Extraction and purification process of a traditional Chinese medicine composition for treating diabetes and its application

Abstract

The present application relates to a kind of extraction and purification process and application of Xiaoke Tongluo traditional Chinese medicine composition, the drug composition is composed of raw astragalus, radix puerariae, raw gypsum, anemarrhena asphodeloides, mulberry bark, silver flower, radix rehmanniae, ophiopogon, cassia twig, notopterygium, angelica pubescens, bone-penetrating incense;The drug is extracted using "flash extraction clarification method", improves the dissolution of active ingredients of drug, improves the cure rate of diabetic patients, and the preparation prepared is convenient to carry, use, store and has stronger preparation stability.

Description

Technical Field

[0001] The present invention relates to the field of medical inventions, and in particular to an extraction and purification process and application of a thirst-quenching and collateral-dredging Chinese medicine composition. Background Art

[0002] Diabetic peripheral neuropathy (DPN) is a chronic complication of diabetes that develops due to prolonged and untreated disease. Neuropathy can affect the autonomic, sensory, and motor nerves, resulting in sensory and motor impairments. Clinically, DPN presents as pain, numbness, and paresthesias in the affected area, and can even lead to muscle atrophy, seriously threatening patients' quality of life. Western medicine remains inconclusive on the causes and pathological mechanisms of DPN, and there are no specific treatments. Symptomatic treatments with Western medications are ineffective, often lacking in effectiveness compared to traditional Chinese medicine.

[0003] Xiaoke Tongluo Recipe is a clinically proven formula developed by the Qiannan Buyi and Miao Autonomous Prefecture Hospital of Traditional Chinese Medicine in Guizhou Province. It consists of raw astragalus, kudzu root, gypsum, rhizome of anemarrhena, white mulberry bark, honeysuckle, raw rehmannia root, ophiopogon, cassia twig, notopterygium wilfordii, angelica dahurica, and radix angelicae radix. It boasts the effects of nourishing qi and yin, warming the meridians and unblocking the collaterals. It is used to treat diabetic peripheral neuropathy (a syndrome characterized by qi and yin deficiency and blocked meridians). Symptoms include fatigue, thirst, excessive drinking, cold feet, tingling, numbness, cold pain in the skin, severe or persistent pain in the extremities, and difficulty sleeping.

[0004] The Xiaoke Tongluo Recipe is currently used clinically as a decoction, taken three times daily. It has been used clinically for over 10 years, treating over 500 patients with remarkable results, recognized by both clinicians and patients. Given the significant clinical efficacy and safety of the Xiaoke Tongluo Recipe, the present inventors intend to develop it into a suitable formulation for clinical use and conduct systematic research on its extraction and purification process to address issues such as incomplete dissolution of the active ingredients in the original decoction and the inconvenience of boiling, carrying, and storing the decoction.

[0005] Invention

[0006] The invention aims to provide an extraction and purification process and application of a traditional Chinese medicine composition for quenching thirst and dredging meridians.

[0007] The traditional Chinese medicine composition of the present invention consists of 20 parts of raw astragalus, 12 parts of kudzu root, 9 parts of raw gypsum, 9 parts of rhizoma anemarrhenae, 9 parts of white mulberry bark, 9 parts of honeysuckle, 9 parts of raw rehmannia root, 9 parts of ophiopogon, 9 parts of cinnamon twig, 9 parts of notopterygium root, 9 parts of angelica root and 9 parts of radix polygoni multiflori.

[0008] The extraction and purification process of the composition of the present invention is as follows:

[0009] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0010] (2) flash extraction: taking the coarse powder, adding 4-8 times of water, extracting 1-3 times at an initial temperature of 50-80℃ and a voltage of 140-180V, each time for 10-20min, filtering to obtain a flash extraction liquid;

[0011] (3) first concentration: concentrating the flash extraction liquid to a clear extract corresponding to 0.5g-1g of the medicinal material per 1mL;

[0012] (4) impurity removal: adding 1.0%-3.0% of a ZTC clarifier B solution to the clear extract, stirring, incubating at 30℃-50℃ for 10-30min, then adding 0.5%-1.5% of a ZTC clarifier A solution, incubating at 30℃-50℃ for 10-30min, standing for 24h, filtering, and reserving the filtrate;

[0013] (5) second concentration: concentrating the filtrate to a thick extract with a density of 1.25-1.28;

[0014] (6) preparation of a preparation: taking the thick extract, adding a pharmaceutically acceptable excipient, and preparing a pharmaceutically acceptable preparation.

[0015] Preferably, the flash extraction is: taking the coarse powder, adding 4-6 times of water, extracting 1-2 times at an initial temperature of 60-70℃ and a voltage of 150-170V, each time for 15-20min, filtering to obtain a flash extraction liquid.

[0016] Further preferably, the flash extraction is: taking the coarse powder, adding 4 times of water, extracting 2 times at an initial temperature of 70℃ and a voltage of 160V, each time for 15min, filtering to obtain a flash extraction liquid.

[0017] Preferably, the first concentration is: concentrating the flash extraction liquid to a clear extract corresponding to 1g of the medicinal material per 1mL.

[0018] Preferably, the impurity removal is: adding 1.5%-2.5% of a ZTC clarifier B solution to the clear extract, stirring, incubating at 40℃-50℃ for 20-30min, then adding 1.0%-1.5% of a ZTC clarifier A solution, incubating at 40℃-50℃ for 20-30min, standing for 24h, filtering, and reserving the filtrate;

[0019] Further preferably, the impurity removal is: adding 2.0% of a ZTC clarifier B solution to the clear extract, stirring, incubating at 40℃ for 20min, then adding 1.0% of a ZTC clarifier A solution, incubating at 40℃ for 20min, standing for 24h, filtering, and reserving the filtrate.

[0020] Preferably, the ratio of the amount of the ZTC clarifier A solution to the amount of the ZTC clarifier B solution is 1:2.

[0021] Preferably, the second concentration is that the filtrate is concentrated to a thick paste with a density of 1.25.

[0022] The preparation according to the present application is granules, mixture, drop pills, tablets.

[0023] The application of the extraction and purification process according to the present application in the preparation of a drug for treating diabetes.

[0024] The "parts" according to the present application can be kg, g and other units known in the art.

[0025] Beneficial effects

[0026] (1) The present application compares the content of effective components of Xiaoke Tongluo Formula by different extraction processes and the retention rate of effective components by different purification processes through experimental research, and finally optimizes the "flash extraction and clarification method" extraction and purification process for Xiaoke Tongluo Formula. After the extraction and purification of Xiaoke Tongluo Formula by using the process, the dosage forms such as mixture, granules and drop pills are prepared, the dissolution of effective components of the drug is improved, the cure rate of diabetes patients is improved, and the prepared preparation is convenient to carry, use, store and has stronger preparation stability.

[0027] (2) The present application passes the extraction method primary selection experiment, and the results show that after the original water extraction and decoction process of Xiaoke Tongluo Formula is used for extraction, the content of polysaccharide and flavonoid effective components in the extraction liquid is 1.94

[0028] mg / ml and 0.87 mg / ml respectively, and after the "flash extraction method" is used for extraction, the content of polysaccharide and flavonoid effective components in the extraction liquid is 2.86 mg / ml and 1.42 mg / ml respectively, and the "flash extraction method" greatly improves the content of effective components in the extraction liquid.

[0029] (3) The present application passes the purification method primary selection, and the results show that the impurity removal rate is alcohol precipitation method>ZTC clarifier method>chitosan flocculation precipitation method, and the total polysaccharide and total flavonoid content after impurity removal is ZTC clarifier method>chitosan flocculation precipitation method>alcohol precipitation method, which indicates that the alcohol precipitation method removes impurities while the loss of effective components is the largest, and considering comprehensively, the ZTC clarifier method can be selected as the best purification process.

[0030] (4) The present application compares the TCM syndrome scores of the decoction group, the preparation group and the control group before treatment, and the results show that the treatment effect of the preparation group is obviously better than that of the decoction group, which indicates that the curative effect is further strengthened after the prescription is extracted and purified by the "flash extraction and clarification method" to prepare the preparation.

[0031] (5) The present application compares the TCSS scores of the decoction group, the preparation group and the control group before treatment, and the results show that the treatment effect of the preparation group is obviously better than that of the decoction group.

[0032] (6) The present invention compared the clinical efficacy of the decoction group, the preparation group and the control group. The results showed that compared with the control group (Western medicine group), the decoction group and the preparation group had significant differences (the control group had an effective rate of 85.0%, the decoction group had an effective rate of 92.5%, and the preparation group had an effective rate of 97.5%). The cure rate of the preparation group was 50.0%, and the cure rate of the decoction group was 30.0%. This shows that the efficacy of the preparation prepared by the "flash extraction clarification method" of the present invention is further improved. DETAILED DESCRIPTION

[0033] The following examples are used to illustrate the present invention but are not intended to limit the scope of the present invention.

[0034] Example 1 Prescription

[0035] 200g raw Astragalus, 120g Pueraria root, 90g raw Gypsum, 90g Anemarrhena, 90g Morus alba bark, 90g Lonicera japonica, 90g raw Rehmannia root, 90g Ophiopogon japonicus, 90g Cassia twig, 90g Notopterygium wilfordii, 90g Duhuo, 90g Radix Angelicae Pubescentis.

[0036] The formula of Example 1 is prepared according to any extraction and purification process of the following Examples 2-13.

[0037] Example 2 Extraction and purification process

[0038] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0039] (2) Flash extraction: Take the coarse powder, add 4 times the amount of water, extract twice at an initial temperature of 70°C and a voltage of 160V, each time for 15 minutes, filter, and obtain the flash extract;

[0040] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0041] (4) Impurity removal: add 2.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 40°C for 20 minutes. Then add 1.0% ZTC clarifier A solution, keep warm at 40°C for 20 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0042] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0043] (6) Preparation: Take the thick paste, add 130 g of soluble starch and 2 g of aspartame, granulate, dry, and shape the particles to obtain granules.

[0044] Example 3 Extraction and purification process

[0045] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0046] (2) Flash extraction: Take the coarse powder, add 6 times of water, extract once at an initial temperature of 50°C and a voltage of 140V for 10 minutes each time, filter, and obtain the flash extract;

[0047] (3) First concentration: concentrate the flash extract to a paste with 0.5 g of medicinal material per 1 mL;

[0048] (4) Impurity removal: add 1.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C for 10 minutes. Then add 0.5% ZTC clarifier A solution, keep warm at 30°C for 10 minutes, let it stand for 24 hours, filter, and use the filtrate for later use.

[0049] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0050] (6) Preparation: Take the thick paste, add 130 g of soluble starch and 2 g of aspartame, granulate, dry, and shape the particles to obtain granules.

[0051] Example 4 Extraction and purification process

[0052] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0053] (2) Flash extraction: Take the coarse powder, add 8 times of water, extract 3 times at an initial temperature of 80 ° C and a voltage of 180 V, each time for 20 minutes, filter, and obtain the flash liquid;

[0054] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0055] (4) Impurity removal: add 3.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C-50°C for 10-30 minutes, then add 1.5% ZTC clarifier A solution, keep warm at 30°C-50°C for 10-30 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0056] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25-1.28;

[0057] (6) Preparation: Take the thick paste, add 130 g of soluble starch and 2 g of aspartame, granulate, dry, and shape the particles to obtain granules.

[0058] Example 5 Extraction and purification process

[0059] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0060] (2) Flash extraction: Take the coarse powder, add 4 times the amount of water, extract twice at an initial temperature of 70°C and a voltage of 160V, each time for 15 minutes, filter, and obtain the flash extract;

[0061] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0062] (4) Impurity removal: add 2.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 40°C for 20 minutes. Then add 1.0% ZTC clarifier A solution, keep warm at 40°C for 20 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0063] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0064] (6) Preparation: Take the thick paste, add 50 g of monosaccharide syrup and 3 g of sodium propylformate, dilute with water to 300 ml, sterilize, and obtain the mixture.

[0065] Example 6 Extraction and purification process

[0066] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0067] (2) Flash extraction: Take the coarse powder, add 6 times of water, extract once at an initial temperature of 50°C and a voltage of 140V for 10 minutes each time, filter, and obtain the flash extract;

[0068] (3) First concentration: concentrate the flash extract to a paste with 0.5 g of medicinal material per 1 mL;

[0069] (4) Impurity removal: add 1.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C for 10 minutes. Then add 0.5% ZTC clarifier A solution, keep warm at 30°C for 10 minutes, let it stand for 24 hours, filter, and use the filtrate for later use.

[0070] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0071] (6) Preparation: Take the thick paste, add 50 g of monosaccharide syrup and 3 g of sodium propylformate, dilute with water to 300 ml, sterilize, and obtain the mixture.

[0072] Example 7 Extraction and purification process

[0073] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0074] (2) Flash extraction: Take the coarse powder, add 8 times of water, extract 3 times at an initial temperature of 80 ° C and a voltage of 180 V, each time for 20 minutes, filter, and obtain the flash liquid;

[0075] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0076] (4) Impurity removal: add 3.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C-50°C for 10-30 minutes, then add 1.5% ZTC clarifier A solution, keep warm at 30°C-50°C for 10-30 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0077] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25-1.28;

[0078] (6) Preparation: Take the thick paste, add 50 g of monosaccharide syrup and 3 g of sodium propylformate, dilute with water to 300 ml, sterilize, and obtain the mixture.

[0079] Example 8 Extraction and Purification Process

[0080] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0081] (2) Flash extraction: Take the coarse powder, add 4 times the amount of water, extract twice at an initial temperature of 70°C and a voltage of 160V, each time for 15 minutes, filter, and obtain the flash extract;

[0082] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0083] (4) Impurity removal: add 2.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 40°C for 20 minutes. Then add 1.0% ZTC clarifier A solution, keep warm at 40°C for 20 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0084] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0085] (6) Preparation: Dry the thick paste, grind it into fine powder, add 120g of polyethylene glycol 4000, and prepare it into pills.

[0086] Example 9 Extraction and Purification Process

[0087] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0088] (2) Flash extraction: Take the coarse powder, add 6 times of water, extract once at an initial temperature of 50°C and a voltage of 140V for 10 minutes each time, filter, and obtain the flash extract;

[0089] (3) First concentration: concentrate the flash extract to a paste with 0.5 g of medicinal material per 1 mL;

[0090] (4) Impurity removal: add 1.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C for 10 minutes. Then add 0.5% ZTC clarifier A solution, keep warm at 30°C for 10 minutes, let it stand for 24 hours, filter, and use the filtrate for later use.

[0091] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0092] (6) Preparation: Dry the thick paste, grind it into fine powder, add 120g of polyethylene glycol 4000, and prepare it into pills.

[0093] Example 10 Extraction and purification process

[0094] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0095] (2) Flash extraction: Take the coarse powder, add 8 times of water, extract 3 times at an initial temperature of 80 ° C and a voltage of 180 V, each time for 20 minutes, filter, and obtain the flash liquid;

[0096] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0097] (4) Impurity removal: add 3.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C-50°C for 10-30 minutes, then add 1.5% ZTC clarifier A solution, keep warm at 30°C-50°C for 10-30 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0098] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25-1.28;

[0099] (6) Preparation: Dry the thick paste, grind it into fine powder, add 120g of polyethylene glycol 4000, and prepare it into pills.

[0100] Example 11 Extraction and purification process

[0101] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0102] (2) Flash extraction: Take the coarse powder, add 4 times the amount of water, extract twice at an initial temperature of 70°C and a voltage of 160V, each time for 15 minutes, filter, and obtain the flash extract;

[0103] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0104] (4) Impurity removal: add 2.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 40°C for 20 minutes. Then add 1.0% ZTC clarifier A solution, keep warm at 40°C for 20 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0105] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0106] (6) Preparation: Take the thick paste, dry it, grind it into fine powder, add 120g of soluble starch, granulate it, dry it, and press it into tablets.

[0107] Example 12 Extraction and purification process

[0108] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0109] (2) Flash extraction: Take the coarse powder, add 6 times of water, extract once at an initial temperature of 50°C and a voltage of 140V for 10 minutes each time, filter, and obtain the flash extract;

[0110] (3) First concentration: concentrate the flash extract to a paste with 0.5 g of medicinal material per 1 mL;

[0111] (4) Impurity removal: add 1.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C for 10 minutes. Then add 0.5% ZTC clarifier A solution, keep warm at 30°C for 10 minutes, let it stand for 24 hours, filter, and use the filtrate for later use.

[0112] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25;

[0113] (6) Preparation: Take the thick paste, dry it, grind it into fine powder, add 120g of soluble starch, granulate it, dry it, and press it into tablets.

[0114] Example 13 Extraction and purification process

[0115] (1) Coarse grinding: weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that passes through a 10-mesh sieve;

[0116] (2) Flash extraction: Take the coarse powder, add 8 times of water, extract 3 times at an initial temperature of 80 ° C and a voltage of 180 V, each time for 20 minutes, filter, and obtain the flash liquid;

[0117] (3) First concentration: concentrate the flash extract to a paste with 1 mL equivalent to 1 g of medicinal material;

[0118] (4) Impurity removal: add 3.0% ZTC clarifier B solution to the clear paste, stir, and keep warm at 30°C-50°C for 10-30 minutes, then add 1.5% ZTC clarifier A solution, keep warm at 30°C-50°C for 10-30 minutes, let it stand for 24 hours, filter, and use the filtrate for later use;

[0119] (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25-1.28;

[0120] (6) Preparation: Take the thick paste, dry it, grind it into fine powder, add 120g of soluble starch, granulate it, dry it, and press it into tablets.

[0121] In order to further verify the effectiveness of the present invention, the inventors conducted a series of verification tests, as follows:

[0122] 1. Prescription composition and theoretical basis

[0123] 1. Prescription composition: Raw Astragalus 20g, Pueraria lobata 12g, Raw Gypsum 9g, Anemarrhena 9g, Morus alba bark 9g, Lonicera japonica 9g, Raw Rehmannia glutinosa 9g, Ophiopogon japonicus 9g, Cinnamomum cassia twig 9g, Notopterygium incisum 9g, Angelica dahurica 9g, and Radix Angelicae Pubescentis 9g.

[0124] 2. Theoretical basis

[0125] Astragalus and Pueraria root are the main medicines for nourishing the spleen and replenishing qi, promoting fluid production and quenching thirst. Anemarrhena asphodeloides, Rehmannia glutinosa and Ophiopogon japonicus are the auxiliary medicines for nourishing yin, promoting fluid production and quenching thirst. Notopterygium wilfordii, Angelica dahurica, Radix Angelicae Pubescentis and Cinnamomum cassia are used as auxiliary medicines for dispelling wind and cold, removing dampness and dredging the meridians, reducing swelling and relieving pain to strengthen the effect of the main medicine. All the medicines are used together to nourish qi and yin, and warm the meridians and dredge the meridians.

[0126] Study on the Second Extraction Process

[0127] Analysis of 1 prescription

[0128] The Xiaoke Tongluo prescription is composed of raw astragalus, kudzu root, gypsum, rhizome of anemarrhena, white mulberry bark, honeysuckle, raw rehmannia root, ophiopogon japonicus, cinnamon twig, notopterygium wilfordii, angelica dahurica, and radix tangerinae. A review of relevant literature indicates that the therapeutic effects of this prescription are primarily based on flavonoids and polysaccharides. The main active ingredients of raw astragalus, raw rehmannia root, ophiopogon japonicus, and radix tangerinae are polysaccharides, while those of kudzu root, rhizome of anemarrhena, honeysuckle, notopterygium wilfordii, and radix tangerinae are flavonoids. Considering the total flavonoid and total polysaccharide content of the extracts as evaluation indicators, five different extraction processes (water extraction, alcohol extraction, fermentation extraction, flash extraction, and enzyme extraction) were experimentally compared to ultimately identify the optimal extraction process.

[0129] 2. Preliminary selection of extraction method

[0130] 2.1 Water extraction

[0131] The medicinal materials (raw astragalus 20g, kudzu root 12g, raw gypsum 9g, anemarrhena 9g, white mulberry bark 9g, honeysuckle 9g, raw rehmannia glutinosa 9g, ophiopogon 9g, cinnamon twig 9g, notopterygium wilfordii 9g, angelica pubescens 9g, and radix polygoni multiflori) were weighed according to the formula ratio and crushed into a coarse powder with a mesh size of 10. 6 times water was added, and the mixture was heated and extracted for 0.5 h. The mixture was filtered, and the filtrate was concentrated and fixed to 250 ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 1.

[0132] 2.2 Alcohol extraction

[0133] The medicinal materials were weighed according to the formula ratio (same as water extraction method), crushed into coarse powder with a mesh size of 10, added with 6 times 60% ethanol, heated and extracted for 0.5 hours, filtered, and the filtrate was concentrated and fixed to 250 ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 1.

[0134] 2.3 Enzymatic hydrolysis

[0135] The medicinal materials were weighed according to the formula ratio (same as water extraction method), crushed into coarse powder with a mesh size of 10, added with 6 times water and 2.0% cellulase, and extracted at 50°C and pH 5.0 for 12 hours. After boiling, the filtrate was filtered and the volume was concentrated to 250 ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 1.

[0136] 2.4 Flash extraction method

[0137] The medicinal materials were weighed according to the formula ratio (same as water extraction method), crushed into coarse powder with a mesh size of 10, and 6 times water was added. The initial extraction temperature was 60°C, the extraction voltage was 160V, and the extraction time was 10 minutes. The filtrate was filtered, concentrated and fixed to 250 ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 1.

[0138] 2.5 Fermentation

[0139] The medicinal materials were weighed according to the formula ratio (same as water extraction method), crushed into coarse powder with a mesh size of 10, added with 6 times the amount of water, boiled and cooled, and then glucose (10% of the total amount of the medicinal materials) was added. The yeast was inoculated with an inoculum amount of 2.0%, and fermented at 35°C for 12 hours. The filtrate was filtered, concentrated and fixed to 250 ml, and the total polysaccharide and total flavonoid contents were determined. The results are shown in Table 1.

[0140] Table 1 Results of active ingredient contents in extracts using different extraction methods

[0141]

[0142] The experimental results in Table 1 show that among the five extraction methods, the order of total polysaccharide content is flash extraction > water extraction > alcohol extraction > fermentation > enzymatic hydrolysis. For total flavonoid content, the order is alcohol extraction > flash extraction > fermentation > water extraction > enzymatic hydrolysis, indicating that the alcohol and flash extraction methods are relatively close. Flash extraction is the optimal extraction method due to its high extraction efficiency, ease of operation, short extraction time, and low extraction cost.

[0143] 3. Optimization of process parameters for flash extraction

[0144] The factors that affect flash extraction performance mainly include the amount of water added, initial temperature, extraction time, extraction voltage, and number of extractions. Due to the large number of influencing factors, this experiment used the total flavonoids and total polysaccharide content in the extract as indicators and used a single-factor investigation method to examine each indicator one by one.

[0145] 3.1 Amount of water added

[0146] According to the formula ratio, 3 parts of medicinal materials (raw astragalus 20g, kudzu root 12g, raw gypsum 9g, anemarrhena 9g, white mulberry bark 9g, honeysuckle 9g, raw rehmannia glutinosa 9g, ophiopogon 9g, cinnamon twig 9g, notopterygium root 9g, angelica dahurica 9g, and radix polygoni multiflori) were weighed and ground into coarse powder with a 10-mesh diameter. 6 times, 8 times, and 10 times of water were added, respectively. The initial extraction temperature was 60°C, the extraction voltage was 160V, the extraction time was 10min, and the filtrate was concentrated and fixed to 250ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 2.

[0147] Table 2 Optimization results of water addition amount

[0148]

[0149] The test results in Table 2 show that the amount of water added has little effect on the total polysaccharide and total flavonoid contents. The process parameters can be selected from 4 times to 8 times. However, considering the subsequent saving of concentration time, adding 4 times of water is selected as the optimal process parameter.

[0150] 3.2 Initial temperature

[0151] According to the proportion of the formula, 6 parts of medicinal materials (raw astragalus 20g, kudzu root 12g, raw gypsum 9g, anemarrhena 9g, white mulberry bark 9g, honeysuckle 9g, raw rehmannia glutinosa 9g, ophiopogon 9g, cinnamon twig 9g, notopterygium root 9g, angelica dahurica 9g, and radix polygoni multiflori) were weighed and ground into coarse powder with a 10-mesh diameter. Four times of water was added to each part, and the initial extraction temperature was set at 30℃, 40℃, 50℃, 60℃, 70℃ and 80℃, respectively. The extraction voltage was 160V, the extraction time was 10min, and the filtrate was concentrated and fixed to 250ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 3.

[0152] Table 3 Initial temperature optimization results

[0153]

[0154] The test results show that the total polysaccharide content tends to be stable after 50℃, and the total flavonoids content does not change much after 70℃. Taking all factors into consideration, 70℃ is selected as the optimal process parameter.

[0155] 3.3 Extraction voltage

[0156] 7 portions of medicinal materials (raw astragalus 20 g, kudzu root 12 g, raw gypsum 9 g, rhizome of anemarrhena 9 g, white mulberry bark 9 g, honeysuckle 9 g, raw rehmannia glutinosa 9 g, ophiopogon 9 g, cinnamon twig 9 g, notopterygium wilfordii 9 g, angelica pubescens 9 g, and radix polygoni multiflori) were weighed according to the formula ratio and crushed into coarse powder with a 10-mesh diameter. Four times water was added to each of the powders. The initial extraction temperature was 70 ° C, and the extraction voltage was set to 60 V, 80 V, 100 V, 120 V, 140 V, 160 V and 180 V, respectively. The extraction was carried out for 10 min, filtered, and the filtrate was concentrated and fixed to 250 ml. The contents of total polysaccharides and total flavonoids were determined. The results are shown in Table 4.

[0157] Table 4 Extraction voltage optimization results

[0158]

[0159]

[0160] The test results show that when the extraction voltage reaches 140V, the contents of total polysaccharides and total flavonoids slow down. Taking comprehensive consideration, 160V is selected as the optimal process parameter.

[0161] 3.4 Number of extractions

[0162] According to the proportion of the formula, 3 parts of medicinal materials (raw astragalus 20g, kudzu root 12g, raw gypsum 9g, anemarrhena 9g, white mulberry bark 9g, honeysuckle 9g, raw rehmannia glutinosa 9g, ophiopogon 9g, cinnamon twig 9g, notopterygium root 9g, angelica 9g, and radix polygoni multiflori) were weighed and ground into coarse powder with a 10-mesh diameter. Four times of water was added to each part. The initial extraction temperature was 70°C, the extraction voltage was set to 160V, and the extraction was performed once, twice, and three times, respectively. The extraction time was 10min. The filtrate was concentrated and fixed to 250ml. The contents of total polysaccharides and total flavonoids were determined. The results are shown in Table 5.

[0163] Table 5 Extraction voltage optimization results

[0164]

[0165] The experimental results showed that the content of total polysaccharides and total flavonoids was slightly higher after extraction twice than after extraction once, and the content was not much different after extraction three times than after extraction twice, so extraction twice was selected as the optimal process parameter.

[0166] 3.5 Extraction time

[0167] According to the proportion of the formula, 5 portions of medicinal materials (raw astragalus 20g, kudzu root 12g, raw gypsum 9g, rhizome of anemarrhena 9g, white mulberry bark 9g, honeysuckle 9g, raw rehmannia glutinosa 9g, ophiopogon 9g, cinnamon twig 9g, notopterygium root 9g, angelica 9g, and radix polygoni multiflori) were weighed and ground into coarse powder with a 10-mesh diameter. Four times of water was added to each portion. The initial extraction temperature was 70°C, the extraction voltage was set to 160V, and the extraction times were 5min, 10min, 15min, 20min, and 25min, respectively. The mixture was filtered, and the filtrate was concentrated and fixed to 250ml. The contents of total polysaccharides and total flavonoids were determined. The results are shown in Table 6.

[0168] Table 6 Optimization results of extraction time

[0169]

[0170] The experimental results showed that after 10 minutes of extraction, the contents of total polysaccharides and total flavonoids increased slightly, and after 20 minutes, the contents of total polysaccharides and total flavonoids did not change much. Therefore, 15 minutes of extraction was selected as the optimal process parameter.

[0171] Three purification process research

[0172] 1. Preliminary selection of purification method

[0173] In order to optimize the best purification process, the present invention compared the alcohol precipitation method, the ZTC clarifier method and the chitosan flocculation precipitation method. The method is:

[0174] Weigh the medicinal materials (raw astragalus 60g, kudzu root 36g, raw gypsum 27g, anemarrhena 27g, mulberry bark 27g, honeysuckle 27g, raw rehmannia glutinosa 27g, ophiopogon 27g, cassia twig 27g, notopterygium root 27g, angelica dahurica 27g, and radix polygoni multiflori) according to the formula ratio, grind them into coarse powder passing 10 mesh, add 4 times water respectively, set the initial extraction temperature to 70℃, the extraction voltage to 160V, extract for 10min, filter, and concentrate the filtrate to a clear paste with a 1:1 ratio of the medicinal materials. Divide it into 3 parts on average and purify it according to the following method.

[0175] 1.1 Alcohol precipitation method

[0176] Take the clear paste, add ethanol to make the alcohol content reach 60%, stir while adding, let it stand for 24 hours, filter, concentrate the filtrate and make the volume to 250 ml, and determine the total polysaccharide and total flavonoid contents. The results are shown in Table 7.

[0177] 1.2 ZTC Clarifier Method

[0178] Take the clear paste, add 2% ZTC clarifier B solution, stir, and keep warm at 40°C for 10 minutes. Then add 1% ZTC clarifier A solution, keep warm at 40°C for 10 minutes, let it stand for 24 hours, filter, concentrate the filtrate and make up to 250 ml. The total polysaccharide and total flavonoid contents were determined. The results are shown in Table 7.

[0179] 1.3 Chitosan flocculation precipitation method

[0180] Take the clear paste, add 250 ml of 1% chitosan acetate solution, flocculation temperature 40 ° C, stirring time 20 min, filter, concentrate the filtrate and make the volume to 250 ml, determine the total polysaccharide and total flavonoids content, the results are shown in Table 7.

[0181] Table 7 Preliminary results of purification methods

[0182]

[0183] The test results show that the impurity removal rate is as follows: alcohol precipitation method > ZTC clarifier method > chitosan flocculation precipitation method; the total polysaccharide and total flavonoid contents after impurity removal are as follows: ZTC clarifier method > chitosan flocculation precipitation method > alcohol precipitation method, indicating that the alcohol precipitation method has the greatest loss of effective ingredients while removing impurities. Taking all factors into consideration, the ZTC clarifier method can be selected as the best purification process.

[0184] Optimization of process parameters for 2ZTC clarifier method

[0185] The factors that affect the purification effect of ZTC clarifier are clarifier dosage, holding temperature, and holding time. This experiment intends to examine these three main factors separately to optimize the impurity removal process parameters. The test method is as follows:

[0186] Weigh the medicinal materials (raw astragalus 200g, kudzu root 120g, raw gypsum 90g, anemarrhena 90g, mulberry bark 90g, honeysuckle 90g, raw rehmannia glutinosa 90g, ophiopogon 90g, cassia twig 90g, notopterygium wilfordii 90g, angelica dahurica 90g, and radix polygoni multiflori) according to the formula ratio, grind them into coarse powder passing 10 mesh, add 6 times water, set the initial extraction temperature to 70℃, set the extraction voltage to 160V, extract for 10min, filter, and concentrate the filtrate to a clear paste with a ratio of 1:1 with the medicinal materials. Divide it into 10 parts on average and set aside.

[0187] 2.1 Clarifying agent dosage

[0188] Three portions of the clear paste were added with 1%, 2% and 3% of ZTC clarifier B solution, respectively, stirred, and kept warm at 40°C for 10 minutes. Then, 0.5%, 1.0% and 1.5% of ZTC clarifier A solution were added, respectively, and kept warm at 40°C for 10 minutes. The mixture was allowed to stand for 24 hours and filtered. The filtrate was concentrated and the volume was made up to 250 ml. The total polysaccharide and total flavonoid contents and impurity removal rate were determined. The results are shown in Table 8.

[0189] Table 8 Optimization results of clarifier dosage

[0190]

[0191] The test results show that when the clarifier dosage reaches 4.5%, although the impurity removal rate is improved, the total polysaccharide and total flavonoid contents are greatly lost. Taking all factors into consideration, the clarifier dosage is selected to be 3.0% (A:B=1:2).

[0192] 2.2 Holding temperature

[0193] Three portions of the clear paste were added with 2% ZTC clarifier B solution, stirred, and kept warm at 30°C, 40°C, and 50°C for 10 min, then added with 1.0% ZTC clarifier A solution, kept warm at 30°C, 40°C, and 50°C for 10 min, allowed to stand for 24 h, filtered, and the filtrate was concentrated and made up to 250 ml. The total polysaccharide and total flavonoid contents and impurity removal rate were determined. The results are shown in Table 9.

[0194] Table 9 Optimization results of insulation temperature

[0195]

[0196] The test results show that different holding temperatures have little effect on the contents of total polysaccharides and total flavonoids, but the impurity removal rate at 30°C is lower. Taking all factors into consideration, 40°C is selected as the optimal process parameter.

[0197] 2.3 Holding time

[0198] Three portions of the paste were added with 2% ZTC clarifier B solution, stirred, and kept warm at 40°C for 10 min, 20 min, and 30 min, respectively. Then, 1.0% ZTC clarifier A solution was added, and kept warm at 40°C for 10 min, 20 min, and 30 min, respectively. The paste was allowed to stand for 24 h, filtered, and the filtrate was concentrated and made up to 250 ml. The total polysaccharide and total flavonoid contents and impurity removal rate were determined. The results are shown in Table 10.

[0199] Table 10 Optimization results of holding time

[0200]

[0201] The test results show that different holding times have little effect on the impurity removal rate, total polysaccharide and total flavonoid contents, and 10min-30min can be selected as the process parameter according to the operating conditions.

[0202] 4. Clinical efficacy

[0203] In order to verify the rationality, scientificity and advancement of the preparation process of the present invention, we extracted and purified the Xiaoke Tongluo Recipe according to the process of the present invention and made it into granules for clinical application. At the same time, the Xiaoke Tongluo Recipe decoction and conventional Western medicine treatment were used as controls. The experimental methods and results are as follows.

[0204] 1 Materials and Methods

[0205] 1.1 Clinical Data

[0206] Methods: 120 patients with diabetic peripheral neuropathy admitted to the Traditional Chinese Medicine Hospital of Qiannan Buyi and Miao Autonomous Prefecture, Guizhou Province, between January 2022 and December 2023 were enrolled in the study. After informed consent, they were divided equally into a control group, a decoction group, and a preparation group, with 40 patients in each group. The control group included 21 males and 19 females aged 42-70 years (mean, 61.35±5.18) years, with a diabetes duration of 2-21 years (mean, 13.41±2.05) years and a DPN duration of 7 months to 6 years (mean, 5.26±1.72) years. The decoction group included 19 males and 21 females aged 39-71 years (mean, 62.53±4.67) years, with a diabetes duration of 2-20 years (mean, 13.61±2.19) years and a DPN duration of 6 months to 8 years (mean, 5.73±0.98) years. In the preparation group, there were 22 males and 18 females; the age ranged from 41 to 69 years (mean, 59.58±4.32) years; the duration of diabetes ranged from 2 to 21 years (mean, 15.66±2.98) years; and the duration of DPN ranged from 8 months to 7 years (mean, 6.13±1.58) years. There were no statistically significant differences in gender, age, or disease duration among the three groups (P>0.05), indicating that the three groups were comparable.

[0207] 1.2 Diagnostic criteria

[0208] Traditional Chinese Medicine Syndrome Differentiation Criteria: Meets the diagnostic criteria for Xiaoke syndrome in the "Guiding Principles for Clinical Research of New Chinese Medicines." Symptoms include thirst, frequent drinking, frequent and sweet urine, rapid digestion, and emaciation. It also meets the diagnostic criteria for Qi deficiency and blood stasis. Primary symptoms include numbness in the extremities, tingling in the hands and feet, a crawling sensation, fatigue, and dry mouth and throat. Secondary symptoms include palpitations and insomnia, sluggish speech, rashes on the skin, subcutaneous bruising, and fever in the five heart regions. A pale tongue with petechiae, cyanotic veins, and a deep, thready, and weak pulse. These are two primary symptoms and one secondary symptom, and a diagnosis can be made based on the tongue and pulse.

[0209] Western medicine diagnostic criteria: Refer to the World Health Organization's "Definition, Diagnosis, and Classification of Diabetes Mellitus" for diabetes diagnosis. Polyuria, polyphagia, polydipsia, unexplained weight loss, plasma glucose exceeding 200 mg / dL, and fasting blood glucose exceeding 7.0 mmol / L. This meets the "Endocrinology" diagnosis of DPN. Symmetrical numbness, burning and tingling in the lower extremities, paresthesia, decreased lower extremity sensation, absent tendon reflexes, and a spongy feeling when walking.

[0210] 1.3 Inclusion and Exclusion Criteria

[0211] Inclusion criteria: meet the diagnostic criteria, can receive systemic treatment for diabetes, have no relevant treatment history within 1 month before treatment, and sign a consent form.

[0212] Exclusion criteria: pregnancy or lactation, severe heart, liver, brain, and kidney diseases, mental abnormalities and inability to cooperate with treatment, foot ulcers or gangrene, acute metabolic disorders in the previous 30 days, and DPN.

[0213] 1.4 Treatment

[0214] All three groups received health education, diabetic diet, increased exercise, strict blood sugar control through drug treatment, and symptomatic medication to keep blood pressure and blood lipids within the acceptable range.

[0215] Control group: methylcobalamin tablets (Jiangxi Qingfeng Pharmaceutical Co., Ltd., approval number H20051440) 0.5 mg, 3 times a day, orally; lipoic acid (Chengdu Beite Pharmaceutical Co., Ltd., approval number H20183534) 0.6 g, mixed with normal saline, was administered intravenously once a day for 8 weeks.

[0216] Decoction group: In addition to the same treatment as the control group, patients were given Xiaoke Tongluo decoction. Dosage: Decoction in water, one dose per day, divided into three doses. Treatment lasted for 8 weeks.

[0217] Preparation group: In addition to the same treatment as the control group, the granules prepared by the present invention were additionally taken. Dosage: Oral, 3 times a day, 10 g each time. Treatment lasted 8 weeks.

[0218] 1.5 Observation indicators

[0219] With reference to the "Guidelines for Clinical Research of New Chinese Medicines", the syndrome score evaluation items include numbness of hands and feet, limb pain, sensory impairment, tendon reflexes, and insomnia and dreaminess. Each item is scored from 0 for none, 1 for mild, 2 for moderate, and 3 for severe. The higher the score, the more severe the symptoms.

[0220] The severity of DPN is evaluated using the Toronto Clinical Scoring System (TCSS), which includes evaluation items such as neuroreflexes, neurological symptoms, and sensory function. The total score ranges from 0 to 19 points. A higher score indicates more severe neurological damage.

[0221] SPSS 22.0 statistical software was used for analysis. The measurement data were expressed as (x ± s) and the t test was used. The enumeration data were expressed as (%) and the χ test was used. 2 Test, P < 0.05 indicates statistically significant differences.

[0222] 1.6 Efficacy Assessment

[0223] Reference to "Guidelines for Clinical Trial of New Drugs of Traditional Chinese Medicine". Cure: limb pain numbness disappeared, knee tendon, achilles tendon reflex returned to normal, TCM syndrome score decreased by more than 90%. Marked effect: limb numbness and abnormal sensation improved, knee tendon and achilles tendon reflex improved significantly, TCM syndrome score decreased by 70% to 90%. Effective: limb numbness and abnormal sensation slightly relieved, knee tendon and achilles tendon reflex improved, TCM syndrome score decreased by 30% to 70%. No effect: limb abnormal sensation unchanged, syndrome score decreased less than 30%.

[0224] 2Results

[0225] 2.1 Comparison of TCM syndrome scores in three groups

[0226] There was no significant difference in TCM syndrome scores among the decoction group, preparation group and control group before treatment (P>0.05). There were significant differences in TCM syndrome scores among the three groups after treatment (P<0.05). The treatment effect of the preparation group was significantly better than that of the decoction group, indicating that the curative effect was further enhanced after the prescription was extracted and purified by "flash clarification method" to prepare the preparation. See Table 11.

[0227] Table 11 Comparison of TCM syndrome scores before and after treatment in three groups

[0228]

[0229]

[0230] Note: *P<0.05 compared with the control group after treatment

[0231] 2.2 Comparison of TCSS scores before and after treatment in three groups

[0232] There was no significant difference in TCSS scores among the decoction group, preparation group and control group before treatment (P>0.05). There were significant differences in TCSS scores among the three groups after treatment (P<0.05). The treatment effect of the preparation group was significantly better than that of the decoction group. See Table 12.

[0233] Table 12 Comparison of TCSS scores before and after treatment in three groups

[0234]

[0235] Note: *P<0.05 compared with the control group after treatment

[0236] 2.3 Comparison of clinical curative effects in three groups

[0237] There was a statistically significant difference in the therapeutic effects between the decoction group, the preparation group, and the control group (P < 0.05). See Table 13.

[0238] Table 13 Comparison of clinical efficacy among three groups of patients

[0239]

[0240] Note: *P<0.05 compared with the control group;

[0241] Although the present invention has been described in detail above using general explanations, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made on the basis of the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention are within the scope of protection claimed by the present invention.

Claims

1. A process for extracting and purifying a Chinese medicine composition for quenching thirst and dredge-clearing meridians, wherein the composition comprises 20 parts of raw astragalus, 12 parts of kudzu root, 9 parts of raw gypsum, 9 parts of rhizoma anemarrhenae, 9 parts of white mulberry bark, 9 parts of honeysuckle, 9 parts of raw rehmannia root, 9 parts of ophiopogon, 9 parts of cinnamon twig, 9 parts of notopterygium root, 9 parts of angelica root, and 9 parts of radix polygoni multiflori. The extraction and purification process of the composition is as follows: (1) Coarse grinding: Weigh each Chinese medicinal material according to the formula ratio and grind it into coarse powder that can pass through a 10-mesh sieve; (2) Flash extraction: Take the coarse powder, add 4-8 times of water, extract 1-3 times at an initial temperature of 50-80℃ and a voltage of 140-180V, each time for 10-20 minutes, filter, and obtain the flash liquid; (3) First concentration: Concentrate the flash extract to a paste equivalent to 0.5g-1g of medicinal material per 1mL; (4) Impurity removal: add 1.0%-3.0% ZTC clarifier B solution to the clear paste, stir, keep warm at 30℃-50℃ for 10min-30min, then add 0.5%-1.5% ZTC clarifier A solution, keep warm at 30℃-50℃ for 10min-30min, let it stand for 24h, filter, and use the filtrate for later use; (5) Second concentration: The filtrate is concentrated to a thick paste with a density of 1.25-1.28; (6) Preparation: Take the thick paste and add pharmaceutically acceptable excipients to prepare a pharmaceutically acceptable preparation.

2. The extraction and purification process according to claim 1, wherein The flash extraction (2) is as follows: taking the coarse powder, adding 4-6 times of water, extracting 1-2 times at an initial temperature of 60-70°C and a voltage of 150-170V, each time for 15-20 minutes, filtering, and obtaining a flash extraction liquid.

3. The extraction and purification process according to claim 2, wherein: The flash extraction (2) is as follows: taking the coarse powder, adding 4 times of water, extracting twice at an initial temperature of 70°C and a voltage of 160V, each time for 15 minutes, filtering, and obtaining a flash extraction liquid.

4. The extraction and purification process according to claim 1, wherein The first concentration (3) is to concentrate the flash extract to a clear paste with 1 mL equivalent to 1 g of medicinal material.

5. The extraction and purification process according to claim 1, wherein The impurity removal (4) is as follows: add 1.5%-2.5% of ZTC clarifier B solution to the clear paste, stir, and keep warm at 40℃-50℃ for 20 minutes. -30min, then add 1.0%-1.5% ZTC clarifier A solution, keep warm at 40℃-50℃ for 20min-30min, let it stand for 24h, filter and use the filtrate for later use.

6. The extraction and purification process according to claim 5, wherein: The (4) impurity removal is as follows: add 2.0% ZTC clarifier B solution to the clear paste, stir, keep warm at 40°C for 20 minutes, then add 1.0% ZTC clarifier A solution, keep warm at 40°C for 20 minutes, let it stand for 24 hours, filter, and use the filtrate for later use.

7. The extraction and purification process according to any one of claims 1, 5 and 6, wherein: The dosage ratio of the ZTC clarifier A solution to the ZTC clarifier B solution is 1:

2.

8. The extraction and purification process according to claim 1, wherein: The second concentration (5) is as follows: the filtrate is concentrated to a thick paste with a density of 1.

25.

9. The extraction and purification process according to claim 1, wherein: The preparation in step (5) is in the form of granules, mixtures, pills or tablets.

10. Use of the product obtained by the extraction and purification process according to claim 9 in the preparation of a drug for treating diabetes.

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