Application of dingxianyin granules in preparation of drugs for treating early renal injury caused by hypertension of yin deficiency and yang hyperactivity

Abstract

The application discloses application of Dingxuan Granules in preparation of medicines for treating early kidney damage caused by hypertension of the type of yin deficiency and yang hyperactivity, and the Dingxuan Granules are prepared from radix rehmanniae, lycium barbarum, gastrodia, uncaria, wine salvia miltiorrhiza, alisma, motherwort and achyranthes bidentata. The Dingxuan Granules have the effects of tonifying liver and kidney, calming liver wind and promoting water and descending qi, and are suitable for people with early kidney damage caused by hypertension.

Description

Technical Field

[0001] This invention relates to the application of Dingxuan Yin granules in the preparation of drugs for treating early kidney damage caused by hypertension of the Yin deficiency and Yang hyperactivity type, and belongs to the technical field of new drug applications. Background Technology

[0002] Early kidney damage caused by hypertension mainly manifests as structural and functional abnormalities of the glomeruli and renal microvessels, triggered by long-term elevated blood pressure leading to changes in renal hemodynamics. Early symptoms are often subtle but can be detected through urinary microalbumin testing and renal function assessment. Timely intervention can slow disease progression.

[0003] Treatment for early-stage kidney damage caused by hypertension needs to balance lowering blood pressure and protecting the kidneys. Therefore, the basic treatment approach is to prioritize drugs with clear kidney-protective effects while effectively controlling blood pressure. Commonly used drugs include renin-angiotensin system inhibitors and sodium-glucose cotransporter 2 inhibitors. However, because patients have hypertension, long-term use of these drugs can lead to side effects such as gastrointestinal discomfort, arrhythmia, allergies, liver and kidney damage, and increased blood pressure.

[0004] This invention utilizes traditional Chinese medicine treatment, based on syndrome differentiation, to tonify the liver and kidneys, calm the liver and extinguish wind, promote diuresis and regulate qi, thus treating patients with early-stage kidney damage caused by hypertension. Summary of the Invention

[0005] The technical problem to be solved by this invention is to provide the application of Dingxuan Yin granules in the preparation of a drug for treating early kidney damage caused by hypertension of the Yin deficiency and Yang hyperactivity type. This invention has the effects of tonifying the liver and kidneys, calming the liver and extinguishing wind, and promoting diuresis and regulating Qi, and is suitable for patients with early kidney damage caused by hypertension.

[0006] To solve the above technical problems, the present invention adopts the following technical solution: Application of Dingxuan Yin Granules in the preparation of drugs for treating early renal damage caused by hypertension of the Yin deficiency and Yang hyperactivity type.

[0007] The aforementioned Dingxuan Yin granules contain the following medicinal active ingredients, calculated by weight: 250-420 parts of Rehmannia glutinosa, 150-350 parts of Lycium barbarum, 150-350 parts of Gastrodia elata, 150-350 parts of Uncaria rhynchophylla, 300-700 parts of Salvia miltiorrhiza (processed with wine), 150-350 parts of Alisma plantago-aquatica, 300-700 parts of Leonurus japonicus, and 100-230 parts of Achyranthes bidentata.

[0008] Specifically, the medicinal active ingredients of the aforementioned Dingxuan Yin granules, calculated by weight, are made from 333 parts of Rehmannia glutinosa, 250 parts of Lycium barbarum, 250 parts of Gastrodia elata, 250 parts of Uncaria rhynchophylla, 500 parts of Salvia miltiorrhiza (processed with wine), 250 parts of Alisma plantago-aquatica, 500 parts of Leonurus japonicus, and 167 parts of Achyranthes bidentata.

[0009] The aforementioned method for preparing Dingxuan Yin granules is carried out according to the following steps: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 8-10 times the amount of water for 0.5-1.5 hours, decoct it 1-4 times, each time for 0.5-2.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.00-1.40 at 70-90℃ to obtain a thick extract; (2) Drying and powdering: Mix the thick extract and soluble starch at a weight ratio of 1:0.5-1.5, dry at 70-90℃ for 2-4 days, and pulverize through a 50-80 mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 60-80% ethanol to make soft material. The weight ratio of dry powder of extract to 60-80% ethanol is 2-3:1. Pass it through a 10-14 mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 3-5:1. Make granules, dry at 50-70℃ for 18-30h, and sieve through 30-60 mesh to make granules.

[0010] In the aforementioned step (1), decoction extraction and concentration: weigh each medicinal material according to the prescription ratio, soak it in 9-10 times the amount of water for 1-1.5 hours, decoct it 2-3 times, each time for 1-1.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.10-1.30 at 80℃ to obtain a thick extract.

[0011] Specifically, in the aforementioned step (1), decoction extraction and concentration: weigh each medicinal material according to the prescription ratio, soak it in 10 times the amount of water for 1 hour, decoct it 3 times, 1 hour each time, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.20-1.30 at 80℃ to obtain a thick extract.

[0012] In step (2) above, drying and powdering: the thick extract and soluble starch are mixed at a weight ratio of 1:1-1.5, dried at 70-80℃ for 2.5-3.5 days, and then pulverized through a 60-70 mesh sieve to obtain dry extract powder.

[0013] Specifically, in step (2) above, drying and powdering: the thick extract and soluble starch are mixed in a weight ratio of 1:1, dried at 70-80℃ for 3 days, and then pulverized through a 60-mesh sieve to obtain dry extract powder.

[0014] In step (3) above, granulation is performed by spraying 65-75% ethanol onto the dry extract powder to make a soft material. The weight ratio of the dry extract powder to 65-75% ethanol is 2.2-2.4:1. The mixture is passed through a 12-mesh sieve, and then dextrin is added. The mass ratio of the extract powder to dextrin is 4:1. The mixture is then granulated and dried at 60°C for 22-26 hours. The granules are then sieved through a 30-50 mesh sieve to obtain the final product.

[0015] Specifically, in the aforementioned step (3), granulation: take the dry extract powder and spray it with 70% ethanol to make soft material. The weight ratio of the dry extract powder to 70% ethanol is 2.3:1. Pass it through a 12-mesh sieve, then add dextrin. The mass ratio of the extract powder to dextrin is 4:1. Make granules, dry them at 60°C for 24 hours, and then sieve them through a 40-mesh sieve to make granules.

[0016] Compared with the prior art, the present invention has the following beneficial effects: The drug for treating hypertension described in this invention is made from Rehmannia glutinosa, Lycium barbarum, Gastrodia elata, Uncaria rhynchophylla, Salvia miltiorrhiza (processed with wine), Alisma plantago-aquatica, Leonurus japonicus, and Achyranthes bidentata. The properties and effects of each component are as follows: Rehmannia glutinosa is the fresh or dried tuberous root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family, which is slowly roasted until it is about 80% dry; it is sweet in taste and cold in nature; it enters the heart, liver, and kidney meridians; it has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluids, and is used for heat entering the blood level, febrile rashes, hematemesis, epistaxis, yin deficiency due to febrile diseases, red tongue with thirst, constipation due to fluid depletion, yin deficiency fever, bone steaming fever, and internal heat with thirst. Goji berries are the dried, ripe fruit of *Lycium barbarum* L., a plant in the Solanaceae family. They are harvested in summer and autumn when ripe, the stems are removed, and the fruit is dried in a cool, shady place until the skin wrinkles. Then, it is sun-dried until the outer skin is hard and the flesh is soft. In rainy weather, they can be dried over a low heat. They are sweet in taste and neutral in nature; they enter the liver and kidney meridians. They nourish the liver and kidneys, benefit essence and improve eyesight. They are used for deficiency of essence and blood, lower back and knee pain, dizziness and tinnitus, impotence and seminal emission, internal heat and thirst, blood deficiency and chlorosis, and blurred vision. Gastrodia elata Bl. is the dried tuber of a plant in the Orchidaceae family. It is sweet in taste and neutral in nature; it enters the liver meridian. It has the effects of calming wind and stopping spasms, suppressing liver yang, and dispelling wind and unblocking the meridians. It is mainly used for infantile convulsions, epilepsy, tetanus, headache and dizziness, hemiplegia, numbness of limbs, and rheumatic pain. Uncaria rhynchophylla (Miq.) Miq. ex Havil., Uncaria macrophylla Wall., Uncaria hirsuta Havil., Uncaria sinensis (Oliv.) Havil., or Uncaria sessilifrudus Roxb. are all plants belonging to the Rubiaceae family. Uncaria rhynchophylla is sweet and cool in nature; it enters the liver and pericardium meridians; it has the effects of calming wind and relieving convulsions, clearing heat and soothing the liver; it is used for internal liver wind, epilepsy and convulsions, high fever convulsions, colds with convulsions, infantile convulsions, eclampsia, headache and dizziness. *Salvia miltiorrhiza* Bge., a plant in the Lamiaceae family, is the dried root and rhizome. Processed *Salvia miltiorrhiza* is a bitter, slightly cold herb; it enters the heart and liver meridians. It has the effects of promoting blood circulation and removing blood stasis, regulating menstruation and relieving pain, clearing the heart and relieving irritability, cooling the blood and reducing swelling. It is used for chest pain, abdominal pain, abdominal masses, painful arthralgia, insomnia, irregular menstruation, dysmenorrhea, amenorrhea, and sores and swelling. *Alisma orientale* (Sam.) Juzep., a plant in the Alismataceae family, is the dried tuber. It is harvested in winter when the stems and leaves begin to wither, washed, dried, and the fibrous roots and rough skin removed. It has a sweet, bland taste and is cold in nature. It enters the kidney and bladder meridians. It has the effects of promoting diuresis and removing dampness, clearing heat, resolving turbidity and lowering lipids. It is used for dysuria, edema, diarrhea with scanty urine, phlegm retention and dizziness, painful urination, and hyperlipidemia.Motherwort is the fresh or dried aerial parts of *Leonurus japonicus* Houtt., a plant in the Lamiaceae family. It tastes bitter and pungent, and is slightly cold in nature. It enters the liver, pericardium, and bladder meridians. It has the effects of promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, and clearing heat and detoxifying. It is used for irregular menstruation, dysmenorrhea, amenorrhea, lochia retention, edema with scanty urine, and carbuncles and boils. Achyranthes bidentata (also known as Huai Achyranthes) is the dried root of *Achyranthes bidentata* Bl., a plant in the Amaranthaceae family. It tastes bitter, sweet, and sour, and is neutral in nature. It enters the liver and kidney meridians. It has the effects of removing blood stasis and promoting menstruation, tonifying the liver and kidneys, strengthening tendons and bones, promoting diuresis and relieving strangury, and guiding blood downwards. It is used for amenorrhea, dysmenorrhea, lower back and knee pain, weakness of tendons and bones, strangury, edema, headache, dizziness, toothache, canker sores, hematemesis, and epistaxis.

[0017] Solution: The efficacy of this invention lies in tonifying the liver and kidneys, calming the liver and suppressing yang, and promoting blood circulation and diuresis. It primarily targets the basic clinical syndrome of yin deficiency with yang hyperactivity and phlegm-blood stasis. This pathogenesis is a fundamental syndrome in clinical practice, and it can be widely used for patients with hypertension. The formula is based on nourishing the liver and kidneys, with Rehmannia glutinosa and Lycium barbarum as the principal herbs, Gastrodia elata and Uncaria rhynchophylla as the assistant herbs to calm the liver and extinguish wind, Salvia miltiorrhiza, Alisma plantago-aquatica, and Leonurus japonicus as the adjuvant herbs to promote blood circulation and diuresis, and Achyranthes bidentata as the guiding herb to direct blood downwards. The prescription embodies multiple treatment methods, including tonifying the liver and kidneys, calming the liver and extinguishing wind, and promoting diuresis and lowering qi. In terms of formula principles, it is generally derived from the principles of Jianling Decoction and Gastrodia elata and Uncaria rhynchophylla Decoction, and the prescription's composition reflects the principles of principal, assistant, adjuvant, and guiding herbs in traditional Chinese medicine, resulting in a reasonable structure. Furthermore, this formula, based on the understanding of yin deficiency with yang hyperactivity in hypertension, recognizes that blood stasis is an important pathogenic factor and pathological product; "if blood stasis is not removed, it can also transform into phlegm and fluid." Therefore, the formula emphasizes blood stasis, forming a formulaic approach of tonifying the liver and kidneys, calming the liver and suppressing yang, and promoting blood circulation and diuresis. Attached Figure Description

[0018] Figure 1 Typical Case 1 (PDF signed version); Figure 2 Typical Case 1 (PDF signed version); Figure 3 Typical Case 2 (Signed PDF Version); Figure 4 Typical Case 2 (PDF signed version); Figure 5 Typical Case 3 (PDF signed version); Figure 6 Typical Case 3 (PDF signed version); Figure 7 Typical Case 4 (PDF signed version); Figure 8 Typical Case 4 (PDF signed version); Figure 9 Typical Case 5 (PDF signed version); Figure 10Typical Case 5 (PDF signed version). Detailed Implementation

[0019] The present invention will be further described below with reference to embodiments, but these embodiments are not intended to limit the scope of the invention.

[0020] Example 1

[0021] Prescription (7-day dose): 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0022] Preparation process: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 10 times the amount of water for 1 hour, decoct it 3 times, 1 hour each time, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.20-1.30 at 80℃ to obtain a thick extract. (2) Drying and powdering: Mix the thick extract and soluble starch in a weight ratio of 1:1, dry at 70-80℃ for 3 days, and pulverize through a 60-mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 70% ethanol to make soft material. The weight ratio of dry powder of extract to 70% ethanol is 2.3:1. Pass it through a 12-mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 4:1. Make granules, dry at 60℃ for 24 hours, and sieve through a 40-mesh sieve to make granules.

[0023] Dosage and administration: One dose per day, taken orally in three divided doses in the morning, noon and evening.

[0024] Example 2

[0025] Prescription (seven-day dose): 250g Rehmannia glutinosa, 350g Lycium barbarum, 150g Gastrodia elata, 150g Uncaria rhynchophylla, 700g Salvia miltiorrhiza (processed with wine), 350g Alisma plantago-aquatica, 700g Leonurus japonicus, and 100g Achyranthes bidentata.

[0026] Preparation process: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 10 times the amount of water for 0.5 hours, decoct once, each time for 2.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.20-1.40 at 90℃ to obtain a thick extract. (2) Drying and powdering: The thick extract and soluble starch are mixed at a weight ratio of 1:0.5, dried at 90°C for 4 days, and then pulverized through a 50-mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 80% ethanol to make soft material. The weight ratio of dry powder of extract to 80% ethanol is 3:1. Pass it through a 10-mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 3:1. Make granules, dry at 70℃ for 30h, and sieve through a 60-mesh sieve to make granules.

[0027] Example 3

[0028] Prescription (daily dose): 420g Rehmannia glutinosa, 150g Lycium barbarum, 350g Gastrodia elata, 50g Uncaria rhynchophylla, 300g Salvia miltiorrhiza (processed with wine), 150g Alisma plantago-aquatica, 300g Leonurus japonicus, and 230g Achyranthes bidentata.

[0029] Preparation process: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 8 times the amount of water for 0.5 hours, decoct it 4 times, each time for 0.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.00-1.20 at 70℃ to obtain a thick extract. (2) Drying and powdering: Mix the thick extract and soluble starch at a weight ratio of 1:1.5, dry at 70°C for 2 days, and pulverize through an 80-mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 60% ethanol to make soft material. The weight ratio of dry powder of extract to 60% ethanol is 2:1. Pass it through a 14-mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 5:1. Make granules, dry at 50℃ for 18 hours, and sieve through a 30-mesh sieve to make granules.

[0030] Example 4

[0031] Prescription (daily dose): 28g Rehmannia glutinosa, 250g Lycium barbarum, 300g Gastrodia elata, 220g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 190g Alisma plantago-aquatica, 600g Leonurus japonicus, and 150g Achyranthes bidentata.

[0032] Preparation process: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 9 times the amount of water for 1 hour, decoct twice for 2 hours each time, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.00-1.20 at 75℃ to obtain a thick extract. (2) Drying and powdering: The thick extract and soluble starch are mixed at a weight ratio of 1:0.8, dried at 75°C for 3 days, and then pulverized through a 60-mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 70% ethanol to make soft material. The weight ratio of dry powder of extract to 70% ethanol is 2.5:1. Pass it through a 12-mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 3.5:1. Make granules, dry at 60℃ for 24 hours, and sieve through a 40-mesh sieve to make granules.

[0033] Dosage and administration: One dose per day, taken orally in three divided doses in the morning, noon and evening.

[0034] Example 5

[0035] Prescription (daily dose): 330g Rehmannia glutinosa, 260g Lycium barbarum, 190g Gastrodia elata, 330g Uncaria rhynchophylla, 400g Salvia miltiorrhiza (processed with wine), 270g Alisma plantago-aquatica, 550g Leonurus japonicus, and 200g Achyranthes bidentata.

[0036] Preparation process: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 0 times the amount of water for 1.5 hours, decoct it 3 times, 1.5 hours each time, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.20-1.40 at 85℃ to obtain a thick extract. (2) Drying and powdering: The thick extract and soluble starch are mixed at a weight ratio of 1:1.2, dried at 85°C for 2 days, and then pulverized through a 60-mesh sieve to obtain the dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 75% ethanol to make soft material. The weight ratio of dry powder of extract to 75% ethanol is 3:1. Pass it through a 12-mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 4.5:1. Make granules, dry at 60℃ for 28 hours, and sieve through a 40-mesh sieve to make granules.

[0037] Dosage and administration: One dose per day, taken orally in three divided doses in the morning, noon and evening.

[0038] This invention has undergone extensive experimental research, and the following are the results of the clinical trial research of this invention: 1. Preparation process research 1.1 Formulation Prescription: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0039] 1.2 Manufacturing Method The above eight ingredients are soaked in 10 times their volume of water for 1 hour for the first time, then decocted for 1 hour. The same process is repeated three times. The mixture is then filtered, and the filtrates are combined. The filtrate is concentrated to a thick extract with a relative density of 1.20-1.30 (80℃). An appropriate amount of soluble starch is added, and the mixture is dried, pulverized, and then an appropriate amount of dextrin is added to form granules. These granules are then dried, sieved, and mixed to produce 1000g of the final product.

[0040] 1.3 Research on Extraction Process 1.3.1 Single-factor investigation Orthogonal experiments can reduce the number of experiments and obtain optimal process parameters. Single-factor experiments were conducted to investigate the material-to-liquid ratio, decoction time, and number of decoctions in the production process of eight medicinal slices, providing basic data for orthogonal experiments. In the single-factor experiments, the yield of extract and crude polysaccharide content were used as indicators, and a comprehensive score was used to determine the range of influence of each factor on the experimental results.

[0041] Overall score = (Oil yield / Maximum oil yield × 50%) + (Polysaccharide content / Maximum polysaccharide content × 50%) 1.3.1.1 Water addition assessment Seven portions of the prescribed medicinal slices were weighed. Water was added at material-to-liquid ratios of 1:6, 1:7, 1:8, 1:9, 1:10, 1:11, and 1:12, respectively, and the slices were decocted twice, each time for 1 hour. The yield of the medicinal slices was determined according to the method under "Ointment Yield," and the polysaccharide content was determined according to the method under "Polysaccharide Content." The results are shown in Table 1.

[0042] Table 1 Results of Single-Factor Investigation of Different Feed-to-Liquid Ratios The results of the single-factor study on the material-liquid ratio show that the influence of the material-liquid ratio on the study results gradually increases with the increase of the material-liquid ratio. The comprehensive score reaches its maximum value when the material-liquid ratio is 1:12, but it is not much different from the material-liquid ratio of 1:10. Considering the energy-saving and environmental protection factors in the actual production process, the orthogonal experiment was conducted with three levels of material-liquid ratios of 1:8, 1:9 and 1:10.

[0043] 1.3.1.2 Examination of extraction time Weigh out 5 portions of the prescribed medicinal slices. Add water at a material-to-liquid ratio of 1:10 and decoct twice, for 0.5, 1, 1.5, 2, and 2.5 hours respectively. Determine the extract yield according to the method under "Ointment Yield" and the polysaccharide content according to the method under "Polysaccharide Content". The results are shown in Table 2.

[0044] Table 2 Results of single-factor investigation of different cooking times To ensure complete cooking while saving time and reducing energy consumption, experiments were conducted at three levels: cooking time of 0.5, 1, and 1.5 hours.

[0045] 1.3.1.3 Examination of the Number of Extractions Weigh out 4 portions of the prescribed medicinal slices. Add water at a material-to-liquid ratio of 1:10 and decoct for 1 hour. Repeat the decoction 1, 2, 3, and 4 times. Determine the extract yield according to the method under "Ointment Yield" and the polysaccharide content according to the method under "Polysaccharide Content". The results are shown in Table 3.

[0046] Table 3 Results of single-factor experiments with different boiling times The results of the single-factor analysis of the number of decoctions show that the highest comprehensive score is achieved when the number of decoctions is 2 or 3, while the lowest comprehensive score is achieved when the number of decoctions is 1. Considering actual production, and to ensure complete decoction while conserving energy, the orthogonal experiment was conducted with three levels of decoctions: 1, 2, and 3.

[0047] 1.3.2 Orthogonal Experiment to Optimize Water Extraction Process Based on the results of the single-factor investigation, an L9 (34) orthogonal experiment was designed for the material-liquid ratio (1:8, 1:9, 1:10), the number of times the decoction was prepared (1 time, 2 times, 3 times), and the preparation time (0.5h, 1.0h, 1.5h) to determine the preparation process. The factor level table of the orthogonal experiment is shown in Table 4, and the results are shown in Table 5.

[0048] Using the "Analyze→General Linear Model→Univariate" function of SPSS 13.0 statistical software, the standardized scores of the three orthogonal experiments were processed. SPSS ANOVA using the Duncan method showed that the influence of the main factors on the water extraction efficiency of the medicinal materials was, in descending order: C (number of decoctions) > A (solid-to-liquid ratio) > B (decoction time). All three factors had a highly significant impact on extraction efficiency, meaning the overall means were highly significantly unequal (Sig.=p=0.000<0.01). Factors A and C (solvent volume level 3) were in different subsets with significant differences; factor B (levels 2 and 3) were in the same subset with no significant difference. This indicates that the optimal extraction processes are A3B2C3 and A3B3C3. Considering that excessive extraction time would affect production efficiency, we selected A3B2C3 as the optimized process.

[0049] Table 4. Factor Levels in the Orthogonal Experiment of Water Decoction Table 5 Results of the orthogonal experiment on the decoction process 1.3.3 Extraction process verification experiment Weigh out 150g of the prescribed amount of medicinal slices, divided into 3 portions. Decoct with water according to the optimized process. Decoction yield and polysaccharide content were determined. Results are shown in Table 6.

[0050] Table 6. Validation Results of the Decoction Process 1.3.4 Determination of Concentration Parameters For the extract solution, we investigated vacuum concentration to four different density (80℃) ranges. The results showed that the extract was best when the density was between 1.2 and 1.3 (80℃).

[0051] Table 7. Research on Concentration Process 1.3.5 Determination of Drying Parameters Because the extract contains a high amount of polysaccharides and has a high viscosity, it was presumably difficult to dry. To shorten the processing time, we investigated different mixing ratios of the extract and soluble starch before drying, using a moisture content of <5% as the standard, and examined the drying time. The results showed that drying for 3 days after mixing the extract and soluble starch at a 1:1 weight ratio was sufficient to meet the requirements.

[0052] Table 8. Study on drying process 1.3.6 Pulverizing dry paste To facilitate subsequent granulation, we pulverized the dry paste. In accordance with standard granulation requirements, we pulverized it through a 60-mesh sieve before storing it.

[0053] 1.4 Research on the Forming Process of Dingxuan Drink 1.4.1 Selection of Formulation Method Considering the actual conditions of the production equipment, we selected the wet granulation process.

[0054] 1.4.2 Screening of wetting agent concentration Ethanol was selected as the wetting agent for granulation. Soft materials were prepared using different concentrations of ethanol, and granulated through a 12-mesh sieve according to pharmacopoeia requirements. The condition of the soft materials was observed, and the optimal wetting agent concentration was determined. The results are shown in Table 9. The results indicate that 60%-80% ethanol can prepare acceptable granules. Considering the sterilizing effect of 70% ethanol, we selected 70% ethanol as the wetting agent.

[0055] Table 9. Screening Results of Wetting Agent Concentration 1.4.3 Selection of fillers To prepare 1000g of granules according to the prescription, an appropriate amount of filler needs to be added. Dextrin, microcrystalline cellulose, and lactose were screened based on granulation performance, granule characteristics, solubility, and flowability. The results are shown in Table 10. The results show that the granules prepared from the above excipients all produced good results. Because dextrin is inexpensive, we chose it as the filler.

[0056] Table 10 Selection of Fillers 1.4.4 Screening of Granulation and Drying Temperature To avoid unsuitable drying temperatures leading to poor granule properties, this study investigated granulation drying temperature using granule properties and drying time as indicators. The results showed that drying at temperatures not exceeding 70℃ resulted in granules with moderate hardness, suitable color, and short drying time.

[0057] Table 11 Screening of Granulation and Drying Temperatures 2 Clinical Trials 2.1 Source of cases All cases in this study were from 30 patients (13 female patients, 17 male patients, and 21 elderly patients) who visited the Department of Cardiology at the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine between January 2025 and December 2025, and met the inclusion and exclusion criteria.

[0058] 2.2 Diagnostic Criteria 2.2.1 The diagnostic criteria for Western medicine adopt the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Hypertension in China (2024 Revised Edition)" [3].

[0059] Hypertension is defined as: a systolic blood pressure ≥140 mmHg and / or a diastolic blood pressure ≥90 mmHg on three separate blood pressure measurements taken on different days without the use of antihypertensive medication. Systolic blood pressure ≥140 mmHg and diastolic blood pressure <90 mmHg is considered isolated systolic hypertension. Patients with a history of hypertension who are currently using antihypertensive medication, even if their blood pressure is below 140 / 90 mmHg, are also diagnosed with hypertension. Based on the level of blood pressure elevation, hypertension is further classified into grades 1, 2, and 3. Grade 1 hypertension (mild): systolic blood pressure 140-159 mmHg, and / or diastolic blood pressure 90-99 mmHg; Grade 2 hypertension (moderate): systolic blood pressure 160-179 mmHg, and / or diastolic blood pressure 100-109 mmHg; Grade 3 hypertension (severe): Systolic blood pressure ≥180 mmHg, and / or diastolic blood pressure ≥110 mmHg. (When systolic and diastolic blood pressure belong to different grades, the higher grade shall prevail.) 2.2.2 Urine test indicators ① Urinary β2-microglobulin (0.01-0.3 mg / L), exceeding 0.3 mg / L indicates kidney damage; ② Urine creatinine (1530-15320 umol / L), exceeding 15320 umol / L indicates kidney damage; ③ The ratio of urine albumin to urine creatinine (<30mg / g) indicates kidney damage if it exceeds 30mg / g.

[0060] 2.2.3 TCM diagnostic criteria refer to the diagnostic criteria for Yin deficiency and Yang hyperactivity in the TCM syndrome diagnostic criteria of the 2002 edition of the "Guiding Principles for Clinical Research of New Chinese Medicines"

[10] . A diagnosis can be made if three main symptoms are present or two main symptoms and two tongue and pulse symptoms are present.

[0061] Main symptoms: dizziness, headache, lower back pain, weak knees, and hot flashes in the palms, soles, and chest.

[0062] Secondary symptoms: palpitations, insomnia, tinnitus, and forgetfulness.

[0063] Tongue and pulse: The tongue is red with little coating, and the pulse is wiry, thin, and rapid.

[0064] 2.2.3 Observation Methods (1) General situation: A complete medical record is established for each patient, recording the patient's age, gender, medical history, contact information and treatment, etc.

[0065] (2) Blood pressure measurement: Blood pressure measurement was performed using a qualified upper arm electronic blood pressure monitor in accordance with the blood pressure measurement specifications of the "Chinese Guidelines for the Prevention and Treatment of Hypertension 2024 Revised Edition". Both groups of patients had their blood pressure measured by the same cardiology nurse at approximately 10:00 AM in the cardiology outpatient clinic before and after treatment, and the systolic and diastolic blood pressures were recorded.

[0066] (3) Record the changes in urinary β2-microglobulin, urinary creatinine, and urinary albumin / urinary creatinine ratio before and after treatment in the two groups.

[0067] 2.3 Treatment Plan Table 12 Treatment methods 2.4 Efficacy observation indicators 2.4.1 Research Indicators ① Changes in blood pressure before and after treatment in both groups; ② Changes in urinary β2-microglobulin, urinary creatinine, and urinary albumin / urinary creatinine ratio before and after treatment in both groups.

[0068] 2.5 Comparison of treatment efficacy between the two groups ①After treatment, the blood pressure of patients who used Dingxuanyin granules decreased significantly and the blood pressure control was more stable than that of patients who did not use Dingxuanyin granules.

[0069] ②After treatment, the patients who used Dingxuanyin granules showed a significant decrease in urinary β2-microglobulin, urinary creatinine, and urinary albumin / creatinine ratio compared to the patients who did not use Dingxuanyin granules, and the renal function damage caused by hypertension was significantly improved.

[0070] Table 13 Treatment Results 3. Typical Cases Typical Case 1: Patient Fei, male, 52 years old. Outpatient number 11764894, presented to the cardiology outpatient department of our hospital on July 14, 2025, with a history of "elevated blood pressure for over 1 year". Present illness: Elevated blood pressure for over 1 year, with self-monitored blood pressure reaching as high as 150 / 100 mmHg. He usually controls his blood pressure with amlodipine besylate tablets. Current symptoms: Elevated blood pressure, occasional dizziness, slurred speech; good mental state, good appetite and sleep, normal bowel movements; pale red tongue with a thick, greasy yellow coating; wiry and rapid pulse.

[0071] Physical examination: P: 70 bpm, 138 / 79 mmHg (after medication), mental status fair, self-positioned, normal lips, jugular vein fullness without distension; symmetrical chest without deformity, symmetrical tactile fremitus in both lungs, clear percussion sounds in both lungs, clear breath sounds in both lungs, no dry or wet rales heard in both lungs; no abnormal bulging or depression in the precordial area, no thrill on palpation of the precordial area, heart size not enlarged, apex dullness on percussion 0.5 cm medial to the left midclavicular line at the 5th intercostal space, heart rate 70 bpm, normal heart sounds, regular rhythm, no pathological murmurs heard in any valve auscultation area; negative hepatojugular reflux test, no edema in both lower extremities.

[0072] Our hospital's examination (2025-07-14 09:40): Urinary microalbumin (urine): β2-microglobulin 0.853mg / L, urinary creatinine 25710umol / L↑.

[0073] Traditional Chinese Medicine Diagnosis: Dizziness (Yin Deficiency and Yang Excess Syndrome) Western medicine diagnosis: Grade 2 primary hypertension, very high risk Kidney damage Treatment prescription: One dose of Dingxuan Yin granules consists of: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0074] Dingxuan Yin Granules, 14 doses, 1 dose daily (3 doses per dose, 14 days in total), for oral administration. On July 28, 2025, the patient's second visit revealed that the dizziness had lessened and improved; the tongue was pale red with a thick, greasy yellow coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease compared to the previous result. The patient was instructed to continue taking Dingxuan Yin granules and oral antihypertensive medication.

[0075] On August 21, 2025, during the third consultation, the patient complained of occasional dizziness and that his blood pressure had fluctuated significantly in recent days. Based on his tongue and pulse symptoms, he was instructed to continue taking Dingxuan Yin granules and Western antihypertensive drugs orally.

[0076] On September 8, 2025, during the fourth consultation, the patient's dizziness improved, and a follow-up urine microalbumin test showed a continued decrease. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive drugs orally.

[0077] On September 22, 2025, the patient returned for a follow-up visit. The dizziness had subsided, and self-monitored blood pressure remained stable. A repeat urine microalbumin test showed a further decrease. The patient was instructed to continue taking Dingxuan Yin granules and oral antihypertensive medication.

[0078] Classic Case 2: Patient Chen, female, 55 years old. Outpatient number 4704769, presented to our cardiology outpatient department on April 17, 2025, with a history of "hypertension for over 10 years". Present illness: Hypertension for over 10 years, with self-monitored blood pressure reaching as high as 170 / 100 mmHg. She routinely uses lecanidipine and bisoprolol to control her blood pressure. Current symptoms: Occasional dizziness; good mental state, appetite and sleep, normal bowel movements; pale red tongue with a thick, greasy yellow coating; wiry and rapid pulse.

[0079] Physical examination: P: 70 bpm, 165 / 101 mmHg (after medication), mental status fair, self-positioned, normal lips, jugular vein fullness without distension; symmetrical chest without deformity, symmetrical tactile fremitus in both lungs, clear percussion sounds in both lungs, clear breath sounds in both lungs, no dry or wet rales heard in both lungs; no abnormal bulging or depression in the precordial area, no thrill on palpation of the precordial area, heart size not enlarged, apex dullness on percussion 0.5 cm medial to the left midclavicular line at the 5th intercostal space, heart rate 70 bpm, normal heart sounds, regular rhythm, no pathological murmurs heard in any valve auscultation area; negative hepatojugular reflux test, no edema in both lower extremities.

[0080] Our hospital's examination (2025-04-17) showed: β2-microglobulin 0.855 mg / L, urine creatinine 18622 umol / L↑, urine microalbumin / urine creatinine 45.6 mg / g.

[0081] Traditional Chinese Medicine Diagnosis: Dizziness (Yin Deficiency and Yang Excess Syndrome) Western medicine diagnosis: Grade 2 primary hypertension, very high risk Kidney damage Treatment prescription: One dose of Dingxuan Yin granules consists of: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0082] Take 14 doses of Dingxuan Yin granules, one dose per day (3 doses per dose, for a total of 14 days), orally. Amlodipine besylate tablets 5mg, one tablet once a day; Bisoprolol fumarate 5mg, one tablet once a day.

[0083] On May 8, 2025, the patient's second visit revealed that their dizziness had lessened and improved; their tongue was pale red with a thick, greasy yellow coating, and their pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease in protein levels. The patient was instructed to continue taking Dingxuan Yin granules and oral antihypertensive medication.

[0084] On July 10, 2025, during the third visit, the patient reported that the dizziness had subsided, and that self-monitored blood pressure was stable. A follow-up urine microalbumin test showed a further decrease compared to the previous result. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0085] Classic Case 3: Patient Mo, male, 55 years old. Outpatient number 11739428, presented to our cardiology outpatient department on May 12, 2025, with a history of "elevated blood pressure for over 1 year". Present illness: Elevated blood pressure for over 1 year, with self-monitored blood pressure reaching a maximum of approximately 170 / 100 mmHg. He regularly takes amlodipine besylate to control his blood pressure. Current symptoms: Occasional dizziness; good mental state, appetite and sleep, normal bowel movements; red tongue with little coating, and a wiry and rapid pulse.

[0086] Physical examination: P: 93 bpm, 152 / 100 mmHg (after medication), mental status fair, self-positioned, normal lips, jugular vein fullness without distension; symmetrical chest without deformity, symmetrical tactile fremitus in both lungs, clear percussion sounds in both lungs, clear breath sounds in both lungs, no dry or wet rales heard in both lungs; no abnormal bulging or depression in the precordial area, no thrill on palpation of the precordial area, heart size not enlarged, apex dullness on percussion 0.5 cm medial to the left midclavicular line at the 5th intercostal space, heart rate 93 bpm, normal heart sounds, regular rhythm, no pathological murmurs heard in any valve auscultation area; negative hepatojugular reflux test, no edema in both lower extremities.

[0087] Our hospital's examination (2025-05-12): Urinary microalbumin (urine): β2-microglobulin 0.901 mg / L, urinary microalbumin / urinary creatinine 1562.04 mg / g.

[0088] Traditional Chinese Medicine Diagnosis: Dizziness (Yin Deficiency and Yang Excess Syndrome) Western medicine diagnosis: Grade 2 primary hypertension, very high risk Kidney damage Treatment prescription: One dose of Dingxuan Yin granules consists of: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0089] Take 7 doses of Dingxuan Yin granules, 1 dose per day (3 doses per dose, 7 days in total), orally; Levoamlodipine besylate tablets 5mg, one tablet once a day.

[0090] On May 19, 2025, the patient's second visit revealed that the dizziness had lessened and was better controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease in the previous result. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0091] On June 4, 2025, during the third visit, the patient reported no significant dizziness. Self-monitored blood pressure was slightly elevated at 152 / 90 mmHg. A repeat urine microalbumin test showed β2-microglobulin at 0.567 mg / L and a urine microalbumin / creatinine ratio of 534.17 mg / g. The patient was instructed to continue taking Dingxuan Yin granules and oral antihypertensive medication.

[0092] On June 25, 2025, during the fourth consultation, the patient did not complain of dizziness, and blood pressure was well controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin / creatinine ratio was 149.05 mg / g, a decrease from the previous reading. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0093] On July 10, 2025, the patient returned for a follow-up visit. There was no dizziness, and blood pressure was well controlled. The tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a further decrease compared to the previous result. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0094] Classic Case 4: Patient Wu, female, 77 years old. Outpatient number 1270725, presented to our cardiology outpatient department on January 9, 2025, due to "hypertension for over 1 year". Present illness: Hypertension for over 8 years, with self-monitored blood pressure reaching as high as 160 / 100 mmHg. She regularly takes nifedipine tablets to control her blood pressure. Current symptoms: Occasional dizziness; good mental state, good appetite and sleep, normal bowel movements; red tongue with little coating, wiry and rapid pulse.

[0095] Physical examination: P: 75 bpm, 141 / 80 mmHg (after medication), mental status fair, self-positioned, normal lips, jugular vein fullness without distension; symmetrical chest without deformity, symmetrical tactile fremitus in both lungs, clear percussion sounds in both lungs, clear breath sounds in both lungs, no dry or wet rales heard in both lungs; no abnormal bulging or depression in the precordial area, no thrill on palpation of the precordial area, heart size not enlarged, apex dullness on percussion 0.5 cm medial to the left midclavicular line at the 5th intercostal space, heart rate 75 bpm, normal heart sounds, regular rhythm, no pathological murmurs heard in any valve auscultation area; negative hepatojugular reflux test, no edema in both lower extremities.

[0096] Our hospital's examination results (2025-01-09): Urinary microalbumin (urine): β2-microglobulin 0.744 mg / L, urinary creatinine 26525 umol / L, urinary microalbumin / urinary creatinine 54.98 mg / g.

[0097] Traditional Chinese Medicine Diagnosis: Dizziness (Yin Deficiency and Yang Excess Syndrome) Western medicine diagnosis: Grade 2 primary hypertension, very high risk Kidney damage Treatment prescription: One dose of Dingxuan Yin granules consists of: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0098] Take 7 doses of Dingxuan Yin granules, 1 dose per day (3 doses per dose, 7 days in total), orally; Amlodipine besylate tablets 5mg, one tablet once a day.

[0099] On January 16, 2025, the patient's second visit revealed that the dizziness had lessened and was better controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease in the previous result. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0100] On February 17, 2025, during the third consultation, the patient did not complain of dizziness, and blood pressure was well controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease compared to the previous result. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0101] On March 5, 2025, during the fourth consultation, the patient reported no significant dizziness and that self-monitored blood pressure was under control. A follow-up urine microalbumin test showed: β2-microglobulin 0.258 mg / L daily, and urine microalbumin / creatinine ratio 51.16 mg / g. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0102] On November 27, 2025, the patient returned for a follow-up visit. There was no dizziness, and blood pressure was well controlled. The tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a further decrease compared to the previous test. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0103] Classic Case 5: Patient Zhou, male, 40 years old. Outpatient number 5284487, visited the cardiology outpatient department of our hospital on October 20, 2025, due to "hypertension for 4+ years". Present illness: Hypertension for 4+ years, without oral antihypertensive medication. Current symptoms: Occasional dizziness; good mental state, good appetite but poor sleep, regular bowel movements, occasional nocturia; red tongue with little coating, wiry and rapid pulse.

[0104] Physical examination: P: 70 bpm, 165 / 108 mmHg (after medication), mental state fair, self-positioned, normal lips, jugular vein fullness without distension; symmetrical chest without deformity, symmetrical tactile fremitus in both lungs, clear percussion sounds in both lungs, clear breath sounds in both lungs, no dry or wet rales heard in both lungs; no abnormal bulging or depression in the precordial area, no thrill on palpation of the precordial area, heart size not enlarged, apex dullness on percussion 0.5 cm medial to the left midclavicular line at the 5th intercostal space, heart rate 70 bpm, normal heart sounds, regular rhythm, no pathological murmurs heard in any valve auscultation area; negative hepatojugular reflux test, no edema in both lower extremities.

[0105] Our hospital's examination results (2025-10-20): Urinary microalbumin (urine): β2-microglobulin 0.518 mg / L, urinary creatinine 19736 umol / L, urinary microalbumin / urinary creatinine 37.25 mg / g.

[0106] Traditional Chinese Medicine Diagnosis: Dizziness (Yin Deficiency and Yang Excess Syndrome) Western medicine diagnosis: Grade 2 primary hypertension, very high risk Kidney damage Treatment prescription: One dose of Dingxuan Yin granules consists of: 333g Rehmannia glutinosa, 250g Lycium barbarum, 250g Gastrodia elata, 250g Uncaria rhynchophylla, 500g Salvia miltiorrhiza (processed with wine), 250g Alisma plantago-aquatica, 500g Leonurus japonicus, and 167g Achyranthes bidentata.

[0107] Take 7 doses of Dingxuan Yin granules, 1 dose per day (3 doses per dose, 7 days in total), orally; Levoamlodipine besylate tablets 5mg, one tablet once a day.

[0108] On November 3, 2025, the patient's second visit revealed that the dizziness had lessened and was better controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine creatinine test showed a decrease in level from 19417 umol / L. The patient was instructed to continue taking Dingxuan Yin granules and oral antihypertensive medication.

[0109] On November 13, 2025, during the third consultation, the patient's dizziness had further improved compared to the previous visit, and blood pressure was well controlled; the tongue was pale red with little coating, and the pulse was wiry and rapid. A repeat urine microalbumin test showed a decrease compared to the previous test. The patient was instructed to continue taking Dingxuan Yin granules and Western antihypertensive medication orally.

[0110] On December 1, 2025, during the fourth consultation, the patient reported significant relief from dizziness. Self-monitored blood pressure remained elevated, and a repeat urine microalbumin test showed a continued decrease. The patient was instructed to continue taking Dingxuan Yin granules, along with levamlodipine besylate 5mg per tablet daily to lower blood pressure.

[0111] On December 15, 2025, the patient returned for a follow-up visit. There was no dizziness, and blood pressure was well controlled. The tongue was pale red with little coating, and the pulse was wiry and rapid. Repeat urinary microalbumin tests showed: β2-microglobulin 13.27 mg / L, urinary creatinine 12633 umol / L, and urinary microalbumin / creatinine ratio 9.29 mg / g.

[0112] He was instructed to continue taking Dingxuan Yin granules and Western antihypertensive drugs orally.

Claims

1. Application of Dingxuan Yin granules in the preparation of drugs for treating early renal damage caused by hypertension of the Yin deficiency and Yang hyperactivity type.

2. The application as described in claim 1, characterized in that: The active medicinal ingredients of the Dingxuan Yin granules, calculated by weight, are: 250-420 parts of Rehmannia glutinosa, 150-350 parts of Lycium barbarum, 150-350 parts of Gastrodia elata, 150-350 parts of Uncaria rhynchophylla, 300-700 parts of Salvia miltiorrhiza (processed with wine), 150-350 parts of Alisma plantago-aquatica, 300-700 parts of Leonurus japonicus, and 100-230 parts of Achyranthes bidentata.

3. The application as described in claim 2, characterized in that: The active medicinal ingredients of the Dingxuan Yin granules, calculated by weight, are: 333 parts Rehmannia glutinosa, 250 parts Lycium barbarum, 250 parts Gastrodia elata, 250 parts Uncaria rhynchophylla, 500 parts Salvia miltiorrhiza (processed with wine), 250 parts Alisma plantago-aquatica, 500 parts Leonurus japonicus, and 167 parts Achyranthes bidentata.

4. The application as described in any one of claims 1-3, characterized in that: The preparation method of the dizziness-relieving granules is carried out according to the following steps: (1) Decoction, extraction and concentration: Weigh each medicinal material according to the prescription ratio, soak it in 8-10 times the amount of water for 0.5-1.5 hours, decoct it 1-4 times, each time for 0.5-2.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.00-1.40 at 70-90℃ to obtain a thick extract; (2) Drying and powdering: Mix the thick extract and soluble starch at a weight ratio of 1:0.5-1.5, dry at 70-90℃ for 2-4 days, and pulverize through a 50-80 mesh sieve to obtain dry extract powder; (3) Granulation: Take the dry powder of extract and spray it with 60-80% ethanol to make soft material. The weight ratio of dry powder of extract to 60-80% ethanol is 2-3:

1. Pass it through a 10-14 mesh sieve, then add dextrin. The mass ratio of extract powder to dextrin is 3-5:

1. Make granules, dry at 50-70℃ for 18-30h, and sieve through 30-60 mesh to make granules.

5. The application as described in claim 4, characterized in that: In step (1), decoction extraction and concentration: weigh each medicinal material according to the prescription ratio, soak it in 9-10 times the amount of water for 1-1.5 hours, decoct it 2-3 times, each time for 1-1.5 hours, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.10-1.30 at 80℃ to obtain a thick extract.

6. The application as described in claim 4 or 5, characterized in that: In step (1), decoction extraction and concentration: weigh each medicinal material according to the prescription ratio, soak it in 10 times the amount of water for 1 hour, decoct it 3 times, 1 hour each time, and combine the decoctions; after filtering the decoctions, combine the filtrates, and concentrate the filtrates to a relative density of 1.20-1.30 at 80℃ to obtain a thick extract.

7. The application as described in claim 4, characterized in that: In step (2), drying and powdering: the thick extract and soluble starch are mixed at a weight ratio of 1:1-1.5, dried at 70-80℃ for 2.5-3.5 days, and then pulverized through a 60-70 mesh sieve to obtain dry extract powder.

8. The application as described in claim 4 or 7, characterized in that: In step (2), drying and powdering: the thick extract and soluble starch are mixed in a weight ratio of 1:1, dried at 70-80℃ for 3 days, and then pulverized through a 60-mesh sieve to obtain dry extract powder.

9. The application as described in claim 4, characterized in that: In step (3), granulation is performed by spraying 65-75% ethanol onto the dry extract powder to make a soft material. The weight ratio of the dry extract powder to 65-75% ethanol is 2.2-2.4:

1. The mixture is passed through a 12-mesh sieve, and then dextrin is added. The mass ratio of the extract powder to dextrin is 4:

1. The mixture is then granulated and dried at 60°C for 22-26 hours. The granules are then sieved through a 30-50 mesh sieve to obtain the final product.

10. The application as described in claim 4 or 9, characterized in that: In step (3), granulation is performed by spraying 70% ethanol into the dry extract powder to make a soft material. The weight ratio of the dry extract powder to 70% ethanol is 2.3:

1. The material is passed through a 12-mesh sieve, and then dextrin is added. The mass ratio of the extract powder to dextrin is 4:

1. The material is then granulated, dried at 60°C for 24 hours, and sieved through a 40-mesh sieve to obtain the granules.

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