Radix lithospermi traditional Chinese medicine compound preparation as well as preparation method and application thereof

Abstract

The invention relates to a lithospermum traditional Chinese medicine compound preparation as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 55 to 75 parts of radix arnebiae seu lithospermi, 10 to 20 parts of poria cocos and 25 to 40 parts of rabdosia lingua. The lithospermum traditional Chinese medicine compound preparation provided by the invention adopts the traditional Chinese medicine composition which takes lithospermum as a main material and is compounded with a proper amount of poria cocos and rabdosia rubescens as a functional component, and the three components supplement each other and have a synergistic effect. Animal experiment results show that the traditional Chinese medicine composition can effectively inhibit heart weight increase of a cardiac hypertrophy mouse model and remarkably reduce the serum LDH level of the cardiac hypertrophy mouse model, a new means is provided for clinical treatment of hypertrophy cardiomyopathy, and the application range of the traditional Chinese medicinal materials in the field of medicine is further widened.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a lithospermum officinale traditional Chinese medicine compound preparation and a preparation method and application thereof. Background Art

[0002] Hypertrophic cardiomyopathy (HCM) is a hereditary cardiomyopathy, which is typically characterized by abnormal thickening of the ventricular wall, which often leads to a smaller ventricular cavity, obstructed left ventricular filling, and a significant decrease in diastolic compliance. Clinical manifestations include exertional dyspnea, chest pain, syncope, and even sudden death in extreme cases, making it an important cause of sudden death in adolescents and athletes. At present, there are various clinical treatments for hypertrophic cardiomyopathy, including drug therapy, non-drug therapy (such as ventricular septal ablation, surgical ventricular septal myectomy), and pacing therapy. However, drug therapy is often accompanied by side effects, non-drug therapy carries certain risks and trauma, and not all patients are suitable for these treatments. Therefore, exploring a safe and effective treatment method has become a difficult problem that needs to be overcome in clinical practice.

[0003] Traditional Chinese medicine has shown its unique advantages in treating hypertrophic cardiomyopathy. With its multi-component, multi-target and multi-pathway mechanism of action, traditional Chinese medicine can comprehensively regulate body functions, improve microcirculation, effectively reduce the burden on the heart, and thus relieve the related symptoms of hypertrophic cardiomyopathy. In addition, traditional Chinese medicine treatment has many advantages such as few side effects and not easy to develop drug resistance, which provides a new idea for the treatment of hypertrophic cardiomyopathy. Among them, Lithospermum officinale, Poria cocos and Lithospermum officinale are commonly used medicinal materials in traditional Chinese medicine, and they each have unique medicinal effects. Lithospermum officinale, derived from the dried roots of Lithospermum officinale or Lithospermum officinale of the Boraginaceae family, has the effects of promoting blood circulation and removing blood stasis, cooling blood and detoxifying. Modern pharmacological studies have revealed that it has multiple pharmacological effects such as anti-inflammatory and antioxidant, providing a scientific basis for traditional Chinese medicine treatment. Poria cocos is the dried sclerotium of the fungus Poria cocos of the Polyporaceae family. Its medication part is the sclerotium. It has the effects of diuresis and dampness, strengthening the spleen and calming the heart, and is often used to treat edema, oliguria, spleen deficiency and poor appetite. The narrow-lined camellia sinensis belongs to the Lamiaceae family. The whole plant can be used as medicine. It has the effects of clearing away heat and detoxifying, reducing swelling and relieving pain. It is often used among the people to treat diseases such as bruises and injuries.

[0004] Although Lithospermum officinale, Poria cocos and Scutellaria baicalensis each have significant pharmacological effects and are widely used in traditional Chinese medicine treatment, there is no report in the prior art on the combined use of these three to treat hypertrophic cardiomyopathy. Summary of the invention

[0005] In order to solve the above problems, the present invention provides a Chinese medicinal compound preparation of Lithospermum officinale and a preparation method and application thereof.

[0006] In a first aspect, the present invention provides a lithospermum officinale Chinese medicine compound preparation, the lithospermum officinale Chinese medicine compound preparation comprising a Chinese medicine composition and pharmaceutical excipients; the Chinese medicine composition comprises the following raw materials in parts by weight: 55-75 parts of Lithospermum officinale, 10-20 parts of Poria cocos and 25-40 parts of Scutellaria baicalensis.

[0007] Furthermore, the Chinese medicine composition comprises the following raw materials in parts by weight: There were 60.5 parts of Lithospermum officinale, 14 parts of Poria cocos and 32 parts of Scutellaria baicalensis.

[0008] Furthermore, the Chinese medicine composition comprises the following raw materials in parts by weight: 55 parts of Lithospermum officinale, 10 parts of Poria cocos and 25 parts of Ipomoea australis.

[0009] Furthermore, the Chinese medicine composition comprises the following raw materials in parts by weight: 75 parts of Lithospermum officinale, 20 parts of Poria cocos and 40 parts of Ipomoea australis.

[0010] Furthermore, the dosage form of the Lithospermum officinale Chinese medicinal compound preparation includes tablets, capsules, decoctions or granules.

[0011] Furthermore, the pharmaceutical excipients include dextrin and 80-90% ethanol by volume, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100:(55-65):(9-17).

[0012] In a second aspect, the present invention provides a method for preparing the lithospermum officinale Chinese medicinal compound preparation according to any one of the first aspects, wherein the method for preparing the lithospermum officinale Chinese medicinal compound preparation comprises the following steps: Mixing and grinding Lithospermum officinale, Poria cocos and Ipomoea australis to obtain a mixed material; The mixed material is added into water for extraction under reduced pressure and reflux, and then the obtained water extract is concentrated and dried to obtain the traditional Chinese medicine composition; The Chinese medicine composition and the pharmaceutical excipients are mixed and formed to obtain the Lithospermum officinale Chinese medicine compound preparation.

[0013] Furthermore, the working condition parameters of the reduced pressure reflux extraction include: pressure of 9~17kPa, temperature of 48~60°C, time of 60~90 minutes, number of times of 1~3 times, and a weight ratio of the mixture to the water of 1:(8~12).

[0014] In a third aspect, the present invention provides the use of the lithospermum Chinese medicinal compound preparation described in any one of the first aspect or the lithospermum Chinese medicinal compound preparation prepared by the preparation method of the lithospermum Chinese medicinal compound preparation described in any one of the second aspect in the preparation of a drug for treating hypertrophic cardiomyopathy.

[0015] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art: The embodiment of the present invention provides a Chinese medicinal compound preparation of lithospermum officinale and its preparation method and application. The Chinese medicinal compound preparation of lithospermum officinale provided by the present invention adopts a Chinese medicinal composition composed of lithospermum officinale as the main ingredient and a proper amount of Poria cocos and narrow-lined striated tea leaves as the effective ingredient. As the main drug, lithospermum officinale has the effect of promoting blood circulation and removing blood stasis, which can improve cardiac microcirculation and reduce myocardial ischemia and damage caused by myocardial hypertrophy. It is supplemented by the diuretic and dampness-inducing, spleen-strengthening and heart-calming effects of Poria cocos, which helps to reduce the burden on the heart and promote the recovery of cardiac function. The heat-clearing and detoxifying effects of narrow-lined striated tea leaves can reduce cardiac inflammation, reduce the damage of inflammatory factors to myocardial cells, and protect myocardial cells. The three complement each other and synergize. The results of animal experiments show that the Chinese medicinal composition can effectively inhibit the increase of heart weight in the mouse model of myocardial hypertrophy and significantly reduce its serum LDH (lactate dehydrogenase) level, which not only provides a new means for the clinical treatment of hypertrophic cardiomyopathy, but also further broadens the application scope of these Chinese medicinal materials in the field of medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0017] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0018] Figure 1 The present invention provides a schematic flow chart of a method for preparing a compound Chinese medicinal preparation of Lithospermum officinale provided in an embodiment of the present invention. DETAILED DESCRIPTION

[0019] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0020] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0021] In a first aspect, the present invention provides a lithospermum officinale Chinese medicine compound preparation, the lithospermum officinale Chinese medicine compound preparation comprising a Chinese medicine composition and pharmaceutical excipients; the Chinese medicine composition comprises the following raw materials in parts by weight: 55-75 parts of Lithospermum officinale, 10-20 parts of Poria cocos and 25-40 parts of Scutellaria baicalensis.

[0022] The embodiment of the present invention provides a Chinese medicinal compound preparation of lithospermum officinale. The Chinese medicinal compound preparation of lithospermum officinale provided by the present invention adopts a Chinese medicinal composition composed of lithospermum officinale as the main ingredient and a proper amount of Poria cocos and narrow-lined schizonepeta as the effective ingredient. As the main drug, lithospermum officinale has the effect of promoting blood circulation and removing blood stasis, which can improve cardiac microcirculation and reduce myocardial ischemia and damage caused by myocardial hypertrophy. It is supplemented by the diuretic and dampness-inducing, spleen-strengthening and heart-calming effects of Poria cocos, which helps to reduce the burden on the heart and promote the recovery of cardiac function. The heat-clearing and detoxifying effects of narrow-lined schizonepeta can reduce cardiac inflammation, reduce the damage of inflammatory factors to myocardial cells, and protect myocardial cells. The three complement each other and synergize. The results of animal experiments show that the Chinese medicinal composition can effectively inhibit the increase of heart weight in the mouse model of myocardial hypertrophy and significantly reduce its serum LDH (lactate dehydrogenase) level, which not only provides a new means for the clinical treatment of hypertrophic cardiomyopathy, but also further broadens the application scope of these Chinese medicinal materials in the field of medicine.

[0023] In some specific embodiments, the Chinese medicine composition comprises the following raw materials in parts by weight: There were 60.5 parts of Lithospermum officinale, 14 parts of Poria cocos and 32 parts of Scutellaria baicalensis.

[0024] In some specific embodiments, the Chinese medicine composition comprises the following raw materials in parts by weight: 55 parts of Lithospermum officinale, 10 parts of Poria cocos and 25 parts of Ipomoea australis.

[0025] In some specific embodiments, the Chinese medicine composition comprises the following raw materials in parts by weight: 75 parts of Lithospermum officinale, 20 parts of Poria cocos and 40 parts of Ipomoea australis.

[0026] In some specific embodiments, the dosage form of the Lithospermum officinale compound preparation includes tablets, capsules, decoctions or granules.

[0027] In some specific embodiments, the pharmaceutical excipient includes dextrin (CAS: 9004-53-9) and 80-90% by volume of ethanol, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100: (55-65): (9-17).

[0028] In a second aspect, the present invention provides a method for preparing the Lithospermum officinale compound Chinese medicine preparation according to any one of the first aspect, such as Figure 1As shown, the preparation method of the Lithospermum officinale Chinese medicine compound preparation comprises the following steps: Mixing and grinding Lithospermum officinale, Poria cocos and Ipomoea australis to obtain a mixed material; The mixed material is added into water for extraction under reduced pressure and reflux, and then the obtained water extract is concentrated and dried to obtain the traditional Chinese medicine composition; The Chinese medicine composition and the pharmaceutical excipients are mixed and formed to obtain the Lithospermum officinale Chinese medicine compound preparation.

[0029] The preparation method of the lithospermum Chinese medicinal compound preparation provided by the embodiment of the present invention is simple to operate and suitable for industrial batch production; at the same time, the preparation method is realized based on the lithospermum Chinese medicinal compound preparation described in any one of the first aspects, and therefore has at least the beneficial effects of the lithospermum Chinese medicinal compound preparation described in any one of the first aspects, which will not be described one by one here.

[0030] In some specific embodiments, the working condition parameters of the reduced pressure reflux extraction include: pressure of 9~17kPa, temperature of 48~60°C, time of 60~90 minutes, number of times of 1~3 times, and the weight ratio of the mixture to the water is 1:(8~12).

[0031] In some specific embodiments, when the dosage form of the Lithospermum officinale compound Chinese medicine preparation is a granule, the preparation method thereof comprises the following steps: Mixing and grinding Lithospermum officinale, Poria cocos and Ipomoea australis to obtain a mixed material; The mixed material is added into water for extraction under reduced pressure and reflux, and then the obtained water extract is concentrated and dried to a dry extract to obtain the traditional Chinese medicine composition; The Chinese medicine composition is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio for mixing, granulation, drying, and granulation to prepare a granular Chinese medicine compound preparation of Lithospermum officinale.

[0032] In a third aspect, the present invention provides the use of the lithospermum Chinese medicinal compound preparation described in any one of the first aspect or the lithospermum Chinese medicinal compound preparation prepared by the preparation method of the lithospermum Chinese medicinal compound preparation described in any one of the second aspect in the preparation of a drug for treating hypertrophic cardiomyopathy.

[0033] It should be noted that the components and raw materials involved in the lithospermum Chinese herbal compound preparation and its preparation method and application provided by the embodiments of the present invention, unless otherwise specified or specified, can be directly commercially available products or homemade using existing public preparation methods; at the same time, the steps and parameters involved, unless otherwise specified or specified, can be carried out according to the processing technology of existing Chinese herbal compound preparations or directly using existing equipment, and the present invention document will not repeat them one by one.

[0034] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to current standards. If there is no corresponding current standard, then the conditions are carried out according to general conventional conditions or according to the conditions recommended by the manufacturer.

[0035] Example 1 This example provides a Chinese medicinal compound preparation of Lithospermum officinale, which comprises a Chinese medicinal composition and pharmaceutical excipients; The Chinese medicine composition comprises the following raw materials in parts by weight: 60.5 parts of Lithospermum officinale, 14 parts of Poria cocos, and 32 parts of Ipomoea australis; The pharmaceutical excipients include dextrin and 88% ethanol by volume, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100:60:13.

[0036] The preparation method of the above-mentioned Lithospermum officinale Chinese medicinal compound preparation comprises the following steps: Step (1): mixing and grinding Lithospermum officinale, Poria cocos and Scutellaria baicalensis to obtain a mixture; Step (2): adding the mixture obtained in step (1) into water for vacuum reflux extraction at a pressure of 13 kPa, a temperature of 55° C., a time of 70 minutes, and a number of times of 2 times, wherein the weight ratio of the mixture to the water is 1:10, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine composition; Step (3): The Chinese medicine composition obtained in step (2) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio for mixing, granulation and drying, and granulation is performed to obtain the Lithospermum officinale Chinese medicine compound preparation.

[0037] The Chinese medicine composition in the Lithospermum officinale Chinese medicine compound preparation provided in this example is recorded as effective ingredient A.

[0038] Example 2 This example provides a Chinese medicinal compound preparation of Lithospermum officinale, which comprises a Chinese medicinal composition and pharmaceutical excipients; The Chinese medicine composition comprises the following raw materials in parts by weight: 55 parts of Lithospermum officinale, 10 parts of Poria cocos and 25 parts of Ipomoea australis; The pharmaceutical excipients include dextrin and 80% ethanol by volume, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100:55:9.

[0039] The preparation method of the above-mentioned Lithospermum officinale Chinese medicinal compound preparation comprises the following steps: Step (1): mixing and grinding Lithospermum officinale, Poria cocos and Scutellaria baicalensis to obtain a mixture; Step (2): adding the mixture obtained in step (1) into water for vacuum reflux extraction at a pressure of 9 kPa, a temperature of 48° C., a time of 90 minutes, and a number of times of 2 times, wherein the weight ratio of the mixture to the water is 1:8, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine composition; Step (3): The Chinese medicine composition obtained in step (2) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio for mixing, granulation and drying, and granulation is performed to obtain the Lithospermum officinale Chinese medicine compound preparation.

[0040] The Chinese medicine composition in the Lithospermum officinale Chinese medicine compound preparation provided in this example is recorded as effective ingredient B.

[0041] Example 3 This example provides a Chinese medicinal compound preparation of Lithospermum officinale, which comprises a Chinese medicinal composition and pharmaceutical excipients; The Chinese medicine composition comprises the following raw materials in parts by weight: 75 parts of Lithospermum officinale, 20 parts of Poria cocos and 40 parts of Anemarrhena asphodeloides; The pharmaceutical excipients include dextrin and 90% ethanol by volume, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100:65:17.

[0042] The preparation method of the above-mentioned Lithospermum officinale Chinese medicinal compound preparation comprises the following steps: Step (1): mixing and grinding Lithospermum officinale, Poria cocos and Scutellaria baicalensis to obtain a mixture; Step (2): adding the mixture obtained in step (1) into water for vacuum reflux extraction at a pressure of 17 kPa, a temperature of 60° C., a time of 60 minutes, and a number of times of 2 times, wherein the weight ratio of the mixture to the water is 1:12, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine composition; Step (3): The Chinese medicine composition obtained in step (2) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio for mixing, granulation and drying, and granulation is performed to obtain the Lithospermum officinale Chinese medicine compound preparation.

[0043] The Chinese medicine composition in the Lithospermum officinale Chinese medicine compound preparation provided in this example is recorded as effective ingredient C.

[0044] Comparative Example 1 This example provides a Chinese medicine preparation and a preparation method thereof, which is different from Example 1 only in that the effective ingredients of the Chinese medicine preparation are prepared using only Lithospermum officinale as raw material; the remaining steps and parameters are the same.

[0045] This example provides a traditional Chinese medicine preparation, which includes a traditional Chinese medicine extract and a pharmaceutical excipient; The Chinese herbal medicine extract comprises the following raw materials in parts by weight: Lithospermum officinale 60.5 parts; The pharmaceutical excipients include dextrin and 88% ethanol by volume, and the weight ratio of the traditional Chinese medicine extract, the dextrin and the ethanol is 100:60:13.

[0046] The preparation method of the above-mentioned Chinese medicine preparation comprises the following steps: Step (1): crushing lithospermum officinale, adding it into water for vacuum reflux extraction, the pressure is 13 kPa, the temperature is 55° C., the time is 70 minutes, the number of times is 2 times, the weight ratio of lithospermum officinale to water is 1:10, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine extract; Step (2): The Chinese medicine extract obtained in step (1) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio to mix, granulate and dry, and granulate to obtain the Chinese medicine preparation.

[0047] The Chinese herbal extract in the Chinese herbal preparation provided in this example is recorded as effective ingredient D.

[0048] Comparative Example 2 This example provides a Chinese medicine preparation and a preparation method thereof, which is different from Example 1 only in that the effective ingredients of the Chinese medicine preparation are prepared using only Poria cocos as raw material; the remaining steps and parameters are the same.

[0049] This example provides a traditional Chinese medicine preparation, which includes a traditional Chinese medicine extract and a pharmaceutical excipient; The Chinese herbal medicine extract comprises the following raw materials in parts by weight: Poria 14 parts; The pharmaceutical excipients include dextrin and 88% ethanol by volume, and the weight ratio of the traditional Chinese medicine extract, the dextrin and the ethanol is 100:60:13.

[0050] The preparation method of the above-mentioned Chinese medicine preparation comprises the following steps: Step (1): crushing the Poria cocos, and then adding it into water for vacuum reflux extraction, the pressure is 13 kPa, the temperature is 55° C., the time is 70 minutes, the number of times is 2 times, the weight ratio of the Poria cocos to the water is 1:10, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine extract; Step (2): The Chinese medicine extract obtained in step (1) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio to mix, granulate and dry, and granulate to obtain the Chinese medicine preparation.

[0051] The Chinese herbal extract in the Chinese herbal preparation provided in this example is recorded as effective ingredient E.

[0052] Comparative Example 3 This example provides a Chinese medicine preparation and a preparation method thereof, which is different from Example 1 only in that the effective ingredients of the Chinese medicine preparation are prepared using only the narrow-lined camellia sinensis as raw material; the remaining steps and parameters are the same.

[0053] This example provides a traditional Chinese medicine preparation, which includes a traditional Chinese medicine extract and a pharmaceutical excipient; The Chinese herbal medicine extract comprises the following raw materials in parts by weight: 32 servings of narrow-lined fragrant tea leaves; The pharmaceutical excipients include dextrin and 88% ethanol by volume, and the weight ratio of the traditional Chinese medicine extract, the dextrin and the ethanol is 100:60:13.

[0054] The preparation method of the above-mentioned Chinese medicine preparation comprises the following steps: Step (1): crushing the narrow-lined sedge, then adding it into water for vacuum reflux extraction, the pressure is 13 kPa, the temperature is 55° C., the time is 70 minutes, the number of times is 2 times, the weight ratio of the narrow-lined sedge to the water is 1:10, and then concentrating and drying the obtained water extract to a dry extract to obtain the Chinese medicine extract; Step (2): The Chinese medicine extract obtained in step (1) is crushed and passed through a 100-mesh sieve, and then dextrin and ethanol are added according to a weight ratio to mix, granulate and dry, and granulate to obtain the Chinese medicine preparation.

[0055] The Chinese herbal extract in the Chinese herbal preparation provided in this example is recorded as effective ingredient F.

[0056] Comparative Example 4 This example provides a Chinese medicinal compound preparation of lithospermum officinale and a preparation method thereof, which is different from Example 1 only in that the weight portions of Poria cocos are adjusted to 35 parts and the weight portions of Rhizoma Coptidis are adjusted to 11 parts; the remaining steps and parameters are the same.

[0057] The Chinese medicine composition in the Lithospermum officinale Chinese medicine compound preparation provided in this example is recorded as effective ingredient G.

[0058] Test Case In this example, according to the test method disclosed in the prior art, the efficacy of the effective ingredients A to G in the traditional Chinese medicine preparations obtained in Examples 1 to 3 and Comparative Examples 1 to 4 was tested for treating hypertrophic cardiomyopathy to evaluate the efficacy thereof.

[0059] Test method: 1. Animal grouping and modeling A total of 90 healthy Kunming mice, half of which were male and half were female, were randomly divided into 9 groups, with 10 mice in each group, namely: blank control group, model control group, and active ingredient A~G treatment groups (7 groups in total).

[0060] Except for the blank control group, mice in other groups were subcutaneously injected with isoproterenol hydrochloride injection to establish a myocardial hypertrophy model. The injection schedule was: 40 mg / kg on the first day, 20 mg / kg on the second day, 10 mg / kg on the third day, and 10 mg / kg starting from the fourth day, once a day for 14 consecutive days.

[0061] The blank control group was subcutaneously injected with an equal amount of normal saline every day as a control.

[0062] After the model is successfully established, the left ventricular weight index (LVWI) of the mice in the model control group should be significantly increased compared with the blank control group, which is in line with the myocardial hypertrophy model standards in the second edition of "Pharmacological Experimental Methodology".

[0063] 2. Drug administration Drug administration and modeling were carried out simultaneously.

[0064] Four hours after the injection of isoproterenol hydrochloride injection every morning, the seven treatment groups were given active ingredients A to G by gavage at a dosage of 50 mg / kg, once a day.

[0065] The blank control group and the model control group were given an equal amount of normal saline by gavage once a day for 4 weeks.

[0066] 3. Index detection The mice were fasted but not watered for 12 hours after the last administration.

[0067] The mice were weighed (BW) and bled by eyeballs before being sacrificed.

[0068] The chest cavity was opened quickly to remove the heart, and the residual blood was washed out with pre-cooled saline. After being blotted dry with filter paper, the left ventricle was separated and the left ventricle weight (LVW) was measured.

[0069] The left ventricular mass index (LVWI = LVW / BW, unit: mg / g) was calculated.

[0070] The test results are shown in Table 1.

[0071] Table 1

[0072] As shown in Table 1, compared with Comparative Examples 1 to 4, the inhibitory effect of the effective ingredients A to C in the Chinese medicinal compound preparation of Lithospermum officinale provided in Examples 1 to 3 of the present invention on the increase of heart weight in the mouse model of myocardial hypertrophy is more obvious, and can effectively slow down or even reverse the process of myocardial hypertrophy, thereby significantly alleviating the related symptoms of hypertrophic cardiomyopathy. In addition, after blood was collected from the mouse eyeball, it was centrifuged at 2000r / min for 10 minutes at 4°C to separate the serum; according to the instructions of the LDH (lactate dehydrogenase) kit, the LDH level in the serum was determined (unit: U / L). The results showed that compared with the serum LDH level of the blank control group mice (412U / L), the serum LDH level of the model group mice was significantly increased to 784U / L, while the LDH levels of the treatment groups using the effective ingredients A to G were reduced to varying degrees, but the LDH of the treatment group using the effective ingredient A decreased most significantly, and the serum LDH level of the mice was reduced to 427U / L, indicating that the effective ingredient A in the Chinese medicinal compound preparation of Lithospermum officinale provided in Example 1 has the best intervention effect on myocardial hypertrophy injury in mice.

[0073] In summary, the embodiments of the present invention provide a Chinese medicinal compound preparation of lithospermum officinale and its preparation method and application. The Chinese medicinal compound preparation of lithospermum officinale provided by the present invention adopts a Chinese medicinal composition composed of lithospermum officinale as the main ingredient and a proper amount of Poria cocos and narrow-lined striated schizonepeta as the effective ingredient. The three complement each other and synergize. The results of animal experiments show that the Chinese medicinal composition can effectively inhibit the increase of heart weight in the myocardial hypertrophy mouse model and significantly reduce its serum LDH level, which not only provides a new means for the clinical treatment of hypertrophic cardiomyopathy, but also further broadens the application scope of these Chinese medicinal materials in the medical field.

[0074] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0075] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A Chinese medicinal compound preparation of Lithospermum officinale, characterized in that: The Lithospermum officinale Chinese medicine compound preparation comprises a Chinese medicine composition and pharmaceutical excipients; in parts by weight, the Chinese medicine composition comprises the following raw materials: 55-75 parts of Lithospermum officinale, 10-20 parts of Poria cocos and 25-40 parts of Scutellaria baicalensis.

2. The Lithospermum officinale Chinese medicinal compound preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: There were 60.5 parts of Lithospermum officinale, 14 parts of Poria cocos and 32 parts of Scutellaria baicalensis.

3. The Lithospermum officinale Chinese medicinal compound preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 55 parts of Lithospermum officinale, 10 parts of Poria cocos and 25 parts of Ipomoea australis.

4. The Lithospermum officinale Chinese medicinal compound preparation according to claim 1, characterized in that: The Chinese medicine composition comprises the following raw materials in parts by weight: 75 parts of Lithospermum officinale, 20 parts of Poria cocos and 40 parts of Ipomoea australis.

5. The Lithospermum officinale Chinese medicinal compound preparation according to any one of claims 1 to 4, characterized in that: The dosage form of the lithospermum officinale Chinese medicinal compound preparation includes tablets, capsules, decoctions or granules.

6. The Lithospermum officinale Chinese medicinal compound preparation according to any one of claims 1 to 4, characterized in that: The pharmaceutical excipients include dextrin and 80-90% ethanol by volume, and the weight ratio of the traditional Chinese medicine composition, the dextrin and the ethanol is 100:(55-65):(9-17).

7. A method for preparing the Lithospermum officinale Chinese medicinal compound preparation according to any one of claims 1 to 6, characterized in that: The preparation method of the Lithospermum officinale Chinese medicinal compound preparation comprises the following steps: Mixing and grinding Lithospermum officinale, Poria cocos and Ipomoea australis to obtain a mixed material; The mixed material is added into water for extraction under reduced pressure and reflux, and then the obtained water extract is concentrated and dried to obtain the traditional Chinese medicine composition; The Chinese medicine composition and the pharmaceutical excipients are mixed and prepared into a shape to obtain the Lithospermum officinale Chinese medicine compound preparation.

8. The method for preparing the Lithospermum officinale Chinese medicinal compound preparation according to claim 7, characterized in that: The working condition parameters of the reduced pressure reflux extraction include: pressure of 9-17 kPa, temperature of 48-60° C., time of 60-90 minutes, number of times of 1-3 times, and a weight ratio of the mixture to the water of 1:(8-12).

9. Use of the Lithospermum officinale Chinese medicinal compound preparation according to any one of claims 1 to 6 or the Lithospermum officinale Chinese medicinal compound preparation prepared by the preparation method of the Lithospermum officinale Chinese medicinal compound preparation according to any one of claims 7 to 8 in preparing a medicament for treating hypertrophic cardiomyopathy.

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