A hypoglycemic traditional Chinese medicine preparation and a preparation method thereof

Abstract

The present application relates to the technical fields of active ingredient extraction and application, and discloses a preparation method of a blood sugar reducing traditional Chinese medicine preparation, comprising the following steps: filtering and centrifugally separating papaya milk obtained by cutting a papaya from a Chinese quince, collecting the upper liquid to obtain pretreated papaya milk; passing the pretreated papaya milk through an ultrafiltration membrane system with a molecular weight of 40000-55000 Dal, and collecting the milk permeating through the ultrafiltration membrane; passing the milk through an ultrafiltration membrane system with a molecular weight of 15000-30000 Dal, and collecting the milk intercepted by the ultrafiltration membrane; performing multi-stage freeze drying on the ultrafiltration membrane milk to obtain milk powder, and then preparing the milk powder into capsules, tablets or granules to obtain the blood sugar reducing traditional Chinese medicine preparation. The present application uses papaya milk as raw material to prepare milk powder with high blood sugar reducing activity through filtering, centrifuging and two-stage ultrafiltration membrane treatment, and the quality of the milk powder is high. The milk powder is used for preparing the blood sugar reducing traditional Chinese medicine preparation, and can improve the blood sugar reducing efficacy of the traditional Chinese medicine preparation.

Description

Technical Field

[0001] This invention relates to the field of active ingredient extraction and application technology, and in particular to a traditional Chinese medicine preparation for lowering blood sugar and its preparation method. Background Technology

[0002] Diabetes mellitus is one of the most common chronic endocrine and metabolic diseases threatening global health. With continuous economic development and changes in lifestyle, diabetes has become a major public health problem in my country, which currently has the largest number of diabetes patients globally, accounting for about a quarter of the world's total. In recent years, the onset of diabetes has shown a trend towards younger ages. Currently, drug treatment is the primary approach. Western medicine preparations have significant blood sugar-lowering effects, but they also have significant side effects, especially since diabetic patients need lifelong medication, which can exacerbate these side effects. Long-term use of Western hypoglycemic drugs may cause liver and kidney damage. Given the chronic nature of diabetes, long-term adjuvant therapy is crucial for controlling the disease and reducing drug side effects. Currently, global diabetes treatment strategies generally emphasize diet therapy, combined with exercise and medication, forming a comprehensive treatment plan. Diet therapy is particularly important for diabetes control. Natural blood sugar-lowering foods are widely available, have few side effects, and are inexpensive, making them easily accessible to the general public and an important means of daily health maintenance and self-care.

[0003] Papaya (Carica papaya L.) is an evergreen softwood shrub or small tree belonging to the genus Carica in the family Caricaceae. Papaya fruit is rich in nutrients, containing a variety of enzymes such as papain A and B, papainase A, lysozyme, lipase, papain protease, catalase, and phenol oxidase. The enzymes are most abundant in the latex of unripe fruit, accounting for about 40% of the dry weight. It also contains a relatively large amount of amino acids, vitamins, and trace elements, as well as various active substances such as sugars, fats, proteins, organic acids, saponins, flavonoids, and calcium salts. Early research by the inventors revealed that papaya has a hypoglycemic effect. Patent application CN 101810750 A disclosed a traditional Chinese medicine preparation containing papaya latex powder for lowering blood sugar. The preparation involves passing papaya latex through a 100-mesh sieve or centrifuging to remove impurities, ultrafiltration through a microporous membrane to remove hygroscopic impurities, and then drying and sterilizing under reduced pressure (65–70℃, 0.08–0.09 MPa) to obtain papaya latex powder. This powder, alone or in combination with other traditional Chinese medicine ingredients, can be used to prepare a hypoglycemic preparation with good hypoglycemic effects. However, the utilization of papaya latex powder in this patent application has the following problems: First, the method is relatively crude, lacking component refinement, and contains some components that have no effect on lowering blood sugar, especially hygroscopic components such as gum, pectin, and mucilage. This leads to moisture absorption in the finished product, reduced product stability, and a lack of targeted efficacy, resulting in insignificant hypoglycemic activity. Second, high-temperature sterilization reduces the enzyme activity in the papaya latex powder, affecting its hypoglycemic efficacy. Summary of the Invention

[0004] To address the above shortcomings, this invention provides a method for preparing a traditional Chinese medicine preparation for lowering blood sugar, thereby improving the efficacy of papaya latex powder and enhancing the auxiliary blood sugar-lowering effect of the traditional Chinese medicine preparation. The specific technical solution is as follows:

[0005] A method for preparing a traditional Chinese medicine preparation for lowering blood sugar includes the following steps:

[0006] (1) The papaya latex extracted from the green papaya fruit is filtered and centrifuged to separate the upper liquid and obtain pretreated papaya latex.

[0007] (2) The pretreated papaya latex obtained in step (1) is passed through an ultrafiltration membrane system with a molecular weight of 40,000 to 55,000 Da, and the latex that has passed through the ultrafiltration membrane is collected.

[0008] (3) Pass the milk obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 15,000 to 30,000 Da, and collect the milk retained by the ultrafiltration membrane.

[0009] (4) The milk obtained in step (3) is freeze-dried in multiple stages to obtain milk powder, and then the milk powder is prepared into capsules, tablets or granules to obtain a traditional Chinese medicine preparation for lowering blood sugar.

[0010] The technical principle of this invention is as follows: First, papaya milk is filtered and centrifuged to remove coarse particulate impurities, fine insoluble impurities, and impurities that are hygroscopic and can damage product stability, making the milk relatively pure and improving the efficiency of subsequent two-stage ultrafiltration. Then, two-stage ultrafiltration membranes are used to sequentially remove microorganisms and macromolecules without hypoglycemic effects, while retaining active ingredients with hypoglycemic effects from the milk, thus enhancing the hypoglycemic efficacy of the milk powder without the need for high-temperature sterilization. Selecting appropriate molecular weight cutoffs for the two-stage ultrafiltration membranes is crucial for the quality of the milk powder. By optimizing the parameters of the two-stage ultrafiltration membranes, the maximum filtration of macromolecules without hypoglycemic effects and those that are hygroscopic is achieved, while retaining active ingredients with hypoglycemic effects from the milk, thereby improving the quality of the milk powder.

[0011] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, step (1), the specific steps for extracting papaya latex from unripe papaya fruit include: selecting large, plump, and fully grown unripe papaya fruits (large, stopped growing but not yet yellowed fruits in the lower part of the fruit tree) from disease-free fruit trees and making 6-8 deep scratches of 2-3 mm on them; collecting papaya latex in a container below the fruit; and adding 0.05-0.1% calcium disodium edetate and 0.03-0.08% tea polyphenols (by weight of the papaya latex) to the papaya latex. As a stabilizer, potassium dihydrogen phosphate and sodium hydroxide are used as a pH buffer pair to adjust and stabilize the pH of the milk to 6.5–7.5. Then, the milk is filtered through 40–60 mesh and 200–300 mesh sieves sequentially. A suitable scratch depth is designed to effectively collect papaya milk with hypoglycemic properties. If the scratch is too deep, the collected milk will contain more hygroscopic substances such as gum, pectin, and mucilage, which have no effect on lowering blood sugar, reducing the efficacy of the milk and increasing the difficulty of subsequent extraction of effective components, thus reducing product stability. Adding disodium calcium edetate and tea polyphenols, combined with pH adjustment, can effectively maintain the stability of the milk and protect its effective active components.

[0012] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, in step (1), a vibrating sieve with a 40-mesh aperture is used for coarse filtration to remove coarse particulate impurities larger than 40 mesh, thereby improving the efficiency of the subsequent plate and frame filter press and the quality of the filtrate; then, a plate and frame filter press is used for filtration, employing a dedicated 200-mesh polyester filter cloth to remove finer suspended solid impurities and make the milk purer. The working pressure is 0.6–0.8 MPa. The plate and frame filter press is simple to operate, easy to clean, and highly efficient.

[0013] Preferably, in the above-mentioned method for preparing a blood sugar-lowering traditional Chinese medicine preparation, in step (1), the filtered milk is ground with a colloid mill to make the milk particles finer, close to the size of colloidal particles, so that the protease can be dissolved more fully.

[0014] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, in step (1), the centrifugation speed is 8000-10000 r / min. Centrifugation removes finer insoluble impurities, making the milk purer and improving the efficiency of two-stage ultrafiltration.

[0015] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, in step (2), the ultrafiltration membrane has a molecular weight of 45,000 Da and a pressure of 0.3–0.4 MPa; in step (3), the ultrafiltration membrane has a molecular weight of 20,000 Da and a pressure of 0.2–0.3 MPa. The content of effective active substances in the milk powder obtained by treatment with 45,000 Da and 20,000 Da is significantly increased. Hollow fiber ultrafiltration membrane is preferably used for ultrafiltration. Hollow fiber ultrafiltration technology is mature and has high processing efficiency. Polyamide is selected as the material of the ultrafiltration membrane.

[0016] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, the multi-stage freeze drying is performed as follows: maintaining at -45 to -40°C for 15 to 30 minutes, maintaining at -30 to -20°C for 15 to 30 minutes, and maintaining at -10°C for 2 to 4 hours.

[0017] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, the milk powder is prepared by using one or more of the following raw materials: Atractylodes lancea, Ligusticum chuanxiong, Scrophularia ningpoensis, Dioscorea opposita, and Paeonia lactiflora. Combining the milk powder with one or more of the following raw materials can further enhance the hypoglycemic effect.

[0018] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, the following ingredients are used as raw materials: 1 part of milk powder, 1.5-28 parts of Atractylodes lancea, 1.5-28 parts of Ligusticum chuanxiong, 0.5-13 parts of Scrophularia ningpoensis, and 1-13 parts of Dioscorea opposita.

[0019] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, 1 part of milk powder and 5-18 parts of red peony root are used as raw materials to prepare the hypoglycemic traditional Chinese medicine preparation. Red peony root is the dried root of the Ranunculaceae plant Paeonia lactiflora. The root contains saponins, flavonoids, tannins, etc., and has the effects of clearing heat and cooling blood, removing blood stasis and relieving pain, and promoting blood circulation. It has good pharmacological effects on lowering blood sugar, lowering blood lipids, and anti-tumor.

[0020] Preferably, in the above-mentioned method for preparing a hypoglycemic traditional Chinese medicine preparation, step (4) includes: extracting the red peony root with 8-10 times its volume of water, extracting 2-3 times, combining the extracts, concentrating under reduced pressure to a thick extract with a relative density of 1.20-1.25, then drying under reduced pressure and pulverizing to obtain red peony root extract powder, mixing the red peony root extract powder with the milk powder, and preparing capsules, tablets, or granules to obtain a hypoglycemic traditional Chinese medicine preparation. The hypoglycemic activity of the combination of milk powder and red peony root extract powder is significantly higher than that of milk powder and red peony root extract powder alone, exhibiting a synergistic effect.

[0021] The present invention also provides a traditional Chinese medicine preparation for lowering blood sugar, which is prepared by the above-described preparation method.

[0022] Compared with the prior art, the beneficial effects of the present invention are:

[0023] 1. In the preparation method of the hypoglycemic traditional Chinese medicine preparation of the present invention, papaya latex is used as raw material and is prepared by filtration, centrifugation and two-stage ultrafiltration membrane treatment to obtain latex powder with high hypoglycemic activity. The latex powder has high quality and can be used to prepare hypoglycemic traditional Chinese medicine preparations, thereby enhancing the hypoglycemic efficacy of the traditional Chinese medicine preparations.

[0024] 2. This invention first filters and centrifuges papaya milk to remove coarse particulate impurities and fine insoluble impurities, making the milk relatively pure and improving the efficiency of subsequent two-stage ultrafiltration. Then, by optimizing the molecular weight cutoff of the two-stage ultrafiltration membranes, microorganisms, large molecular impurities that do not have a hypoglycemic effect and are prone to moisture absorption and damage product stability are successively removed, while active ingredients with hypoglycemic effects in the milk are extracted. High-temperature sterilization is no longer required, which can enhance the hypoglycemic efficacy of the milk powder.

[0025] 3. In the preparation method of the hypoglycemic traditional Chinese medicine preparation of the present invention, by combining the processed milk powder with one or more of Atractylodes lancea, Ligusticum chuanxiong, Scrophularia ningpoensis, Dioscorea opposita and Paeonia lactiflora, the hypoglycemic effect can be further enhanced, which helps to maintain a healthy blood sugar level.

[0026] 4. In the preparation method of the hypoglycemic traditional Chinese medicine preparation of the present invention, the processing of papaya latex is carried out at room temperature, which can maximize the protection of the activity of the active ingredients and improve the quality of the latex powder; no complicated procedures are required, the preparation process is relatively simple, the processes involved are relatively mature technologies, the processing efficiency is high, the cost is low, only water is needed as the solvent system, it is green and pollution-free, safe and efficient, and conducive to large-scale production. Attached Figure Description

[0027] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0028] Figure 1 This is a graph showing the results of the glucose tolerance test in a hyperglycemic model mouse in the experimental examples of this invention. Detailed Implementation

[0029] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. Unless otherwise defined, all technical terms used below have the same meaning as commonly understood by those skilled in the art. The technical terms used herein are for the purpose of describing specific embodiments only and are not intended to limit the scope of protection of the present invention. Unless otherwise specifically stated, all raw materials, reagents, instruments, and equipment used in the present invention are commercially available or can be prepared by existing methods.

[0030] Example 1: Preparation of Milk Powder

[0031] The method for preparing the milk powder in this embodiment includes:

[0032] (1) Select large, plump, and fully grown green papayas from disease-free fruit trees, and make 6-8 cuts 2-3 mm deep with a knife. Collect the papaya latex in a container under the fruit. Add 0.08% disodium calcium edetate and 0.05% tea polyphenols by weight of the collected papaya latex as stabilizers. Adjust the pH of the latex to 7 using potassium dihydrogen phosphate-sodium hydroxide solution. Then, coarsely filter the papaya latex through a 40-mesh vibrating screen and then filter it through a plate and frame filter press using a special 200-mesh polyester filter cloth.

[0033] The filtered milk was ground once in a colloid mill; then it was centrifuged for 10 minutes at 8000 r / min, and the supernatant was collected to obtain pretreated papaya milk.

[0034] (2) Pass the pretreated papaya latex obtained in step (1) through an ultrafiltration membrane system with a molecular weight of 45000 Dal and a pressure of 0.3 MPa, and collect the latex that has passed through the ultrafiltration membrane.

[0035] (3) Pass the milk obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 20000 Da1 at a pressure of 0.2 MPa and collect the milk retained by the ultrafiltration membrane.

[0036] (4) The milk obtained in step (3) is subjected to multi-stage freeze-drying to obtain milk powder. The multi-stage freeze-drying is carried out in the following order: holding at -45℃ for 20 min, holding at -25℃ for 30 min, and holding at -10℃ for 3 h.

[0037] The above filtration, centrifugation, and ultrafiltration are all carried out at room temperature. If the next step cannot be carried out in time (more than 2 hours) during the preparation process, the milk needs to be stored in an environment below 10°C.

[0038] Comparative Example 1

[0039] This comparative example differs from Example 1 in that it does not include steps (2) and (3), and the pretreated papaya latex is directly freeze-dried, while the rest is the same as in Example 1.

[0040] Comparative Example 2

[0041] The difference between this comparative example and Example 1 is that an ultrafiltration membrane system with a molecular weight of 10,000 Dal is used in step (3), while the rest is the same as in Example 1.

[0042] Comparative Example 3

[0043] The difference between this embodiment and embodiment 1 is that an ultrafiltration membrane system with a molecular weight of 65000 Dal is used in step (2), while the rest is the same as in embodiment 1.

[0044] Comparative Example 4

[0045] The difference between this comparative example and Example 1 is that in step (1), 0.2% cystine, 0.1% ethylenediaminetetraacetic acid, and 0.5% sodium sulfite are used to replace 0.08% disodium calcium edetate and 0.05% tea polyphenols, and the pH is not adjusted (the pH of the milk is 5). Otherwise, it is the same as Example 1.

[0046] The enzyme content and activity of the milk powder prepared in Example 1 and Comparative Examples 1-4 were tested using ultraviolet spectrophotometry.

[0047] Table 1. Enzyme content and activity of the milk powders prepared in Example 1 and Comparative Examples 1-4

[0048] project Total enzyme content Total enzyme activity (u / g) Example 1 97％ 3.4 million Comparative Example 1 52％ 1.6 million Comparative Example 2 92％ 3.2 million Comparative Example 3 86％ 2.8 million Comparative Example 4 94％ 3 million

[0049] Example 2: Preparation of the hypoglycemic composition

[0050] The hypoglycemic composition comprises, by weight, the following ingredients: 1 part milk powder, 18 parts Atractylodes lancea, 12 parts Ligusticum chuanxiong, 8 parts Scrophularia ningpoensis, and 4 parts Dioscorea opposita. The milk powder is the milk powder prepared in Example 1.

[0051] The preparation method of the hypoglycemic composition in this embodiment includes the following steps:

[0052] S1. Remove impurities from the medicinal materials and slice them; grind 6 portions of Ligusticum chuanxiong into powder and pass it through a 60-mesh sieve;

[0053] S2. Place sliced ​​Atractylodes lancea, the remaining Ligusticum chuanxiong, Scrophularia ningpoensis, and Dioscorea opposita into a herbal extraction tank. Add 8 times the amount of drinking water and decoct twice. Soak the herbs for 1 hour before the first decoction. Each decoction should last 1.5 hours. Filter both decoctions through a 120-mesh sieve and combine them to obtain the decoction. Transfer the decoction to a single-effect evaporator for vacuum concentration until a thick extract with a relative density of 1.25 (60℃) is obtained. Vacuum concentration conditions: temperature 60℃, pressure 0.06 MPa.

[0054] S3. Dry the thick extract under reduced pressure using a vacuum dryer. Drying conditions: temperature 85℃, vacuum degree 0.08Mpa; until the moisture content of the extract block is ≤5%. Remove and pulverize using a high-efficiency pulverizer. Pass the fine powder through a 60-mesh sieve for later use.

[0055] S4. Mix the formula amount of milk powder and chuanxiong powder with the dry extract powder evenly. The mixing equipment is a two-dimensional or three-dimensional mixer. The mixing time is 20 minutes until the fine powder has a uniform color and is homogeneous, thus obtaining the hypoglycemic composition.

[0056] Example 3

[0057] The hypoglycemic composition of this embodiment consists of the following raw materials by weight: 1 part milk powder, 20 parts Atractylodes lancea, 4 parts Ligusticum chuanxiong, 13 parts Scrophularia ningpoensis, and 2 parts Dioscorea opposita. The milk powder is the milk powder prepared in Example 1.

[0058] The difference between the preparation method of the hypoglycemic composition in this embodiment and that in Example 1 is that, except for step (1) which involves pulverizing 2 kg of Ligusticum chuanxiong, the rest is as described in Example 2.

[0059] Example 4

[0060] The hypoglycemic composition comprises, by weight, the following ingredients: 1 part milk powder and 10 parts red peony root. The milk powder is the milk powder prepared in Example 1.

[0061] The preparation method of the hypoglycemic composition in this embodiment includes the following steps:

[0062] S1. Remove impurities from the red peony root and slice it;

[0063] S2. Place sliced ​​red peony root in a herbal extraction tank, add 8 times the amount of drinking water, and decoct twice. Soak the herbs for 1 hour before the first decoction, and decoct for 1.5 hours each time. Filter both decoctions through a 120-mesh sieve, combine them, and obtain the decoction. Transfer the decoction to a single-effect evaporator for vacuum concentration until a thick extract with a relative density of 1.25 (60℃) is obtained. Vacuum concentration conditions: temperature 80℃, pressure 0.09MPa;

[0064] S3. The thick extract is dried under reduced pressure using a vacuum dryer under the following conditions: temperature 85℃, vacuum degree 0.08MPa; until the moisture content of the extract blocks is ≤5%. The dried extract is then removed and pulverized using a high-efficiency pulverizer. The fine powder is passed through a 60-mesh sieve to obtain dried peony extract powder.

[0065] S4. Mix the formula amount of milk powder and dry extract powder evenly. The mixing equipment is a two-dimensional or three-dimensional mixer. The mixing time is 20 minutes until the fine powder has a uniform color and is homogeneous, thus obtaining the hypoglycemic composition.

[0066] Preparation of Traditional Chinese Medicine Preparations for Lowering Blood Sugar

[0067] The milk powder prepared in Example 1, the hypoglycemic composition prepared in Example 2, Example 3 or Example 4, with or without pharmaceutically acceptable excipients, are formulated into capsules, tablets or granules to obtain a hypoglycemic traditional Chinese medicine preparation.

[0068] Example 5

[0069] The milk powder prepared in Example 1 was filled into capsules to obtain a hypoglycemic capsule.

[0070] Example 6

[0071] The hypoglycemic composition prepared in Example 2 was filled into capsules to obtain hypoglycemic capsules.

[0072] Example 7

[0073] The hypoglycemic composition prepared in Example 4 was filled into capsules to obtain hypoglycemic capsules.

[0074] Example 8

[0075] The hypoglycemic composition prepared in Example 2 was mixed with citric acid at a weight ratio of 100:1, and then filled into capsules to obtain a hypoglycemic capsule.

[0076] The following experiment was commissioned to the Guangxi Center for Disease Control and Prevention.

[0077] Experimental examples help maintain healthy blood sugar levels in animal studies.

[0078] The testing was conducted according to the "Methods for Functional Testing and Evaluation of Health Foods" (2023 edition).

[0079] 1.1 Experimental Materials and Conditions

[0080] Test samples: Milk powder A (Example 1), milk powder B (Comparative Example 1), milk powder C (Comparative Example 2), hypoglycemic composition A (Example 2), hypoglycemic composition B (Example 4), and dried peony extract powder (prepared according to the preparation method in Example 4).

[0081] Experimental animals: (Grade II) Healthy adult male Kunming mice, weighing 23-28 grams.

[0082] Experimental environmental conditions: Temperature in the experimental animal room: 22-25℃, relative humidity: 55-70%.

[0083] 1.2 Test Methods

[0084] (1) Dosage selection and administration method of the test substance:

[0085] Based on the recommended human dosage of the sample (equivalent to 50 mg / kg BW), three experimental groups of hypoglycemic composition A were set up with low, medium, and high doses of 0.5, 1, and 1.5 g / kg BW (equivalent to 10, 20, and 30 times the recommended human dosage, respectively). At the same time, experimental groups of medium dose milk powder A, milk powder B, milk powder C, hypoglycemic composition B, and dried peony extract powder were set up. A model control group was set up, with 13 mice in each group. In addition, a normal animal test sample group (high dose hypoglycemic composition A) and a blank control group were set up, with 13 mice in each group. Blood glucose-lowering composition A solutions with concentrations of 25, 50, and 75 mg / mL were prepared using distilled water and the solution. Then, aqueous solutions of milk powder A, milk powder B, milk powder C, blood glucose-lowering composition B, and dried peony extract powder with concentrations of 50 mg / mL were prepared. These solutions were administered to the corresponding dosage groups of animals via gavage at a volume of 0.2 mL / 10 g BW. The model control group and normal animal control group received an equal volume of distilled water, while the normal animal test sample group received an equal volume of blood glucose-lowering composition A solution at a concentration of 75 mg / mL. All solutions were administered via gavage once daily for 30 consecutive days.

[0086] (2) Animal modeling of hyperglycemia:

[0087] Mice were fasted for 24 hours and then given a single intraperitoneal injection of alloxan (100 mg / kg BW) to induce hyperglycemia. Five days later, after a 4-hour fast, blood was drawn from the inner canthus of the eye to measure blood glucose levels. Mice with a blood glucose level of 10–25 mmol / L were considered to have successfully developed a hyperglycemic model.

[0088] (3) Hypoglycemic model animal experiment:

[0089] Hyperglycemic model mice were randomly divided into groups based on their blood glucose levels after a 4-hour fast: one model control group and eight experimental groups (with a difference between groups not exceeding 1.1 mmol / L). The experimental groups were given sample solutions of the corresponding concentrations, while the model control group was given distilled water. Fasting blood glucose levels were measured for 30 consecutive days (fasting was the same as before the experiment), and the blood glucose levels of each group were compared.

[0090] (4) Glucose tolerance test in hyperglycemic model animals:

[0091] Hyperglycemic model mice were randomly divided into groups based on their blood glucose levels after a 4-hour fast: one model control group and three experimental groups (with a difference between groups not exceeding 1.1 mmol / L). The experimental groups were given the corresponding concentration of sample solution, while the model control group received distilled water, for 30 consecutive days. On day 31, the mice were fasted for 4 hours. The experimental groups were given the corresponding concentration of sample solution, while the model control group received distilled water. Fifteen minutes later, each group was orally administered glucose solution (2.0 g / kg BW). Blood glucose levels were measured at 0, 0.5, and 2 hours after glucose administration. Changes in blood glucose levels and the area under the blood glucose curve were observed between the model control group and the experimental groups at these time points (0, 0.5, and 2 hours).

[0092] Area under the blood glucose curve = 0.25 × (0-hour blood glucose value + 4 × 0.5-hour blood glucose value + 3 × 2-hour blood glucose value)

[0093] (5) Normal animal experiments

[0094] Twenty-six mice were randomly divided into two groups based on their blood glucose levels after a 4-hour fast: a test sample group (high-dose hypoglycemic composition A) and a blank control group, with 13 mice in each group. The test sample group was given the corresponding concentration of the sample solution, while the model control group was given distilled water, for 30 consecutive days. Fasting blood glucose levels were measured (fasting was the same as before the experiment), and the blood glucose levels and percentage decrease in blood glucose were compared among the groups.

[0095] Experimental results:

[0096] Table 1 shows the fasting blood glucose results of normal animal experimental mice. As can be seen from the table, the blood glucose level of the experimental group on day 30 was not significantly different from that before the experiment, nor was it significantly different from that of the blank control group, indicating that the sample had virtually no effect on the fasting blood glucose of normal mice.

[0097] Table 1. Fasting blood glucose results in normal mice

[0098]

[0099] The results of the hypoglycemic experiment in hyperglycemic model animals are shown in Table 2. As can be seen from the table, compared with the model group, all groups (low, medium, and high doses) of hypoglycemic composition A reduced blood glucose levels in the hyperglycemic model rats, with the high-dose group showing a significant reduction in blood glucose levels. The milk powder prepared in this invention can itself reduce blood glucose levels in hyperglycemic model rats. The hypoglycemic effect is enhanced when combined with Atractylodes lancea, Ligusticum chuanxiong, Scrophularia ningpoensis, Dioscorea opposita, or Paeonia lactiflora, indicating that the components in the hypoglycemic composition have a synergistic effect, which enhances its hypoglycemic effect.

[0100] Table 2. Fasting blood glucose results in hyperglycemic model mice.

[0101]

[0102]

[0103] Results of glucose tolerance test in hyperglycemic model mice are shown in Figure 1 As shown in Table 3, the blood glucose levels of mice in each group first increased and then decreased from 0 min. Compared with the model control group, the blood glucose levels of both the hypoglycemic composition group and the milk powder group decreased at 2 h. Table 3 shows that compared with the model control group, the area under the blood glucose curve of mice in the high- and medium-dose hypoglycemic composition A experimental groups was significantly reduced, indicating that both the high- and medium-dose hypoglycemic compositions can inhibit the glucose-induced increase in blood glucose.

[0104] Table 3 Results of glucose tolerance test in hyperglycemic model mice

[0105]

[0106] The foregoing description of specific exemplary embodiments of the present invention is intended to illustrate and demonstrate the technical solutions of the invention. These descriptions are not intended to limit the invention to the precise forms disclosed, and it will be apparent that many changes and variations can be made based on the foregoing teachings. The exemplary embodiments were chosen and described in order to explain the specific principles of the invention and its practical application, thereby enabling those skilled in the art to implement and utilize various different exemplary embodiments of the invention, as well as various different choices and variations. The scope of the invention is intended to be defined by the claims and their equivalents.

Claims

1. A method for preparing a traditional Chinese medicine preparation for lowering blood sugar, characterized in that, Includes the following steps: (1) Make 6-8 deep scratches of 2-3 mm on the green papaya fruit, collect the papaya latex in a container under the fruit, add 0.05-0.1% disodium calcium edetate and 0.01-0.03% tea polyphenols by weight of the papaya latex to the papaya latex, and adjust the pH of the latex to 6.5-7.5 with potassium dihydrogen phosphate and sodium hydroxide; filter the papaya latex, centrifuge to separate it, collect the upper liquid to obtain pretreated papaya latex; (2) Pass the pretreated papaya latex obtained in step (1) through an ultrafiltration membrane system with a molecular weight of 45000 Dal at a pressure of 0.3~0.4 MPa, and collect the latex that has passed through the ultrafiltration membrane. (3) Pass the milk obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 20000 Da at a pressure of 0.2~03 MPa, and collect the milk retained by the ultrafiltration membrane; (4) The milk obtained in step (3) is freeze-dried in multiple stages to obtain milk powder. Then, 1 part of milk powder and 5-18 parts of red peony root are used as raw materials. The red peony root is extracted with 8-10 times water, and extracted 2-3 times. The extracts are combined and concentrated under reduced pressure to a thick extract with a relative density of 1.20-1.

25. Then, the extract is vacuum dried under reduced pressure and pulverized to obtain red peony root extract powder. The red peony root extract powder and milk powder are mixed to prepare capsules, tablets or granules to obtain a traditional Chinese medicine preparation for lowering blood sugar.

2. The method for preparing the hypoglycemic traditional Chinese medicine preparation according to claim 1, characterized in that, In step (1), the papaya juice is filtered by sequentially using 40-60 mesh and 200-300 mesh sieves.

3. The method for preparing the hypoglycemic traditional Chinese medicine preparation according to claim 1, characterized in that, In step (1), the centrifugal speed is 8000-10000 r / min.

4. The method for preparing the hypoglycemic traditional Chinese medicine preparation according to claim 1, characterized in that, In step (4), the multi-stage freeze drying is performed as follows: maintaining at -45~-40℃ for 15~30min, maintaining at -30~-20℃ for 15~30min, and maintaining at -10℃ for 2~4h.

5. A traditional Chinese medicine preparation for lowering blood sugar, characterized in that, The traditional Chinese medicine preparation is prepared by the preparation method described in any one of claims 1 to 4.

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