225g, Energetic 150g, Scented Skin 180g, Taxa 225g, Safflower 90g, Jade porridge 75g, Dermis 75g

Formulation Method:

1) Extract Astragalus, Energizer, Taxa, Ginseng or Ginseng, Persimmon or Namgapi with 70% ethanol and filter, and extract the distillate at 50-70 ℃ until it becomes a thin paste with a relative density of 1.25-1.30. Concentrate.

2) Extract the volatile oil from the skin and dermis with water to obtain volatile oil A, aqueous solution B and medicinal waste C.

3) Add water, sweet ginseng, jade, safflower, add water, and filter the obtained aqueous solution to obtain filtrate D.

4) Filter the aqueous solution B after extraction of volatile oil from the basal and dermis, collect the aqueous solution filtrate E, add water, decoct the medicinal residue C, and filter to obtain the filtrate F.

5) The filtrate D and the filtrate E are mixed, and the filtrate F is mixed and concentrated until it becomes a thin paste having a relative density of 1.25 to 1.30. Then, ethanol is added during stirring to give an alcohol concentration of 60 to 80%. Allow to stand still, filter, and concentrate the filtrate at 60-70 ° C until a thin paste G with a relative density of 1.25-1.30.

6) A thin paste obtained in step 1), volatile oil A and a thin paste G obtained in step 5) form the active ingredient of the herbal composition.

Example 3

Capsule

Prescription:

Astragalus 450g, Rich 112.5g, Ginseng 225g, Salvia 225g, Energetic 150g, Namgapi 200g, Taxa 225g, Safflower 90g, Jade porridge 75g, Dermis 75g Cinnamon 90g

1000 capsules are prepared by the general procedure.

Dosage: 4 tablets each time, 3 times daily, used to treat dilated cardiomyopathy.

Example 4

Granules

Prescription:

Astragalus 450g, Rich 112.5g, Red Ginseng 300g, Sweet Ginseng 225g, Energetic 150g, Namgagapi 200g, Taxa 225g, Safflower 90g, Jade porridge 75g, Dermis 75g Gye 90g

Granules are prepared by the general procedure and used to treat dilated cardiomyopathy.

1 is a microscopic view staining the myocardium of rats of group A by the general HE staining method.

Figure 2 is a microscopic view staining the myocardium of group B rats by the normal HE staining method.

Figure 3 is a microscopic view staining the myocardium of rats of group C by the general HE staining method.

Figure 4 is a microscopic view staining the myocardium of group B rats by the normal HE staining method.

Figure 5 is a microscopic view staining the myocardium of group B rats by the normal HE staining method.

FIG. 6 is a micrograph of myocardium of group B rats stained with a general V _G staining method. FIG.

Figure 7 is a microscopic view staining the myocardium of rats of group C by the general V _G staining method.

Claims (22)

Astragalus 150-450 weights, Rich 40-120 weights, Ginseng or sugar ginseng 75-225 weights, Salvia ginseng 75-225 weights, Energizer (wood mugwort) 50-150 weights, Scented or Nangapi 60-180 weights A kind of Chinese medicine composition characterized in that it is prepared from raw materials such as powder, 75 to 225 parts by weight, 25 to 75 parts by weight of jade, 30 to 90 parts by weight, 30 to 90 parts by weight of safflower, and 25 to 75 parts by weight of dermis ( Application in the manufacture of drugs for treating cardiomyopathy of 中 成 物). The method of claim 1, The Chinese herbal composition is 450 parts by weight of Astragalus, 112.5 parts by weight, rich in ginseng or sugar ginseng 225 parts by weight, 225 parts by weight of sweet ginseng, 150 parts by weight of sperm (woodwort), 180 parts by weight of scented skin or Namgapi, 225 parts by weight of tack, Application made by the raw material medicine of 75 weight part, gage 90 weight part, safflower 90 weight part, dermis 75 weight part. The method of claim 1, The active ingredient of the herbal composition is 1) Extract Astragalus, Energizer, Taxa, Ginseng or Ginseng, Ginseng or Persimmon Ginseng with appropriate amount of 70% ethanol, and filter the extract. Concentrating to 2) extracting the volatile oil of the basal and dermis; 3) adding an appropriate amount of water to weigh the rich, sweet ginseng, jade, safflower, and filtering the obtained aqueous solution; The aqueous solution after extraction of oil from the basal and dermis was filtered to collect an aqueous solution filtrate, and then, by adding an appropriate amount of water, the residue was filtered and filtered to mix the aqueous solution; The various aqueous solutions obtained as described above were mixed and concentrated until a thin paste having a relative density of 1.25 to 1.30 was measured at 60 ° C., and ethanol was added during the stirring process. When the alcohol concentration reached 70%, the solution was left still and filtered. Concentrate the filtrate to a thin paste with a relative density of 1.25-1.30 as measured by 60 ° C heat. Application characterized in that consisting of active ingredients prepared through. The method of claim 1, The active ingredient of the herbal composition is 1) Extract Astragalus, Energizer, Taxa, Ginseng or Ginseng, Ginseng or Persimmon Ginseng with an appropriate amount of 70% ethanol, and filter the extract. Concentration until 2) extracting volatile oil from the dermis and dermis with water to obtain volatile oil A, aqueous solution B and medicinal residue C; 3) adding water, weighing rich, sweet ginseng, jade, safflower, filtering the obtained aqueous solution to obtain filtrate D; 4) filtering the aqueous solution B after extraction of the volatile oil from the basal and dermis to collect the aqueous solution filtrate E, and then adding water to decoct the medicinal residue C, and filtering to obtain the filtrate F; 5) Filtrate D and filtrate E are mixed with filtrate F and concentrated until a thin paste having a relative density of 1.25 to 1.30, and ethanol is added in the stirring process, and when the alcohol concentration reaches 60 to 80%, Place and filter, and concentrate the filtrate at 60-70 ° C. until a thin paste G having a relative density of 1.25-1.30, 6) constituting the active ingredient of the herbal composition with the thin paste obtained in step 1), the volatile oil A and the thin paste G obtained in step 5). Application characterized in that consisting of the active ingredient prepared through. The method according to claim 1, wherein The cardiomyopathy is characterized in that the dilated cardiomyopathy. The method of claim 5, The herbal composition is an application, characterized in that applied to the drug to treat chronic myocardial weakness caused by dilated cardiomyopathy. The method of claim 5, The herbal composition is characterized in that applied to drugs that lower the serum cerebral natriuretic peptide. The method of claim 5, The herbal composition is an application, characterized in that applied to the drug to reduce myocardial necrosis. The method of claim 5, The herbal composition is applied to a drug that reduces myocardial fibrosis. The method according to any one of claims 1, 2, 3, 4, 6, 7, 8, or 9, The drug formulation prepared by the herbal composition is an application, characterized in that the capsule, tablets, granules, powders, oral solution or pills. The method of claim 5, The drug formulation prepared by the herbal composition is an application, characterized in that the capsule, tablets, granules, powders, oral solution or pills. Astragalus 150-450 weights, Rich 40-120 weights, Ginseng or sugar ginseng 75-225 weights, Salvia ginseng 75-225 weights, Energizer (wood mugwort) 50-150 weights, Scented or Nangapi 60-180 weights A kind of Chinese medicine composition characterized in that it is prepared from raw materials such as powder, 75 to 225 parts by weight, 25 to 75 parts by weight of jade, 30 to 90 parts by weight, 30 to 90 parts by weight of safflower, and 25 to 75 parts by weight of dermis. Application in treating cardiomyopathy. The method of claim 12, The Chinese herbal composition is 450 parts by weight of Astragalus, 112.5 parts by weight, rich in ginseng or sugar ginseng 225 parts by weight, 225 parts by weight of sweet ginseng, 150 parts by weight of sperm (woodwort), 180 parts by weight of scented skin or Namgapi, 225 parts by weight of tack, Application made by the raw material medicine of 75 weight part, gage 90 weight part, safflower 90 weight part, dermis 75 weight part. The method of claim 12, The active ingredient of the herbal composition is 1) Extract Astragalus, Energizer, Taxa, Ginseng or Ginseng, Ginseng or Persimmon Ginseng with appropriate amount of 70% ethanol, and filter the extract. And to concentrate. 2) extracting the volatile oil of the basal and dermis; 3) adding an appropriate amount of water to weigh the rich, sweet ginseng, jade, safflower, and filtering the obtained aqueous solution; The aqueous solution after extraction of oil from the basal and dermis was filtered to collect an aqueous solution filtrate, and then, by adding an appropriate amount of water, the residue was filtered and filtered to mix the aqueous solution; The various aqueous solutions obtained as described above were mixed and concentrated until a thin paste having a relative density of 1.25 to 1.30 was measured at 60 ° C., and ethanol was added during the stirring process. When the alcohol concentration reached 70%, the solution was left still and filtered. Concentrate the filtrate to a thin paste with a relative density of 1.25-1.30 as measured by 60 ° C heat. Application characterized in that consisting of active ingredients prepared through. The method of claim 12, The active ingredient of the herbal composition is 1) Extract Astragalus, Energizer, Taxa, Ginseng or Dried Ginseng, Scented Ginseng or Southern Oysters with an appropriate amount of 70% ethanol and filter the extract. Concentrating to 2) extracting volatile oil from the dermis and dermis with water to obtain volatile oil A, aqueous solution B and medicinal residue C; 3) adding water, weighing rich, sweet ginseng, jade, safflower, filtering the obtained aqueous solution to obtain filtrate D; 4) filtering the aqueous solution B after extraction of the volatile oil from the basal and dermis, collecting the aqueous solution filtrate E, adding water again, decocting the medicinal residue C, and filtering to obtain the filtrate F; 5) Filtrate D and filtrate E are mixed with filtrate F and concentrated until a thin paste having a relative density of 1.25 to 1.30, and ethanol is added in the stirring process, and when the alcohol concentration reaches 60 to 80%, Place and filter, and concentrate the filtrate at 60-70 ° C. until a thin paste G having a relative density of 1.25-1.30, 6) constituting the active ingredient of the herbal composition with the thin paste obtained in step 1), the volatile oil A and the thin paste G obtained in step 5). Application characterized in that consisting of the active ingredient prepared through. The method according to claim 12, wherein The cardiomyopathy is characterized in that the dilated cardiomyopathy. The method of claim 16, The herbal composition is an application, characterized in that applied to the drug to treat chronic myocardial weakness caused by dilated cardiomyopathy. The method of claim 16, The herbal composition is characterized in that applied to drugs that lower the serum cerebral natriuretic peptide. The method of claim 16, The herbal composition is applied to a drug that reduces myocardial necrosis. The method of claim 16, The herbal composition is applied to a drug that reduces myocardial fibrosis. The method according to any one of claims 12, 13, 14, 15, 17, 18, 19 or 20, The drug formulation prepared by the herbal composition is an application, characterized in that the capsule, tablets, granules, powders, oral solution or pills. The method of claim 16, The drug formulation prepared by the herbal composition is an application, characterized in that the capsule, tablets, granules, powders, oral solution or pills.

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