Medical use of shenqijiangtang preparation

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition and medical application thereof. The traditional Chinese medicine composition is mainly prepared from ginseng stem and leaf saponin, Schisandra chinensis, Astragalus membranaceus, Chinese yam, Rehmannia glutinosa, raspberry, Ophiopogon japonicus, Poria cocos, Bupleurum smithii, Alisma orientale and Medicago polymorpha L. The ginseng and astragalus blood sugar lowering preparation prepared from the traditional Chinese medicine composition has obvious blood pressure lowering effect, and can be used for treating hypertension, especially salt-sensitive hypertension.

Description

Technical Field

[0001] This invention relates to the medicinal use of ginseng and astragalus hypoglycemic preparations, specifically to their use in the preparation of drugs for treating hypertension and / or lowering blood pressure, belonging to the field of traditional Chinese medicine technology. Background Technology

[0002] Hypertension is a chronic disease characterized by elevated arterial blood pressure, which may be accompanied by functional or organic damage to organs such as the heart, brain, and kidneys.

[0003] Hypertension is classified into primary hypertension and secondary hypertension, with approximately 90-95% of cases being primary hypertension. Hypertension is a major risk factor for serious illnesses such as stroke, myocardial infarction (heart attack), heart failure, aneurysms (such as aortic aneurysms), and peripheral artery disease, and is also a cause of chronic kidney disease. Even mild elevations in arterial blood pressure can shorten life expectancy.

[0004] Based on current medical advancements and diagnostic methods, hypertension where the exact cause of elevated blood pressure can be identified is called secondary hypertension; conversely, hypertension where the exact cause cannot be identified is called primary hypertension. The majority of hypertension cases are primary hypertension, but a definitive diagnosis requires ruling out secondary hypertension first. Currently, it is believed that secondary hypertension accounts for 5% to 10% of hypertension cases, but with continuous advancements in medical technology and diagnostic methods, the proportion of secondary hypertension will continue to increase, while the proportion of primary hypertension will continue to decrease.

[0005] Essential hypertension is caused by a combination of genetic and environmental factors. In 2005, the American Society of Hypertension (ASH) defined hypertension as a progressive cardiovascular syndrome caused by many factors, leading to changes in the function and structure of the heart and blood vessels. Therefore, the primary goal of essential hypertension treatment is to minimize the overall risk of cardiovascular death and disability.

[0006] Salt-sensitive hypertension, a type of essential hypertension, is an important and specific form of hypertension characterized by a significant increase in blood pressure caused by high salt intake. Salt intake is a significant environmental factor in hypertension, and blood pressure salt sensitivity increases with age, particularly in hypertensive patients. The primary cause of salt-sensitive hypertension is high salt intake, and it is related to impaired sodium metabolism in the kidneys, the renin-angiotensin-aldosterone system, sympathetic nervous system activation, endocrine mechanisms, and genetic factors. Family history, dietary habits, and gender can all increase the risk of developing salt-sensitive hypertension. Controlling salt intake can lower blood pressure levels.

[0007] Furthermore, high blood pressure is not the same as hypertension. High blood pressure is merely a symptom, not an independent disease. Many diseases, such as acute and chronic nephritis, pyelonephritis, hyperthyroidism, pheochromocytoma, Cushing's syndrome, and primary aldosteronism, can cause elevated blood pressure. Blood pressure may also rise during emotional excitement or exercise; dietary factors can also cause a short-term increase in blood pressure.

[0008] Ginseng and Astragalus hypoglycemic preparations (including Ginseng and Astragalus hypoglycemic granules, tablets, and capsules) are common traditional Chinese medicines for treating diabetes. Clinically, they are suitable for prediabetes, type 2 diabetes, and complications caused by deficiency of both Qi and Yin. Deficiency of both Qi and Yin is characterized by insufficient vital energy and depletion of Yin fluids, manifested as fatigue, shortness of breath, reluctance to speak, dry throat and mouth, thirst, flushed cheeks in the afternoon, scanty urination, constipation, thin tongue with little or no coating, and a weak and rapid pulse. Among these, Ginseng and Astragalus hypoglycemic granules produced by Lunan Houpu Pharmaceutical Co., Ltd. are recommended by the "Guidelines for the Diagnosis and Treatment of Prediabetes" and the "Guidelines for the Diagnosis and Treatment of Type 2 Diabetes," demonstrating significant clinical efficacy. Summary of the Invention

[0009] The inventors would like to clarify that this invention represents a further development of new pharmaceutical uses for ginseng and astragalus hypoglycemic preparations, and the new pharmaceutical uses of ginseng and astragalus hypoglycemic preparations described in this invention are derived from clinical feedback.

[0010] The ginseng and astragalus hypoglycemic preparations described in this invention include, but are not limited to, ginseng and astragalus hypoglycemic granules, ginseng and astragalus hypoglycemic tablets, and ginseng and astragalus hypoglycemic capsules.

[0011] One of the objectives of this invention is to provide the use of a traditional Chinese medicine composition mainly composed of ginseng stem and leaf saponins, schisandra, astragalus, yam, rehmannia, raspberry, ophiopogon, poria, trichosanthes root, alisma, and wolfberry in the preparation of drugs for treating hypertension.

[0012] Preferably, the traditional Chinese medicine composition contains the following components:

[0013] Ginseng stem and leaf saponins 3-10 parts by weight, Schisandra chinensis 50-70 parts by weight, Astragalus membranaceus 110-130 parts by weight

[0014] 50-70 parts by weight of yam, 150-200 parts by weight of rehmannia root, and 25-40 parts by weight of raspberry.

[0015] 50-70 parts by weight of Ophiopogon japonicus, 50-70 parts by weight of Poria cocos, and 50-70 parts by weight of Trichosanthes kirilowii.

[0016] Alisma plantago-aquatica 50-70 parts by weight, Lycium barbarum 110-130 parts by weight.

[0017] More preferably, the traditional Chinese medicine composition contains the following components:

[0018] Ginseng stem and leaf saponins 6 parts by weight, Schisandra chinensis 62 parts by weight, Astragalus membranaceus 124 parts by weight

[0019] 62 parts by weight of yam, 186 parts by weight of rehmannia root, and 31 parts by weight of raspberry.

[0020] 62 parts by weight of Ophiopogon japonicus, 62 parts by weight of Poria cocos, and 62 parts by weight of Trichosanthes kirilowii.

[0021] Alisma plantago-aquatica 62 parts by weight, Lycium barbarum 124 parts by weight.

[0022] The hypertension mentioned above refers to either primary hypertension or secondary hypertension.

[0023] Preferably, the primary hypertension can be hypertension caused by dietary factors.

[0024] More preferably, the hypertension caused by dietary factors refers to hypertension caused by a high-sugar and / or high-salt diet.

[0025] Specifically, the aforementioned primary hypertension is salt-sensitive hypertension.

[0026] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of drugs for lowering high blood pressure.

[0027] The high blood pressure mentioned above can be caused by a high-sugar and / or high-salt diet.

[0028] The main objective of this invention is to provide the use of ginseng and astragalus hypoglycemic preparations in the preparation of drugs for treating hypertension and / or lowering blood pressure; the ginseng and astragalus hypoglycemic preparations include, but are not limited to, ginseng and astragalus hypoglycemic granules, ginseng and astragalus hypoglycemic tablets, ginseng and astragalus hypoglycemic capsules, etc.

[0029] Pharmacodynamic experiments have confirmed that Shenqi Jiangtang Granules have significant regulatory effects on hypertension induced by high-sugar diet, high-salt diet, and high-sugar + high-salt diet in rats, and have a significant blood pressure lowering effect. At the same time, it can increase the NO content in rat kidney tissue, thereby regulating blood pressure. Specific Implementation

[0030] The present invention will be further illustrated below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. After reading the present invention, any modifications of the present invention in various equivalent forms by those skilled in the art will fall within the scope defined by the appended claims.

[0031] Example 1: Commercially available ginseng and astragalus hypoglycemic granules

[0032]

Ingredients

[0033]

Characteristics

[0034]

Indications

[0035]

Specifications

[0036] [Dosage and Administration] Oral administration. 1g each time, 3 times a day. One month is one course of treatment. If the effect is not significant or the symptoms are more severe before treatment, the dosage can be up to 3g each time, 3 times a day.

[0037] Example 2: Astragalus and Ginseng Hypoglycemic Tablets

[0038] Prescription: Ginseng stem and leaf saponins 6g, Schisandra chinensis 62g, Astragalus membranaceus 124g, Dioscorea opposita 62g, Rehmannia glutinosa 186g, Rubus idaeus 31g, Ophiopogon japonicus 62g, Poria cocos 62g, Trichosanthes kirilowii 62g, Alisma plantago-aquatica 62g, Lycium barbarum 124g.

[0039] Preparation method: Dioscorea opposita, Trichosanthes kirilowii, Rubus idaeus, and Poria cocos are pulverized into fine powder; Ophiopogon japonicus is soaked twice in warm water for 2 hours each time, the soaking liquids are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃); Schisandra chinensis is percolated with 50% ethanol, the ethanol is recovered from the percolate, and the paste is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃); Astragalus membranaceus, Rehmannia glutinosa, Lycium barbarum, and Alisma plantago-aquatica are decocted twice with water for 2 hours each time, the decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.15-1.20 (55-60℃), cooled, ethanol is added to make the alcohol content about 60%, allowed to stand, the supernatant is filtered, the ethanol is recovered, and the paste is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃). Combine the above-mentioned fine powders of yam, ophiopogon japonicus, schisandra chinensis, and astragalus membranaceus, mix well, dry, pulverize into fine powder, mix well, add appropriate amounts of ginseng stem and leaf saponins and dextrin, make into granules, dry, add appropriate amounts of aluminum hydroxide and magnesium stearate, mix well, press into 1000 tablets, coat with film, and the product is ready.

[0040] Example 3: Ginseng and Astragalus Hypoglycemic Capsules

[0041] Prescription: Ginseng stem and leaf saponins 6g, Schisandra chinensis 62g, Astragalus membranaceus 124g, Dioscorea opposita 62g, Rehmannia glutinosa 186g, Rubus idaeus 31g, Ophiopogon japonicus 62g, Poria cocos 62g, Trichosanthes kirilowii 62g, Alisma plantago-aquatica 62g, Lycium barbarum 124g.

[0042] Preparation method: Dioscorea opposita, Trichosanthes kirilowii, Rubus idaeus, and Poria cocos are pulverized into fine powder; Ophiopogon japonicus is soaked twice in warm water for 2 hours each time, the soaking liquids are combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃); Schisandra chinensis is percolated with 50% ethanol, the ethanol is recovered from the percolate, and the paste is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃); Astragalus membranaceus, Rehmannia glutinosa, Lycium barbarum, and Alisma plantago-aquatica are decocted twice with water for 2 hours each time, the decoctions are combined, filtered, and the filtrate is concentrated to a clear paste with a relative density of 1.15-1.20 (55-60℃), cooled, ethanol is added to make the alcohol content about 60%, allowed to stand, the supernatant is filtered, the ethanol is recovered, and the paste is concentrated to a thick paste with a relative density of 1.25-1.35 (55-60℃). Combine the above-mentioned fine powders of yam, ophiopogon japonicus, schisandra chinensis, and astragalus membranaceus, along with ginseng stem and leaf saponins. Mix well, dry, add an appropriate amount of starch, mix well or granulate, and encapsulate to make 1000 capsules. Alternatively, mix the above-mentioned ophiopogon japonicus, schisandra chinensis, and astragalus membranaceus with fine powders of yam and trichosanthes kirilowii, dry, pulverize, add an appropriate amount of ginseng stem and leaf saponins, fine powders of raspberry and poria cocos, and magnesium stearate. Mix well, encapsulate to make 1000 capsules.

[0043] Example 4: Astragalus and Ginseng Hypoglycemic Granules

[0044] Prescription: Ginseng stem and leaf saponins 3g, Schisandra chinensis 70g, Astragalus membranaceus 110g, Dioscorea opposita 70g, Rehmannia glutinosa 150g, Rubus idaeus 40g, Ophiopogon japonicus 50g, Poria cocos 70g, Trichosanthes kirilowii 50g, Alisma plantago-aquatica 70g, Lycium barbarum 110g.

[0045] Preparation method: Refer to Example 2.

[0046] Example 5: Astragalus and Ginseng Hypoglycemic Granules

[0047] Prescription: Ginseng stem and leaf saponins 10g, Schisandra chinensis 50g, Astragalus membranaceus 130g, Dioscorea opposita 50g, Rehmannia glutinosa 200g, Rubus idaeus 25g, Ophiopogon japonicus 70g, Poria cocos 50g, Trichosanthes kirilowii 70g, Alisma plantago-aquatica 50g, Lycium barbarum 130g.

[0048] Preparation method: Refer to Example 2.

[0049] II. Pharmacological Experiments

[0050] To verify the efficacy of the ginseng and astragalus hypoglycemic preparation in lowering blood pressure, the inventors conducted relevant pharmacodynamic studies. It should be noted that the drugs selected for the following pharmacodynamic tests are those obtained from the representative formulations and preparation methods of this invention. The inventors also conducted pharmacodynamic experiments on drugs obtained from other formulations and preparation methods included in this invention. The experimental results show that drugs obtained from other formulations and preparation methods have the same or similar effects, but due to space limitations, they are not listed here.

[0051] In addition, the following pharmacodynamic experiments only take some animal models as examples to verify the efficacy of the present invention. For hypertension caused by other reasons mentioned in the present invention, the inventors also conducted relevant pharmacodynamic experiments, and the experimental results showed that they had the same or similar effects. Here, they will not be enumerated one by one.

[0052] The inventors would like to state that the following experimental studies were all carried out on the basis of the proven drug safety in acute toxicity tests and long-term toxicity tests, and the administered doses in the experimental studies were all within the safe dose range.

[0053] I. Regulatory effect of Shenqi Jiangtang Granule on hypertension in rats induced by high-salt diet

[0054] 1 Materials

[0055] 1.1 Animals:

[0056] Wistar rats, SPF grade, 180 - 220 g, experimental animal license number: SYXK(Shandong)20180008, provided by Lunan Pharmaceutical Group Co., Ltd., and adaptively fed for one week before the experiment.

[0057] 1.2 Drugs, reagents

[0058] 1.2.1 Drugs

[0059] Shenqi Jiangtang Granule (National Drug Approval Number Z10950075, Lunan Houpu Pharmaceutical Co., Ltd.)

[0060] 1.2.3 Dosage of drugs

[0061] Shenqi Jiangtang Granule: 0.18 g / kg (low dose), 0.26 g / kg (medium dose), 0.52 g / kg (high dose)

[0062] 2. Model establishment, grouping and drug administration

[0063] Fifty rats were randomly divided into a blank group, a model group, and three dose groups of Shenqi Jiangtang Granule (high, medium, and low); among them, the rats in the blank group were fed with ordinary feed + distilled water, and the rats in the model group and the three dose groups of Shenqi Jiangtang Granule were fed with 8% (mass fraction) high-salt feed + distilled water, and the rats in the three dose groups of Shenqi Jiangtang Granule were simultaneously given the corresponding drugs.

[0064] The blood pressure of the rats was measured at the 2nd, 4th, 6th, and 8th weeks of feeding.

[0065] The blood pressure of the rats was measured by the non-invasive tail artery pressure method, and measured three times continuously, and the average value was taken.

[0066] After measuring blood pressure in week 8, rats were anesthetized, kidney tissue was harvested, and kidney medulla was used to prepare kidney tissue protein supernatant. The NO content in the supernatant was then measured.

[0067] 3. Statistical Processing

[0068] SPSS 22.0 software was used to perform statistical analysis on the obtained data. Quantitative data were analyzed using... This indicates that one-way ANOVA was used for comparisons among multiple groups, and independent samples t-tests were used for comparisons between two groups. A p-value < 0.05 was considered statistically significant.

[0069] 4. Results and Conclusions

[0070] 4.1 Comparison of blood pressure in rats

[0071] Compared with the control group, the blood pressure of rats in the other groups gradually increased with the extension of feeding time (P<0.01 or P<0.05), with the most significant increase in the model group, indicating that a high-salt diet can induce elevated blood pressure in rats. Compared with the model group, the blood pressure of rats in the three dosage groups of Shenqi Jiangtang Granules showed little difference at weeks 2 and 4 of feeding. However, the high-dose group of Shenqi Jiangtang Granules showed lower blood pressure than the model group at weeks 6 and 8 of feeding (P<0.01 or P<0.05), while the medium- and low-dose groups showed significantly lower blood pressure than the model group at week 8 of feeding (P<0.05). The experimental results indicate that Shenqi Jiangtang Granules have a significant regulatory effect on blood pressure induced by a high-salt diet in rats, demonstrating a significant antihypertensive effect.

[0072] Table 1 Comparison of blood pressure in rats of different groups ( n=10)

[0073]

[0074] Note: Compared with the blank group, @ P < 0.05, *P < 0.01;

[0075] Compared with the model group, △ P < 0.05 # P < 0.01.

[0076] 4.2 NO content in rat kidney tissue

[0077] Compared with the blank group, the content of NO in the renal tissues of rats in the model group was significantly lower (P < 0.01), indicating that in the rat hypertension model induced by high salt, high-salt diet can affect the content of NO in the kidneys of rats; compared with the model group, the content of NO in the renal tissues of rats in the three dose groups of Shenqi Jiangtang Granule was significantly higher (P < 0.01 or P < 0.05). There was no significant difference in the content of NO in the renal tissues of rats in the high-dose group of Shenqi Jiangtang Granule compared with the blank group. The above results suggest that Shenqi Jiangtang Granule can regulate blood pressure by increasing the content of NO in the renal tissues of model rats.

[0078] Table 2 Comparison of the content of NO in the renal tissues of rats in each group ( n = 10)

[0079]

[0080]

[0081] Note: Compared with the blank group, @ P < 0.05, *P < 0.01;

[0082] Compared with the model group, △ P < 0.05, # P < 0.01.

[0083] II. Regulatory effect of Shenqi Jiangtang Granule on hypertension in rats induced by high-fructose and high-salt diet

[0084] 1 Materials

[0085] 1.1 Animals:

[0086] SD rats, SPF grade, 180 - 220 g, experimental animal license number: SYXK (Lu) 20180008, provided by Lunan Pharmaceutical Group Co., Ltd., and adaptively fed for one week before the experiment.

[0087] 1.2 Drugs, reagents

[0088] 1.2.1 Drugs

[0089] Shenqi Jiangtang Granule (National Drug Approval Number Z10950075, Lunan Houpu Pharmaceutical Co., Ltd.)

[0090] 1.2.3 Dosage of drugs

[0091] Shenqi Jiangtang Granule: 0.18 g / kg (low dose), 0.26 g / kg (medium dose), 0.52 g / kg (high dose)

[0092] 2. Model establishment, grouping and drug administration

[0093] Fifty rats were randomly divided into a blank control group, a model group, and three dosage groups of Shenqi hypoglycemic granules (high, medium, and low). The rats in the blank control group were fed with ordinary feed and distilled water, while the rats in the model group and the three dosage groups of Shenqi hypoglycemic granules were fed with high fructose feed and 2% (mass fraction) saline. After one week of feeding, the rats in the three dosage groups of Shenqi hypoglycemic granules were given the corresponding drugs.

[0094] Blood pressure was measured in rats at weeks 0, 1, 3, and 5 of feeding.

[0095] Rat blood pressure was measured using the non-invasive tail artery pressure method, with three consecutive measurements taken and the average value recorded.

[0096] 3. Statistical Processing

[0097] SPSS 22.0 software was used to perform statistical analysis on the obtained data. Quantitative data were analyzed using... This indicates that one-way ANOVA was used for comparisons among multiple groups, and independent samples t-tests were used for comparisons between two groups. A p-value < 0.05 was considered statistically significant.

[0098] 4. Results and Conclusions

[0099] Compared with the control group, the blood pressure of rats in the other groups gradually increased with the extension of feeding time (P<0.01 or P<0.05), with the most significant increase in the model group, indicating that a high-fructose, high-salt diet can induce elevated blood pressure in rats. Compared with the model group, the high-dose group of Shenqi Jiangtang Granules had lower blood pressure in the 3rd and 5th weeks of feeding (P<0.01 or P<0.05), while the medium- and low-dose groups of Shenqi Jiangtang Granules had significantly lower blood pressure in the 5th week of feeding (P<0.05). The experimental results show that Shenqi Jiangtang Granules have a significant regulatory effect on blood pressure induced by a high-sugar, high-salt diet in rats, exhibiting a significant antihypertensive effect.

[0100] Table 3 Comparison of blood pressure values ​​in rats of different groups ( n=10)

[0101]

[0102] Note: Compared with the blank group, @ P < 0.05, *P < 0.01;

[0103] Compared with the model group, △ P < 0.05 # P < 0.01.

[0104] III. Regulatory effect of Shenqi Jiangtang Granules on hypertension induced by a high-fructose diet in rats

[0105] In addition to the pharmacodynamic experiments conducted on the effects of Shenqi Jiangtang Granules on blood pressure changes in rats induced by high-salt and high-fructose-high-salt diets, the inventors also conducted pharmacodynamic experiments on high-fructose-induced hypertension in rats. The results showed that Shenqi Jiangtang Granules also have a regulatory effect on high-fructose-induced hypertension in rats, as shown in Table 4 below.

[0106] Table 4 Comparison of blood pressure values ​​in rats of different groups during the high fructose induction experiment ( n=10)

[0107]

[0108] Note: Compared with the blank group, @ P < 0.05, *P < 0.01;

[0109] Compared with the model group, △ P < 0.05 # P < 0.01.

Claims

1. The use of a traditional Chinese medicine composition in the preparation of a drug for treating hypertension, said traditional Chinese medicine composition being made from the following components: 3-10 parts by weight of ginseng stem and leaf saponins Schisandra chinensis 50-70 parts by weight Astragalus membranaceus 110-130 parts by weight 50-70 parts by weight of yam 150-200 parts by weight of Rehmannia glutinosa 25-40 parts by weight of raspberries 50-70 parts by weight of Ophiopogon japonicus 50-70 parts by weight of Poria cocos 50-70 parts by weight of pollen 50-70 parts by weight of Alisma plantago-aquatica 110-130 parts by weight of wolfberries.

2. The use as described in claim 1, characterized in that, The traditional Chinese medicine composition is made from the following components: 6 parts by weight of ginseng stem and leaf saponins Schisandra chinensis 62 parts by weight Astragalus membranaceus 124 parts by weight 62 parts by weight of yam 186 parts by weight of Rehmannia glutinosa 31 parts by weight of raspberries 62 parts by weight of Ophiopogon japonicus 62 parts by weight of Poria cocos 62 parts by weight of pollen 62 parts by weight of Alisma plantago-aquatica 124 parts by weight of wolfberry.

3. The use as described in any one of claims 1-2, characterized in that... The hypertension mentioned refers to either primary hypertension or secondary hypertension.

4. The use as described in claim 3, characterized in that... The primary hypertension mentioned above is hypertension caused by dietary factors.

5. The use as described in claim 4, characterized in that... The hypertension caused by dietary factors refers to hypertension caused by a high-sugar and / or high-salt diet.

6. The use as described in claim 3, characterized in that... The primary hypertension mentioned is salt-sensitive hypertension.

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