Traditional Chinese medicine preparation for reducing blood sugar and preparation method thereof

Abstract

The invention relates to the technical field of active ingredient extraction and application, and discloses a preparation method of a traditional Chinese medicine preparation for reducing blood sugar, which comprises the following steps: filtering and centrifugally separating papaya milk cut from papaya green fruits, and collecting supernatant liquid to obtain pretreated papaya milk; enabling the pretreated papaya milk to pass through an ultrafiltration membrane system with the molecular weight of 40000-55000Dal, and collecting milk penetrating through an ultrafiltration membrane; enabling the milk to pass through an ultrafiltration membrane system with the molecular weight of 15000-30000 Dal, and collecting the milk intercepted by an ultrafiltration membrane; performing multi-stage freeze drying on the ultrafiltration membrane milk to obtain milk powder, and preparing capsules, tablets or granules from the milk powder to obtain the traditional Chinese medicine preparation for reducing blood sugar. The milk powder with high hypoglycemic activity is prepared from the papaya milk as the raw material through filtration, centrifugation and two-stage ultrafiltration membrane treatment, and the milk powder is high in quality and can improve the hypoglycemic effect of the traditional Chinese medicine preparation when being used for preparing the hypoglycemic traditional Chinese medicine preparation.

Description

Technical Field

[0001] The invention relates to the technical field of active ingredient extraction and application, and in particular to a blood sugar lowering traditional Chinese medicine preparation and a preparation method thereof. Background Art

[0002] Diabetes is one of the common chronic endocrine metabolic diseases that threatens human health worldwide. With the continuous development of the economy and the change of lifestyle, diabetes has become one of the major public health problems facing my country. China has now become the country with the largest number of diabetes patients in the world, accounting for about a quarter of the total number of diabetes in the world. In recent years, the incidence of diabetes has shown a trend of younger age. At present, drug treatment is mainly used. Western medicine preparations have significant hypoglycemic effects, but the side effects are relatively large. In particular, diabetics need to take medication for life, and the side effects will be greater. Long-term use of Western medicine hypoglycemic drugs may cause liver and kidney damage. In view of the chronic characteristics of diabetes, long-term auxiliary treatment is essential for controlling the disease and reducing drug side effects. At present, the global treatment strategy for diabetes generally attaches importance to diet therapy, combined with exercise therapy and drug therapy, which together constitute a comprehensive treatment plan. Among them, diet therapy is particularly important for diabetes control. Natural hypoglycemic foods have the characteristics of wide sources, small side effects, and low prices. They are easily accepted by ordinary people and are an important means of daily health care and self-care.

[0003] Papaya (Carica papaya L.) is an evergreen softwood small tree of the genus Carica of the family Caricaceae. Papaya fruit is rich in nutrients, including chymopapain A and B, papain A, lysozyme, lipase, papain, catalase, phenoloxidase and other enzymes. The enzyme content is highest in the latex of immature fruits, accounting for about 40% of the dry weight; it also contains a large amount of amino acids, vitamins and trace elements, as well as sugars, fats, proteins, organic acids, saponins, flavonoids, calcium salts and other active substances. The inventors found in their early studies that papaya has a hypoglycemic effect. In the patent application with the publication number CN 101810750 A, a hypoglycemic Chinese medicine preparation containing papaya latex powder is disclosed. The papaya latex is passed through a 100-mesh sieve or centrifuged to remove impurities, the hygroscopic impurities are removed by ultrafiltration with a microporous filter membrane, and the papaya latex powder is dried under reduced pressure and sterilized (65-70°C, 0.08-0.09Mpa). The papaya latex powder is prepared into a hypoglycemic preparation alone or in combination with other Chinese medicine ingredients, which has a good hypoglycemic effect. The use of papaya latex powder in the patent application has the following problems: first, the use is relatively extensive, and the ingredients are not refined. It contains some ingredients that have no effect on hypoglycemia, especially gum, pectin, mucus juice and other hygroscopic ingredients, which will cause the finished product to absorb moisture and reduce product stability. The effect is not well targeted and the hypoglycemic activity is not significant; second, the use of high-temperature sterilization will reduce the enzyme activity in the papaya latex powder, affecting the hypoglycemic effect. Summary of the invention

[0004] In view of the above shortcomings, the present invention provides a method for preparing a Chinese medicine preparation for lowering blood sugar, improves the efficacy of papaya latex powder, and improves the auxiliary blood sugar lowering effect of the Chinese medicine preparation. The specific technical scheme is as follows:

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

[0006] (1) filtering and centrifuging papaya latex cut from green papaya fruits, collecting the upper liquid, and obtaining pretreated papaya latex;

[0007] (2) passing the pretreated papaya latex obtained in step (1) through an ultrafiltration membrane system with a molecular weight of 40,000 to 55,000 Da1, and collecting the latex that passes through the ultrafiltration membrane;

[0008] (3) passing the latex obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 15,000 to 30,000 Da1, and collecting the latex retained by the ultrafiltration membrane;

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

[0010] The technical principle of the technical solution of the present invention is: firstly, the papaya latex is filtered and centrifuged to remove coarse particle impurities, fine insoluble impurities, and impurities that are easy to absorb moisture and destroy the stability of the product, so that the milk is relatively pure and the efficiency of the subsequent two-stage ultrafiltration is improved; then, a two-stage ultrafiltration membrane is used to intercept and remove microorganisms and macromolecular substances without hypoglycemic effect, intercept the active ingredients with hypoglycemic effect in the milk, and improve the hypoglycemic effect of the milk powder without high temperature sterilization. Selecting a suitable molecular weight cutoff of the two-stage ultrafiltration membrane is critical to the quality of the milk powder. By optimizing the parameters of the two-stage ultrafiltration membrane, macromolecular substances without hypoglycemic effect and easy to absorb moisture are filtered out to the greatest extent, and the active ingredients with hypoglycemic effect in the milk are retained, thereby improving the quality of the milk powder.

[0011] Preferably, in the preparation method of the above-mentioned Chinese medicine preparation for hypoglycemic effect, in the step (1), the papaya latex cut from the green papaya fruit comprises the following specific steps: selecting a large, full, full-grown green papaya fruit (a large green fruit at the bottom of the fruit tree that has stopped growing but has not turned yellow) from a disease- and insect-free fruit tree and making 6 to 8 scratches with a depth of 2 to 3 mm, collecting the papaya latex in a container under the fruit, adding 0.05 to 0.1% of calcium disodium edetate and 0.03 to 0.08% of tea polyphenols ( 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 40-60 mesh and 200-300 mesh screens are used for filtering in turn; designing a suitable scratch depth can effectively collect papaya milk with blood sugar lowering effect. If the scratch is too deep, the collected milk contains more gum, pectin, mucus juice and other substances that are easy to absorb moisture and have no effect on lowering blood sugar, which reduces the efficacy of the milk and increases the difficulty of subsequent interception of effective ingredients, reducing the stability of the product. By adding disodium calcium edetate and tea polyphenols combined with pH adjustment, the stability of the milk can be effectively maintained and the effective active ingredients of the milk can be protected.

[0012] Preferably, in the preparation method of the above-mentioned Chinese medicine preparation for hypoglycemic effect, in the step (1), a vibrating screen machine with a sieve hole of 40 mesh is used for coarse filtration to filter out coarse particle impurities above 40 mesh, thereby improving the efficiency and filtrate quality of the subsequent plate-frame filter press; and then a plate-frame filter press device is used for filter press, and a special 200-mesh polyester filter press cloth is used for filter press, in order to remove finer suspended solid impurities and make the milk purer. The working pressure is 0.6-0.8MPa, and the plate-frame filter press is simple and easy to operate, easy to clean, and very efficient.

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

[0014] Preferably, in the method for preparing the above-mentioned Chinese medicine preparation for lowering blood sugar, in the step (1), the centrifugal speed is 8000-10000 r / min. Centrifugal separation removes finer insoluble impurities, makes the milk purer, and improves the efficiency of the two-stage ultrafiltration.

[0015] Preferably, in the preparation method of the above-mentioned hypoglycemic Chinese medicine preparation, in the step (2), the molecular weight of the ultrafiltration membrane is 45000Dal and the pressure is 0.3-0.4MPa; in the step (3), the molecular weight of the ultrafiltration membrane is 20000Dal and the pressure is 0.2-03MPa. The content of effective active substances in the milk powder obtained by the treatment with 45000Dal and 20000Dal is greatly increased. Ultrafiltration preferably uses hollow fiber ultrafiltration membrane. The hollow fiber ultrafiltration method is mature in technology and has high processing efficiency. The ultrafiltration membrane material is polyamide.

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

[0017] Preferably, in the preparation method of the above-mentioned Chinese medicine preparation for hypoglycemia, the latex powder and one or more of Atractylodes macrocephala, Chuanxiong rhizome, Scrophularia ningpoensis, Chinese yam, and red peony root are used as raw materials to prepare the Chinese medicine preparation for hypoglycemia. The latex powder is combined with one or more of Atractylodes macrocephala, Chuanxiong rhizome, Scrophularia ningpoensis, Chinese yam, and red peony root to further enhance the hypoglycemic effect.

[0018] Preferably, in the preparation method of the above-mentioned hypoglycemic traditional Chinese medicine preparation, according to weight parts, 1 part of latex powder, 1.5-28 parts of Atractylodes lancea, 1.5-28 parts of Chuanxiong, 0.5-13 parts of Scrophularia ningpoensis, and 1-13 parts of Dioscorea opposita are used as raw materials to prepare the hypoglycemic traditional Chinese medicine preparation.

[0019] Preferably, in the preparation method of the above-mentioned hypoglycemic Chinese medicine preparation, 1 part of latex powder and 5 to 18 parts of red peony root are used as raw materials to prepare the hypoglycemic Chinese medicine preparation. Red peony root is the dried root of the Ranunculaceae plant Sichuan red peony root, which 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, and has good pharmacological effects on lowering blood sugar, lowering blood lipids, and anti-tumor.

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

[0021] The present invention also provides a Chinese medicine preparation for reducing blood sugar, and the Chinese medicine preparation is prepared by the above-mentioned preparation method.

[0022] Compared with the prior art, the present invention has the following beneficial effects:

[0023] 1. In the preparation method of the hypoglycemic Chinese medicine preparation of the present invention, papaya latex is used as a raw material to prepare a latex powder with high hypoglycemic activity through filtration, centrifugation, and two-stage ultrafiltration membrane treatment. The latex powder has high quality and is used to prepare the hypoglycemic Chinese medicine preparation, which can improve the hypoglycemic effect of the Chinese medicine preparation.

[0024] 2. The present invention first filters and centrifuges papaya latex to remove coarse particle impurities and fine insoluble impurities, so that the latex is relatively pure and the efficiency of the subsequent two-stage ultrafiltration is improved; then, the molecular weight cutoff of the two-stage ultrafiltration membrane is optimized to sequentially intercept and remove microorganisms and macromolecular impurities that have no hypoglycemic effect and easily absorb moisture to destroy product stability, and intercept active ingredients with hypoglycemic effect in the latex, without the need for high-temperature sterilization, thereby improving the hypoglycemic effect of the latex powder.

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

[0026] 4. In the preparation method of the hypoglycemic Chinese medicine preparation of the present invention, the treatment of papaya latex is carried out at room temperature, which can protect the activity of the effective ingredients to the greatest extent 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 treatment 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 is conducive to large-scale production. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments. Obviously, the drawings described below are some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0028] Figure 1 This is a graph showing the results of a glucose tolerance test on hyperglycemia model mice in a test example of the present invention. DETAILED DESCRIPTION

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

[0030] Example 1 Preparation of milk powder

[0031] The preparation method of the milk powder of the present embodiment comprises:

[0032] (1) Selecting a large, full-grown, full-term papaya fruit from a pest-free fruit tree, using a knife to make 6 to 8 scratches with a depth of 2 to 3 mm, and using a container to collect papaya latex under the fruit; adding 0.08% of calcium disodium edetate and 0.05% of tea polyphenols as stabilizers to the collected papaya latex, and using potassium dihydrogen phosphate-sodium hydroxide solution to adjust the pH of the latex to 7; then coarse filtering the papaya latex with a 40-mesh vibrating screen machine, and then entering a plate-frame filter press device for filter pressing, and using a dedicated 200-mesh polyester filter press cloth for filter pressing;

[0033] The filtered latex was put into a colloid mill for grinding once; then centrifuged at a speed of 8000 r / min for 10 min, and the upper layer of liquid was collected to obtain the pretreated papaya latex;

[0034] (2) passing the pretreated papaya latex obtained in step (1) through an ultrafiltration membrane system with a molecular weight of 45000 Da1 at a pressure of 0.3 MPa, and collecting the latex that passes through the ultrafiltration membrane;

[0035] (3) passing the latex obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 20,000 Da1 at a pressure of 0.2 MPa, and collecting the latex retained by the ultrafiltration membrane;

[0036] (4) The milk obtained in step (3) is subjected to multi-stage freeze-drying to obtain milk powder, wherein the multi-stage freeze-drying is carried out in the following order: keeping at -45°C for 20 minutes, keeping at -25°C for 30 minutes, and keeping at -10°C for 3 hours.

[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 is different from Example 1 in that it does not include step (2) and step (3), and the pretreated papaya latex is directly freeze-dried. Other steps are the same as Example 1.

[0040] Comparative Example 2

[0041] This comparative example is different from Example 1 in that an ultrafiltration membrane system with a molecular weight of 10000 Da1 is used in step (3), and the rest is the same as Example 1.

[0042] Comparative Example 3

[0043] This embodiment differs from Embodiment 1 in that an ultrafiltration membrane system with a molecular weight of 65,000 Da1 is used in step (2), and the rest is the same as Embodiment 1.

[0044] Comparative Example 4

[0045] This comparative example is different from Example 1 in that: in step (1), 0.2% cystine, 0.1% ethylenediaminetetraacetic acid, and 0.5% sodium sulfite are used to replace 0.08% calcium disodium edetate and 0.05% tea polyphenols, and the pH is not adjusted (the pH of the milk is 5). Other aspects are the same as in Example 1.

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

[0047] Table 1 Enzyme content and activity of milk powder prepared in Example 1 and Comparative Examples 1 to 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 hypoglycemic composition

[0050] The hypoglycemic composition is composed of the following raw materials by weight: 1 part of milk powder, 18 parts of Atractylodes lancea, 12 parts of Chuanxiong, 8 parts of Scrophularia ningpoensis, and 4 parts of Dioscorea opposita. The milk powder is the milk powder prepared in Example 1.

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

[0052] S1. Remove impurities from the herbs and slice them; crush 6 parts of Chuanxiong and pass through a 60-mesh sieve;

[0053] S2. Take sliced ​​Atractylodes lancea, the remaining Chuanxiong, Scrophularia ningpoensis, and Chinese yam and put them into a Chinese medicine extraction tank. Add 8 times the amount of drinking water as the medicinal materials, decoct and extract twice. Soak for 1 hour before the first decoction, and decoct for 1.5 hours each time. Both decoctions are filtered with a 120-mesh sieve and combined to obtain a decoction. The decoction is transferred to a single-effect evaporation concentrator and concentrated under reduced pressure to a thick extract with a relative density of 1.25 (60°C). Decompression concentration conditions: temperature 60°C, pressure 0.06Mpa.

[0054] S3. Dry the thick extract under reduced pressure in a vacuum dryer under the following conditions: temperature 85°C, vacuum degree 0.08Mpa; dry until the moisture content of the extract is ≤5%. Take it out and crush it with a high-efficiency crusher. Pass the fine powder through a 60-mesh sieve for later use.

[0055] S4. The formula amount of milk powder and Chuanxiong powder and dry extract powder are mixed 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 uniform, to obtain a hypoglycemic composition.

[0056] Example 3

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

[0058] The method for preparing the hypoglycemic composition of this embodiment is different from that of Embodiment 1 in that, in step (1), 2 kg of Chuanxiong is crushed, and the rest is the same as that of Embodiment 2.

[0059] Example 4

[0060] The hypoglycemic composition is composed of the following raw materials by weight: 1 part of latex powder and 10 parts of red peony root. The latex powder is the latex powder prepared in Example 1.

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

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

[0063] S2. Take sliced ​​red peony root and place it in a Chinese medicine extraction tank, add 8 times the amount of drinking water as the medicinal material, decoct and extract twice, soak for 1 hour before the first decoction, decoct for 1.5 hours each time, filter the two decoctions with a 120-mesh sieve, combine, and obtain the decoction. The decoction is transferred to a single-effect evaporation concentrator and concentrated under reduced pressure to a thick extract with a relative density of 1.25 (60°C). Conditions for reduced pressure concentration: temperature 80°C, pressure 0.09MPa;

[0064] S3. Dry the thick extract under reduced pressure in a vacuum dryer under the following conditions: temperature 85°C, vacuum degree 0.08MPa; dry until the moisture content of the extract is ≤5%. Take it out and crush it with a high-efficiency grinder. The fine powder is passed through a 60-mesh sieve to obtain red peony root dry extract powder;

[0065] S4. The formula amount of milk powder and dry extract powder are mixed 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 uniform, to obtain a hypoglycemic composition.

[0066] Preparation of Chinese herbal medicine for lowering blood sugar

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

[0068] Example 5

[0069] The milk powder prepared in Example 1 was filled into capsules to obtain blood sugar lowering capsules.

[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 the mixture was filled into capsules to obtain hypoglycemic capsules.

[0076] The following tests were commissioned to be conducted by the Guangxi Center for Disease Control and Prevention.

[0077] Experimental example: Animal studies that help maintain healthy blood sugar levels

[0078] The testing is based on the "Methods for Testing and Evaluation of Health Food Functions" (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), blood sugar lowering composition A (Example 2), blood sugar lowering composition B (Example 4), red peony root dry 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: experimental animal room temperature: 22-25°C, relative humidity: 55-70%.

[0083] 1.2 Test methods

[0084] (1) Dose selection and test substance administration method:

[0085] According to the recommended human dosage of the sample (equivalent to 50 mg / kg BW), three low, medium and high doses of hypoglycemic composition A test groups were set up, namely 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, a medium dose of milk powder A test group, a milk powder B test group, a milk powder C test group, a hypoglycemic composition B test group and a red peony root dry extract powder test group were set up. A model control group was set up, with 13 mice in each group; a normal animal test sample group (high dose of hypoglycemic composition A) and a blank control group were also set up, with 13 mice in each group. Distilled water and hypoglycemic composition A were used to prepare hypoglycemic composition A solutions with concentrations of 25, 50, and 75 mg / mL, and 50 mg / mL aqueous solutions of latex powder A, latex powder B, latex powder C, hypoglycemic composition B, and red peony root dry extract powder were prepared respectively, and given to animals in corresponding dosage groups by gavage, with a gavage volume of 0.2 mL / 10 g BW. The model control group and the normal animal control group were given an equal volume of distilled water, and the test sample group of normal animals was given an equal volume of 75 mg / mL hypoglycemic composition A solution, once a day, for 30 consecutive days.

[0086] (2) Animal modeling of hyperglycemia:

[0087] After fasting for 24 hours, mice were given a single intraperitoneal injection of alloxan (100 mg / kg BW) to establish the model. After fasting for 4 hours 5 days later, blood was collected from the inner canthus of the eye to measure blood sugar. The blood sugar value of 10-25 mmol / L was considered a successful hyperglycemia model mouse.

[0088] (3) Experiment on hypoglycemia in hyperglycemic model animals:

[0089] The hyperglycemia model mice were randomly divided into groups according to the blood glucose level after fasting for 4 hours, and 1 model control group and 8 experimental groups (the difference between the groups was no more than 1.1mmol / L) were set up. The experimental group was given sample solution of corresponding concentration, and the model control group was given distilled water. The fasting blood glucose value was measured for 30 consecutive days (fasting was the same as before the experiment), and the blood glucose values ​​of the animals in each group were compared.

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

[0091] The hyperglycemic model mice were randomly divided into groups according to the blood glucose level after fasting for 4 hours, and 1 model control group and 3 experimental groups (the difference between the groups was no more than 1.1mmol / L) were set up; the experimental group was given the sample solution of the corresponding concentration, and the model control group was given distilled water for 30 consecutive days. On the 31st day, the mice were fasted for 4 hours, the experimental group was given the sample solution of the corresponding concentration, and the model control group was given distilled water. After 15 minutes, each group was orally given glucose solution (2.0g / kg BW), and the blood glucose values ​​of each group at 0, 0.5, and 2 hours after glucose administration were measured. The changes in blood glucose values ​​and the area under the blood glucose curve at the time points (0, 0.5, and 2 hours) of glucose administration in the model control group and the experimental group were observed.

[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 testing

[0094] 26 mice were selected and randomly divided into a test sample group (high-dose hypoglycemic composition A) and a blank control group according to the fasting blood sugar level for 4 hours, with 13 mice in each group. The test sample group was given a sample solution of corresponding concentration, and the model control group was given distilled water for 30 consecutive days. The fasting blood sugar value (fasting is the same as before the experiment) was measured, and the blood sugar value and blood sugar reduction percentage of each group of animals were compared.

[0095] Test results:

[0096] Table 1 shows the fasting blood glucose results of normal animal test mice. As can be seen from the table, the blood glucose value of the experimental group on the 30th day was not significantly different from that before the test, and was not significantly different from that of the blank control group, indicating that the sample had little effect on the fasting blood glucose of normal mice.

[0097] Table 1 Fasting blood glucose results of normal mice

[0098]

[0099] The results of the hypoglycemic test on hyperglycemic model animals are shown in Table 2. As can be seen from the table, compared with the model group, the low, medium and high dose groups of hypoglycemic composition A can all reduce the blood sugar levels of hyperglycemic model rats, and the blood sugar values ​​of rats in the medium and high dose groups of hypoglycemic composition A are significantly reduced. The milk powder prepared by the present invention can reduce the blood sugar level of hyperglycemic model rats by itself, and the hypoglycemic effect is improved when used in combination with Atractylodes, Chuanxiong, Scrophularia, Dioscorea or Paeonia lactiflora, indicating that the components in the hypoglycemic composition have a synergistic effect and can enhance its hypoglycemic effect.

[0100] Table 2 Fasting blood glucose results of hyperglycemia model mice

[0101]

[0102]

[0103] The results of the glucose tolerance test in hyperglycemic mice are shown in Figure 1 As shown in Table 3, starting from 0 min, the blood glucose of each group of mice first increased and then decreased. Compared with the mice in the model control group, the blood glucose levels of the hypoglycemic composition group and the milk powder group decreased at 2 h. As shown in Table 3, compared with the model control group, the areas under the blood glucose curves of the mice in the high- and medium-dose hypoglycemic composition A experimental groups were significantly reduced, indicating that both high- and medium-dose hypoglycemic compositions can inhibit the increase in blood glucose induced by 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 exemplify the technical solutions of the present invention. These descriptions are not intended to limit the present invention to the precise form disclosed, and it is clear that many changes and variations can be made based on the above teachings. The purpose of selecting and describing exemplary embodiments is to explain the specific principles of the present invention and its practical application, so that those skilled in the art can realize and utilize various different exemplary embodiments of the present invention and various different selections and changes. The scope of the present invention is intended to be defined by the claims and their equivalents.

Claims

1. A method for preparing a Chinese medicine preparation for lowering blood sugar, characterized in that: The following steps are involved: (1) filtering and centrifuging papaya latex cut from green papaya fruits, collecting the upper liquid, and obtaining pretreated papaya latex; (2) passing the pretreated papaya latex obtained in step (1) through an ultrafiltration membrane system with a molecular weight of 40,000 to 55,000 Da1, and collecting the latex that passes through the ultrafiltration membrane; (3) passing the latex obtained in step (2) through an ultrafiltration membrane system with a molecular weight of 15,000 to 30,000 Da1, and collecting the latex retained by the ultrafiltration membrane; (4) The milk obtained in step (3) is subjected to multi-stage freeze-drying to obtain milk powder, and then the milk powder is prepared into capsules, tablets or granules to obtain a Chinese medicine preparation for lowering blood sugar.

2. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 1, characterized in that: In the step (1), the papaya latex cut from the green papaya fruit specifically comprises the following steps: making 6 to 8 scratches with a depth of 2 to 3 mm on the green papaya fruit, collecting the papaya latex with a container under the fruit, adding 0.05 to 0.1% of calcium disodium edetate and 0.01 to 0.03% of tea polyphenols by weight of the papaya latex to the papaya latex, adjusting the pH value of the latex to 6.5 to 7.5 with potassium dihydrogen phosphate and sodium hydroxide; and filtering with 40 to 60 mesh and 200 to 300 mesh sieves in turn.

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

4. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 1, characterized in that: In the step (2), the molecular weight of the ultrafiltration membrane is 45000 Dal, and the pressure is 0.3-0.4 MPa; in the step (3), the molecular weight of the ultrafiltration membrane is 20000 Dal, and the pressure is 0.2-03 MPa.

5. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 1, characterized in that: In the step (4), the multi-stage freeze drying is 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.

6. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 1, characterized in that: In the step (4), the latex powder and one or more of Atractylodes macrocephala, Ligusticum chuanxiong, Scrophularia ningpoensis, Dioscorea opposita, and Paeonia lactiflora are used as raw materials to prepare a Chinese medicine preparation for lowering blood sugar.

7. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 6, characterized in that: In the step (4), according to weight parts, 1 part of latex 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 are used as raw materials to prepare a Chinese medicine preparation for lowering blood sugar.

8. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 6, characterized in that: In the step (4), 1 part of the latex powder and 5 to 18 parts of red peony root are used as raw materials to prepare a Chinese medicine preparation for lowering blood sugar.

9. The method for preparing the hypoglycemic Chinese medicine preparation according to claim 8, characterized in that: The step (4) comprises: extracting the red peony root with 8 to 10 times of water, extracting 2 to 3 times, combining the extracts, concentrating under reduced pressure to a thick extract with a relative density of 1.20 to 1.25, then vacuum drying under reduced pressure and crushing to obtain red peony root extract powder, mixing the red peony root extract powder with latex powder, preparing capsules, tablets or granules, and obtaining a Chinese medicine preparation for lowering blood sugar.

10. A Chinese medicine preparation for lowering blood sugar, characterized in that: The traditional Chinese medicine preparation is prepared by the preparation method according to any one of claims 1 to 9.

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