A traditional Chinese medicine composition, its preparation method and application

Abstract

This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition, its preparation method, and its application. The traditional Chinese medicine composition, by weight, comprises the following components: 2-15 parts of ginger-processed Pinellia ternata, 2-15 parts of stir-fried Atractylodes macrocephala, 15-25 parts of Gastrodia elata, 15-25 parts of Poria cocos, 2-15 parts of dried tangerine peel, 5-15 parts of Polyporus umbellatus, 2-15 parts of cinnamon twig, 5-15 parts of Alisma plantago-aquatica, and 1-8 parts of Panax notoginseng powder. This traditional Chinese medicine composition, by combining various components in a specific ratio, allows the components to synergistically work together to achieve the effects of strengthening the spleen and resolving phlegm, promoting diuresis and eliminating turbidity, and calming the liver and unblocking the meridians. Precise proportions and dosages ensure that the entire formula exerts a synergistic effect in improving metabolism, reducing inflammation, and protecting the kidneys, thereby effectively delaying target organ damage while stabilizing blood pressure.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, and more specifically, to a traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Hypertension is a prominent cardiovascular health problem, affecting as many as 245 million people, and its onset is increasingly affecting younger people. Salt-sensitive hypertension (SSH), as a subtype of hypertension with unique epidemiological characteristics and pathophysiological mechanisms, is a key focus and challenge in the prevention and control of hypertension in my country.

[0003] Salt-sensitive hypertensive disorder (SSH) exhibits significant population heterogeneity and geographical clustering, with approximately 28%–42% of patients with primary hypertension being salt-sensitive. SSH is not only characterized by a significant increase in blood pressure after high salt intake, but is also a syndrome involving water and sodium metabolism disorders, sympathetic nerve activation, vascular endothelial dysfunction, and a low-grade inflammatory state. Patients often present with abnormal blood pressure rhythms, early target organ damage (especially kidney damage), metabolic disorders, and enhanced inflammatory responses. While current Western medicine treatments can control blood pressure to some extent, challenges remain in reversing metabolic abnormalities, inhibiting inflammatory oxidative stress, and effectively protecting target organs (especially the kidneys). Furthermore, conventional antihypertensive drugs are difficult to use to control blood pressure in SSH patients, and some drugs are prone to causing electrolyte disturbances or adverse metabolic reactions.

[0004] Traditional Chinese medicine (TCM) often categorizes hypertension as "dizziness" or "headache," and treats it traditionally from the perspectives of liver yang hyperactivity and phlegm retention. However, with changes in modern lifestyles and disease patterns, especially the significant role of high-salt diets, traditional treatment principles are no longer fully applicable to the clinical characteristics of hypertension-related hypertension (SSH). Recent studies have shown a close relationship between SSH and the TCM concept of "phlegm-dampness retention," with the key pathogenesis being spleen deficiency leading to phlegm-dampness retention, and treatment focusing on strengthening the spleen and resolving phlegm. Although some classic formulas are used to treat hypertension, there is still a lack of specific formulas targeting the core pathogenesis of SSH—"phlegm-dampness retention"—that also possess antihypertensive and target organ protective effects. The systematization of TCM treatment in this area, and the development of formula-syndrome correspondence, still require further exploration and improvement.

[0005] Therefore, there is an urgent need to develop a traditional Chinese medicine preparation that targets the TCM pathogenesis of salt-sensitive hypertension, has the effects of stabilizing blood pressure, improving metabolism, reducing inflammatory response and protecting target organs, in order to make up for the shortcomings of existing treatments and meet clinical needs.

[0006] In view of this, the present invention is hereby proposed. Summary of the Invention

[0007] The purpose of this invention is to provide a traditional Chinese medicine composition based on the TCM principle of "strengthening the spleen and resolving phlegm," targeting the core pathogenesis of "phlegm-dampness accumulation" in salt-sensitive hypertension, along with its preparation method and application. This composition aims to provide a novel TCM preparation for clinical use that not only stabilizes and controls blood pressure but also effectively improves metabolic disorders, reduces inflammatory responses, and provides clear protection to target organs such as the kidneys. Furthermore, its formulation is safe and easy to prepare into a stable and convenient modern dosage form.

[0008] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted: A traditional Chinese medicine composition, by weight, comprises the following components: 2-15 parts of ginger-processed Pinellia ternata, 2-15 parts of stir-fried Atractylodes macrocephala, 15-25 parts of Gastrodia elata, 15-25 parts of Poria cocos, 2-15 parts of dried tangerine peel, 5-15 parts of Polyporus umbellatus, 2-15 parts of cinnamon twig, 5-15 parts of Alisma plantago-aquatica, and 1-8 parts of Panax notoginseng powder.

[0009] The aforementioned traditional Chinese medicine composition combines various components in a specific ratio to achieve synergistic effects, thereby strengthening the spleen, resolving phlegm, eliminating dampness and turbidity, and calming the liver and unblocking the meridians. This ratio is not a simple additive process, but rather an organic combination of principal, assistant, adjuvant, and guiding herbs to target the core pathogenesis of "phlegm-dampness accumulation" in salt-sensitive hypertension, achieving multi-target holistic regulation. The dosage range of each component is particularly crucial. Spleen-strengthening and dampness-eliminating herbs (such as Poria, Alisma, and Polyporus) are used in relatively high doses to promote sodium and water excretion; liver-calming and meridian-unblocking herbs (such as Gastrodia and Panax notoginseng) are used in moderate doses to balance blood pressure reduction and target organ protection; and qi-regulating and phlegm-resolving herbs (such as Citrus reticulata and Pinellia ternata) and warming and unblocking herbs (such as Cinnamomum cassia) are used in appropriate doses to aid digestion and promote qi circulation. This precise ratio and dosage ensure that the entire formula exerts a synergistic effect across multiple aspects, including improving metabolism, reducing inflammation, and protecting the kidneys, thereby effectively delaying target organ damage while stabilizing blood pressure.

[0010] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 4-12 parts of ginger-processed Pinellia ternata, 4-12 parts of stir-fried Atractylodes macrocephala, 18-22 parts of Gastrodia elata, 18-22 parts of Poria cocos, 4-12 parts of dried tangerine peel, 8-12 parts of Polyporus umbellatus, 6-10 parts of cinnamon twig, 8-12 parts of Alisma plantago-aquatica, and 2-7 parts of Panax notoginseng powder.

[0011] Preferably, the traditional Chinese medicine composition comprises a pharmaceutical preparation.

[0012] Preferably, the pharmaceutical preparation includes any one of granules, tablets, capsules, oral liquids, or pills.

[0013] The preparation method of the traditional Chinese medicine composition as described above includes the following steps: The raw materials are mixed and then boiled and separated into solid and liquid components.

[0014] This preparation process allows the effective components of each herb to fully dissolve, interact, and synergistically enhance each other during decoction. After concentration and enrichment, the overall chemical composition and compatibility ratio of the original formula, which "strengthens the spleen, resolves phlegm, and promotes diuresis and eliminates turbidity," are preserved and optimized to the greatest extent. This ensures that the final Chinese medicine composition can fully carry out and stably exert its comprehensive efficacy in lowering blood pressure and protecting target organs in salt-sensitive hypertension.

[0015] Preferably, the decocting temperature is 95~100℃ and the time is 20~60min.

[0016] The application of the traditional Chinese medicine composition as described above or the traditional Chinese medicine composition prepared by the method described above in the preparation of a drug for treating salt-sensitive hypertension.

[0017] Preferably, the application includes delaying or alleviating renal fibrosis caused by salt-sensitive hypertension.

[0018] A pharmaceutical composition for treating salt-sensitive hypertension comprises: the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the method of preparing the traditional Chinese medicine composition, and a chemical antihypertensive drug.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The traditional Chinese medicine composition provided by this invention, through a specific ratio of ginger-processed Pinellia ternata, stir-fried Atractylodes macrocephala, Gastrodia elata, Poria cocos, Citrus reticulata peel, Polyporus umbellatus, Cinnamomum cassia, Alisma plantago-aquatica, and Panax notoginseng powder, constructs a system of principal, assistant, and adjuvant herbs that simultaneously strengthen the spleen, resolve phlegm, promote diuresis and eliminate dampness, and soothe the liver and unblock the meridians. This ratio targets the core pathogenesis of "phlegm and dampness accumulation" in salt-sensitive hypertension, and can achieve multi-target synergistic regulation. While exerting a stable antihypertensive effect, it also has the comprehensive effects of improving water and sodium metabolism, reducing inflammatory response, and protecting the kidney target organ, making up for the shortcomings of the existing treatments that simply lower blood pressure and disconnect organ protection.

[0020] (2) The preparation method of the traditional Chinese medicine composition provided by the present invention is simple and convenient, which is conducive to the enrichment and stability of active ingredients, ensuring that the final preparation can efficiently carry and reproduce the overall efficacy of the prescription design, and at the same time provides a reliable and repeatable process route for the industrial production of modern traditional Chinese medicine preparations (such as granules) with stable and uniform quality. Attached Figure Description

[0021] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0022] Figure 1Blood pressure in DahlSS rats after high-salt feeding; Figure 2 HE staining results of rats in each group after 8 weeks of drug administration. Detailed Implementation

[0023] The technical solution of the present invention will be clearly and completely described below with reference to the accompanying drawings and specific embodiments. However, those skilled in the art will understand that the embodiments described below are some embodiments of the present invention, but not all embodiments, and are only used to illustrate the present invention, and should not be regarded as limiting the scope of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall be followed. Where the manufacturers of reagents or instruments are not specified, they are all conventional products that can be purchased commercially.

[0024] One aspect of the present invention relates to a traditional Chinese medicine composition, comprising, by weight, the following components: 2-15 parts of ginger-processed Pinellia ternata, 2-15 parts of stir-fried Atractylodes macrocephala, 15-25 parts of Gastrodia elata, 15-25 parts of Poria cocos, 2-15 parts of dried tangerine peel, 5-15 parts of Polyporus umbellatus, 2-15 parts of cinnamon twig, 5-15 parts of Alisma plantago-aquatica, and 1-8 parts of Panax notoginseng powder.

[0025] In some specific implementations, the amount of ginger pinellia, by weight, can be, for example, but not limited to, any one of 2, 4, 6, 8, 10, 12, 14, or 15 parts, or a range of any two.

[0026] In some specific implementations, the amount of stir-fried Atractylodes macrocephala, by weight, can be, for example, but not limited to, any one of 2, 4, 6, 8, 10, 12, 14, or 15 parts, or a range of any two.

[0027] In some specific implementations, the amount of Gastrodia elata by weight can be, for example, but not limited to, any one of 15, 17, 19, 21, 23, or 25 parts, or a range between any two.

[0028] In some specific implementations, the weight of Poria cocos can be, for example, but not limited to, any one of 15 parts, 17 parts, 19 parts, 21 parts, 23 parts, or 25 parts, or a range of any two.

[0029] In some specific implementations, the tangerine peel, by weight, can be, for example, but not limited to, any one of 2 parts, 4 parts, 6 parts, 8 parts, 10 parts, 12 parts, 14 parts, or 15 parts, or a range of any two.

[0030] In some specific implementations, the weight percentage of *Polyporus umbellatus* can be, for example, but not limited to, any one of 5, 7, 9, 11, 13, or 15 parts, or a range of any two.

[0031] In some specific implementations, the cinnamon twigs, by weight, can be, for example, but not limited to, any one of 2, 4, 6, 8, 10, 12, 14, or 15 parts, or a range of any two.

[0032] In some specific implementations, the amount of Alisma plantago-aquatica, by weight, can be, for example, a point value or a range of any two of 5, 7, 9, 11, 13, or 15 parts.

[0033] In some specific implementations, the amount of Panax notoginseng powder, by weight, can be, for example, but not limited to, any one of 1 part, 3 parts, 5 parts, 7 parts, or 8 parts, or a range of any two.

[0034] The aforementioned traditional Chinese medicine composition, through a specific ratio of ginger-processed Pinellia ternata, stir-fried Atractylodes macrocephala, Gastrodia elata, Poria cocos, Citrus reticulata peel, Polyporus umbellatus, Cinnamomum cassia twig, Alisma plantago-aquatica, and Panax notoginseng powder, constructs a system of principal, assistant, and adjuvant herbs that simultaneously strengthen the spleen, resolve phlegm, promote diuresis and eliminate dampness, and soothe the liver and unblock the meridians. This formulation targets the core pathogenesis of "phlegm-dampness accumulation" in salt-sensitive hypertension, achieving multi-target synergistic regulation. While exerting a stable antihypertensive effect, it also has comprehensive effects such as improving water and sodium metabolism, reducing inflammatory response, and protecting the kidneys, thus compensating for the shortcomings of existing treatments that simply lower blood pressure without organ protection.

[0035] All components in the formulation of this invention are listed in the Chinese Pharmacopoeia and are essential drugs. If they are formulated into related preparations through pharmacological research, they are stable, safe, easy to use, and easy to produce.

[0036] This invention starts from the core pathogenesis of "phlegm-dampness retention" and takes strengthening the spleen and resolving phlegm as the treatment principle. It targets the key aspects of symptomatic hypertensive disorder (SSH) – "water and sodium retention, metabolic disorders, and failure of clear yang to ascend" – demonstrating the advantages of multi-component, multi-target, and holistic regulation. It not only focuses on lowering blood pressure but also strives to improve the internal metabolic-inflammatory environment, providing new strategies and ideas for the prevention and treatment of SSH and its target organ damage. Toxicological and animal experiments have confirmed its safety and antihypertensive potential, demonstrating significant clinical translational value.

[0037] Furthermore, the traditional Chinese medicine composition, by weight, comprises the following components: 4-12 parts of ginger-processed Pinellia ternata, 4-12 parts of stir-fried Atractylodes macrocephala, 18-22 parts of Gastrodia elata, 18-22 parts of Poria cocos, 4-12 parts of dried tangerine peel, 8-12 parts of Polyporus umbellatus, 6-10 parts of cinnamon twig, 8-12 parts of Alisma plantago-aquatica, and 2-7 parts of Panax notoginseng powder.

[0038] Furthermore, the traditional Chinese medicine composition includes: a pharmaceutical preparation form.

[0039] All conventional pharmaceutical formulations in the art can be used in this invention. In some specific embodiments, the pharmaceutical formulations include, but are not limited to, any one of granules, tablets, capsules, oral liquids or pills.

[0040] Furthermore, the traditional Chinese medicine composition also includes clinically acceptable excipients. Depending on the type of drug formulation, the appropriate type of excipient is selected adaptively, and the present invention does not impose specific limitations.

[0041] Furthermore, the traditional Chinese medicine composition of the present invention is made into granules and taken twice a day, 30 minutes after breakfast and dinner.

[0042] Another aspect of the present invention relates to a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps: The raw materials are mixed and then boiled and separated into solid and liquid components.

[0043] The preparation method of the traditional Chinese medicine composition is simple and facilitates the enrichment and stabilization of active ingredients, ensuring that the final formulation can efficiently carry and reproduce the overall efficacy of the prescription design. At the same time, it provides a reliable and repeatable process route for the industrial production of modern traditional Chinese medicine preparations (such as granules) with stable and uniform quality.

[0044] Furthermore, the simmering temperature is 95~100℃ (for example, it can be any one of 95℃, 96℃, 97℃, 98℃, 99℃ or 100℃ or any range between two), and the time is 20~60min (for example, it can be any one of 20min, 25min, 30min, 35min, 40min, 45min, 50min, 55min or 60min or any range between two).

[0045] Furthermore, the decoction is performed 1 to 2 times.

[0046] Furthermore, the amount of water used for decocting is 2-5 cm above the surface of the herbs.

[0047] Furthermore, the solid-liquid separation uses a filter material with a pore size of 95-105 mesh (for example, it can be any one of 95 mesh, 97 mesh, 99 mesh, 101 mesh, 103 mesh or 105 mesh, or a range of any two).

[0048] After solid-liquid separation, the filtrate can be made into different drug dosage forms, such as granules, according to actual needs. There are no restrictions on the specific methods; conventional methods in this field can be used.

[0049] Another aspect of the present invention relates to the use of the aforementioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the method thereof in the preparation of a medicament for treating salt-sensitive hypertension.

[0050] Furthermore, the treatment includes delaying or reducing renal fibrosis caused by salt-sensitive hypertension.

[0051] Another aspect of the present invention relates to a pharmaceutical composition for treating salt-sensitive hypertension, comprising: the traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the method of preparing the traditional Chinese medicine composition, and a chemical antihypertensive drug.

[0052] This invention does not specifically limit the use of chemical antihypertensive drugs. Conventional chemical antihypertensive drugs in the art can be used in combination with the traditional Chinese medicine composition of this invention to achieve better therapeutic effects. In some specific embodiments, the chemical antihypertensive drugs include, but are not limited to, at least one of: angiotensin II receptor antagonists, angiotensin-converting enzyme inhibitors, calcium channel blockers, or diuretics.

[0053] The embodiments of the present invention will be described in detail below with reference to examples. However, those skilled in the art will understand that the following examples are for illustrative purposes only and should not be considered as limiting the scope of the invention. Unless otherwise specified in the examples, conventional conditions or conditions recommended by the manufacturer are followed. Reagents or instruments whose manufacturers are not specified are all commercially available conventional products.

[0054] Example 1 The traditional Chinese medicine composition provided in this example includes the following components by weight: 6 parts ginger-processed Pinellia ternata, 6 parts stir-fried Atractylodes macrocephala, 20 parts Gastrodia elata, 20 parts Poria cocos, 6 parts dried tangerine peel, 10 parts Polyporus umbellatus, 6 parts cinnamon twig, 10 parts Alisma plantago-aquatica, and 3 parts Panax notoginseng powder.

[0055] The preparation method is the same as in Example 4.

[0056] Example 2 The traditional Chinese medicine composition provided in this example includes the following components by weight: 2 parts ginger-processed Pinellia ternata, 15 parts stir-fried Atractylodes macrocephala, 15 parts Gastrodia elata, 25 parts Poria cocos, 2 parts dried tangerine peel, 15 parts Polyporus umbellatus, 15 parts cinnamon twig, 10 parts Alisma plantago-aquatica, and 3 parts Panax notoginseng powder.

[0057] The preparation method is the same as in Example 4.

[0058] Example 3 The traditional Chinese medicine composition provided in this example includes the following components by weight: 8 parts ginger-processed Pinellia ternata, 2 parts stir-fried Atractylodes macrocephala, 25 parts Gastrodia elata, 15 parts Poria cocos, 15 parts dried tangerine peel, 5 parts Polyporus umbellatus, 2 parts cinnamon twig, 5 parts Alisma plantago-aquatica, and 1 part Panax notoginseng powder.

[0059] The preparation method is the same as in Example 4.

[0060] Example 4 The method for preparing the traditional Chinese medicine composition provided in this embodiment includes the following steps: 1. Mix the raw materials of Chinese medicinal herbs and decoct them at 100℃ for 30 minutes. After decoction, use 100-mesh filter material to separate the solid and liquid while hot to obtain the extract. 2. Concentrate the filtrate of the above extract under reduced pressure to obtain a clear paste; 3. Sift the clear paste, spray dry it, and collect the powder in time to obtain the intermediate; 4. Mix the above intermediates for 30 minutes, and then pass the intermediates through a 100-mesh sieve; 5. Dry granulate the above mixture into 12-30 mesh particles.

[0061] Comparative Example 1 The difference between this comparative example and Example 1 is that no Gastrodia elata, Polyporus umbellatus, Cinnamomum cassia, or Panax notoginseng powder were added.

[0062] Comparative Example 2 The traditional Chinese medicine composition provided in this comparative example includes the following components by weight: 25 parts ginger-processed Pinellia ternata, 1 part stir-fried Atractylodes macrocephala, 1 part Gastrodia elata, 30 parts Poria cocos, 1 part dried tangerine peel, 1 part Polyporus umbellatus, 25 parts cinnamon twig, 1 part Alisma plantago-aquatica, and 1 part Panax notoginseng powder.

[0063] The preparation method is the same as in Example 4.

[0064] Experimental Example (1) Establishment of a salt-sensitive hypertensive rat model fed with high salt content Dahl salt-sensitive rats (DahlSS) were fed a diet of 4% NaCl to establish a salt-sensitive hypertension model, while the control group was fed a low-salt diet of 0.3% NaCl. Blood pressure was measured using a non-invasive tail sphygmomanometer after 4 weeks of high-salt feeding. The results showed that the blood pressure of the high-salt-fed DahlSS was higher than that of the low-salt-fed group. (See attached results). Figure 1 , A p-value < 0.05 indicates that the difference between the two groups is statistically significant.

[0065] (2) Effects of traditional Chinese medicine composition on blood pressure in Dahl SS patients on high-salt diet After being fed a high-salt diet for 4 weeks, DahlSS rats were randomly divided into the HS group (high-salt group), V group (valsartan group), XH group (high-dose group of Example 1), BM group (medium-dose group of Example 1), BL group (low-dose group of Example 1), S2 group (high-dose group of Example 2), S3 group (high-dose group of Example 3), D1 group (high-dose group of Comparative Example 1) and D2 group (high-dose group of Comparative Example 2).

[0066] Dosage was calculated using the body surface area-dose conversion method as described in *Pharmacological Experimental Methodology*. The clinically equivalent dose was selected as the medium-dose group, half the concentration as the low-dose group, and twice the concentration as the high-dose group. Valsartan capsules (80 mg / capsule) were manufactured by Novartis Pharmaceuticals Beijing Co., Ltd., prepared as a 1.5 mg suspension per milliliter, and administered by gavage at a dose of 30 mg / kg. Ten rats fed a low-salt diet were designated as the LS group (low-salt group). The LS and HS groups were administered equal volumes of distilled water by gavage. All drugs were stored at 4°C. Blood pressure was measured once before administration and every 4 weeks during the administration period (tail pressure method), along with body weight.

[0067] Systolic blood pressure SBP Four weeks after administration, compared with the high-salt group, the blood pressure of the valsartan group (V) and the high-dose group of Example 1 (XH) decreased significantly (P<0.05), while the blood pressure of XM, XL, S2, S3 and D1 decreased significantly (P>0.05), and no significant decrease in blood pressure was observed in the D2 group.

[0068] After 8 weeks of administration, compared with the high-salt group, blood pressure decreased in the valsartan group, the high, medium, and low dose groups of Example 1, and the high-dose group of Example 3, with statistically significant differences (P<0.05). The valsartan group showed a significant reduction in blood pressure, with a statistically significant difference compared to the low-dose group of Example 1 (P<0.05), but no difference compared to the high and medium dose groups of Example 1 (P>0.05). This indicates that long-term use of the high-dose group of Example 1 can control systolic blood pressure elevation to a certain extent (see Table 1).

[0069] Diastolic blood pressure (DBP) Four weeks after administration, compared with the high-salt group, the valsartan group (V), the high- and medium-dose groups of Example 1 (XH, XM) showed a decrease in blood pressure, with statistically significant differences (P<0.05). The blood pressure decreased on day 1, but the difference was not statistically significant (P>0.05). No significant decrease in blood pressure was observed in other groups.

[0070] After 8 weeks of administration, compared with the high-salt group, the valsartan group showed a statistically significant decrease in blood pressure (P<0.05). Blood pressure at XH, XM, and XL levels also decreased, but the differences were not statistically significant (P>0.05). No significant decrease in diastolic blood pressure was observed in other groups. This indicates that long-term use of the high dose in Example 1 can control systolic blood pressure elevation to a certain extent (see Table 2).

[0071] Table 1. Changes in systolic blood pressure (SBP) (mmHg) in rats before and after drug administration.

[0072] Table 2. Changes in diastolic blood pressure (DBP) (mmHg) in rats before and after drug administration.

[0073] Note: LS: Low-salt group, HS: High-salt group, V: Valsartan group, XH: High-dose group of Example 1, XM: Medium-dose group of Example 1, XL: Low-dose group of Example 1, S2: High-dose group of Example 2, S3: High-dose group of Example 3, D1: High-dose group of Comparative Example 1, D2: High-dose group of Comparative Example 2. Compared with LS, P<0.05; compared with HS, △P<0.05; compared with V, ▲P<0.05.

[0074] (3) Effect of Example 1 on renal fibrosis in DahlSS rats fed with high salt Eight weeks later, kidney tissue was stained with hematoxylin and eosin (HE) under a light microscope. It was found that the glomeruli in the low-salt group were of normal volume, the capillary loops were normally open, the renal tubules and renal interstitium were normal, and no inflammatory cell infiltration was observed. In the high-salt group, most glomeruli showed fibrosis and hyaline degeneration, capillary loop occlusion, increased mesangial matrix, basement membrane-like material, collagen fibers, and plasma protein deposition, and renal tubule atrophy and disappearance; there was extensive fibrosis in the renal interstitium, accompanied by a large number of inflammatory cell infiltrations. In the valsartan group, a small number of glomerular fibrosis, hyalinization, and glomerular capillary loop occlusion were observed. Some renal tubules atrophied and degenerated, and there was mild proliferation of renal interstitial fibrosis tissue with a small amount of inflammatory cell infiltration. Example 1: In the high-dose group, some glomerular fibrosis and hyalinization were observed, with a few capillary loop stenosis, a small number of mesangial cells, mesangial matrix and collagen fibers increased, a small number of renal tubular atrophy, mild proliferation of renal interstitial fibrosis tissue, and a small number of inflammatory cell infiltrations. In Example 1, the mid-dose group showed fibrosis and hyaline degeneration in some glomeruli, partial capillary loop occlusion, increased mesangial matrix, basement membrane-like material, collagen fibers, and plasma protein deposition in some areas, and atrophy and disappearance of some renal tubules; fibrous tissue proliferation in some renal interstitium, accompanied by partial inflammatory cell infiltration. Example 1: In the low-dose group, most glomeruli showed fibrosis and hyalinization, some capillary loops were occluded, and there was an increase in mesangial matrix, basement membrane-like material, collagen fibers, and plasma protein deposition. Some renal tubules atrophied and disappeared. The renal interstitium showed extensive fibrosis with abundant inflammatory cell infiltration. See [link to example]. Figure 2 .

[0075] Although the present invention has been illustrated and described with specific embodiments, it should be understood that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; those skilled in the art should understand that modifications can be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein, without departing from the spirit and scope of the present invention; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, By weight, it includes the following components: 2-15 parts of ginger-processed Pinellia ternata, 2-15 parts of stir-fried Atractylodes macrocephala, 15-25 parts of Gastrodia elata, 15-25 parts of Poria cocos, 2-15 parts of dried tangerine peel, 5-15 parts of Polyporus umbellatus, 2-15 parts of cinnamon twig, 5-15 parts of Alisma plantago-aquatica, and 1-8 parts of Panax notoginseng powder.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, By weight, it includes the following components: 4-12 parts of ginger-processed Pinellia ternata, 4-12 parts of stir-fried Atractylodes macrocephala, 18-22 parts of Gastrodia elata, 18-22 parts of Poria cocos, 4-12 parts of dried tangerine peel, 8-12 parts of Polyporus umbellatus, 6-10 parts of cinnamon twig, 8-12 parts of Alisma plantago-aquatica, and 2-7 parts of Panax notoginseng powder.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that, The traditional Chinese medicine composition includes: a pharmaceutical preparation.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The pharmaceutical preparations include any one of the following: granules, tablets, capsules, oral liquids, or pills.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, Includes the following steps: The raw materials are mixed and then boiled and separated into solid and liquid components.

6. The method for preparing the traditional Chinese medicine composition according to claim 5, characterized in that, The decocting temperature is 95~100℃, and the time is 20~60min.

7. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 or the traditional Chinese medicine composition according to claim 5 or 6 in the preparation of a drug for treating salt-sensitive hypertension.

8. The application according to claim 7, characterized in that, The applications include delaying or reducing renal fibrosis caused by salt-sensitive hypertension.

9. A pharmaceutical composition for treating salt-sensitive hypertension, characterized in that, The composition comprises: a traditional Chinese medicine composition as described in any one of claims 1 to 4 or a traditional Chinese medicine composition prepared by the method described in claim 5 or 6, and a chemical antihypertensive drug.

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