Traditional Chinese medicine preparation for treating multi-system atrophic upright hypotension and preparation method of traditional Chinese medicine preparation

Abstract

The invention discloses a traditional Chinese medicine preparation for treating multi-system atrophic upright hypotension and a preparation method. The traditional Chinese medicine preparation is prepared from the following raw materials: ginseng, astragalus membranaceus, antler, roasted ephedra, rehmannia, radix ophiopogonis, radix paeoniae alba, rhizoma cimicifugae and pericarpium citri reticulatae viride. The traditional Chinese medicine composition has the effects of tonifying qi, warming yang, nourishing blood and yin and ascending and descending qi function, and emphasizes the effect of ascending and descending qi function in blood pressure regulation by perfecting the etiology and pathogenesis of MSA erect hypotension; the pathogenesis of the MSA erect hypotension is mainly viscera asthenia and qi and blood ascending and descending disorder, so that the treatment effect is achieved by ascending yang and nourishing yin.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, in particular to a traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy and a preparation method thereof. Background Art

[0002] Multiple system atrophy (MSA) is a sporadic neurodegenerative disease of unknown etiology and is a difficult disease of the nervous system. MSA is characterized by progressive autonomic failure accompanied by Parkinson's syndrome and / or cerebellar ataxia.

[0003] There is currently no accurate epidemiological data in my country, and there is a general lack of awareness and attention to MSA, which has led to many patients being missed or misdiagnosed in the early stages and failing to receive timely and correct treatment.

[0004] International studies show that the average incidence of MSA is 0.6-0.7 per 100,000 people, the prevalence is 3.4-4.9 per 100,000 people, and the average age of onset is 53 years. MSA progresses rapidly and has a poor prognosis. Approximately 50% of patients require assistance with walking within 3 years of the onset of motor symptoms, 60% require a wheelchair after 5 years, and after 6-8 years, patients are typically completely bedridden. The average lifespan is approximately 8-10 years.

[0005] MSA has an insidious onset, high disability, and a short lifespan. It is a difficult and challenging brain disease that seriously endangers people's health. However, research on this issue is currently insufficient.

[0006] MSA autonomic dysfunction:

[0007] The primary characteristic of MSA is the early onset of progressive autonomic dysfunction. The main clinical manifestations of autonomic dysfunction include orthostatic hypotension (OH), urinary dysfunction (frequent urination, urgency, incontinence, or urinary retention), and sexual dysfunction. Rapid progression of autonomic symptoms portends a poor prognosis and shortened lifespan.

[0008] The most common initial symptom of MSA is autonomic dysfunction, accounting for about 73%, while only 3% of patients have motor symptoms as the initial symptom.

[0009] Among MAS patients, 94.7% had impaired autonomic nervous function, and the incidence of symptoms was as follows: orthostatic hypotension 77.7%, urinary dysfunction 66.7%, and erectile dysfunction 16.6%.

[0010] Autonomic dysfunction severely impacts patients' quality of life. When patients with orthostatic hypotension change position, such as suddenly standing up from lying down, squatting, or sitting, they experience dizziness, blurred vision, weakness in the lower limbs, and, in severe cases, syncope. This can lead to decreased mobility and even serious consequences such as falls and fractures.

[0011] Therefore, improving MAS autonomic nervous function and correcting orthostatic hypotension will greatly improve the patient's quality of life, increase safety, and delay the progression of the disease.

[0012] Supine (nocturnal) hypertension in MSA:

[0013] More than half of MAS patients experience supine hypertension (SH). MSA patients also experience autonomic dysfunction, including altered circadian rhythms of blood pressure and elevated nocturnal blood pressure.

[0014] The development of supine hypertension is associated with autonomic nervous system dysregulation. Nocturnal hypertension has a higher predictive value for subclinical target organ damage than daytime blood pressure. Nocturnal hypertension is closely associated with the incidence of adverse cardiovascular events, including congestive heart failure, left ventricular hypertrophy, proteinuria, and cerebral infarction.

[0015] Treatment status and difficulties:

[0016] Western medicine treatment: Currently, there is no specific medication for MSA orthostatic hypotension. Previous clinical studies on the treatment of orthostatic hypotension have included patients with MSA.

[0017] Drugs that improve standing blood pressure include midodrine and droxidopa. Midodrine's significant increase in nocturnal blood pressure limits its clinical application. Droxidopa, a synthetic prodrug of the amino acid norepinephrine, received accelerated approval from the US FDA as an orphan drug in 2014 and is currently the only drug approved for the treatment of neurogenic orthostatic hypotension (NOH). However, droxidopa also raises supine and nocturnal blood pressure.

[0018] Current status of traditional Chinese medicine treatment:

[0019] Traditional Chinese Medicine (TCM) often diagnoses and treats dizziness or syncope based on symptoms, focusing on raising yang and lifting sunken qi, invigorating qi and nourishing yin, and warming yang and strengthening the brain. However, these studies are generally small in scale, with small sample sizes and a lack of multicenter RCTs. Treatments often involve a combination of Chinese and Western medicine, with a relative lack of pure TCM treatments. TCM etiology, pathogenesis, and syndromes remain in their initial stages of exploration, lacking a systematic understanding and corresponding norms and diagnostic criteria. Summary of the Invention

[0020] In response to the problems of the prior art, the present invention aims to provide a traditional Chinese medicine preparation for treating orthostatic hypotension in multiple system atrophy, which effectively increases standing blood pressure while minimizing the effect on supine (nocturnal) blood pressure. Another object of the present invention is to provide a method for preparing the aforementioned traditional Chinese medicine preparation.

[0021] To achieve the above object, the present invention provides a traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy, the raw materials of which include: ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon, white peony root, cimicifuga, and green peel.

[0022] Furthermore, the Chinese medicine preparation is made from the following raw materials in parts by weight:

[0023] 5-15 parts of ginseng, 15-30 parts of astragalus, 10-30 parts of antler, 6-9 parts of roasted ephedra, 15-30 parts of rehmannia, 10-30 parts of ophiopogon, 15-60 parts of white peony root, 10-12 parts of cimicifuga, and 15-30 parts of green peel.

[0024] Furthermore, the Chinese medicine preparation is made from the following raw materials in parts by weight:

[0025] 10 parts of ginseng, 30 parts of astragalus, 30 parts of antler, 6 parts of roasted ephedra, 30 parts of rehmannia, 30 parts of ophiopogon, 30 parts of white peony root, 10 parts of cimicifuga, 20 parts of green peel.

[0026] Furthermore, the Chinese medicine preparation also includes pharmaceutically acceptable excipients.

[0027] Furthermore, the ginsenosides contained in the ginseng have a bidirectional regulation on blood pressure, wherein the ginsenosides PDS from ginseng stems and leaves cause a decrease in blood pressure, while the ginsenosides PTS cause an increase in blood pressure.

[0028] Furthermore, in the astragalus, α-tyrosine, γ-aminobutyric acid and astragaloside IV are effective ingredients for lowering blood pressure; astragaloside IV is an effective ingredient for increasing blood pressure, thereby achieving a bidirectional regulation effect on blood pressure.

[0029] Furthermore, 3-9 g of the ephedra ephedra increases blood pressure, while 10 g or more of the ephedra ephedra ephedra lowers blood pressure due to cardiac inhibition.

[0030] Furthermore, the water extract of Rehmannia root has a blood pressure lowering effect on hypertension and a stabilizing effect on blood pressure in cold conditions, thereby making Rehmannia root have a bidirectional regulating effect on blood pressure.

[0031] A method for preparing a traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy, comprising:

[0032] The Chinese medicine formula granules are prepared by mixing ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon japonicus, white peony root, cimicifuga heracleifolia and green peel.

[0033] Furthermore, the preparation method is specifically as follows:

[0034] Using prescription extraction process flow, we can prepare Astragalus formula granules, Ginseng formula granules, Rehmannia root formula granules, Ophiopogon formula granules, White Peony root formula granules, Honey Ephedra formula granules, Cimicifuga formula granules, Cimicifugae formula granules, and Rehmannia root formula granules;

[0035] Deer antler formula granules are prepared using a prescription powdering process;

[0036] The prepared various formula granules are mixed according to a set weight ratio to obtain traditional Chinese medicine formula granules.

[0037] The present invention has the effects of invigorating qi and warming yang, nourishing blood and nourishing yin, and raising and lowering qi. By improving the etiology and pathogenesis of MSA orthostatic hypotension, it emphasizes the role of the rise and fall of qi in blood pressure regulation; it proposes that the pathogenesis of MSA orthostatic hypotension is mainly due to deficiency of internal organs and imbalance of qi and blood rise and fall, thereby achieving the therapeutic effect by raising yang and nourishing yin. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 It is the technical roadmap of the present invention;

[0039] Figure 2 It is a test flow chart of the present invention;

[0040] Figure 3 This is a chart comparing the scores of the OHQ scale and its subscales before and after treatment within the same group;

[0041] Figure 4 is the inter-group comparison graph of the mean improvement of the OHQ scale and its subscales after treatment;

[0042] Figure 5 It is the intra-group and inter-group comparison graph of standing SBP;

[0043] Figure 6 It is the intra-group and inter-group comparison graph of upright DBP;

[0044] Figure 7 It is the intra-group and inter-group comparison chart of standing HR;

[0045] Figure 8 is the intra-group and inter-group comparison graph of supine SBP;

[0046] Figure 9 is the intra-group and inter-group comparison graph of supine DBP;

[0047] Figure 10 It is the intra-group and inter-group comparison graph of supine HR;

[0048] Figure 11 This is a comparison chart of the scores of Part I of the UMSARA scale before and after treatment within and between groups;

[0049] Figure 12This is a chart comparing the scores of the Vertigo Symptom Scale and its subscales before and after treatment within the same group;

[0050] Figure 13 This is a comparison chart of the Vertigo Symptom Scale and its subscale scores between groups before and after treatment;

[0051] Figure 14 This is a comparison chart of the changes in activity balance confidence scale scores within and between groups;

[0052] Figure 15 It is the intra-group and inter-group comparison graph of overall SBP;

[0053] Figure 16 It is the intra-group and inter-group comparison chart of the overall DBP;

[0054] Figure 17 It is the intra-group and inter-group comparison chart of the overall HR;

[0055] Figure 18 This is the process flow chart of Astragalus formula granules;

[0056] Figure 19 This is the process flow chart of ginseng formula granules;

[0057] Figure 20 This is the process flow chart of Rehmannia root formula granules;

[0058] Figure 21 This is the process flow chart of Ophiopogon japonicus formula granules;

[0059] Figure 22 This is the process flow chart of white peony root formula granules;

[0060] Figure 23 This is the process flow chart of honey ephedra formula granules;

[0061] Figure 24 This is the process flow chart of Cimicifuga formula granules;

[0062] Figure 25 This is the process flow chart of Qingpi formula granules;

[0063] Figure 26 Process flow chart of Rehmannia root formula granules

[0064] Figure 27 This is the process flow chart of deer antler formula granules. DETAILED DESCRIPTION

[0065] The following combination Figure 1-Figure 27 The specific embodiments of the present invention are described in detail. It should be understood that the specific embodiments described herein are only used to illustrate and explain the present invention and are not used to limit the present invention.

[0066] MSA orthostatic hypotension can cause dizziness and, in severe cases, syncope, which in Traditional Chinese Medicine falls under the rubric of "vertigo" and "syncope." If the clear yang qi cannot reach the top of the head, the brain marrow is deprived of nourishment, leading to vertigo. If the qi's ascending and descending function is suddenly disrupted, leading to a lack of smooth connection between yin and yang qi, syncope can occur.

[0067] The key challenge in treating orthostatic hypotension in MSA lies in effectively raising standing blood pressure while minimizing the impact on supine (nocturnal) blood pressure. This invention, by combining disease differentiation with syndrome differentiation, can improve the clinical symptoms of dizziness and syncope, ultimately treating MSA orthostatic hypotension.

[0068] The invention discloses a traditional Chinese medicine preparation for treating orthostatic hypotension caused by multiple system atrophy. The raw materials include ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon, white peony root, cimicifuga and green peel.

[0069] Ginseng tastes sweet, slightly bitter, and slightly warm. It enters the spleen, lung, heart, and kidney meridians. It has the effects of significantly replenishing vital energy and strengthening the meridians. Ginseng stem and leaf glycosides contain both pressor (PTS) and antihypertensive (PDS) components, and can induce bidirectional changes in blood pressure. Ginseng stem and leaf saponins, including diol (PDS) and triol (PTS) saponins, have a certain effect on blood pressure, with PDS causing a decrease in blood pressure and intravenous PTS causing an increase in blood pressure.

[0070] Ginseng root contains a variety of ginsenosides, with a total saponin content of approximately 5%. Over 40 ginsenosides have been isolated and identified, including ginsenoside Ro, ginsenosides Ra1, Ra2, Ra3, Rb1, Rb2, Rb3, Rc, Re, Rg1, Rg2, Rh1, Rh2, I, and K. Ginseng regulates blood pressure in three ways: either increasing, decreasing, or biphasic, with a primary effect being antihypertensive. These mechanisms are: direct action on vascular smooth muscle; and activation of presynaptic Q2 to reduce sympathetic neurotransmitter release. Experimental studies have shown that the diol group (PDS) of ginseng stems and leaves primarily lowers blood pressure, an effect related to its cholinergic effects. Intravenous injection of the triol group (PTS) can elevate blood pressure, an effect that may not be attributable to α- and β-receptors but rather to central nervous system effects. The presence of both pressor (PTS) and antihypertensive (PDS) components in ginseng stem and leaf glycosides confirms their biphasic effects on blood pressure.

[0071] Astragalus root is sweet and slightly warm. It enters the lung and spleen meridians and has the effects of tonifying qi and raising yang. α-Tyrosine, γ-aminobutyric acid, and astragaloside IV are the active ingredients in astragalus root that lower blood pressure, while astragaloside IV is the active ingredient that raises blood pressure, achieving a dual-action blood pressure regulation effect.

[0072] The main components of Astragalus are astragaloside, astragaloside polysaccharide, astragaloflavonoids, aminobutyric acid (AABA) and other amino acids, trace elements (selenium, manganese, iron, zinc, copper), and calcium. Astragalus has a biphasic effect on blood pressure regulation. Regarding blood pressure lowering, α-tyrosine, γ-aminobutyric acid, and astragaloside IV are the active components of Astragalus, with mechanisms related to vasodilation, diuresis, central nervous system peptides, and the renin-angiotensin-aldosterone system. Astragalus has a blood pressure-raising effect, and its mechanism of action is to improve cardiac function and increase cardiac output. Astragalus has a clear cardiotonic effect, and Astragaloside IV is the active component with positive inotropic effects. Astragaloside IV not only exerts a positive inotropic effect on the left ventricle of rats with normal and suppressed cardiac function, but also improves both systolic and diastolic function without increasing myocardial oxygen consumption. This results in increased cardiac contraction amplitude and cardiac output, achieving a blood pressure-raising effect.

[0073] Deer antlers are salty and warm in nature. They enter the liver and kidney meridians and have the effects of warming the kidneys, strengthening yang, and promoting spermatogenesis and blood circulation.

[0074] Ephedra sinica (Zhi Ma Huang) is pungent, slightly bitter, and warm in nature, and enters the lung and bladder meridians. Its pungent, warm, ascending and dispersing properties are strong, promoting lung qi. Small doses (3-9g) of Zhi Ma Huang can increase blood pressure, while large doses (greater than 10g) can lower blood pressure due to cardiac depressant effects.

[0075] Rehmannia root is sweet in taste and enters the heart, liver, and kidney meridians. It has the effects of nourishing blood and yin, and replenishing essence and marrow. The acidic portion of Rehmannia root water extract, which primarily contains glycosides, alkaloids, and phosphates, has a significant antihypertensive effect on experimental hypertension and stabilizes blood pressure in cold conditions, demonstrating that Rehmannia root has a bidirectional regulatory effect on blood pressure.

[0076] Different extracts of Rehmannia glutinosa have different effects. The aqueous extract of Rehmannia glutinosa has significant antihypertensive, sedative, and anti-inflammatory effects, while the ether and ethanol extracts do not. The acidic portion of the aqueous extract has antihypertensive and sedative effects, while the neutral and alkaline portions are less significant. The acidic portion of the aqueous extract primarily contains glycosides, alkaloids, and phosphoric acid.

[0077] Ophiopogon japonicus has a sweet, slightly bitter, and slightly cold taste. It enters the lung, stomach, and heart meridians. It nourishes yin and promotes the production of body fluids. Ophiopogon japonicus injection can rapidly raise blood pressure in rats with hemorrhagic shock and significantly increase the rate of change of left ventricular pressure, cardiac output, and maximum myocardial contraction.

[0078] White peony root is bitter, sour, and slightly cold. It enters the liver and spleen meridians. It nourishes blood, softens the liver, and calms liver yang, guiding blood back to the liver.

[0079] Cimicifuga herba is pungent, slightly sweet, and slightly cold. It enters the lung, spleen, stomach, and large intestine meridians. Its entry into the spleen and stomach meridians is known to draw the clear yang energy upward, making it a key herb for raising yang and lifting the sunken.

[0080] Qingpi (a Chinese tangerine peel) is bitter, pungent, and warming. It enters the liver, gallbladder, and stomach meridians. Its primary action is the liver meridian, where its bitter properties can dissipate downward, while its pungent properties can dissipate and warm. Qingpi has anti-shock properties, causing a significant increase in blood pressure, a significant decrease in heart rate, and a significant increase in pulse pressure in healthy cats, while also significantly reducing blood flow.

[0081] Through the combination of ginseng, astragalus, deer antler, roasted ephedra, rehmannia, ophiopogon, white peony root, cimicifuga, and green peel, it has the effects of invigorating qi and warming yang, nourishing blood and nourishing yin, and raising and lowering qi.

[0082] The Chinese medicine preparation is made from the following raw materials in parts by weight:

[0083] 5-15 parts of ginseng, 15-30 parts of astragalus, 10-30 parts of antler, 6-9 parts of roasted ephedra, 15-30 parts of rehmannia, 10-30 parts of ophiopogon, 15-60 parts of white peony root, 10-12 parts of cimicifuga, 15-30 parts of green peel. In order to form a medicine, pharmaceutically acceptable excipients are also included.

[0084] The Chinese medicine preparation is prepared according to the optimal formula from the following raw materials in parts by weight: 10 parts of ginseng, 30 parts of astragalus, 30 parts of antler, 6 parts of roasted ephedra, 30 parts of rehmannia, 30 parts of ophiopogon, 30 parts of white peony root, 10 parts of cimicifuga, and 20 parts of green peel.

[0085] The present invention provides a method for preparing a traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy, and the preparation method comprises:

[0086] The Chinese medicine formula granules are prepared by mixing ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon japonicus, white peony root, cimicifuga heracleifolia and green peel.

[0087] Furthermore, the preparation method is specifically as follows:

[0088] Using prescription extraction process flow, we can prepare Astragalus formula granules, Ginseng formula granules, Rehmannia root formula granules, Ophiopogon formula granules, White Peony root formula granules, Honey Ephedra formula granules, Cimicifuga formula granules, Cimicifugae formula granules, and Rehmannia root formula granules; Figures 18-26 This is the process flow chart for extracting variety formula granules.

[0089] The specific process of extracting Astragalus formula granules is as follows:

[0090]

[0091] The specific process of extracting ginseng formula granules is as follows:

[0092]

[0093]

[0094] The specific process of extracting Rehmannia root formula granules is as follows:

[0095]

[0096]

[0097] The specific process of extracting Ophiopogon japonicus formula granules is as follows:

[0098]

[0099]

[0100] The specific process of extracting white peony root granules is as follows:

[0101]

[0102]

[0103] The specific process of extracting honey ephedra formula granules is as follows:

[0104]

[0105] The specific process of extracting Cimicifuga formula granules is as follows:

[0106]

[0107] The specific process of extracting green peel formula granules is as follows:

[0108]

[0109]

[0110] The specific process of extracting Rehmannia root formula granules is as follows:

[0111]

[0112]

[0113] Deer antler formula granules are prepared using a prescription powdering process; Figure 27 This is the process flow chart for powder variety formula granules.

[0114] The process of preparing antler formula granules by powdering process is as follows:

[0115]

[0116] The prepared various formula granules are mixed according to a set weight ratio to obtain traditional Chinese medicine formula granules.

[0117] The traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy of the present invention can increase standing blood pressure while not affecting supine blood pressure. It is suitable for patients with early-stage multiple system atrophy with autonomic nervous system damage as the first symptom, avoiding dizziness and even syncope caused by orthostatic hypotension. It can also be used for patients in the early and middle stages of the disease to improve their mobility by improving orthostatic hypotension. It is a safer drug for patients who experience side effects such as supine hypertension and urinary retention when taking drugs such as midodrine and droxidopa.

[0118] To verify the actual efficacy of the Chinese medicine preparations for treating orthostatic hypotension due to multiple system atrophy (MSA) of the present invention, a multicenter, randomized, double-blind, placebo-controlled clinical study design (ethics approval number: 2022XLA001-2) was conducted. Sixty patients with MSA-OH who visited the outpatient clinics and wards of the Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, and Beijing Hospital of Traditional Chinese Medicine between January 2022 and January 2024 were enrolled and randomly divided into a test group and a control group of 30 patients using a random number table. Before treatment, the patients' general demographic information, medical history, and medication status were collected, and a physical examination was performed. Simultaneously, the OHQ scale, UMSARS scale part I, vertigo clinical symptom assessment scale, and balance confidence scale were evaluated, and 24-hour ambulatory blood pressure (ABPM) monitoring and safety testing were performed on the patients. During the treatment, the test group was given the formula granules of the Chinese medicine preparation of the present invention, while the control group was given a placebo containing 5% of the original drug. Both groups took one bag each time, twice daily, for 4 consecutive weeks. During treatment, patients underwent weekly ABPM monitoring, and adverse reactions and their onset were recorded. After treatment, the aforementioned scales, ABPM monitoring, and safety testing were repeated, and all data were collected and analyzed.

[0119] 1 Research Methods

[0120] This study employed a multicenter, randomized, double-blind, placebo-controlled clinical study design. The experimental procedures were approved by the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences, with the ethics approval number being 2022XLA001-2.

[0121] 1.1 Study Design

[0122] (1) Randomization and blinding: This study adopted the block randomization method. SAS statistical software was used to generate a random number table based on the number of cases and random ratio of each participating unit. The subjects were randomly divided into the experimental group and the control group in a 1:1 ratio. After screening qualified subjects, random numbers were assigned according to the randomization sequence.

[0123] (2) Control: The experimental group was given a TCM formula granule at a designated daily dose. The control group received a TCM formula granule simulant containing 5% of the original drug. The appearance, smell, and packaging of the simulant were identical to the experimental drug to ensure the implementation of the blind method.

[0124] (3) Sample size: The sample size of this study was calculated using G*Power3.1 software. Referring to the improvement effect of similar Chinese medicine on BP in MSA-OH patients in previous studies, the effect size of Jiuwei Shengyang Fang was set to 0.8. Covariance analysis was selected, α = 0.05 (two-tailed) and power = 0.80 were set, and it was calculated that 26 cases were required for each group, with a total sample size of 52 cases. Considering the 20% dropout rate, the sample size was expanded to 62 cases. According to the patient flow and recruitment cycle of the participating centers, 60 cases were finally included (30 cases in the experimental group and 30 cases in the control group). The actual statistical power of ANCOVA was 0.85, which met the analysis requirements.

[0125] (4) Setting up a subject diary: Establish a subject's life diary for comparison with the 24-hour BP monitoring record.

[0126] 1.2 Research subjects

[0127] (1) Case source: 60 patients with MSA-OH who visited the outpatient clinics of the Department of Neurology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, and Beijing Haidian District Hospital of Traditional Chinese Medicine from January 2022 to January 2024 were enrolled and randomly divided into an experimental group and a control group of 30 cases each using a random number table. All patients were aware of the relevant risks and signed informed consent.

[0128] (2) Diagnostic criteria

[0129] The specific diagnostic basis for multiple system atrophy (MSA) includes clinical symptoms (such as movement disorders, autonomic dysfunction, ataxia, etc.) and imaging and pathological examination results. The present invention requires that the supine blood pressure be measured after the subject remains in a supine state for more than 10 minutes. The standing blood pressure requires measuring the BP of the subject when he or she stands for 3 minutes. If the systolic blood pressure (SBP) drops by ≥20mmHg after standing, or the diastolic blood pressure (DBP) drops by ≥10mmHg, and is accompanied by related symptoms, OH can be diagnosed. For OH patients who have difficulty standing, cannot stand, or have severe symptoms, the supine-standing test is changed to a supine-sitting method, and the diagnostic criteria are adjusted to a SBP drop of ≥15mmHg or a DBP drop of ≥7mmHg.

[0130] 1.3 Intervention plan

[0131] (1) Medication regimen:

[0132] The treatment group was given the granules of the present invention, 1 bag each time, twice a day, in the morning and at noon, for 4 weeks. The formula is as follows: ginseng, astragalus, antler, roasted ephedra, rehmannia, ophiopogon, white peony root, cimicifuga, and green peel.

[0133] The control group was given a placebo containing 5% of the original drug, 1 bag each time, twice a day, in the morning and at noon, for a course of 4 weeks.

[0134] 1.4 Observation indicators

[0135] (1) General demographic information, medical history, medication status, and physical examination, such as gender, age, height, weight, current medical history, past medical history, drug sensitivity history, body temperature, respiration, heart rate (HR), blood pressure, etc.

[0136] (2) Main efficacy indicators

[0137] ① Scale indicators: Each patient was administered the Orthostatic Low BP Questionnaire (OHQ) before and after treatment to assess the patient's functional status and clinical manifestations.

[0138] The OHQ scale includes the OH Symptom Assessment Scale (OHSA) and the OH Daily Activities Scale (OHDAS). The OHSA assesses symptom severity and includes six indicators: dizziness, visual impairment, weakness, fatigue, difficulty concentrating, and head and neck discomfort. The OHDAS assesses the impact on daily activities and includes four indicators: short-term standing, long-term standing, short-term walking, and long-term walking. Scores for each OHSA and OHDAS component and the total score are calculated.

[0139] ② Blood pressure indicators: The main BP efficacy indicators are supine BP, standing BP and HR to evaluate the improvement of patients' postural BP.

[0140] This method uses a wireless intelligent electronic BP meter to collect 24-hour BP data from patients. Each patient uses a non-invasive ambulatory BP monitor to record 24-hour BP changes five times before treatment, at one, two, and three weeks, and after treatment completion. Measurements are taken once every 30 minutes from 8:00 AM to 10:00 PM, and once every 60 minutes from 10:00 PM to 8:00 AM the following day. Valid 24-hour BP readings are considered complete and valid if they reach at least 75% of the total number of monitoring times. All data are analyzed in conjunction with patient diary records to ensure data integrity and accuracy.

[0141] (3) secondary efficacy indicators;

[0142] ① Unified Multiple System Atrophy Rating Scale (UMSARS): UMSARS-I was used to evaluate the autonomic nervous function of MSA patients.

[0143] ②Vertigo clinical symptom evaluation scale: includes the main symptoms, secondary symptoms and concomitant symptoms scale of vertigo, based on the severity of vertigo and its impact on quality of life.

[0144] ③Balance Confidence Scale (ABC): evaluates the patient's fall risk.

[0145] ④Overall BP and HR.

[0146] (4) Safety evaluation indicators: including adverse event records, vital signs and physical examinations, as well as blood routine, urine routine, blood biochemistry, blood pregnancy test (only for female subjects of childbearing age) and electrocardiogram examination.

[0147] 1.5 Data collection and efficacy evaluation time:

[0148] (1) 24-hour ambulatory BP monitoring data were collected before treatment and on days 7+1, 14+1, 21+1, and 28+3 after treatment. Efficacy evaluation was based on the comparison of the mean BP values ​​before treatment and on days 28+3 after treatment.

[0149] (2) Each scale was evaluated before treatment and 28+3 days after treatment.

[0150] 1.6 Statistical methods

[0151] The experiment of the present invention adopted two-sided test, and P value ≤ 0.05 indicated that the difference was statistically significant. 2 Test or non-parametric test. Measurement data that conform to normal distribution are described by mean ± standard deviation, and those that do not conform to normal distribution are described by median (interquartile range) / M (IQR). Inter-group comparisons are performed using independent sample T test or Mann-Whitney U test. For data at more than 3 time points, the Benjamini-Hochberg (BH) method is used to correct the P value. Intra-group comparisons are performed using repeated measures analysis of variance or Friedman test. If the test result is significant, a paired sample T test or Wilcoxon signed rank test is performed, and BH correction is performed. For data with less than 3 time points, paired sample T test or Wilcoxon signed rank test is selected based on normality and homogeneity of variance. In addition, BP as an indicator is greatly affected by baseline values. In order to better understand the effect of the intervention and further evaluate the impact of baseline differences on the results, the difference is calculated by the "post-intervention value minus the baseline value" method, and it is used as the result indicator for inter-group comparisons. Figure 1 This is the technical roadmap of the present invention. Figure 2 The experimental flow chart is shown in Figure 2.

[0152] 1.7 Patient Baseline Information

[0153] A total of 60 patients were enrolled in this study and randomly divided into an experimental group and a control group of 30 patients using a random number table. During implementation, 2 patients in the experimental group and 3 patients in the control group dropped out. There were no statistically significant differences between the two groups in general characteristics (age, sex, height, weight, BMI), duration of illness, SBP, DBP, and HR (P>0.05). See Table 1 for details.

[0154]

[0155] 1.8 Efficacy evaluation

[0156] 1.8.1 Main efficacy indicators

[0157] (1) OHQ scale

[0158] In the OHQ scale and its subscale scores, except for the OHQ scale data of the control group after treatment that did not meet the normality test, the rest of the data passed the normality test. The data of both groups met the variance homogeneity test. In the experimental group, the OHQ scale score decreased significantly after treatment compared with that before treatment, which was statistically significant (t=2.43, P=0.022). The OHQ scale was further divided into OHSA and OHDAS for comparison. It was found that the OHDAS subscale score decreased significantly after treatment compared with that before treatment (t=2.51, P=0.018), and the OHSA score after treatment did not change significantly compared with that before treatment (t=1.20, P=0.061) (see Table 2 for details). Figure 3 The intergroup comparison results showed that the difference between the OHQ scale after 4 weeks of treatment and the baseline was not statistically significant between the two groups (P<0.05). There was also no significant statistical difference between the OHSA and OHD-AS subscales after 4 weeks of treatment and the baseline between the two groups (P<0.05) (see Figure 4 ).

[0159]

[0160] (2) Evaluation of standing BP changes

[0161] ① Evaluation of standing SBP changes

[0162] In the standing SBP data, the SBP in the control group at week 3 did not pass the normality test. However, the SBP in both the experimental and control groups at other time points conformed to a normal distribution, and both groups passed the homogeneity of variance test. Based on this, repeated measures analysis of variance was performed in the experimental group, and the Friedman test was performed in the control group. The results showed that the SBP in the experimental group changed significantly over time (time effect: F = 3.89, P = 0.005); there was no significant difference in the SBP change in the control group (χ 2=1.51, P=0.825). Further post hoc analysis showed that the SBP of the experimental group was significantly higher than that before treatment at the second week (t=-3.00, P=0.006, BHP=0.029) and the fourth week (t=-2.99, P=0.006, BHP=0.029), while there was no significant difference at other time points. (See Figure 5 Left).

[0163] In the test of the difference between standing SBP and pre-treatment values, the data of the control group at week 1 did not pass the normality test, but the data at other time points were in accordance with the normal distribution, and both groups met the test of homogeneity of variance. Intergroup comparison showed that there were significant differences in SBP between the two groups at week 1 (Z = 2.59, P = 0.010, BHP = 0.025), week 2 (t = 2.31, P = 0.025, BHP = 0.033), and week 4 (t = 2.58, P = 0.013, BHP = 0.025). There was no significant difference in SBP between the two groups at week 3 (t = 1.98, P = 0.053, BHP = 0.053) (see for details). Figure 5 Right), compared with the baseline period, *P<0.05.

[0164] ② Changes in DBP in standing position

[0165] The standing DBP data did not conform to a normal distribution at week 1 in the control group, but conformed to a normal distribution at other time points in both the experimental and control groups. Both groups passed the homogeneity of variance test. Based on this, a repeated measures analysis of variance was performed in the experimental group, and a Friedman test was performed in the control group. The results showed that the DBP in the experimental group changed significantly over time (time effect: F = 4.70, P = 0.002), while there was no significant difference in the DBP change in the control group (χ2 = 0.001). 2 =0.83, P=0.934). Further post hoc analysis showed that the DBP of the experimental group was significantly higher than that before treatment at week 1 (t=-2.77, P=0.010, BHP=0.029), week 2 (t=-3.11, P=0.004, BHP=0.022), week 3 (t=-2.71, P=0.012, BHP=0.029), and week 4 (t=-3.30, P=0.003, BHP=0.022). Figure 6 Left).

[0166] In the test of the difference between the standing DBP and pre-treatment values, the DBP difference in the control group at week 1 did not pass the normality test, but the DBP difference at other time points was in accordance with the normal distribution, and both groups passed the test of homogeneity of variance. The inter-group comparison results showed that the DBP difference between the two groups at week 1 (Z = 2.59, P = 0.011, BHP = 0.023), week 2 (t = 2.75, P = 0.008, BHP = 0.023), week 3 (t = 2.42, P = 0.019, BHP = 0.025), and week 4 (t = 2.32, P = 0.025, BHP = 0.025) were significantly different (see for details). Figure 6 Left), compared with the baseline period, *P<0.05.

[0167] ③ Changes in standing HR

[0168] In the standing HR data, the data of the control group at week 4 did not conform to the normal distribution, while the data of the experimental and control groups at other time points conformed to the normal distribution. Both groups passed the variance homogeneity test. Based on this, repeated measures analysis of variance was performed in the experimental group, and Friedman test was performed in the control group. The results showed that the HR of the experimental group changed significantly over time (time effect: F = 5.95, P < 0.001), while there was no significant difference in HR change in the control group (χ 2 =6.52, P=0.164). Further post hoc analysis showed that the HR of the experimental group was significantly higher than that before treatment at week 1 (t=-2.86, P=0.008, BHP=0.020), week 2 (t=-4.00, P<0.001, BHP=0.004), week 3 (t=-3.22, P=0.003, BHP=0.014), and week 4 (t=-3.12, P=0.004, BHP=0.014) (see for details). Figure 7 Left).

[0169] In the test of the difference between the standing HR and pre-treatment values, the HR differences in the experimental group at weeks 1, 2, and 3 did not conform to a normal distribution, while the differences at other time points and at each time point in the control group all conformed to a normal distribution, and the assumption of homogeneity of variance was met in both groups. The intergroup comparison results showed that the HR differences in the experimental group at weeks 1 (Z = 1.36, P = 0.175, BHP = 0.175), 2 (Z = 2.56, P = 0.011, BHP = 0.016), 3 (Z = 3.06, P = 0.002, BHP = 0.009), and 4 (t = 2.61, P = 0.012, BHP = 0.016) were significantly higher than those in the control group (see for details). Figure 7 (Right), *P < 0.05 compared with the baseline period. #P < 0.05 compared with the control group.

[0170] (3) Changes in BP in supine position

[0171] ① Changes in supine SBP

[0172] The supine SBP data of the experimental group at week 3 did not conform to a normal distribution. The data of the experimental group at other time points and the control group all met the normality test, and the data of both groups met the variance homogeneity test. The results showed that the supine SBP of the experimental group was significantly different from that before treatment after 4 weeks of treatment (χ2=10.94, P=0.027). However, after BH correction, the difference in SBP at week 4 did not reach statistical significance (t=2.72, P=0.011, BHP=0.067). There was no significant difference in SBP changes at different time points in the control group (time effect: F=0.75, P=0.524) (see for details). Figure 8 Left).

[0173] For the difference test of supine SBP at each time point compared with that before treatment, the data of the experimental group and the control group were in accordance with the assumption of normal distribution and homogeneity of variance. The intergroup comparison results showed that there was no significant difference between the two groups at each time point compared with that before treatment (BHP>0.05) (see Figure 8 right).

[0174] ② Changes in supine DBP

[0175] In the supine DBP data, normality test and homogeneity of variance assumptions were met at all time points in both the experimental and control groups. Repeated measures analysis of variance was performed on the two groups at all time points. The results showed that there were no significant differences in the group factor (F = 1.63, P = 0.203), the time factor (F = 0.20, P = 0.938), and the interaction effect of group and time (F = 0.10, P = 0.981) (see for details). Figure 9 Left).

[0176] For the difference test of supine DBP at each time point compared with the pre-treatment period, the difference in the control group at week 1 did not conform to the normal distribution, while the difference in the experimental group and the control group at other time points conformed to the normal distribution, and the data of the two groups met the assumption of homogeneity of variance. The inter-group comparison results showed that there was no significant difference in the difference between the groups at each time point compared with the pre-treatment period (BHP>0.05) (see Figure 9 right).

[0177] ③ Changes in HR in supine position

[0178] In the supine HR data, the HR at weeks 3 and 4 of the experimental group did not conform to a normal distribution, while the data at other time points in the experimental group and the control group all conformed to a normal distribution. Both groups met the assumption of homogeneity of variance. The Friedman test was used for the experimental group, and repeated measures analysis of variance was used for the control group. The results showed that there was no significant difference in HR changes at different time points between the experimental group (time effect: F = 0.98, P = 0.423) and the control group (χ2 = 3.67, P = 0.452) (see for details). Figure 10Left).

[0179] The difference in HR between the supine position and pre-treatment values ​​in the experimental group at week 3 did not conform to a normal distribution. The differences in HR between the experimental group and the control group at other time points conformed to a normal distribution, and both groups met the assumption of homogeneity of variance. The intergroup comparison results showed that the difference in HR between the two groups at week 2 compared with pre-treatment values ​​was significantly different (t = -2.75, P = 0.008, BHP = 0.033). There were no statistically significant differences in the comparisons at the other time points (BHP > 0.05) (see Figure 10 right).

[0180] 1.8.2 Secondary efficacy indicators

[0181] (1) UMSARS Scale Part I

[0182] In the analysis of the UMSARA scale Part I, the data before and after treatment in the experimental group did not conform to the normal distribution, while the data in the control group conformed to the normal distribution, and both groups passed the variance homogeneity test. The scores of the UMSARA scale Part I in the experimental group (Z = -3.26, P = 0.018) and the control group (t = -3.53, P = 0.002) were significantly lower after treatment compared with the baseline. However, the inter-group comparison showed that the difference between the baseline and the treatment after 4 weeks was not statistically significant between the two groups (P>0.05) (see Table 3, Figure 11 ).

[0183]

[0184] Note: *P<0.05 compared with baseline. △: indicates the statistical value is Z value, and the unmarked value is t value.

[0185] (2) Vertigo Symptom Scale and its subscales

[0186] The results of the changes in the scores of the Vertigo Symptom Scale and its subscales showed that the main and secondary symptom scales of the clinical symptoms of vertigo disease did not conform to the normal distribution before and after treatment in both groups, while the other scales were in accordance with the normal distribution at each time point, and all scales in both groups passed the variance homogeneity test. There was no statistically significant decrease in the scores of the Vertigo Symptom Scale and its subscales in the treatment group and the control group compared with the baseline after treatment (P>0.05). There was no statistically significant difference in the Vertigo Symptom Scale and its subscales between the two groups after 4 weeks of treatment compared with the baseline (P>0.05) (see Table 4, Figure 12 、 Figure 13 ).

[0187]

[0188]

[0189] Note: △ indicates that the statistical value is Z value, and the unmarked value is t value.

[0190] (3) Activity Balance Information Scale

[0191] The results of the activity balance confidence scale analysis showed that there was no statistically significant difference between the two groups in the activity balance confidence scale scores after 4 weeks of treatment compared with the baseline (P>0.05). There was no statistically significant change in the activity balance confidence scale scores after treatment in the treatment group or the control group compared with the baseline (P>0.05). (See Table 5, Figure 14 )

[0192]

[0193] (4) Overall blood pressure evaluation

[0194] ① Overall SBP changes

[0195] In the overall SBP data, the SBP of the experimental group before treatment did not conform to the normal distribution, while the data of the experimental group and the control group at other time points all conformed to the normality assumption. The control group did not meet the variance homogeneity test. The experimental group met the variance homogeneity assumption. Based on the above results, the Friedman test was used for both groups, and the results showed that the experimental group (χ 2 =1.17, p=0.880) and control group (χ 2 =1.54, p=0.819) There was no significant difference in SBP changes at different time points ( Figure 15 Left).

[0196] The differences in the overall BPSBP at each time point compared to before treatment were all in accordance with normal distribution. The SBP at week 1 did not meet the assumption of homogeneity of variance, while the two groups met the assumption of homogeneity of variance at the remaining time points. The intergroup comparison results showed that there was no significant difference in the SBP difference at each time point between the two groups (BHP>0.05) (see Figure 15 right).

[0197] ② Overall DBP changes

[0198] In the overall DBP data, the pre-treatment DBP of the control group did not conform to the normal distribution, while the data of the experimental and control groups at other time points conformed to the normal distribution, and the data of both groups met the assumption of homogeneity of variance. Due to the collinearity problem of the control group data, the premise assumption of repeated measures variance analysis could not be met. Therefore, the Friedman test was used for both groups. The results showed that the experimental group (χ 2 =7.34, P=0.119) and the control group (χ 2 =2.64, P=0.621) There was no significant difference in DBP changes at different time points (see Figure 16 Left).

[0199] The differences in DBP between the control group and pre-treatment time points except for the second week did not conform to the normal distribution, while the differences in DBP between the treatment group and pre-treatment time points conformed to the normal distribution. Both groups met the assumption of homogeneity of variance. The inter-group comparison results showed that there was no significant difference in the DBP difference between the two groups at each time point (BHP>0.05) (see Figure 16 right).

[0200] ③ Overall HR changes

[0201] The overall HR data for the control group at weeks 3 and 4 did not conform to a normal distribution, whereas the data for the experimental and control groups at other time points conformed to a normal distribution. Both groups met the assumption of homogeneity of variance. Repeated measures analysis of variance for the experimental group revealed significant differences in HR at different time points (time effect: F = 7.43, p < 0.001). Post hoc tests showed that compared with baseline HR, the HR at week 1 (t = -3.16, P = 0.004, BHP = 0.010), week 2 (t = 4.90, P < 0.001, BHP < 0.001), week 3 (t = 2.71, P = 0.012, BHP = 0.023), and week 4 (t = -3.13, P = 0.004, BHP = 0.010) were significantly different from those at baseline in the control group (χ2). 2 =5.156, P=0.2717)(See Figure 17 Left).

[0202] The difference in overall HR between the experimental group and pre-treatment values ​​at week 1 did not conform to a normal distribution, while the differences at other time points in the experimental group and the control group conformed to a normal distribution. Both groups met the assumption of homogeneity of variance. The inter-group comparison results showed that the HR difference between the experimental group and pre-treatment values ​​after 1 week (Z=2.34, P=0.020, BHP=0.025), 2 weeks (t=3.29, P=0.002, BHP=0.007), 3 weeks (t=2.31, P=0.025, BHP=0.025), and 4 weeks (t=2.43, P=0.019, BHP=0.025) of treatment was statistically significant compared with the control group (see for details). Figure 17 right).

[0203] 2. Main technical indicators achieved by this invention and key problems solved

[0204] 2.1 Main technical indicators achieved

[0205] 2.1.1 Improvement in standing blood pressure: After 4 weeks of treatment, the standing systolic blood pressure (SBP) of the experimental group was significantly increased compared with the baseline (+6.4±11.4 mmHg), while there was no significant change in the control group (-0.5±8.3 mmHg). The difference between the two groups was statistically significant (P=0.025). The standing diastolic blood pressure (DBP) increased by 4.6±7.4 mmHg in the experimental group, while it changed to +0.5±5.5 mmHg in the control group (P=0.025).

[0206] 2.1.2 Supine Blood Pressure Stable, Showing a Decreasing Trend: After 4 weeks of treatment, supine SBP decreased by 5.4±10.5 mmHg in the experimental group and by 1.8±8.6 mmHg in the control group compared with baseline, with no statistically significant difference between the groups (p>0.05). Supine DBP decreased by 2.2±6.8 mmHg in the experimental group and by 0.3±6.0 mmHg in the control group (p>0.05). The SBP reduction in the experimental group approached the clinically recognized threshold for significance (usually 5 mmHg).

[0207] 2.1.3 Safety standards were met: No serious adverse events occurred, and the incidence of mild adverse reactions was 10.7% (3 / 28 cases, including nighttime fever, dry throat, and hot soles), which was lower than the preset safety threshold (serious adverse events ≤5%, non-serious adverse events ≤20%).

[0208] Innovations of the present invention:

[0209] Previous studies have focused on the spleen and kidneys in the pathogenesis of OH, believing that spleen and kidney deficiency and the misalignment of yin and yang are the primary causes of MSA-OH. Building on this theory, the present invention highlights the role of the liver in the pathogenesis of MSA-OH and emphasizes the importance of regulating qi in its treatment. The liver governs the flow of qi and regulates the body's qi. Its flow through the heart meridians promotes blood circulation throughout the body. Through the liver's regulation of blood, the body maintains a harmonious balance of qi and blood in various states, thereby stabilizing blood pressure and maintaining a clear mind. The liver stores blood, and its function is to store it. "Suwen: The Formation of the Five Zang Organs" states, "Thus, when a person lies down, blood returns to the liver." Wang Bing's commentary adds, "The liver stores blood, and the heart circulates it. When a person is active, blood circulates to the various meridians; when a person is still, blood returns to the liver." This study describes the effects of movement, stillness, sitting, and lying on blood circulation, suggesting that, in addition to previous methods of strengthening the spleen and kidneys, blood pressure can be regulated in both supine and standing positions by combining methods of nourishing blood, softening the liver, and raising and lowering qi. The traditional Chinese medicine preparation of this invention, based on the core principles of "tonifying spleen qi, warming kidney yang, nourishing liver blood, nourishing kidney essence, regulating liver qi, and regulating the qi mechanism," offers a new perspective for treating the clinical paradox of "coexisting supine hypertension and orthostatic hypotension." By employing the therapeutic approach of "raising yang and nourishing yin, regulating both ascending and descending," the preparation achieves bidirectional regulation, both elevating standing blood pressure and lowering supine blood pressure (-5.4 mmHg). This overcomes the limitation of traditional medications (such as midodrine) that "raising blood pressure necessarily increases BP," and opens up new avenues for exploring multi-target interventions for autonomic dysfunction.

[0210] Evaluation of introducing ABPM into traditional Chinese medicine for the treatment of OH:

[0211] By combining ABPM with the high-frequency data collection of patient diaries, a full-time dynamic analysis of 24-hour blood pressure fluctuations in MSA-OH patients was achieved, overcoming the risk of misjudgment of efficacy that can occur with traditional single-shot measurements. Furthermore, by incorporating subjective events such as dizziness and falls into patient diaries, a dual verification system of "objective indicators + patient experience" was established. This method provides a more objective basis for verifying the efficacy of the traditional Chinese medicine preparations presented in this invention.

[0212] The traditional Chinese medicine preparation of the present invention can bidirectionally regulate blood pressure. It is suitable for patients experiencing side effects such as supine hypertension and urinary retention associated with medications such as midodrine and droxidopa, and is particularly suitable for the elderly and those with cardiovascular disease. Furthermore, it can be used as an early intervention drug in a stepwise approach, in combination with non-drug therapies, to slow disease progression.

Claims

1. A Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy, characterized in that: The raw materials of the traditional Chinese medicine preparation include: ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon japonicus, white peony root, cimicifuga heracleifolia, and green peel.

2. The Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: The Chinese medicine preparation is made from the following raw materials in parts by weight: 5-15 parts of ginseng, 15-30 parts of astragalus, 10-30 parts of antler, 6-9 parts of roasted ephedra, 15-30 parts of rehmannia, 10-30 parts of ophiopogon, 15-60 parts of white peony root, 10-12 parts of cimicifuga, and 15-30 parts of green peel.

3. The Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 2, characterized in that: The Chinese medicine preparation is made from the following raw materials in parts by weight: 10 parts of ginseng, 30 parts of astragalus, 30 parts of antler, 6 parts of roasted ephedra, 30 parts of rehmannia, 30 parts of ophiopogon, 30 parts of white peony root, 10 parts of cimicifuga, 20 parts of green peel.

4. The Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: The Chinese medicine preparation also includes pharmaceutically acceptable auxiliary materials.

5. The Chinese medicinal preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: The ginsenosides contained in the ginseng have a bidirectional regulation on blood pressure, wherein the ginsenosides PDS from ginseng stems and leaves cause a decrease in blood pressure, while the ginsenosides PTS cause an increase in blood pressure.

6. The Chinese medicinal preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: In the astragalus, α-tyrosine, γ-aminobutyric acid and astragaloside IV are effective components for lowering blood pressure; astragaloside IV is an effective component for increasing blood pressure, thereby achieving a bidirectional regulation effect on blood pressure.

7. The Chinese medicinal preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: 3-9g of the roasted ephedra increases blood pressure, while 10g or more of the roasted ephedra lowers blood pressure due to cardiac inhibition.

8. The Chinese medicinal preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 1, characterized in that: The water extract of Rehmannia root has a blood pressure lowering effect on hypertension and a blood pressure stabilizing effect on cold conditions, thereby making Rehmannia root have a bidirectional regulating effect on blood pressure.

9. A method for preparing a traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy, characterized in that: The preparation method is used to prepare the traditional Chinese medicine preparation according to any one of claims 1 to 8, and the preparation method is: The Chinese medicine formula granules are prepared by mixing ginseng, astragalus, antler, roasted ephedra, rehmannia root, ophiopogon japonicus, white peony root, cimicifuga heracleifolia and green peel.

10. The method for preparing the traditional Chinese medicine preparation for treating orthostatic hypotension due to multiple system atrophy according to claim 9, characterized in that: The preparation method is specifically as follows: Using prescription extraction process flow, we can prepare Astragalus formula granules, Ginseng formula granules, Rehmannia root formula granules, Ophiopogon formula granules, White Peony root formula granules, Honey Ephedra formula granules, Cimicifuga formula granules, Cimicifugae formula granules, and Rehmannia root formula granules; Deer antler formula granules are prepared using a prescription powdering process; The prepared various formula granules are mixed according to a set weight ratio to obtain traditional Chinese medicine formula granules.

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