Traditional Chinese medicine composition for regulating blood pressure and preparation method thereof

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating hypotension and a preparation method thereof. The traditional Chinese medicine composition is prepared from ginseng, astragalus membranaceus, rhizoma cimicifugae, radix bupleuri, radix ophiopogonis, schisandra chinensis and platycodon grandiflorum. Pharmacological experiments prove that the traditional Chinese medicine composition disclosed by the invention has a remarkable blood pressure regulating effect and takes effect quickly after being used for animal models with hemorrhagic hypotension and experimental hypotension.

Description

Technical Field

[0001] The present invention relates to a Chinese medicine composition and a preparation method thereof, in particular to a Chinese medicine composition for regulating blood pressure, belonging to the field of Chinese medicine. Background Art

[0002] Hypotension can be divided into acute and chronic hypotension. The first type of chronic hypotension is primary hypotension, which has an unknown cause and is not associated with organic disease or malnutrition. It often occurs in women with poor physical fitness and is prone to genetic predisposition. The second type is secondary hypotension, which is generally believed to be caused by cardiovascular disease, endocrine dysfunction, chronic wasting disease, malnutrition, and high-altitude hypotension, and is often accompanied by various clinical symptoms. It also includes postural hypotension and supine hypotension syndrome.

[0003] According to statistics, the incidence of low blood pressure is high, reaching as high as 10% among the elderly. Long-term low blood pressure can significantly reduce the patient's body function, leading to cerebral infarction and myocardial infarction, and in severe cases, death, so it should not be ignored.

[0004] Currently, there is no effective treatment for hypotension, and long-term medication is required to improve the condition. However, long-term medication is prone to toxic side effects and blood pressure cannot be maintained at normal levels after discontinuation of the medication.

[0005] Traditional Chinese medicine believes that low blood pressure falls into the category of dizziness and deficiency of both qi and blood, which is often caused by congenital deficiency of the body, malnutrition after birth, deficiency of both qi and yin, weak pulse, and dry meridians; or improper diet and work and rest, insufficient qi in the middle; or emotional frustration, stagnation of liver qi; or invasion of dampness, malfunction of the triple burner, imbalance of yin and yang, and poor blood circulation.

[0006] Based on the increasing trend of patients with hypotension in recent years, there is an urgent clinical need for a drug with reliable efficacy, rapid effect and few side effects to meet the medication needs. Summary of the Invention

[0007] In response to the above-mentioned clinical needs, the present invention aims to provide a novel Chinese medicine composition with blood pressure-increasing, cardiotonic, and respiratory-stimulating effects. Through precise pharmacological experiments, it has been confirmed that the composition is effective in treating hypotension, with rapid effects and minimal side effects.

[0008] The present invention specifically relates to a traditional Chinese medicine composition for treating hypotension. The composition is made from ginseng, astragalus, cimicifuga, bupleurum, ophiopogon, schisandra chinensis, and platycodon. Experimental data confirms that the composition has a significant blood pressure-regulating effect. In animal models of hemorrhagic hypotension and experimental hypotension, the composition exhibits rapid effects and significantly improves the quality of life of the experimental animals.

[0009] The technical objectives of the present invention are achieved through the following technical solutions: A traditional Chinese medicine composition for preventing and treating hypotension is prepared from the following traditional Chinese medicine components: ginseng, ophiopogon japonicus, astragalus root, cimicifuga heracleifolia, bupleurum root, schisandra chinensis, and platycodon grandiflorum.

[0010] The various medicinal materials and their weight portions are as follows: 6-50 parts by weight of ginseng, 9-100 parts by weight of ophiopogon japonicus, 10-300 parts by weight of astragalus, 6-100 parts by weight of cimicifuga, and 9-100 parts by weight of bupleurum.

[0011] Further, it is made from the following Chinese medicinal components: 6-50 parts by weight of ginseng, 9-100 parts by weight of ophiopogon, 10-300 parts by weight of astragalus, 6-100 parts by weight of cimicifuga, 9-100 parts by weight of bupleurum, 3-60 parts by weight of schisandra, and 9-200 parts by weight of platycodon.

[0012] Further preferably, it is made from the following Chinese medicinal components: 20-50 parts by weight of ginseng, 50-95 parts by weight of ophiopogon japonicus, 35-60 parts by weight of schisandra chinensis, 60-130 parts by weight of astragalus, 50-95 parts by weight of cimicifuga, 20-80 parts by weight of bupleurum, and 60-130 parts by weight of platycodon grandiflorum.

[0013] In a preferred embodiment, the Chinese medicine composition used is composed of: 40 parts by weight of ginseng, 80 parts by weight of ophiopogon, 50 parts by weight of schisandra chinensis, 120 parts by weight of astragalus, 80 parts by weight of cimicifuga, 30 parts by weight of bupleurum, and 120 parts by weight of platycodon.

[0014] The second object of the present invention is to provide a pharmaceutical use of the above-mentioned Chinese medicine composition.

[0015] The Chinese medicine composition of the present invention is scientifically formulated, and pharmacological results show that the Chinese medicine composition of the present invention has a good effect on regulating blood pressure and heart rhythm. Typical cases confirm that the Chinese medicine composition of the present invention has a significant therapeutic effect on hypotension. After administration, the Chinese medicine composition has a rapid effect, few adverse reactions, and can significantly improve the quality of life of the test animals, and the animals' weight, immunity, and physical strength recover quickly.

[0016] Specifically, the invention provides a use of the traditional Chinese medicine composition in preparing a drug for treating hypotension.

[0017] In particular, the invention provides a use of the Chinese medicine composition in combination with a Qi-tonifying drug in the preparation of a drug for treating hypotension. The Qi-tonifying drug is not limited to Chinese patent medicines, Western medicines or Chinese herbal medicine slices, etc. The third object of the present invention is to provide a preparation of the above-mentioned Chinese medicine composition, wherein the Chinese medicine composition is a conventional preparation prepared from the Chinese medicine composition. The Chinese medicine oral preparation is one of a decoction, a pill, a tablet, a mixture, a capsule, a granule or an ointment.

[0018] In a preferred embodiment, the oral Chinese medicine preparation is a granule.

[0019] Furthermore, the Chinese medicine composition of the present invention is prepared according to the following method: A. Grind ginseng into fine powder and set aside; B. Take half of the ginseng powder, add 50%-65% ethanol and extract twice with Cimicifuga heracleifolia, Bupleurum chinense and Schisandra chinensis. Filter and concentrate the filtrate to extract I with a relative density of 1.18-1.26 at 50-60°C. Set aside. C. Extract Platycodon grandiflorum, Astragalus membranaceus, and Ophiopogon japonicus with 8-10 times the amount of water, extract 2-3 times, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract II with a relative density of 1.05-1.18, set aside; D. Combine Extract I and Extract II, add the other half of the ginseng powder, and add pharmaceutically acceptable excipients through conventional procedures to prepare a traditional Chinese medicine preparation.

[0020] The present invention has the following advantages: (1) The Chinese medicine composition of the present invention has a reasonable formula, has a significant therapeutic effect on hypotension, has a rapid effect, and can simultaneously improve the quality of life and enhance immunity.

[0021] (2) The composition of the present invention is prepared from traditional Chinese medicine, has little toxicity and side effects, and is highly safe.

[0022] (3) There are very few products clinically used to treat hypotension. The development of the Chinese medicine composition of the present invention provides patients with further clinical options. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 : Effects on body weight in experimental hypotensive rats.

[0024] Figure 2 : Effects on cardiac rhythm in experimentally hypotensive rats.

[0025] Figure 3 : Effects on blood pressure in hemorrhagic hypotensive guinea pigs.

[0026] Figure 4 : Effects on myocardial tension-time index in hemorrhagic hypotensive guinea pigs.

[0027] Figure 5 Comparison of 24-hour SBP before and after treatment.

[0028] Figure 6 Comparison of 24H DBP before and after treatment.

[0029] Figure 7 : Comparison of clinical efficacy before and after treatment. DETAILED DESCRIPTION

[0030] To verify the efficacy of the Chinese herbal composition of the present invention in treating hypotension, the inventors conducted pharmacodynamic studies. It should be noted that the drugs selected for the pharmacodynamic studies were those obtained from representative formulations and preparation methods of the present invention. Due to space limitations, the tests and results related to other formulations and preparation methods encompassed by the present invention are not exhaustively listed here.

[0031] Test Example 1 Effect on Experimental Hypotensive Rats 1 Experimental Methods 1.1 Experimental Animals Healthy Wistar rats weighing 180-220 g, half male and half female, were selected. The experimental animal qualification certificate number is SYXK (Lu) 2020-0018. They were adaptively raised for 1 week before the start of the experiment. The males and females were separated and had free access to water and food.

[0032] 1.2 Drugs and reagents Shengmai Yin is commercially available, with an oral gavage dose of 2.7 ml / kg. Each example group was administered with a crude drug dosage of 5.0 g / kg / d, and the oral gavage volume was 5 ml / kg. Example 1 was diluted with water to a crude drug content of 2.5 g / mL as the low-dose group. Example 8 was administered with a crude drug dosage of 0.8 g / kg / d.

[0033] 1.3 Modeling and drug administration Ten healthy rats were taken as a blank control group. In addition, healthy rats were randomly selected and given 10 ml / kg of compound reserpine suspension twice a day. At the 8th week, rats with systolic blood pressure ≤ 80 mmHg were considered to have successfully established a model. The rats with successful modeling were randomly divided into a model group, Example 1 group, Example 1 low-dose group, Example 3 group, Comparative Example 1 group, Comparative Example 3 group, Comparative Example 8 group, and a positive control drug group, with 10 rats in each group.

[0034] The blank control group was gavaged with the same volume of normal saline from the first week to the end of the experiment. The model group was gavaged with the same volume of normal saline from the eighth week. Each treatment group was given the corresponding drug twice a day from the eighth week for one week.

[0035] 1.4 Index determination method The animals were weighed and echocardiograms were performed 1 hour after the last dose.

[0036] 1.5 Data Processing Methods The original experimental data were statistically analyzed using SPSS 20.0 software. The mean and standard deviation of the results were calculated. One-way analysis of variance was used for comparison between groups, and P < 0.05 was considered statistically significant.

[0037] 2 Experimental Results By recording the weight of the rats, it was found that compared with the blank control group, the weight of the model group rats increased after the first week of modeling, but the growth trend gradually slowed down. At the end of the experiment, the weight was significantly lower than that of the blank control group (P < 0.01). Compared with the model group, the weight of the rats in each drug-treated group increased to varying degrees, but there was no significant difference between Comparative Example 1, Comparative Example 3, and Comparative Example 8 (P > 0.05). Among them, the weight of the rats in Example 1 group was closer to that of the normal control group. At the same time, the rats in Example 1 group were more active and lively than those in the other groups, and their back fur was more shiny.

[0038] According to the heart rate value results, it was found that the heart rate of rats in each group increased significantly after modeling. After the end of the experiment, the heart rate value of the model group increased significantly compared with the blank control group (P < 0.01); compared with the model group, the embodiment group and the positive control drug group were significant (P < 0.01), and there was no significance in the comparative embodiment group (P > 0.05).

[0039] Specific results can be found in Figure 1 、 Figure 2 shown.

[0040] Test Example 2 Effect on Guinea Pigs with Hemorrhagic Hypotension 1 Experimental Methods 1.1 Experimental Animals Healthy guinea pigs, half male and half female, weighing (400 ± 20) g, were used. Laboratory animal qualification certificate number: SYXK (Lu) 2020-0018. Animals were acclimated to the animal in a clean animal laboratory before the experiment.

[0041] 1.2 Drugs and reagents The crude drug dosage of each example group was 4.3 g / kg / d, and the gavage volume was 5 ml / kg.

[0042] 1.3 Modeling and drug administration Guinea pigs were fasted but not watered for 24 hours before the experiment, and their weight was recorded. Anesthesia was performed with 10% urethane (12 mL / kg), and the abdomen was opened. A polyethylene tube was inserted into the duodenum. The right common carotid artery was isolated, incised, and then a polyethylene tube was inserted. A polychannel physiological recorder was connected to monitor changes in mean arterial pressure (MAP), systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR). The right femoral artery was isolated, incised, and then a polyethylene tube was inserted to exsanguinate. Blood pressure and heart rate were monitored. Model establishment was considered successful when MAP stabilized at 50-60 mmHg for 20 minutes, and the hemostasis was stopped by ligation.

[0043] The guinea pigs with successful modeling were randomly divided into 7 groups, namely, hemorrhagic hypotension model group, Example 1 group, Example 3 group, Example 5 group, Comparative Example 2 group, Comparative Example 5 group, and Comparative Example 6 group, with 10 guinea pigs in each group. The model group was gavaged with an equal volume of distilled water.

[0044] 1.4 Observation indicators and measurement methods The blood pressure and heart rate were recorded after successful model establishment and 3 hours after drug administration, and the myocardial tension time index was calculated.

[0045] 1.5 Data Processing SPSS 22.0 statistical software was used for analysis and processing. P < 0.05 was considered statistically significant.

[0046] 2 Results 2.1 Effects on Hypotensive Guinea Pigs with Blood Loss Before modeling, the blood pressure values of guinea pigs in each group were within the normal range, with no significant difference (P>0.05).

[0047] After modeling, the blood pressure values of guinea pigs and rats in each group were significantly reduced. Compared with the values before modeling, the blood pressure values of each group after modeling were significant (P < 0.01). After administration, the blood pressure values recorded clearly showed that the Chinese medicine composition of the present invention can significantly improve blood pressure values. At 60 minutes, the blood pressure values of Example 1, Example 3, and Example 5 groups were significantly improved compared with the model group (P < 0.01), while the comparative example group was not significant.

[0048] Table 1 Effects of the Examples of the Present Invention on Blood Pressure in Guinea Pigs with Hemorrhagic Hypotension Compared with the values before modeling, *P<0.01 Compared with the model group, # P<0.01.

[0049] By calculating the myocardial tension time index, it was found that the Chinese medicinal compositions of Examples 1, 3 and 5 of the present invention had a significant effect on improving the myocardial tension time index of guinea pigs within 60 minutes (P<0.01).

[0050] The above results are as follows Figure 3 、 Figure 4 shown.

[0051] Clinical trials 1.1 Clinical Data 1.1.1 Diagnostic criteria Meet the diagnostic criteria for chronic primary hypotension established by the WHO in 1999: systolic blood pressure ≤ 100 mmHg and / or diastolic blood pressure ≤ 60 mmHg (brachial artery blood pressure when the patient is sitting in a quiet resting position) in three blood pressure measurements on different days, either alone or simultaneously for at least one time, excluding secondary hypotension caused by organic disease or drugs, and excluding orthostatic hypotension.

[0052] 1.1.2 Inclusion criteria (1) Meet the above diagnostic criteria; (2) Age 18–85 years old; (3) able to participate in follow-up; (4) Voluntarily participate in this study and have signed the informed consent.

[0053] 1.1.3 Exclusion criteria (1) Patients with secondary hypotension or hypotensive crisis; (2) Patients with chronic liver and kidney diseases such as chronic renal insufficiency and liver insufficiency; (3) Patients with abnormal coagulation function; (4) Those who suffer from mental illness, cannot cooperate with treatment or have impaired consciousness; (5) Patients who are allergic to the drugs used in this study or have contraindications to the drugs.

[0054] 1.1.5 Shedding standards (1) Combination medication outside the prescribed range or poor compliance, which affects the efficacy and safety judgment; (2) Those who are not suitable to continue treatment due to adverse reactions or serious adverse events; (3) Those who need to withdraw from or terminate the experiment for various reasons.

[0055] 1.1.6 General Information Fifty patients with hypotension aged 18 to 80 years who visited Shandong Provincial Hospital of Traditional Chinese Medicine between January 2022 and January 2023 were enrolled. They were randomly divided into an experimental group and a control group (n=25) using a random number table. There were no significant differences in general information between the groups, and baseline data were consistent (P>0.05).

[0056] Control group: conventional western medicine treatment, oral administration of midodrine hydrochloride (National Medicine Approval No. H20060550), 2.5 mg each time, 2-3 times a day or as prescribed by the doctor, for 5 consecutive weeks.

[0057] The experimental group received traditional Chinese medicine treatment, including 12g of ginseng, 15g of ophiopogon, 6g of schisandra chinensis, 9g of cimicifuga, 6g of bupleurum, 15g of astragalus, and 9g of platycodon, once a day. The decoction was taken orally for 5 consecutive weeks.

[0058] 1.1.7 Evaluation of treatment efficacy (1) Blood pressure indicators: Measure the patient's 24-hour average systolic blood pressure (24hSBP) and 24-hour average diastolic blood pressure (24hDBP) before and after treatment.

[0059] Efficacy criteria Marked effect: The patient's 24-hour average systolic blood pressure is increased by 15 mmHg or more; ② The patient's nocturnal systolic blood pressure is increased by 10 mmHg or more; ③ The patient's 24-hour average diastolic blood pressure is increased by 10 mmHg or more; ④ The patient's nocturnal diastolic blood pressure is increased by 7 mmHg or more.

[0060] Effective: The test is considered effective if at least one of the following items is met: ① The patient's 24-hour average systolic blood pressure increases by 7-15 mmHg or more; ② The patient's nocturnal systolic blood pressure increases by 5-10 mmHg or more; ③ The patient's 24-hour average diastolic blood pressure increases by 5-10 mmHg or more; ④ The patient's nocturnal diastolic blood pressure increases by 4-7 mmHg or more.

[0061] Ineffective: The patient's blood pressure did not reach the markedly effective and effective standards.

[0062] Total effectiveness = marked effect + effectiveness.

[0063] 1.1.8 Safety evaluation and evaluation standards Routine blood and urine tests, as well as liver and kidney function tests, were performed before and after treatment and compared. Safety evaluation criteria: Level 1: Safe, no adverse reactions. Level 2: Relatively safe, no special treatment required, and no impact on continued administration. Level 3: Safety concerns exist, with moderate adverse reactions occurring. Administration can continue after treatment. Level 4: Severe adverse reactions occur, requiring trial discontinuation.

[0064] 1.1.9 Statistical methods Data were processed using SPSS 22.0 software. P < 0.05 indicated statistical significance. Treatment effects were analyzed using GraphPad Prism 6.0.

[0065] 1.2.1 Results A total of 50 patients were included in this experiment. The patients had high compliance and all completed the study.

[0066] 1.2.2 Comparison of 24-hour ambulatory blood pressure between the experimental group and the control group Compared with before the experiment, the 24-hour average systolic blood pressure and 24-hour average diastolic blood pressure of both the experimental group and the control group increased significantly (P < 0.05), and the blood pressure increase in the experimental group was more significant (P < 0.05).

[0067] Specific results can be found in Figure 5 、 6and Table 2 Table 2 Comparison of blood pressure reduction before and after treatment Note: &Compared with before intervention, P<0.05; #Compared with control group, P<0.05.

[0068] 1.2.3 Comparison of clinical efficacy before and after treatment Compared with the results before the experiment, the total effective rate of the experimental group was 96%, including 17 cases of marked effect, 7 cases of effective effect, and 1 case of ineffectiveness; the total effective rate of the control group was 80%, including 5 cases of marked effect, 15 cases of effective effect, and 1 case of ineffectiveness. Figure 7 .

[0069] Typical Cases 1) Patient Gau, a 59-year-old female, was first diagnosed on February 6, 2023, with symptoms of paroxysmal dizziness for over two years, worsening for one week. Two years prior, she experienced dizziness without a clear cause and sought treatment at a local hospital. Her blood pressure was measured at 90 / 50 mmHg, and she was diagnosed with essential hypotension. Her symptoms were alleviated with medication, but the specific cause is unknown. She subsequently experienced occasional dizziness, which she ignored. One week prior, she experienced dizziness after exertion, which worsened with movement, accompanied by palpitations, chest tightness, and general fatigue, leading to her presentation to our hospital. Initial visit: The patient presented with a weak constitution, dizziness, shortness of breath, fatigue, lethargy, dry mouth and throat, occasional chest tightness and palpitations, chills and cold extremities, poor appetite, insomnia and frequent dreams, yellow urine, dry stool, red tongue with scant coating, and a weak pulse. Physical examination revealed blood pressure (BP) of 80 / 55 mmHg, heart rate of 85 bpm. Diagnosis indicated qi and yin deficiency, and treatment was to invigorate qi, nourish yin, and raise the pulse. Yiqi Shengmai Decoction was prescribed with modifications: ginseng 12g, ophiopogon 15g, schisandra chinensis 6g, cimicifuga 9g, bupleurum 6g, astragalus 15g, and platycodon 9g. Seven doses were taken daily, decocted in water. The patient was advised to increase exercise, rest, and maintain adequate nutrition.

[0070] Second visit on February 14, 2023: The patient's dizziness and fatigue were significantly alleviated, palpitations and chest tightness were slightly alleviated, sleep improved, bowel movements were normal, tongue was pale red, tongue coating was slightly red, and pulse was weak. Blood pressure was measured: 85 / 60 mmHg, and the above treatment was continued for 14 doses.

[0071] Third visit on February 27, 2023: The patient's symptoms were significantly alleviated, and the blood pressure was measured at 95 / 60 mmHg. After taking 14 doses of the above medicine, the patient was followed up two months later. The blood pressure was maintained at 95-105 / 60-70 mmHg, the activity tolerance increased, and there was no obvious discomfort.

[0072] Example 1 Preparation of granules Formula: 40g ginseng, 80g ophiopogon, 50g schisandra, 120g astragalus, 80g cimicifuga, 30g bupleurum, 120g platycodon Preparation method: A. Grind ginseng into fine powder and set aside; B. Take half of the ginseng powder, add Cimicifuga heracleifolia, Bupleurum chinense, and Schisandra chinensis and extract twice with 50% ethanol. Filter and concentrate the filtrate to extract I with a relative density of 1.26 at 55°C. Set aside. C. Extract Platycodon grandiflorum, Astragalus membranaceus, and Ophiopogon japonicus with 8 times the amount of water for 3 times. Centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract II with a relative density of 1.08, which is then set aside. D. Combine Extract I and Extract II, add the other half of the ginseng powder, and add pharmaceutically acceptable excipients through conventional procedures to prepare Chinese medicine granules.

[0073] Example 2 Preparation of the mixture Formula: 40g ginseng, 95g ophiopogon, 50g schisandra, 60g astragalus, 95g cimicifuga, 30g bupleurum, 120g platycodon Preparation method: A. Grind ginseng into fine powder and set aside; B. Take half of the ginseng powder, add Cimicifuga heracleifolia, Bupleurum chinense, and Schisandra chinensis and extract twice with 65% ethanol. Filter and concentrate the filtrate to form extract I with a relative density of 1.18 at 50-60°C. Set aside. C. Extract Platycodon grandiflorum, Astragalus membranaceus, and Ophiopogon japonicus with 10 times the amount of water, extract twice, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract II with a relative density of 1.05, set aside; D. Combine Extract I and Extract II, add the other half of the ginseng powder, and add pharmaceutically acceptable excipients through conventional procedures to prepare a traditional Chinese medicine preparation.

[0074] Example 3 Preparation of granules Formula: Ginseng 50g, Ophiopogon 50g, Schisandra 50g, Astragalus 60g, Cimicifuga 95g, Bupleurum 20g, Platycodon 60g The preparation method is the same as that of Example 1.

[0075] Example 4 Preparation of the mixture Formula: 40g ginseng, 95g ophiopogon, 60g schisandra, 60g astragalus, 95g cimicifuga, 80g bupleurum, 60g platycodon The preparation method is the same as that of Example 1.

[0076] Example 5 Preparation of granules Formula: 40g ginseng, 65g ophiopogon, 35g schisandra, 130g astragalus, 50g cimicifuga, 80g bupleurum, 130g platycodon The preparation method is the same as that of Example 1.

[0077] Example 6 Preparation of the mixture Formula: 40g ginseng, 95g ophiopogon, 35g schisandra, 130g astragalus, 90g cimicifuga, 80g bupleurum, 130g platycodon The preparation method is the same as that of Example 1.

[0078] Example 7 Preparation of granules Formula: Ginseng 20g, Ophiopogon japonicus 55g, Schisandra chinensis 35g, Astragalus membranaceus 60g, Cimicifuga heracleifolia 95g, Bupleurum chinense 80g, Platycodon grandiflorum 100g The preparation method is the same as that of Example 1.

[0079] Preparation of Comparative Example 1 Granules Formula: 40g ginseng, 80g ophiopogon, 50g schisandra, 120g astragalus, 80g cimicifuga, 30g bupleurum, 120g platycodon Preparation method: A. Extract ginseng, Cimicifuga heracleifolia, Bupleurum chinense, and Schisandra chinensis with 50% ethanol twice, filter, and concentrate the filtrate to form extract I with a relative density of 1.26 at 55°C. Set aside. B. Extract Platycodon grandiflorum, Astragalus membranaceus, and Ophiopogon japonicus with 10 times the amount of water for 3 times. Centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract II with a relative density of 1.08, which is then set aside. C. Combine Extract I and Extract II, add pharmaceutically acceptable excipients through conventional procedures to prepare Chinese medicine granules.

[0080] Comparative Example 2 Preparation of Granules Formula: 40g of ginseng, 10g of ophiopogon japonicus, 25g of schisandra chinensis, 180g of atractylodes macrocephala, 30g of cimicifugae, 10g of cinnamon twig, 130g of platycodon grandiflorum, and 10g of dried ginger. The preparation method is the same as that of Example 1.

[0081] Comparative Example 3 Preparation of Granules Formula: Codonopsis pilosula 40g, Ophiopogon japonicus 55g, Schisandra chinensis 35g, Astragalus membranaceus 60g, Cimicifuga heracleifolia 95g, Ephedra root 5g, Platycodon grandiflorum 100g The preparation method is the same as that of Example 1.

[0082] Comparative Example 4 Preparation of Granules Formula: 40g of ginseng, 10g of ophiopogon japonicus, 10g of schisandra chinensis, 180g of astragalus, 20g of cimicifugae, 10g of bupleurum, and 130g of platycodon grandiflorum The preparation method is the same as that of Example 1.

[0083] Comparative Example 5 Preparation of Decoction Formula: 10 grams of ginseng, 10 grams of Cimicifuga, 50 grams of Astragalus, 10 grams of Bupleurum, 6 grams of dried tangerine peel, 10 grams of roasted licorice, 15 grams of Atractylodes, 10 grams of Astragalus, 10 grams of Rubus, 10 grams of Schisandra, and 15 grams of Ophiopogon.

[0084] Preparation method: Add the above medicinal materials to water and boil for 2 hours.

[0085] Comparative Example 6 Preparation of Granules Formula: 10 grams of ginseng, 10 grams of Cimicifuga, 50 grams of Astragalus, 10 grams of Bupleurum, 6 grams of dried tangerine peel, 10 grams of roasted licorice, 15 grams of Atractylodes, 10 grams of Astragalus, 10 grams of Rubus, 10 grams of Schisandra, and 15 grams of Ophiopogon.

[0086] Preparation method: A. Grind ginseng into fine powder and set aside; B. Take half of the ginseng powder, add Cimicifuga heracleifolia, Bupleurum chinense, and Schisandra chinensis and extract twice with 55% ethanol. Filter and concentrate the filtrate to extract I with a relative density of 1.26 at 55°C. Set aside. C. Extract tangerine peel, roasted liquorice root, atractylodes macrocephala, astragalus root, ophiopogon japonicus, complanatus complanatus, and raspberry with 8-10 times the amount of water, extract three times, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain extract II with a relative density of 1.08, which is set aside; D. Combine Extract I and Extract II, add the other half of the ginseng powder, and add pharmaceutically acceptable excipients through conventional procedures to prepare Chinese medicine granules.

[0087] Comparative Example 7 Preparation of Decoction Formula: 30g ginseng, 30g lotus seeds, 10g polygonatum, 30g wolfberry, 10g cinnamon, 10g licorice Preparation method: (1) Prepare 30 grams of ginseng, 30 grams of lotus seeds, 10 grams of polygonatum, 30 grams of wolfberry, 10 grams of cinnamon, and 10 grams of licorice; (2) Wash the lotus seeds, soak them in boiling water for 0.5 hours, peel and remove the core; (3) Mix the various Chinese medicines in (1) and (2), put them into a sterilized container and soak them in water for 20 minutes; (4) Place the soaked Chinese medicine in a casserole, add water until the water level exceeds the Chinese medicine by 2 inches, first boil the water in the casserole over high heat, then switch to low heat and continue to boil for 45 minutes; (5) Prepare the above decoction.

[0088] Comparative Example 8 Preparation of Decoction Formula: 3 grams of ginseng Preparation method: Ginseng ultrafine powder is obtained through a series of processes including drying, slicing, coarse powder, and ultrafine grinding.

Claims

1. A Chinese medicine composition for regulating blood pressure, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6-50 parts by weight of ginseng, 9-100 parts by weight of ophiopogon, 10-300 parts by weight of astragalus, 6-100 parts by weight of cimicifuga, and 9-100 parts by weight of bupleurum.

2. The Chinese medicine composition according to claim 1, wherein The traditional Chinese medicine composition further contains 3-60 parts by weight of Schisandra chinensis and 9-200 parts by weight of Platycodon grandiflorum.

3. The Chinese medicine composition according to claim 1, wherein The components of the traditional Chinese medicine are: 20-50 parts by weight of ginseng, 20-100 parts by weight of ophiopogon, 15-60 parts by weight of schisandra chinensis, 50-200 parts by weight of astragalus, 10-95 parts by weight of cimicifuga, 10-100 parts by weight of bupleurum, and 10-180 parts by weight of platycodon. Further preferably, the components of the traditional Chinese medicine are: 40 parts by weight of ginseng, 80 parts by weight of ophiopogon, 50 parts by weight of schisandra chinensis, 120 parts by weight of astragalus, 80 parts by weight of cimicifuga, 30 parts by weight of bupleurum, and 120 parts by weight of platycodon.

4. The Chinese medicine composition according to claim 1, wherein The Chinese medicine composition is used in preparing a drug for treating hypotension.

5. The Chinese medicine composition according to claim 4, characterized in that The Chinese medicine composition is used in combination with qi-invigorating drugs in the preparation of drugs for treating hypotension.

6. The Chinese medicine composition according to claims 1-5, characterized in that The Chinese medicine composition is prepared according to the following method: A. Grind ginseng into fine powder and set aside; B. Take half of the ginseng powder, add 50%-65% ethanol and extract twice with Cimicifuga heracleifolia, Bupleurum chinense and Schisandra chinensis. Filter and concentrate the filtrate to extract I with a relative density of 1.18-1.26 at 50-60°C. Set aside. C. Extract Platycodon grandiflorum, Astragalus membranaceus, and Ophiopogon japonicus with 8-10 times the amount of water, extract 2-3 times, centrifuge the decoction, filter, and concentrate the filtrate under reduced pressure to obtain an extract II with a relative density of 1.05-1.18, set aside; D. Combine Extract I and Extract II, add the other half of the ginseng powder, and add pharmaceutically acceptable excipients through conventional procedures to prepare a traditional Chinese medicine preparation.

7. The Chinese medicine composition according to claim 6, wherein the Chinese medicine preparation in step D is an oral preparation.

8. The Chinese medicine composition according to claim 7, wherein the oral Chinese medicine preparation is one of a decoction, a pill, a tablet, a mixture, a capsule, a granule or an ointment.

9. The Chinese medicine composition according to claim 8, wherein the oral Chinese medicine preparation is a granule.

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