Pharmaceutical composition for improving cardiac ejection fraction as well as preparation method and application of pharmaceutical composition

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a pharmaceutical composition for improving the cardiac ejection fraction and a preparation method and application of the pharmaceutical composition. The pharmaceutical composition provided by the invention is prepared from the following raw materials: rhizoma pinellinae praeparata, rhizoma atractylodis, radix polygonati officinalis and liquiritin. The raw materials are specifically combined, so that the anti-inflammatory ability of an organism is enhanced, inflammatory response is relieved, the immune function is adjusted, the workload of the heart is reduced, myocardial damage can be relieved and the ejection fraction can be improved by inhibiting release of inflammatory mediators, scavenging free radicals and the like while myocardial energy metabolism is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a pharmaceutical composition for improving cardiac ejection fraction, a preparation method thereof, and an application thereof. Background Art

[0002] Cardiovascular disease (CVD) is one of the major health problems worldwide. For example, diseases such as coronary heart disease, myocardial infarction, and heart failure can directly endanger life. Cardiovascular disease causes approximately 18 million deaths each year, accounting for more than 30% of the global death toll, bringing extremely adverse effects to patients and their families.

[0003] Currently, heart failure is mostly treated with Western medicine, but its use is limited due to its numerous side effects. While heart failure isn't specifically identified in Traditional Chinese Medicine (TCM), there are numerous existing literature discussing its treatment, based on clinical manifestations such as palpitations, restlessness, heart paralysis, and edema. For example, Chinese Patent CN 105617168 A describes a treatment for heart failure by specifically combining astragalus, ginseng, salvia miltiorrhiza, Trillium, Polygonum multiflorum, Heishunpian, antler glue, Poria, donkey-hide gelatin, jujube seeds, charred betel nut, and roasted licorice. However, this TCM composition requires numerous raw materials and is complex to prepare. Summary of the Invention

[0004] The purpose of the present invention is to provide a pharmaceutical composition for improving cardiac ejection fraction, a preparation method and application thereof, which can improve cardiac ejection fraction, requires few raw materials and has a simple preparation method.

[0005] The invention provides a pharmaceutical composition for improving cardiac ejection fraction. The pharmaceutical composition comprises the following raw materials: pinellia ternata, atractylodes lancea, polygonatum odoratum and liquiritin.

[0006] Preferably, the pharmaceutical composition comprises the following raw materials in parts by mass: 50-55 parts of Pinellia ternata, 18-25 parts of Atractylodes lancea, 15-20 parts of Polygonatum odoratum and 10-12 parts of liquiritin.

[0007] The present invention provides a method for preparing the pharmaceutical composition described in the above technical solution, comprising the following steps:

[0008] soaking the radix pinelliae in an ethanol solution with a volume concentration of 55% to 65% to obtain soaked radix pinelliae;

[0009] soaking atractylodes lancea and polygonatum odoratum in a cellulase solution with a mass concentration of 0.5%-0.7% to obtain soaked atractylodes lancea and polygonatum odoratum;

[0010] drying and crushing the soaked Pinellia ternata, Atractylodes lancea and Polygonatum odoratum in sequence to obtain crushed matter;

[0011] mixing the pulverized material with water, steaming and filtering in sequence to obtain a filtrate and a filter residue;

[0012] mixing the filter residue with water, performing ultrasonic extraction and filtering to obtain an ultrasonic extract;

[0013] The filtrate and the ultrasonic extract are mixed and then spray-dried to obtain a powder;

[0014] The powder is mixed with liquiritin to obtain a pharmaceutical composition.

[0015] Preferably, the particle size of the pulverized material is 100-150 μm.

[0016] Preferably, when the pulverized material is mixed with water for steaming, the mass volume ratio of the pulverized material to water is 1 g: 20-25 mL;

[0017] The number of steaming is 2-3 times; the time of steaming is 1-1.5 hours per time.

[0018] Preferably, when the filter residue is mixed with water for ultrasonic extraction, the mass volume ratio of the filter residue to water is 1 g: 12-15 mL;

[0019] The parameters of the ultrasonic extraction include: temperature of 65-70° C., time of 38-42 min, and power of 310-330 W.

[0020] Preferably, the spray drying parameters include: pressure of -0.08 to -0.09 MPa, and temperature of 155-175°C.

[0021] Preferably, the time for soaking the pinellia tuber in the ethanol solution is 3.5-4 hours;

[0022] The time for soaking Atractylodes lancea and Polygonatum odoratum in the cellulase solution is 5.5-6 hours respectively.

[0023] The present invention provides use of the pharmaceutical composition described in the above technical solution in the preparation of a product for improving cardiac ejection fraction.

[0024] The present invention provides a product for improving cardiac ejection fraction, comprising: the pharmaceutical composition described in the above technical solution.

[0025] Beneficial effects:

[0026] The present invention provides a pharmaceutical composition for improving cardiac ejection fraction, which comprises the following raw materials: Rhizoma Pinelliae, Rhizoma Atractylodis, Polygonatumodoratum (Mill.) Druce and liquiritin. The Rhizoma Pinelliae and Atractylodis provided by the present invention both have the effects of drying dampness and resolving phlegm; the yin-nourishing and dryness-removing effect of Polygonatum odoratum can alleviate the problem of yin deficiency and dryness caused by dampness-removing and phlegm-resolving drugs; liquiritin has anti-inflammatory and immunomodulatory effects, which can enhance the overall anti-inflammatory ability, reduce inflammatory reactions, and regulate immune function, which helps to improve symptoms related to chronic inflammation. Therefore, after the above-mentioned composition is specifically combined, it is beneficial to reduce the workload of the heart and alleviate myocardial damage.

[0027] Based on the above technical advantages, the present invention provides a method for preparing the pharmaceutical composition described in the above technical solution. The method comprises soaking Pinellia ternata in an ethanol solution, soaking Atractylodes lancea and Polygonatum odoratum in a cellulase solution, and then subjecting the raw materials to pulverization, steaming, filtering, ultrasonic extraction, and spray drying. This facilitates the precipitation of effective active ingredients from the different raw materials, improving myocardial energy metabolism while also reducing myocardial damage and improving ejection fraction by inhibiting the release of inflammatory mediators and scavenging free radicals. DETAILED DESCRIPTION

[0028] In the present invention, unless otherwise specified, the raw materials, methods and equipment used are all conventionally selected.

[0029] When the present invention utilizes an ethanol solution with a volume concentration of 55%-65% to soak the Chinese pinellia, there is no special requirement for the amount of the ethanol solution used, as long as the Chinese pinellia is completely submerged; when the present invention utilizes a cellulase solution with a mass concentration of 0.5%-0.7% to soak the atractylodes lancea and polygonatum, there is no special requirement for the amount of the cellulase solution used, as long as the atractylodes lancea and polygonatum are completely submerged.

[0030] In order to further illustrate the present invention, the solutions provided by the present invention are described in detail below in conjunction with the embodiments, but they should not be understood as limiting the scope of protection of the present invention.

[0031] Example 1

[0032] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0033] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0034] (2) Preparation process:

[0035] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0036] Completely soaking the French pinellia in a 60% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0037] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0038] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0039] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0040] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0041] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0042] Example 2

[0043] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0044] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 53 parts of Pinellia ternata, 18 parts of Atractylodes lancea, 17 parts of Polygonatum odoratum and 10 parts of liquiritin.

[0045] (2) Preparation process:

[0046] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0047] Completely soaking the French pinellia in a 60% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0048] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0049] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0050] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0051] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0052] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0053] Example 3

[0054] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0055] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0056] (2) Preparation process:

[0057] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0058] Completely soaking the French pinellia in a 65% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0059] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.6% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0060] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 120 μm;

[0061] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0062] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0063] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 172° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0064] Comparative Example 1

[0065] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0066] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 60 parts of Pinellia ternata, 15 parts of Atractylodes lancea, 10 parts of Polygonatum odoratum and 15 parts of Liquorice glycosides.

[0067] (2) Preparation process:

[0068] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0069] Completely soaking the French pinellia in a 60% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0070] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0071] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0072] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0073] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0074] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0075] Comparative Example 2

[0076] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0077] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 55 parts of Astragalus membranaceus, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of liquiritin.

[0078] (2) Preparation process:

[0079] Wash Astragalus, Atractylodes and Polygonatum thoroughly and set aside;

[0080] The astragalus root is completely soaked in an ethanol solution with a volume concentration of 60% for 4 hours to obtain the soaked astragalus root; the soaked astragalus root is air-dried and set aside;

[0081] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0082] The dried Astragalus, Atractylodes and Polygonatum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0083] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0084] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0085] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0086] Comparative Example 3

[0087] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0088] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0089] (2) Preparation process:

[0090] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0091] Completely soaking the French pinellia in water for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0092] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0093] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0094] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0095] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0096] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0097] Comparative Example 4

[0098] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0099] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0100] (2) Preparation process:

[0101] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0102] Completely soaking the French pinellia in a 60% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0103] Completely soaking Atractylodes lancea and Polygonatum odoratum in water for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0104] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0105] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0106] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0107] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0108] Comparative Example 5

[0109] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0110] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0111] (2) Preparation process:

[0112] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0113] Completely soaking the French pinellia in a 60% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0114] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.5% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0115] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 80 μm;

[0116] The crushed material is mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture is steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue is mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue; the second filter residue is mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a third time for 1.5 hours and filtered to obtain a third filtrate and a third filter residue;

[0117] The first filtrate, the second filtrate and the third filtrate are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0118] Comparative Example 6

[0119] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0120] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0121] (2) Preparation process:

[0122] Wash Pinellia ternata, Atractylodes lancea and Polygonatum odoratum and set aside;

[0123] Completely soaking the French pinellia in a 50% volume concentration ethanol solution for 4 hours to obtain soaked French pinellia; air-drying the soaked French pinellia for later use;

[0124] Completely soaking Atractylodes lancea and Polygonatum odoratum in a 0.9% cellulase solution for 6 hours to obtain soaked Atractylodes lancea and Polygonatum odoratum; drying the soaked Atractylodes lancea and Polygonatum odoratum separately for later use;

[0125] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0126] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0127] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0128] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.07 MPa and 145° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0129] Comparative Example 7

[0130] A method for preparing a pharmaceutical composition for improving cardiac ejection fraction, comprising the following steps:

[0131] (1) The pharmaceutical composition is composed of the following raw materials in parts by mass: 50 parts of Pinellia ternata, 20 parts of Atractylodes lancea, 15 parts of Polygonatum odoratum and 10 parts of Liquorice glycosides.

[0132] (2) Preparation process:

[0133] Wash and dry Pinellia ternata, Atractylodes lancea and Polygonatum odoratum separately and set aside;

[0134] The dried Pinellia ternata, Atractylodes lancea and Polygonatum odoratum were mixed and ground to obtain a powder with a particle size of 150 μm;

[0135] The crushed material was mixed with water at a mass volume ratio of 1 g:20 mL to obtain a mixture; the mixture was steamed for a first time for 1.5 hours and filtered to obtain a first filtrate and a first filter residue; the first filter residue was mixed with water at a mass volume ratio of 1 g:20 mL, steamed for a second time for 1.5 hours and filtered to obtain a second filtrate and a second filter residue;

[0136] The first filter residue and the second filter residue were combined and recorded as the filter residue, and the filter residue was mixed with water at a mass volume ratio of 1 g:15 mL, and ultrasonically extracted at 68 ° C and 320 W for 40 min, and filtered to obtain the ultrasonic extract;

[0137] The first filtrate, the second filtrate and the ultrasonic extract are combined and spray-dried under the conditions of -0.09 MPa and 155° C. to obtain powder; the powder is uniformly mixed with liquiritin powder to obtain a pharmaceutical composition.

[0138] Application Example 1

[0139] 55 healthy rats weighing 200-210 g were selected and randomly divided into 11 groups, with 5 rats in each group; the pharmaceutical compositions prepared in Examples 1-3 and Comparative Examples 1-7 were taken and gavaged to rats at a dose of 0.4 mg / kg, once a day for one week; at the same time, the same dose of water was gavaged as a blank control.

[0140] After the last oral administration, the rats were observed by electrocardiogram to see if they had arrhythmia. The number of rats with arrhythmia in each group was counted. The results are shown in Table 1.

[0141] Table 1 The incidence of arrhythmia in rats under different treatments

[0142] deal with Number of rats with arrhythmia Arrhythmia rate Example 1 0 0 Example 2 0 0 Example 3 0 0 Comparative Example 1 1 20％ Comparative Example 2 2 40％ Comparative Example 3 0 0 Comparative Example 4 0 0 Comparative Example 5 0 0 Comparative Example 6 0 0 Comparative Example 7 0 0 Blank control 0 0

[0143] Combined with the data in Table 1, it can be seen that the pharmaceutical compositions of Examples 1-3 and Comparative Examples 3-7 did not induce arrhythmias in healthy rats after feeding them to rats. However, changing the dosage of the raw materials in the pharmaceutical composition in Comparative Example 1 and the type of raw materials in the pharmaceutical composition in Comparative Example 2 both caused arrhythmias in healthy rats to varying degrees. This shows that changing the type of raw materials in a pharmaceutical composition or increasing the dosage may cause the pharmaceutical composition to produce adverse effects.

[0144] Application Example 2

[0145] Based on the results of Application Example 1, the pharmaceutical compositions prepared in Examples 1-3 and Comparative Examples 3-7 were selected to conduct the following experiments;

[0146] Healthy rats weighing 200-210 g were selected and intraperitoneally injected with doxorubicin hydrochloride at a dose of 3 mg / kg, once every other day, for a total of 6 injections. On the second day after the last injection, 45 rats with a left ventricular ejection fraction of less than 50% were screened and randomly divided into 10 groups, with 5 rats in each group. The pharmaceutical compositions prepared in Examples 1-3 and Comparative Examples 3-7 were gavaged to rats at a dose of 10 mg / kg, and the blank control was gavaged with the same dose of water. The administration was continued for 10 days, and on the 5th day of administration, each treatment was again intraperitoneally injected with 3 mg / kg of doxorubicin hydrochloride. On the 5th day of the last administration, 3 mg / kg of doxorubicin hydrochloride was again intraperitoneally injected. 2 hours after the last administration, the left ventricular ejection fraction (i.e., the average left ventricular ejection fraction of the surviving rats in the same group) was calculated by ultrasound, and the death of rats during the experiment was counted. The results are shown in Table 2.

[0147] Table 2 Heart failure in rats under different treatments

[0148] deal with Number of dead rats Left ventricular ejection fraction (%) Example 1 0 67.85 Example 2 0 65.72 Example 3 0 60.57 Comparative Example 3 1 51.45 Comparative Example 4 2 55.21 Comparative Example 5 0 50.65 Comparative Example 6 1 52.48 Comparative Example 7 2 49.58 Blank control 3 40.85

[0149] Combined with the data in Table 2, it can be seen that, compared with Comparative Examples 3-7 and the blank control, after oral administration of the pharmaceutical compositions in Examples 1-3 to rats, the number of rat deaths during the experiment was 0, and the left ventricular ejection fraction was significantly improved (the initial left ventricular ejection fraction of the rats was less than 50%); however, in Comparative Examples 3-7, when a certain parameter in the preparation of the traditional Chinese medicine composition was changed, certain active ingredients in the raw materials may be lost, which is not conducive to the release of its efficacy and, therefore, is not conducive to improving the cardiac ejection fraction of the rats.

[0150] Although the above embodiment provides a detailed description of the present invention, it is only a part of the embodiments of the present invention, not all of the embodiments. People can also obtain other embodiments based on this embodiment without creativity, and these embodiments all fall within the scope of protection of the present invention.

Claims

1. A pharmaceutical composition for improving cardiac ejection fraction, characterized in that: The pharmaceutical composition comprises the following raw materials: pinellia ternata, atractylodes lancea, polygonatum odoratum and liquiritin.

2. The pharmaceutical composition according to claim 1, characterized in that The pharmaceutical composition comprises the following raw materials in parts by mass: 50-55 parts of Pinellia ternata, 18-25 parts of Atractylodes lancea, 15-20 parts of Polygonatum odoratum and 10-12 parts of liquiritin.

3. The method for preparing the pharmaceutical composition according to claim 1 or 2, characterized in that: The steps include: soaking the radix pinelliae in an ethanol solution with a volume concentration of 55% to 65% to obtain soaked radix pinelliae; soaking atractylodes lancea and polygonatum odoratum in a cellulase solution with a mass concentration of 0.5%-0.7% to obtain soaked atractylodes lancea and polygonatum odoratum; drying and crushing the soaked Pinellia ternata, Atractylodes lancea and Polygonatum odoratum in sequence to obtain crushed matter; mixing the pulverized material with water, steaming and filtering in sequence to obtain a filtrate and a filter residue; mixing the filter residue with water, performing ultrasonic extraction and filtering to obtain an ultrasonic extract; The filtrate and the ultrasonic extract are mixed and then spray-dried to obtain a powder; The powder is mixed with liquiritin to obtain a pharmaceutical composition.

4. The preparation method according to claim 3, characterized in that The particle size of the pulverized material is 100-150 μm.

5. The preparation method according to claim 3, characterized in that When the crushed material is mixed with water and steamed, the mass volume ratio of the crushed material to water is 1 g: 20-25 mL; The number of steaming is 2-3 times; the time of steaming is 1-1.5 hours per time.

6. The preparation method according to claim 3, characterized in that When the filter residue is mixed with water for ultrasonic extraction, the mass volume ratio of the filter residue to water is 1 g: 12-15 mL; The parameters of the ultrasonic extraction include: temperature of 65-70° C., time of 38-42 min, and power of 310-330 W.

7. The preparation method according to claim 3, characterized in that The spray drying parameters include: pressure of -0.08 to -0.09 MPa and temperature of 155-175°C.

8. The preparation method according to claim 3, characterized in that The time for soaking the pinellia tuber in the ethanol solution is 3.5-4 hours; The time for soaking Atractylodes lancea and Polygonatum odoratum in the cellulase solution is 5.5-6 hours respectively.

9. Use of the pharmaceutical composition according to claim 1 or 2 in the preparation of a product for improving cardiac ejection fraction.

10. A product for improving cardiac ejection fraction, characterized in that: The product comprises: the pharmaceutical composition according to claim 1 or 2.