Traditional Chinese medicine composition for treating hypotension, preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating hypotension and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20-40 parts of Cnesmone scandens, 10-25 parts of Murraya paniculata, 10-25 parts of Ledum palustre, 15-25 parts of Amomum villosum, 3-10 parts of Fructus Aurantii Immaturus, 3-10 parts of Bupleurum chinense, and 3-10 parts of Osmanthus fragrans. The traditional Chinese medicine composition is a pure traditional Chinese medicine formula, has a good blood pressure raising effect, has small toxic and side effects, and is particularly suitable for hypotension people with spleen and stomach qi deficiency.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine pharmaceutical technology, specifically relating to a traditional Chinese medicine composition for treating hypotension, its preparation method, and its application. Background Technology

[0002] Hypotension refers to a condition where the systemic arterial pressure is lower than normal. Currently, there is no unified standard for the diagnosis of hypotension. Generally, it is considered that an upper limb arterial blood pressure below 90 / 60 mmHg (12 / 8 kPa) in adults is hypotension. Symptoms of hypotension mainly include fatigue, lethargy, insomnia, forgetfulness, headache, dizziness, and even fainting or shock. In Traditional Chinese Medicine (TCM), hypotension falls under the categories of "dizziness, palpitations, and general weakness." According to TCM diagnosis, hypotension has several types. One type, spleen and stomach qi deficiency hypotension, is mainly caused by damage to the spleen and stomach, insufficient production of qi and blood, and lack of nourishment for the brain. Patients with this type often experience the following symptoms: dizziness, weakness, diarrhea, abdominal distension and discomfort (worse after meals), fatigue, shortness of breath, poor appetite, pale tongue, thin white coating, and slow or weak pulse.

[0003] Currently, commonly used medications for treating hypotension include volume vasodilators (such as fludrocortisone), vasoconstrictors (such as midodrine hydrochloride and octreotide), and adjuvant drugs (such as acarbose and erythropoietin). These are mostly symptomatic treatments, but they are difficult to maintain normal blood pressure after discontinuation, failing to address the root cause of hypotension. Relapses are common, and side effects are significant. For example, fludrocortisone is often accompanied by adverse reactions such as sodium and water retention, hypertension, and hypokalemia, while midodrine hydrochloride is often accompanied by adverse reactions such as arrhythmia, chills, and rash. Therefore, there is an urgent need to develop an effective drug with fewer side effects, especially for hypotension caused by spleen and stomach qi deficiency. Summary of the Invention

[0004] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition for treating hypotension, which has a good blood pressure-raising effect, can effectively treat hypotension, has few toxic side effects, and is especially suitable for people with hypotension due to spleen and stomach qi deficiency. This invention also provides a method for preparing the traditional Chinese medicine composition and its application.

[0005] The technical solution of the present invention is as follows: The traditional Chinese medicine composition for treating hypotension described in this invention is made from the following raw materials in parts by weight: 20-40 parts of *Symplocos buergeriana*, 10-25 parts of *Citrus aurantium*, 10-25 parts of *Rhododendron molle*, 15-25 parts of cardamom, 3-10 parts of immature bitter orange, 3-10 parts of *Bupleurum chinense*, and 3-10 parts of *Osmanthus fragrans*.

[0006] The sources of each medicinal material in the aforementioned traditional Chinese medicine composition are as follows: The root of *Helicteres BI.*, a plant in the Sterculiaceae family, is described as "sticky hairy fire hemp".

[0007] The said Glycosmis pentaphylla is the root of Glycosmis pentaphylla (Retz.) Correa, a plant of the Rutaceae family.

[0008] The said Barleria lupulina is the root of Barleria lupulina Lindl., a plant of the Acanthaceae family.

[0009] The said Amomum subulatum is the tuberous root of Amomum subulatum Roxb., a plant of the Zingiberaceae family.

[0010] The said Bupleurum chinense is the dried root of Bupleurum chinense DC., a plant of the Apiaceae family.

[0011] The said Fructus Aurantii Immaturus is the dried young fruit of Citrus aurantium L., a plant of the Rutaceae family.

[0012] The said Polygala arillata is the root of Polygala arillata Buch. Ham., a plant of the Polygalaceae family.

[0013] In the said traditional Chinese medicine composition, the nature, flavor, meridian tropism, and functions and indications of each medicinal material are as follows: Helicteres viscida, bitter and slightly astringent in flavor, cool in nature. It acts on the earth and wind elements. It can tonify the earth to strengthen the stomach, tonify qi and secure collapse. It is used by Dai physicians to treat abdominal pain and diarrhea, loss of appetite, hematochezia, uterine prolapse, rectocele and the like.

[0014] Glycosmis pentaphylla, bland in flavor, neutral in nature. It acts on the four elements. It can tonify the earth to strengthen the stomach, dispel wind, activate blood and relieve pain. It is used by Dai physicians to treat weak and diseased constitution, lassitude, wind-damp-cold impediment syndrome, wind-damp-heat impediment syndrome, swelling and pain of limbs and joints, disadvantageous flexion and extension, traumatic injury and the like.

[0015] Barleria lupulina, slightly sweet, aromatic, cool in nature. It acts on the water and earth elements. It can regulate and tonify water and blood, dissipate blood stasis to reduce swelling, and relieve pain. It is used by Dai physicians to treat weak and diseased constitution, loss of appetite, traumatic injury, fracture, wind-damp-cold impediment syndrome, swelling and pain of limbs and joints, disadvantageous flexion and extension and the like.

[0016] Amomum subulatum, slightly bitter in flavor, aromatic, warm in nature. It acts on the fire, wind and earth elements. It can tonify fire and earth, strengthen the stomach to promote digestion, move qi and relieve pain. It is used by Dai physicians to treat epigastric and abdominal distension and pain, dyspepsia, nausea and vomiting, loss of appetite, wind-cold common cold, nasal obstruction and rhinorrhea, nausea and desire to vomit, dizziness and headache, general aching, sunstroke, dyspeptic abdominal pain and the like.

[0017] Fructus Aurantii Immaturus, bitter, pungent and sour in flavor, slightly cold in nature. It acts on the spleen and stomach meridians. It can break qi to resolve stagnation, resolve phlegm and dissipate fullness. It is used for internal stagnation of retained food, fullness and pain due to stuffiness, dysentery with tenesmus, constipation, phlegm stagnation and qi obstruction, chest impediment, chest binding syndrome, and viscus ptosis.

[0018] Bupleurum chinense (Northern Bupleurum) has a pungent and bitter taste, and is slightly cold in nature. It enters the liver, gallbladder, and lung meridians. It disperses and reduces fever, soothes the liver and relieves stagnation, and raises yang qi. It is used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0019] Osmanthus flowers from Hebao Mountain are sweet and neutral in nature. They are used in traditional Chinese medicine to nourish and regulate the body. In Dai medicine, they are used to treat weakness, fatigue, insomnia, and loss of appetite.

[0020] Explanation: In this formula, *Heliotropium indicum* tonifies the spleen and stomach, replenishes qi, and consolidates the body's vital energy. It is the principal herb, as it nourishes the spleen and stomach, regulates the middle jiao, and strengthens qi. *Citrus aurantium* tonifies the spleen and stomach, and when combined with *Heliotropium indicum*, it enhances the spleen-tonifying effect. *Rhododendron molle* tonifies water and blood, and when combined with *Heliotropium indicum*, it ensures a source for the generation of qi and blood; these two herbs are the assistant herbs. Fennel and cardamom strengthen the stomach, aid digestion, and promote qi circulation; *Citrus aurantium* excels at regulating qi and relieving chest congestion. The combination of these two herbs ensures smooth flow of qi and blood, tonifying without stagnation. *Bupleurum chinense* regulates liver qi, ensuring normal liver function, and also raises yang qi. With the assistance of *Bupleurum chinense*, the qi-tonifying and raising effect of *Heliotropium indicum* is doubled, allowing the qi in the chest to circulate to the heart vessels and regulate blood circulation. These three herbs are the adjuvant herbs. *Osmanthus fragrans* harmonizes the four herbs and harmonizes the overall effects; it is the guiding herb. When used together, these herbs work synergistically to tonify the spleen and stomach, replenish vital energy, and promote blood circulation.

[0021] The preparation method of the traditional Chinese medicine composition for treating hypotension according to the present invention includes the following steps: Take the following medicinal materials: *Symplocos buergeriana*, *Citrus aurantium*, *Rhododendron molle*, *Amomum villosum*, *Citrus aurantium*, *Bupleurum chinense*, and *Osmanthus fragrans*. Add water and decoct to extract the extract. Concentrate the extract under reduced pressure to form an extract, dry it under reduced pressure, pulverize it into a dry extract, mix it evenly, and then add commonly used pharmaceutical excipients to prepare an oral preparation.

[0022] The dosage forms of the oral preparations include granules, tablets, capsules, powders, or oral liquids.

[0023] The traditional Chinese medicine composition described in this invention is used in the preparation of a drug for treating hypotension.

[0024] Compared with the prior art, the present invention has the following beneficial effects: The traditional Chinese medicine composition of this invention has a pressor effect at all dosages, and the pressor effect is relatively stable. It can regulate the arrhythmia caused by hypotension. The present invention has conducted pharmacodynamic tests, and the results show that the traditional Chinese medicine composition of this invention has a significant pressor effect on hypotensive rats. Its mechanism is related to increasing serum ET and decreasing NO / ET. Other possible mechanisms of action include decreasing NO, regulating the RAS system, and improving energy loss. Detailed Implementation

[0025] The present invention will be further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are for illustrative purposes only and should not be construed as limiting the scope of protection of the present invention. Unless otherwise specified, the reagents and materials used in the embodiments are commercially available.

[0026] Example 1 The traditional Chinese medicine composition for treating hypotension described in this invention is made from the following raw materials in parts by weight: 30 parts of *Hypericum perforatum*, 20 parts of *Citrus aurantium*, 20 parts of *Rhododendron simsii*, 20 parts of *Amomum villosum*, 6 parts of *Citrus aurantium*, 6 parts of *Bupleurum chinense*, and 6 parts of *Osmanthus fragrans*. The preparation method is as follows: Weigh the above raw materials according to the weight composition, add water and boil twice. The first time, boil for 2 hours with 8 times the amount of water (V / W), and the second time, boil for 1 hour with 6 times the amount of water (V / W). Filter, combine the filtrates, concentrate under reduced pressure to form an extract, dry under reduced pressure, pulverize into a dry extract powder, add maltodextrin and magnesium stearate, mix thoroughly, and dry granulate to obtain the final product.

[0027] Example 2 The traditional Chinese medicine composition for treating hypotension described in this invention is made from the following raw materials in parts by weight: 40 parts of *Hypericum perforatum*, 25 parts of *Citrus aurantium*, 25 parts of *Rhododendron simsii*, 25 parts of *Amomum villosum*, 10 parts of *Citrus aurantium*, 10 parts of *Bupleurum chinense*, and 10 parts of *Osmanthus fragrans*. The preparation method is as follows: Weigh the above raw materials according to the weight composition, add water and decoct twice. The first time, decoct for 2 hours with 8 times the amount of water (V / W), and the second time, decoct for 1 hour with 6 times the amount of water (V / W). Filter, combine the filtrates, concentrate under reduced pressure to form an extract, dry under reduced pressure, pulverize into a dry extract powder, add maltodextrin and magnesium stearate, mix thoroughly, granulate, compress into tablets, and coat with a film to obtain the final product.

[0028] Example 3 The traditional Chinese medicine composition for treating hypotension described in this invention is made from the following raw materials in parts by weight: 20 parts of *Hypericum perforatum*, 10 parts of *Citrus aurantium*, 10 parts of *Rhododendron simsii*, 15 parts of *Amomum villosum*, 3 parts of *Citrus aurantium*, 3 parts of *Bupleurum chinense*, and 3 parts of *Osmanthus fragrans*. The preparation method is as follows: Weigh the above raw materials according to the weight composition, add water and decoct twice. The first time, decoct for 2 hours with 8 times the amount of water (V / W), and the second time, decoct for 1 hour with 6 times the amount of water (V / W). Filter, combine the filtrates, concentrate under reduced pressure to form an extract, dry under reduced pressure, pulverize into a dry extract powder, add maltodextrin and magnesium stearate, mix thoroughly, and fill into capsules to obtain the final product.

[0029] Example 4 Pharmacodynamic tests were conducted on the traditional Chinese medicine composition described in this invention.

[0030] 1. Experimental Materials 1.1 Drugs and Reagents The traditional Chinese medicine composition used in this example is the granules prepared in Example 1, which is provided by Ruiyang Pharmaceutical Co., Ltd.

[0031] Positive control drug: Midodrine Hydrochloride Tablets, specification: 2.5mg, produced by Sinopharm Group ChuanKang Pharmaceutical Co., Ltd.

[0032] 1.2 Animals and Feeding Environment 73 SPF-grade male Wistar rats, weighing 150-180g, 5-6 weeks old, were provided by Beijing Vital River Laboratory Animal Technology Co., Ltd. The laboratory animal certificate number is 110011221101640716, and the laboratory animal production license number is SCXK (Beijing) 2021-0011.

[0033] The rats are kept in a barrier environment, with a room temperature of 20-26℃, a ventilation frequency of ≥15 times / h, a humidity of 40-70%, a minimum static pressure difference of ≥10Pa in the communicating area, and a 12h / 12h day-night light-dark alternation cycle; the laboratory animal use license number is SYXK (Shandong) 20180031.

[0034] 1.3 Experimental Instruments BP-2010A non-invasive blood pressure measurement and analysis system, Softron Biotechnology Co., Ltd., Beijing; LE203E / 02 electronic balance, Mettler Toledo Instruments (Shanghai) Co., Ltd.; ACS-JJ-Tiger electronic pricing scale, Mettler Toledo (Changzhou) Measurement Technology Co., Ltd.; Hitachi 7180 automatic biochemical analyzer, Hitachi High-Technologies Corporation, Japan; UV2201 ultraviolet-visible spectrophotometer, Shimadzu Corporation, Japan; Spectra Max I3 multi-mode microplate reader, Molecular Devices (MD), USA.

[0035] 1.4 Statistical Analysis SPSS 22.0 statistical software is used for one-way analysis of variance, T-test or non-parametric test on the data. The data are expressed as . If the measurement data has homogeneous variance, the LSD test of one-way analysis of variance is used for inter-group comparison. If the measurement data has heterogeneous variance, the Dunnet's T3 test of one-way analysis of variance is adopted. P<0.05 is considered to have statistical significance.

[0036] 2 Experimental Methods 2.1 Model Preparation Seventy-three male SPF-grade Wistar rats were randomly selected, with 10 rats serving as the normal control group. The remaining 63 rats were administered compound reserpine suspension by gavage (0.16 mg / kg / day for the first 45 days, then adjusted to 0.192 mg / kg / day) twice daily to establish a hypotension model, for 51 or 52 consecutive days. The systolic blood pressure of the model group was significantly lower than that of the normal control group, with an average pressure difference ≥20 mmHg. The difference in systolic blood pressure between the two groups was statistically significant (P<0.05), indicating successful model establishment.

[0037] 2.2 Experimental Grouping Fifty hypotensive model rats were selected and randomly divided into high, medium, and low dose groups of the test substance, a midodrine hydrochloride group, and a model control group, with 10 rats in each group, based on their systolic blood pressure.

[0038] 2.3 Administration Fifty hypotensive animals continued to be administered reserpine compound (0.192 mg / kg / day, twice daily). 0.5–1 hour after the first administration of reserpine compound, the corresponding test solution (low, medium, and high doses were 0.63, 1.26, and 2.52 g / kg, respectively), midodrine hydrochloride solution (0.45 mg / kg), or the solvent was administered by gavage. The normal control group received the solvent. Administration was once daily for 36 consecutive days.

[0039] 2.4 Detection Indicators General physical examination; weight; blood pressure; heart rate; serum sodium. + K + The levels of aldosterone (ALD), renin, nitric oxide (NO), endothelin (ET), angiotensin-converting enzyme (ACE), angiotensin II (Ang II), albumin (ALB), C-reactive protein (CRP), interleukin-1 (IL-1), tumor necrosis factor-α (TNF-α), serum creatinine (SCr), lactate (LA), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and superoxide dismutase (SOD); the serum nitric oxide / endothelin (NO / ET) ratio; and the relative weights of the heart, spleen, and kidneys, etc.

[0040] 3. Experimental Results 3.1 General physical signs observation Throughout the experiment, the rats were generally in normal condition, with no obvious abnormalities observed in their activity, mental state, diet, or excretion. No animal deaths occurred.

[0041] 3.2 Weight During the administration period, there were no significant differences in body weight among the rats in each group of the herbal composition of this invention and the midodrine hydrochloride group compared with the model group and the normal group (P>0.05). Statistical results are shown in Table 1.

[0042] Table 1. Body weight (g) of rats before and after drug administration

[0043] Note: The day of administration is counted as D1, n=10.

[0044] 3.3 Blood Pressure After repeated oral administration of compound reserpine to rats (for 51 or 52 consecutive days), blood pressure, including SBP, DBP, and MAP, decreased significantly (P < 0.05). Following grouping, the test sample was administered continuously for 36 days, with the following results: After continuous administration of the traditional Chinese medicine composition of the present invention at a low dose (0.63g / kg / d) for 7-8 days, the systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) were significantly higher than those of the model control group (P<0.05). By day 35-36 of administration, SBP, DBP, and MAP were all significantly higher than those of the model control group (P<0.01).

[0045] After administration of the traditional Chinese medicine composition of this invention at medium and high doses (1.26 and 2.52 g / kg) and midodrine hydrochloride (0.45 mg / kg) for 17-18 days, SBP, DBP, and MAP were significantly higher than those in the model control group (P<0.05, 0.01). By day 35-36 of administration, SBP, DBP, and MAP were still significantly higher than those in the model control group (P<0.01).

[0046] Compared with the midodrine hydrochloride group, there was no significant difference in blood pressure indicators in the dosage group of the traditional Chinese medicine composition of the present invention (P>0.05).

[0047] After 21-22 days of administration, the DBP and MAP of the high-dose group of the traditional Chinese medicine composition of this invention were significantly higher than those of the midodrine hydrochloride group (P<0.05); after 35-36 days of administration, the SBP, DBP, and MAP of the low-dose group were significantly higher than those of the midodrine hydrochloride group (P<0.05).

[0048] The statistical results are shown in Table 2.

[0049] Table 2. Blood pressure and heart rate in rats

[0050]

[0051] Note: n=10; #P<0.05, ##P<0.01, compared with the normal control group; *P<0.05, **P<0.01, compared with the model control group; △P<0.05, compared with the midodrine hydrochloride group.

[0052] 3.4 Heart Rate After repeated (7 consecutive weeks) gavage administration of compound reserpine to rats, the heart rate (HR) increased significantly (P<0.05). Following grouping, the test drug was administered continuously for 36 days, and the results are as follows: After continuous administration of the low-dose (0.63 g / kg / d) traditional Chinese medicine composition of the present invention for 7-8 days, the HR was significantly lower than that of the model control group (P<0.05). Up to 36 days of administration, the HR was lower than that of the model control group. Except for 28-29 days, there was no significant statistical difference, and the HR at other time points was P<0.01. After continuous administration of the medium-dose (1.26 g / kg) for 21-22 days and 35-36 days, the HR was significantly lower than that of the model control group (P<0.05). After administration of the high-dose (2.52 g / kg) for 17-18 days, 21-22 days, and 35-36 days, the HR was significantly lower than that of the model control group (P<0.05, 0.01, 0.01).

[0053] The hazard ratio (HR) of midodrine hydrochloride (0.45 mg / kg) was significantly lower than that of the model control group after 17-18 days, 21-22 days and 35-36 days of administration (P<0.05, 0.01, 0.01).

[0054] At multiple time points, the effects of each dose of the test sample on HR were basically consistent with those of lidocaine hydrochloride.

[0055] The statistical results are shown in Table 2.

[0056] 3.5 NO and ET Compound reserpine is a vasodilator. In this study, compared with the normal control group, the serum NO level of rats in the model control group was increased, but there was no statistical significance (P>0.05), and there was no significant difference in ET content (P>0.05).

[0057] Compared with the model control group, the serum ET content in the high- and medium-dose groups of the traditional Chinese medicine composition of the present invention was significantly increased (P<0.05), and the NO / ET value was significantly lower than that in the model control group (P<0.05). The NO content in the high- and medium-dose groups was reduced, but there was no significant difference compared with the model control group (P>0.05).

[0058] Analysis: Endothelin (ET) is a vasoactive substance with a strong vasoconstrictive effect. The herbal composition of this invention can exert a vasoconstrictive effect by increasing serum endothelin levels.

[0059] The statistical results are shown in Table 3.

[0060] Table 3 Effects on serum NO and ET levels in rats

[0061] Note: n=10 for each indicator; #P<0.05, ##P<0.01, compared with the normal control group; *P<0.05, **P<0.01, compared with the model control group.

[0062] 3.6 Serum SCr and ALB, HDL-C, LDL-C Compared with the normal control group, the compound reserpine model resulted in a decrease in serum SCr, but the difference was not statistically significant and did not cause significant changes in ALB, HDL-C, or LDL-C (P>0.05).

[0063] Compared with the model control group, SCr was significantly increased in the medium-dose group and ALB was significantly decreased in the low-dose group (P<0.05), but the differences were basically consistent with those in the normal control group (P>0.05). No other significant differences were found.

[0064] Analysis: Decreased creatinine may be related to excessive energy consumption caused by increased heart rate. The herbal composition and midodrine hydrochloride of this invention can improve this metabolic abnormality. The dosage in this study showed the strongest improvement effect.

[0065] All animals in the low-dose group had ALB levels within the normal range of our laboratory, and there was no dose dependence. Therefore, the analysis concluded that the reduction in ALB from low-dose treatment was not biologically significant.

[0066] The statistical results are shown in Table 4.

[0067] Table 4. Statistical results of blood lipids, renal function, and albumin levels in rats.

[0068] Note: n=10; *P<0.05, compared with the model control group.

[0069] 3.7 Renin, ACE, AngII and ALD Compared with the normal control group, the serum AngII level of rats in the model control group was significantly increased (P<0.01); the ACE level was increased, but not statistically significant (P>0.05); and no significant changes were observed in Renin and ALD (P>0.05).

[0070] AngII: Compared with the model control group, serum AngII levels were decreased in all dosage groups of the herbal composition of this invention and in the midodrine hydrochloride group. The differences between the medium and high dosage groups were statistically significant (P<0.01, 0.05). While the AngII level in the low dosage group was slightly lower than that in the model control group, there was no statistically significant difference (P>0.05). All dosage groups were essentially consistent with the normal control group. Although the AngII level in the midodrine hydrochloride group was slightly lower than that in the model control group, there was no statistically significant difference (P>0.05), and it remained significantly higher than that in the normal control group (P<0.05). Compared with the midodrine hydrochloride group, the medium dosage group had lower AngII levels than the midodrine hydrochloride group (P<0.05), while no significant differences were observed between the low and high dosage groups (P>0.05).

[0071] Renin: Compared with the model control group, serum Renin in the medium and high dose groups of the traditional Chinese medicine composition granules of the present invention showed an increasing trend, although the difference was not significant (P>0.05).

[0072] Analysis: Long-term intake of compound reserpine has no significant effect on the formation of renin, aldosterone, and angiotensin-converting enzyme, but it can cause a feedback increase in angiotensin II. The herbal composition of this invention (0.63-2.52 g / kg) can regulate AngII to normal levels; the herbal composition of this invention (1.26, 2.52 g / kg) shows a trend of increasing renin, suggesting that the pressor effect of this product may be related to the increase in renin levels; the herbal composition of this invention (1.26 g / kg) shows an inhibitory effect on ACE. The pressor effect of this product may be related to the regulation of the renin-angiotensin system (RAS).

[0073] The statistical results are shown in Table 5.

[0074] Table 5 Effects of serum renin, ACE, AngII and ALD in rats

[0075] Note: n=10; #P<0.05, ##P<0.01, compared with the normal control group; *P<0.05, **P<0.01, compared with the model control group; △P<0.05, compared with the midodrine hydrochloride group.

[0076] 4. Conclusion The herbal composition of this invention exhibits a stable pressor effect at all dosages, and can regulate cardiac arrhythmias caused by hypotension. Medium and high doses can increase the vasoactive substance ET, and its pressor mechanism may be related to the vasoconstriction caused by increased ET. Medium and high doses can decrease NO, and its pressor mechanism may be related to the inhibition of the vasodilatory response of NO. Medium doses can increase SCr, indicating that this product may have an inhibitory effect on energy expenditure. Medium and high doses tend to increase renin, and its pressor mechanism may be related to the increase in renin levels. Long-term intake of compound reserpine can cause a feedback increase in AngII; this product can inhibit ACE, regulate abnormal AngII levels back to normal, and thus achieve the effect of regulating blood pressure.

[0077] In summary, the herbal composition of this invention (0.63-2.52 g / kg) has a significant pressor effect on hypotensive rats. Its mechanism is related to increasing serum ET and decreasing NO / ET. Other possible mechanisms of action include decreasing NO, regulating the RAS system, and improving energy loss, which provides evidence of the effectiveness of this drug for clinical development.

Claims

1. A traditional Chinese medicine composition for treating hypotension, characterized in that, It is made from the following ingredients in parts by weight: 20-40 parts of sticky hair firewood, 10-25 parts of five-leaf mountain small orange, 10-25 parts of variegated false rhododendron, 15-25 parts of fennel and cardamom, 3-10 parts of immature bitter orange, 3-10 parts of northern bupleurum, and 3-10 parts of lotus flower from Hebao Mountain. The root of *Sesamum indicum* is the root of the plant *Sesamum indicum*, belonging to the Sterculiaceae family. Wuyeshan small orange is the root of the Rutaceae plant Wuyeshan small orange; The root of *Rhododendron variegatum*, a plant in the Acanthaceae family; Fennel cardamom is the tuberous root of the cardamom plant, which belongs to the ginger family. Citrus aurantium is the dried young fruit of Citrus aurantium, a plant in the Rutaceae family. Northern Bupleurum is the dried root of Bupleurum chinense, a plant in the Apiaceae family. Osmanthus fragrans from Hebao Mountain is the root of Osmanthus fragrans from Hebao Mountain, a plant belonging to the Polygalaceae family.

2. A method for preparing the traditional Chinese medicine composition for treating hypotension according to claim 1, characterized in that, Includes the following steps: Take the following medicinal materials: *Symplocos buergeriana*, *Citrus aurantium*, *Rhododendron molle*, *Amomum villosum*, *Citrus aurantium*, *Bupleurum chinense*, and *Osmanthus fragrans*. Add water and decoct to extract the extract. Concentrate the extract under reduced pressure to form an extract, dry it under reduced pressure, pulverize it into a dry extract, mix it evenly, and then add commonly used pharmaceutical excipients to prepare an oral preparation.

3. The use of the traditional Chinese medicine composition for treating hypotension according to claim 1 in the preparation of a drug for treating hypotension.

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