An Astragalus membranaceus granule for treating palpitation and its preparation method

Abstract

The present invention discloses an astragalus granule for treating palpitation. The traditional Chinese medicine granule is prepared by extracting the following traditional Chinese medicine materials in parts by weight: 30-50 parts of astragalus membranaceus, 20-30 parts of codonopsis pilosula, 15-20 parts of atractylodes macrocephala, 20-30 parts of poria cocos, 15-25 parts of panax notoginseng, 20-30 parts of cinnamon, 18-22 parts of ophiopogon japonicus, etc. It can replenish qi and strengthen the spleen, tonify the heart qi, tonify the heart yang, nourish yin and moisten the lung, replenish the lung qi, purge the liver and soothe the liver, nourish the kidney yin, remove stasis and resolve phlegm for palpitation due to deficiency of both the heart and spleen, achieving good effects, and also discloses its preparation method.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to an astragalus granule for treating palpitation and a preparation method thereof. Background Art

[0002] Palpitation is a heart-related disease caused by multiple factors, such as excessive mental stress, excessive emotional excitement, overwork. In addition, diseases such as conduction block, atrial or ventricular premature beats, sinus tachycardia or bradycardia, supraventricular tachycardia, sick sinus syndrome, rheumatic heart disease, coronary heart disease, and angina pectoris can also lead to symptoms such as uneasiness in the heart, palpitation, and abnormal heartbeat, thus causing serious adverse effects on physical and mental health and life safety.

[0003] Traditional Chinese medicine has unique advantages in treating palpitation. Starting from the heart, it differentiates the primary disease, distinguishes between deficiency and excess, combines the tongue coating and pulse condition, and conducts syndrome differentiation and treatment. The treatment of palpitation by traditional Chinese medicine has definite curative effect and small toxic and side effects. It can regulate the body function of patients as a whole, and the curative effect is stable after taking effect. In the early Han Dynasty, Zhang Zhongjing, a famous doctor, recorded in "Treatise on Febrile Diseases - Differentiation and Treatment of Symptoms and Syndromes of Taiyang Disease, Lower Part": "For those with knotted and intermittent pulses and palpitation, Zhigancao Decoction is the main treatment." According to different syndromes, ancient physicians used Anshen Dingzhi Pills, Guipi Decoction, Tianwang Buxin Pills, Linggui Zhugan Decoction, etc. for addition and subtraction treatment. However, if the treatment does not conduct syndrome differentiation, the desired effect cannot be achieved. Summary of the Invention

[0004] In view of this, the purpose of the present invention is to provide an astragalus granule for treating palpitation aiming at the problems existing in the prior art.

[0005] To achieve the above purpose, the present invention adopts the following technical scheme:

[0006] An astragalus granule for treating palpitation, which is prepared by extracting the following Chinese medicinal materials in parts by weight: 30 - 50 parts of astragalus membranaceus, 20 - 30 parts of codonopsis pilosula, 15 - 20 parts of atractylodes macrocephala, 20 - 30 parts of poria cocos, 15 - 25 parts of panax notoginseng, 20 - 30 parts of cinnamon, 18 - 22 parts of ophiopogon japonicus, 15 - 25 parts of lilium brownii, 20 - 30 parts of dioscorea opposita, 10 - 20 parts of acanthopanax senticosus, 15 - 25 parts of bupleurum chinense, 20 - 30 parts of prunella vulgaris, 20 - 30 parts of haliotis diversicolor, 15 - 25 parts of margaritifera, 20 - 30 parts of lycium barbarum, 15 - 25 parts of dendrobium officinale, 20 - 30 parts of ligustrum lucidum, 18 - 22 parts of adenophora stricta, 20 - 30 parts of angelica sinensis, 10 - 20 parts of persica, 20 - 30 parts of ligusticum wallichii, 10 - 14 parts of pinellia ternata.

[0007] The Astragalus membranaceus granule for treating palpitation is prepared by extracting the following traditional Chinese medicine materials by weight: 40 parts of Astragalus membranaceus, 25 parts of Codonopsis pilosula, 18 parts of Atractylodes macrocephala, 25 parts of Poria cocos, 20 parts of Panax notoginseng, 25 parts of Cinnamomum cassia, 20 parts of Ophiopogon japonicus, 20 parts of Lilium brownii, 25 parts of Dioscorea opposita, 15 parts of Acanthopanax senticosus, 20 parts of Bupleurum chinense, 25 parts of Prunella vulgaris, 25 parts of Haliotis diversicolor, 20 parts of Margaritifera usta, 25 parts of Lycium barbarum, 20 parts of Dendrobium officinale, 25 parts of Ligustrum lucidum, 20 parts of Adenophora tetraphylla, 25 parts of Angelica sinensis, 15 parts of Prunus persica, 25 parts of Ligusticum wallichii, and 12 parts of Pinellia ternata.

[0008] The preparation method of the Astragalus membranaceus granule for treating palpitation comprises the following steps:

[0009] (1) Weigh each medicinal material. For Haliotis diversicolor and Margaritifera usta, add water ten times their weight and decoct for 1 hour.

[0010] (2) Pulverize Panax notoginseng, Cinnamomum cassia, Angelica sinensis, Prunus persica, and Ligusticum wallichii into powders of 20 - 80 meshes, and reflux and extract twice with 65 - 75% ethanol, filter to obtain an ethanol extract filtrate.

[0011] (3) Put the residue after ethanol extraction and other medicinal materials into the water decoction of Haliotis diversicolor and Margaritifera usta, add water and decoct twice. The added water volume is made up to 10 times the dry weight of all medicinal materials, filter to obtain a water extract filtrate.

[0012] (4) Combine the ethanol extract filtrate and the water extract filtrate, concentrate under reduced pressure into a clear paste, and dry and pulverize it by vacuum belt drying to obtain a dry paste powder.

[0013] (5) Add dextrin and a sweetening agent to the dry paste powder, mix evenly, and granulate to obtain the Astragalus membranaceus granule.

[0014] In the preparation method step (2) of the Astragalus membranaceus granule for treating palpitation, the first extraction time is 2 - 4 h, the second extraction time is 1 - 3 h; the ethanol is 70% ethanol, and the addition amount of 70% ethanol is 4 - 8 times the mass of the powder.

[0015] In the preparation method step (3) of the Astragalus membranaceus granule for treating palpitation, the first water decoction time is 2 - 4 h, the second water decoction time is 1 - 3 h.

[0016] In the preparation method step (4) of the Astragalus membranaceus granule for treating palpitation, the vacuum degree during concentration under reduced pressure is -0.07 - -0.08 Mpa, the temperature is 60°C - 65°C, and the density of the clear paste measured at 60°C is 1.15 - 1.35.

[0017] The density of the clear paste of the Astragalus membranaceus granule for treating palpitation measured at 60°C is 1.25.

[0018] Application of the Astragalus membranaceus granule for treating palpitation in the preparation of drugs for treating palpitation.

[0019] The application of the Astragalus membranaceus granule for treating palpitations in the preparation of a medicament for treating palpitations, wherein the palpitations are of the syndrome type of deficiency of both the heart and spleen.

[0020] The above traditional Chinese medicines all conform to the standards of the Chinese Pharmacopoeia.

[0021] Traditional Chinese medicine believes that palpitations are caused by exogenous or endogenous factors, resulting in deficiency of qi, blood, yin and yang, and the heart losing its nourishment; or phlegm retention and blood stasis blocking the heart vessels, causing the main clinical manifestations of rapid and violent palpitations in the heart, panic and uneasiness, and even inability to control oneself. Palpitations occur due to panic and fatigue, and occur intermittently. When not occurring, the patient is normal. For those with milder conditions, it is called jingji (fright palpitations); if there is palpitations all day long, especially worse with a little exertion, and the overall condition is poor, for those with more severe conditions, it is called zhengchong (severe palpitations). Zhengchong is mostly accompanied by jingji, and those with jingji that do not heal for a long time can also turn into zhengchong.

[0022] Although the Inner Canon of Huangdi does not have the disease names of palpitations, jingji or zhengchong, there are records of similar symptoms. For example, in Plain Questions: Treatise on the Pathogenic Factors of Pain, it is said that "when frightened, the heart has nowhere to rely, the spirit has nowhere to return, and the thoughts have nowhere to settle, so the qi is in chaos." It is also believed that the causes include the leakage of primordial qi, the blockage of the heart vessels, sudden fright, and recurrence of exogenous pathogens, etc., and there is a profound understanding of the changes in the pulse conditions of palpitations. In Plain Questions: Treatise on the Nine Divisions of the Pulse, it is said that "when the pulse is uneven, there is disease." It is the earliest record that the uneven pulse rhythm is a manifestation of disease. In Plain Questions: Treatise on the Normal Pulse Conditions of Healthy People, it is said that "when the pulse stops completely, it means death; when the pulse is suddenly slow and then rapid for several days, it also means death." It is the earliest to recognize the relationship between severe arrhythmia during palpitations and the prognosis of the disease. Zhang Zhongjing in the Han Dynasty used jingji, palpitations in the heart, and palpitations below the heart as disease names in Treatise on Febrile Diseases and Synopsis of Prescriptions of the Golden Chamber. He believed that the main causes included fright, water retention, deficiency and damage, and being affected by pathogens after sweating, etc. He recorded the intermittent, slow and irregular, and rapid and irregular pulses manifested during palpitations and their differences, and put forward the basic treatment principles and commonly used prescriptions such as Zhigancao Decoction for treating palpitations. In the Song Dynasty, the chapter on Jingji Zhengchong and Amnesia in Prescriptions for Universal Relief was the first to put forward the disease name of zhengchong, and gave a relatively detailed description of the etiology, pathogenesis, complications, and treatment methods of jingji and zhengchong. In Danxi's Treatise on Jingji and Zhengchong, the theory that palpitations should be "attributed to deficiency and phlegm" was put forward. In the Ming Dynasty, On Jingji, Zhengchong and Amnesia in The Orthodox Medical Tradition gave a detailed description of the differences and connections between jingji and zhengchong. In Complete Works of Jingyue: Zhengchong, Fright and Panic, it is believed that zhengchong is caused by yin deficiency and overstrain, and "when the deficiency is mild, the palpitation is also mild; when the deficiency is severe, the palpitation is also severe." In terms of treatment and nursing, it is advocated that "it is advisable to quickly control sexual desires and reduce fatigue, and strictly abstain from alcohol and sex"; "it is advisable to quickly nourish qi and essence, and strengthen the root." In the Qing Dynasty, Correction of Errors in Medical Works discussed that blood stasis blocking the interior leads to palpitations and zhengchong, and recorded that treating palpitations with Xuefu Zhuyu Decoction often achieved good results.

[0023] The location of palpitation is mainly in the heart. Due to the lack of nourishment of the mind, the mind is shaken and palpitates restlessly. However, its onset is related to the dysfunction of the spleen, kidney, lung, and liver. For example, if the spleen fails to produce blood, there will be insufficient heart blood, and the lack of nourishment of the mind will cause palpitations. If the spleen fails to transport and transform properly, phlegm-dampness will be generated internally, disturbing the mind and causing restlessness of the mind and the onset of the disease. If the kidney yin is insufficient and unable to control the heart fire, or if the kidney yang is deficient and the heart yang lacks warmth, both can lead to palpitation. If the lung qi is deficient and unable to assist the heart in governing qi and regulating the circulation of qi and blood, the heart vessels will have poor blood circulation and cause restlessness of the heart. If the liver qi is stagnant, qi stagnation and blood stasis occur, or qi stagnation turns into fire, resulting in poor blood circulation in the heart vessels and the mind being disturbed, all of which can trigger palpitation. TCM syndrome types are divided into timidity of heart and gallbladder, deficiency of both heart and spleen, hyperactivity of fire due to yin deficiency, deficiency of heart yang, water flooding the heart, blood stasis in the heart vessels, phlegm-fire disturbing the heart, etc., among which the syndrome of deficiency of both heart and spleen is the most common.

[0024] Symptoms of palpitation with the syndrome of deficiency of both heart and spleen: Palpitation with shortness of breath, dizziness and vertigo, sallow complexion, fatigue and weakness, poor appetite and abdominal distension. Pale tongue, thready and weak pulse. Since the heart governs blood vessels and the spleen is the source of qi and blood production, deficiency of both heart and spleen leads to insufficient production of qi and blood. Insufficient blood fails to nourish the heart, resulting in palpitation and shortness of breath; insufficient blood fails to nourish the head and face, so there is dizziness and vertigo, sallow complexion; deficiency of both heart and spleen, with both qi and blood deficiency, leads to fatigue and weakness; the spleen fails to transport and transform properly, so there is poor appetite and abdominal distension; the tongue is the sprout of the heart, the heart governs blood vessels, and insufficient heart blood leads to a pale tongue and a thready and weak pulse.

[0025] Since deficiency of both heart and spleen leads to insufficient production of qi and blood, the present invention first uses drugs to tonify qi and strengthen the spleen to provide the source for qi and blood production. At the same time, the heart governs blood vessels, and the vessels are the channels for blood circulation. The circulation of blood in the vessels mainly depends on the promotion and regulation of heart qi. When heart qi is sufficient, the heart beats powerfully and rhythmically. When heart qi is insufficient and heart yang is deficient and weak, the heart beats slowly and weakly. It is advisable to tonify heart qi and heart yang.

[0026] The lung and the heart are both located in the upper jiao. The lung governs qi and the heart governs blood. The circulation of blood depends on the promotion of qi. The lung assisting the heart in promoting blood circulation is a necessary condition for the normal circulation of blood. Therefore, the heart is the "monarch" and the lung is the "prime minister". Therefore, in treatment, mainly by nourishing yin and moistening the lung, tonifying lung qi, the purpose of tonifying the heart and spleen can be achieved.

[0027] The heart governs blood vessels and the mind, and the liver governs free flow of qi and stores blood. "Essence of Medical Cases by Ling Xiaowu·Palpitation": "The heart is insufficient in substance and excessive in function, and the liver is the mother of the heart... Treatment should be to clear the heart and harmonize the stomach, supplemented by soothing the liver." Therefore, the relationship between the heart and the liver is mainly reflected in two aspects: blood circulation and mental state. The liver generates the heart, that is, wood generates fire. For example, the liver stores blood to nourish the heart, and the free flow of qi of the liver helps the heart promote blood circulation. Using the therapeutic methods of purging the liver and soothing the liver can promote the growth of heart yang.

[0028] The kidneys are the foundation of innate constitution, and the nourishment and warmth of the five internal organs depend on their yin and yang. Kidney yin deficiency prevents kidney water from ascending to the heart, which in turn impairs heart yin. Heart and kidney yin deficiency leads to internal fire, impeding blood circulation and stagnant heart vessels, resulting in heart failure and restlessness. The Jingyue Complete Works states that palpitations are primarily caused by yin deficiency and overwork: "When yin is deficient in the lower body, the primordial qi lacks its roots and cannot return to its source. Therefore, in the upper body, it flutters in the chest and chest, and in the lower body, it vibrates at the navel." "Although treatments for palpitations and panic are divided between the heart, spleen, liver, and kidney, yang is ultimately governed by yin, and the heart originates from the kidney. Therefore, restlessness in the upper body is always due to the lower body, and heart qi deficiency is always due to essence." Replenishing kidney yin, as the kidney nourishes the liver, just as water generates wood, can help alleviate palpitations.

[0029] Stagnant blood and turbid phlegm block the heart, obstructing the heart vessels and hindering the smooth flow of qi and blood, which can cause palpitations. According to "Medical Records of Combining Chinese and Western Medicine: On the Treatment of Heart Diseases," "The heart belongs to fire, while phlegm and fluid belong to water. Fire fears water, so it causes palpitations. Phlegm-clearing drugs should be used together with heart-nourishing drugs." Therefore, treatment emphasizes both resolving phlegm and nourishing the heart.

[0030] The present invention uses Astragalus, Codonopsis, Atractylodes macrocephala, and Poria to invigorate Qi and strengthen the spleen, Panax notoginseng and cinnamon to invigorate the heart Qi and yang, which are all monarch drugs; Ophiopogon japonicus, Lilium, Chinese yam, and Acanthopanax senticosus to nourish Yin, moisten the lungs, and invigorate the lung Qi, which are all minister drugs; Bupleurum, Prunella vulgaris, Semen Cassiae, and Mother of Pearl to purge and soothe the liver, Lycium barbarum, Dendrobium, Ligustrum lucidum, and Adenophora australis to invigorate the kidney Yin, which are all adjuvant drugs; Angelica sinensis, peach kernel, Chuanxiong, and Pinellia ternata to remove blood stasis and resolve phlegm, which are all guiding drugs. It contains astragalus, codonopsis, atractylodes, poria, panax notoginseng, cinnamon, ophiopogon, lily, yam, acanthopanax, bupleurum, prunella vulgaris, cassia seed, mother of pearl, wolfberry, dendrobium, privet fruit, adenophora, angelica, peach kernel, ligustrum lucidum, and pinellia. It is effective in treating palpitations caused by deficiency of both heart and spleen, and can invigorate qi and strengthen the spleen, replenish heart qi, replenish heart yang, nourish yin and moisten the lungs, replenish lung qi, purge and calm the liver, replenish kidney yin, and remove blood stasis and resolve phlegm.

[0031] The results of clinical studies showed that in the Example 1 group of the present invention, 28 cases were markedly effective, 31 cases were effective, 4 cases were ineffective, and the effective rate was 93.7%; in the control group, 17 cases were markedly effective, 35 cases were effective, 11 cases were ineffective, and the effective rate was 82.5%; the total effective rate of clinical treatment in the Example 1 group of the present invention was higher than that in the control group, and the difference was statistically significant (P<0.05). The TCM syndrome score in the Example 1 group was lower than that in the control group, and the difference was statistically significant (P<0.05). The cardiac function index of the patients in the Example 1 group of the present invention was better than that in the control group, and the difference was statistically significant (P<0.05). This shows that the present invention has a significant therapeutic effect on palpitations caused by deficiency of both the heart and spleen, and the effect is better than that of the Wenxin Granule in the control group. DETAILED DESCRIPTION

[0032] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms also fall within the scope defined by the appended claims of this application.

[0033] Example 1: Take 400 g of Astragalus membranaceus, 250 g of Codonopsis pilosula, 180 g of Atractylodes macrocephala, 250 g of Poria cocos, 200 g of Panax notoginseng, 250 g of Cinnamomum cassia, 200 g of Ophiopogon japonicus, 200 g of Lilium brownii, 250 g of Dioscorea opposita, 150 g of Eleutherococcus senticosus, 200 g of Bupleurum chinense, 250 g of Prunella vulgaris, 250 g of Haliotis diversicolor, 200 g of Concha margaritifera usta, 250 g of Lycium barbarum, 200 g of Dendrobium officinale, 250 g of Ligustrum lucidum, 200 g of Adenophora stricta, 250 g of Angelica sinensis, 150 g of Prunus persica, 250 g of Ligusticum wallichii, 120 g of Pinellia ternata. The preparation method includes the following steps:

[0034] (1) Weigh each medicinal material. For Haliotis diversicolor and Concha margaritifera usta, add ten times the weight of water and decoct for 1 hour.

[0035] (2) Crush Panax notoginseng, Cinnamomum cassia, Angelica sinensis, Prunus persica, and Ligusticum wallichii into powders of 50 meshes, and reflux extract twice with 70% ethanol. The addition amount of ethanol is 6 times the mass of the powder. The first extraction time is 3 h, and the second extraction time is 2 h. Filter to obtain an ethanol extract filtrate.

[0036] (3) Put the filter residue after ethanol extraction and other medicinal materials into the water decoction of Haliotis diversicolor and Concha margaritifera usta, and decoct twice with water. The first water decoction time is 3 h, and the second water decoction time is 2 h. Add water to make up to 10 times the dry weight of all medicinal materials. Filter to obtain a water extract filtrate.

[0037] (4) Combine the ethanol extract filtrate and the water extract filtrate, and concentrate under reduced pressure to obtain a clear paste. The vacuum degree during reduced pressure concentration is -0.07 Mpa, and the temperature is 62 °C. The density of the clear paste measured at 60 °C is 1.25. Then, dry it by vacuum belt drying and crush it to obtain dry paste powder.

[0038] (5) Add dextrin and sweetener to the dry paste powder, mix well, and granulate to obtain Astragalus granules.

[0039] Example 2: Take 300 g of Astragalus membranaceus, 300 g of Codonopsis pilosula, 150 g of Atractylodes macrocephala, 300 g of Poria cocos, 150 g of Panax notoginseng, 300 g of Cinnamomum cassia, 180 g of Ophiopogon japonicus, 250 g of Lilium brownii, 200 g of Dioscorea opposita, 200 g of Eleutherococcus senticosus, 150 g of Bupleurum chinense, 300 g of Prunella vulgaris, 200 g of Haliotis diversicolor, 250 g of Concha margaritifera usta, 200 g of Lycium barbarum, 250 g of Dendrobium officinale, 200 g of Ligustrum lucidum, 220 g of Adenophora stricta, 200 g of Angelica sinensis, 200 g of Prunus persica, 200 g of Ligusticum wallichii, 140 g of Pinellia ternata. The preparation method includes the following steps:

[0040] (1) Weigh each medicinal material. For abalone shell and mother-of-pearl, add water at ten times the weight and decoct for 1 hour.

[0041] (2) Grind notoginseng, cinnamon, angelica, peach kernel, and chuanxiong into a powder of 80 meshes, and reflux extract twice with 65% ethanol. The added amount of ethanol is 8 times the mass of the powder. The first extraction time is 2 h, and the second extraction time is 3 h. Filter to obtain an ethanol extract filtrate.

[0042] (3) Put the filter residue after ethanol extraction and other medicinal materials into the water decoction of abalone shell and mother-of-pearl, decoct twice with water. The first water decoction time is 2 h, and the second water decoction time is 3 h. Add water to make up to 10 times the dry weight of all medicinal materials. Filter to obtain a water extract filtrate.

[0043] (4) Combine the ethanol extract filtrate and the water extract filtrate, and concentrate under reduced pressure into a clear paste. The vacuum degree during reduced pressure concentration is -0.08 Mpa, and the temperature is 60 °C. The density of the clear paste measured at 60 °C is 1.35. Then carry out vacuum belt drying and pulverization to obtain a dry paste powder.

[0044] (5) Add dextrin and sweetener to the dry paste powder, mix well, and granulate to obtain astragalus granules.

[0045] Example 3: Take 500 g of astragalus membranaceus, 200 g of codonopsis pilosula, 200 g of atractylodes macrocephala, 200 g of poria cocos, 250 g of notoginseng, 200 g of cinnamon, 220 g of ophiopogon japonicus, 150 g of lilium brownii, 300 g of dioscorea opposita, 100 g of acanthopanax senticosus, 250 g of bupleurum chinense, 200 g of prunella vulgaris, 300 g of abalone shell, 150 g of mother-of-pearl, 300 g of wolfberry fruit, 150 g of dendrobium officinale, 300 g of ligustrum lucidum, 180 g of adenophora stricta, 300 g of angelica sinensis, 100 g of peach kernel, 300 g of chuanxiong, and 100 g of pinellia ternata. The preparation method includes the following steps:

[0046] (1) Weigh each medicinal material. For abalone shell and mother-of-pearl, add water at ten times the weight and decoct for 1 hour.

[0047] (2) Grind notoginseng, cinnamon, angelica, peach kernel, and chuanxiong into a powder of 20 meshes, and reflux extract twice with 75% ethanol. The added amount of ethanol is [the multiple of the powder mass] times. The first extraction time is 4 h, and the second extraction time is 1 h. Filter to obtain an ethanol extract filtrate.

[0048] (3) Put the filter residue after ethanol extraction and other medicinal materials into the water decoction of abalone shell and mother-of-pearl, decoct twice with water. The first water decoction time is 4 h, and the second water decoction time is 1 h. Add water to make up to 10 times the dry weight of all medicinal materials. Filter to obtain a water extract filtrate.

[0049] (4) Combine the ethanol extract filtrate and the water extract filtrate, and concentrate under reduced pressure into a clear paste. The vacuum degree during reduced pressure concentration is -0.07 Mpa, the temperature is 65 °C, and the density of the clear paste measured at 60 °C is 1.15. Then, carry out vacuum belt drying and pulverization to obtain dry paste powder;

[0050] (5) Add dextrin and sweetener to the dry paste powder, mix well, and granulate to obtain Astragalus granules.

[0051] Example 4: Clinical research

[0052] General information: Select 126 patients with palpitations admitted to Nanjing Hospital of Traditional Chinese Medicine as the research objects. They were grouped into a control group and an observation group according to the random number table method, with 63 cases in each group. The age of the patients in the control group was 25 - 86 years old; there were 35 males and 28 females; the course of disease was 2 - 8 years. The age of the patients in the observation group was 23 - 84 years old, 32 males and 31 females; the course of disease was 2 - 9 years. There was no significant difference in the general information of the two groups of patients, including gender and age comparison (P > 0.05). They were comparable. This study was approved by the hospital's medical ethics committee.

[0053] Inclusion and exclusion criteria: Inclusion criteria: ① Confirmed as patients with palpitations; ② Sustained palpitations for at least 1 week; ③ Voluntarily participated in this study. At the same time, through traditional Chinese medicine syndrome differentiation, it belongs to palpitations of the syndrome of deficiency of both the heart and spleen. Symptoms: Palpitations with shortness of breath, dizziness and vertigo, sallow complexion, fatigue, poor appetite and abdominal distension. Pale tongue, thready and weak pulse. Exclusion criteria: ① Patients with organic lesions; ② Patients with abnormal cardiac function; ③ Patients with malignant tumors; ④ Lactating and pregnant women.

[0054] Administration method: The patients in the control group were given Wenxin Granules (National Drug Approval Number Z10950026) 9 g / time, 3 times / d; the patients in the Example 1 group were given the granules prepared by the method of Example 1 (Daily prescription: Astragalus membranaceus 40 g, Codonopsis pilosula 25 g, Atractylodes macrocephala 18 g, Poria cocos 25 g, Panax notoginseng 20 g, Cinnamon 25 g, Ophiopogon japonicus 20 g, Lilium brownii 20 g, Dioscorea opposita 25 g, Acanthopanax senticosus 15 g, Bupleurum chinense 20 g, Prunella vulgaris 25 g, Haliotis diversicolor 25 g, Margaritifera 20 g, Lycium barbarum 25 g, Dendrobium officinale 20 g, Ligustrum lucidum 25 g, Adenophora tetraphylla 20 g, Angelica sinensis 250 g, Prunus persica 15 g, Ligusticum wallichii 25 g, Pinellia ternata 12 g), three times a day.

[0055] Observation indicators: ① Total effective rate of clinical treatment: Marked effect: Clinical symptoms and abnormal heart rate completely disappear; Effective: Clinical symptoms and heart rate gradually return to normal; Ineffective: Clinical symptoms and abnormal heart rate still exist or even worsen. Total effective rate of clinical treatment = (number of marked effect cases + number of effective cases) / total number of cases × 100.00%. ② TCM syndrome scores before and after treatment, see Table 1: The score range for each item is 0 - 3 points. 0 point indicates no clinical symptoms, and 3 points indicate very severe clinical symptoms. ③ Cardiac function indicators before and after treatment: left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV), left ventricular ejection fraction (LVEF).

[0056] Table 1 TCM symptom score table

[0057]

[0058] Results: Comparison of the total effective rate of treatment between the two groups of patients, see Table 2; Comparison of the TCM syndrome scores between the two groups of patients, see Table 3; Comparison of the cardiac function indicators between the two groups of patients, see Table 4.

[0059] Table 2 Comparison of the total effective rate of treatment between the two groups of patients

[0060] Group Marked effect Effective Ineffective Effective rate (%) Control group 17 35 11 82.5 Example 1 group 28 31 4 93.7

[0061] Table 3 Comparison of the TCM syndrome scores between the two groups of patients

[0062]

[0063] Compared with before treatment in the same group: *P < 0.05; Compared with after treatment in the control group: #P < 0.05

[0064] Table 4 Comparison of the cardiac function indicators between the two groups of patients

[0065]

[0066] Compared with before treatment in the same group: *P < 0.05; Compared with after treatment in the control group: #P < 0.05

[0067] Conclusion: As can be seen from Table 2, in the Example 1 group, there were 28 cases with marked effect, 31 cases with effective, and 4 cases with ineffective, and the effective rate was 93.7%; in the control group, there were 17 cases with marked effect, 35 cases with effective, and 11 cases with ineffective, and the effective rate was 82.5%; the total effective rate of clinical treatment in the Example 1 group was higher than that in the control group, and the difference was statistically significant (P < 0.05). As can be seen from Table 3, the TCM syndrome score in the Example 1 group was lower than that in the control group, and the difference was statistically significant (P < 0.05). As can be seen from Table 4, the cardiac function indicators of the patients in the Example 1 group were better than those in the control group, and the difference was statistically significant (P < 0.05). It shows that the present invention has a significant therapeutic effect on palpitation with syndrome of deficiency of both heart and spleen, and the effect is better than that of the control group's Wenxin Granules.

[0068] Although embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Huangqi granule for treating palpitation, characterized in that, The described Astragalus granule is prepared by extracting traditional Chinese medicinal materials in the following parts by weight: 30 - 50 parts of Astragalus membranaceus, 20 - 30 parts of Codonopsis pilosula, 15 - 20 parts of Atractylodes macrocephala, 20 - 30 parts of Poria cocos, 15 - 25 parts of Panax notoginseng, 20 - 30 parts of Cinnamomum cassia, 18 - 22 parts of Ophiopogon japonicus, 15 - 25 parts of Lilium brownii, 20 - 30 parts of Dioscorea opposita, 10 - 20 parts of Acanthopanax senticosus, 15 - 25 parts of Bupleurum chinense, 20 - 30 parts of Prunella vulgaris, 20 - 30 parts of Haliotis diversicolor, 15 - 25 parts of Margaritifera usta, 20 - 30 parts of Lycium barbarum, 15 - 25 parts of Dendrobium officinale, 20 - 30 parts of Ligustrum lucidum, 18 - 22 parts of Adenophora stricta, 20 - 30 parts of Angelica sinensis, 10 - 20 parts of Prunus persica, 20 - 30 parts of Ligusticum wallichii, 10 - 14 parts of Pinellia ternata.

2. The Astragalus membranaceus particle for treating palpitation according to claim 1, wherein The described Astragalus granule is prepared by extracting traditional Chinese medicinal materials in the following parts by weight: 40 parts of Astragalus membranaceus, 25 parts of Codonopsis pilosula, 18 parts of Atractylodes macrocephala, 25 parts of Poria cocos, 20 parts of Panax notoginseng, 25 parts of Cinnamomum cassia, 20 parts of Ophiopogon japonicus, 20 parts of Lilium brownii, 25 parts of Dioscorea opposita, 15 parts of Acanthopanax senticosus, 20 parts of Bupleurum chinense, 25 parts of Prunella vulgaris, 25 parts of Haliotis diversicolor, 20 parts of Margaritifera usta, 25 parts of Lycium barbarum, 20 parts of Dendrobium officinale, 25 parts of Ligustrum lucidum, 20 parts of Adenophora stricta, 25 parts of Angelica sinensis, 15 parts of Prunus persica, 25 parts of Ligusticum wallichii, 12 parts of Pinellia ternata.

3. The Astragalus membranaceus particle for treating palpitation according to claim 1, wherein The preparation method includes the following steps: (1) Weigh each medicinal material. For Haliotis diversicolor and Margaritifera usta, add ten times the weight of water and decoct for 1 hour. (2) Crush Panax notoginseng, Cinnamomum cassia, Angelica sinensis, Prunus persica, and Ligusticum wallichii into powders of 20 - 80 meshes, and reflux - extract twice with 65 - 75% ethanol, filter to obtain an ethanol - extracted filtrate. (3) Put the residue after ethanol extraction and other medicinal materials into the water - decocted solution of Haliotis diversicolor and Margaritifera usta, decoct twice with water, add water to make up to 10 times the dry weight of all medicinal materials, filter to obtain a water - extracted filtrate. (4) Combine the ethanol - extracted filtrate and the water - extracted filtrate, concentrate under reduced pressure into a clear paste, and dry and crush it by vacuum belt drying to obtain a dry paste powder. (5) Add dextrin and a sweetening agent to the dry paste powder, mix well, and granulate to obtain the Astragalus granule.

4. The Astragalus membranaceus granule for treating palpitation according to claim 3, wherein In step (2) of the described preparation method, the first extraction time is 2 - 4 h, the second extraction time is 1 - 3 h; the ethanol is 70% ethanol, and the addition amount of 70% ethanol is 4 - 8 times the mass of the powder.

5. The Astragalus membranaceus granule for treating palpitation according to claim 3, wherein, In step (3) of the described preparation method, the first water - decocting time is 2 - 4 h, the second water - decocting time is 1 - 3 h.

6. The Astragalus membranaceus particle for treating palpitation according to claim 3, wherein In step (4) of the described preparation method, the vacuum degree during reduced - pressure concentration is - 0.07 - - 0.08 Mpa, the temperature is 60°C - 65°C, and the density of the clear paste measured at 60°C is 1.15 - 1.

35.

7. The Astragalus membranaceus granule for treating palpitation according to claim 6, characterized in that, The density of the clear paste measured at 60°C is 1.

25.

8. The application of the Astragalus granule for treating palpitation as described in claim 1 in the preparation of a drug for treating palpitation.

9. Use of the Astragalus membranaceus particle for treating palpitation according to claim 1 in the preparation of a medicament for treating palpitation, characterized in that The palpitation is of the syndrome type of deficiency of both heart and spleen.

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