CN108543002B - Mulberry grass hypoglycemic tablets and preparation process thereof - Google Patents

Abstract

The invention discloses a mulberry leaf hypoglycemic tablet, which comprises the following components: mulberry leaf, potentilla discolor, anemarrhena, trichosanthes root and kaki calyx; also comprises the following components: fish meal, white dextrin, corn flour, starch, zeolite powder and beef essence. It can give full play to the drug effect of each component and can effectively treat diabetes of dogs and cats. The invention also discloses a preparation method of the mulberry leaf hypoglycemic tablet, wherein fresh mulberry leaves, rhizoma anemarrhenae and calyx kaki are processed through natural drying, thus avoiding the loss of drug effect and environmental pollution caused by drying the medicinal materials; by extraction process, high-efficiency blood sugar lowering compound Chinese medicinal components such as folium Mori polysaccharide, DNJ (1-deoxynojirimycin), rutin, etc. can be extracted; the tablet preparation with stable drug effect is prepared by the processes of granulation, tabletting and the like, is convenient to take and use, and has good development prospect.

Description

Mulberry grass hypoglycemic tablets and preparation process thereof

Technical Field

The invention belongs to the technical field of diabetes blood sugar reduction of dogs and cats, and particularly relates to a mulberry leaf blood sugar reduction tablet and a preparation process thereof.

Background

Diabetes is a group of metabolic diseases characterized by chronic hyperglycemia due to various causes such as heredity and environment. Prolonged illness may cause multiple system damage, resulting in chronic complications of the eyes, kidneys, nerves, and organs such as the heart, cerebral vessels, lower limbs, etc. Acute metabolic disorders such as ketoacidosis, hypertonic coma and lactic acidosis can occur in severe conditions or under stress, which threatens life and is often accompanied by pyogenic infection, urinary tract infection, pulmonary tuberculosis and the like. The disease is harmful to human health, and also to the health of animals such as dogs and cats. According to incomplete statistics, the incidence rate of diabetes of the current breed canines is about 30%, the incidence rate of diabetes of the pet cats is about 35%, and the incidence rate of diabetes of the zoo primates is about 85% (mostly caused by the feeding of tourists). Animal diabetes is mainly manifested by symptoms of polydipsia, diuresis, polyphagia, weight loss, gradual emaciation and the like, and even serious patients can suffer from vomiting, dehydration, low body temperature, unconsciousness, coma and the like.

The current research on the treatment of the diabetes for the animals is less, a plurality of pet breeders have poor cognition on the diabetes of the animals, do not know the disease condition of the diabetes of the animals at all and have no treatment consciousness, and animal clinics are in a rest state for the disease. Animal diabetes is mainly divided into two types, i-type diabetes and ii-type diabetes, wherein the i-type diabetes is an autoimmune disease, and the immune system of the body attacks cells producing insulin in the body, which finally results in insulin deficiency in the body; type II diabetes, also called insulin-independent diabetes or acquired diabetes, is due to the failure of insulin to exert its intended action, resulting in abnormal insulin content due to defects in the production and secretion process of insulin.

The current treatment for canine and feline diabetes is mainly by injecting insulin, and two defects mainly exist by adopting the method: on one hand, people need to pay great care for animals, insulin needs to be injected into the animals at regular time and quantity every day, and the animals are fed according to the diabetes diet at regular time and quantity; on the other hand, the cost of the treatment process is relatively high, requiring regular examinations in addition to daily injections of insulin. In addition, the other method is to treat the animal diabetes mellitus by using medicines, and the existing medicines for treating the animal diabetes mellitus are fewer, wherein more chromium element blood sugar reducing tablets with dogs and cats are used. The chromium element contained in the chromium element hypoglycemic tablets for dogs and cats is a key component for treating diabetes, is very important for the formation of fat and protein, has close relation with the metabolism of glucose, and maintains proper blood sugar concentration by controlling insulin in the bodies of patients with hyperglycemia and hypoglycemia. Although chromium is a very effective ingredient for treating diabetes, chromium is effective only for type ii diabetes because it maintains blood glucose concentration by controlling insulin. More than 95 percent of canine diabetes is type I diabetes, and type II diabetes is rare; type i diabetes and type ii diabetes in feline diabetes each account for about 50%. Therefore, the chromium element blood sugar-reducing tablets for dogs and cats have no obvious treatment effect on the diabetes of dogs and cats.

Therefore, in order to solve the treatment problem of canine and feline diabetes, a canine and feline diabetes treatment drug with obvious treatment effect and low cost needs to be provided.

Disclosure of Invention

In order to solve the technical problems, the invention provides the mulberry grass hypoglycemic tablets and the preparation process thereof, and the mulberry grass hypoglycemic tablets can treat diabetes of dogs and cats and have obvious treatment effect.

The mulberry leaf hypoglycemic tablet is characterized by comprising the following components in parts by weight: 3-5 parts of mulberry leaf, 2-4 parts of potentilla discolor, 1-3 parts of rhizoma anemarrhenae, 2-5 parts of trichosanthes root and 1-3 parts of calyx kaki.

Preferably, the composition also comprises the following components in parts by weight: 6-9 parts of fish meal, 5-9 parts of white dextrin, 12-18 parts of corn flour, 2-4 parts of starch, 2-5 parts of zeolite powder and 0.4-0.6 part of beef flavor.

The preparation process of the mulberry leaf hypoglycemic tablets is characterized by comprising the following steps:

(1) screening and processing the traditional Chinese medicines: firstly, screening qualified mulberry leaves, potentilla discolor, rhizoma anemarrhenae, trichosanthes roots and persimmon calyx, and then respectively processing the medicinal materials according to requirements;

(2) traditional Chinese medicine extraction: weighing the mulberry leaves, the potentilla discolor and the rhizoma anemarrhenae prepared in the step (1) according to a formula, and extracting the components;

(3) and (3) granulating: respectively crushing the trichosanthes root, the persimmon calyx and the corn flour according to requirements, sieving the fish meal according to requirements, weighing all powder materials according to a formula, and adding all the powder materials and the Chinese medicinal concentrated thick paste liquid prepared in the step (2) into a granulator for granulation;

(4) drying and finishing granules: drying the granules prepared in the step (3) by using a dryer, and granulating the dried granules by using a granulator to obtain a semi-finished product;

(5) total mixed pressing sheet: putting the semi-finished product prepared in the step (4) and magnesium stearate into a mixer for mixing; and then adding the mixed particles into a tabletting machine for tabletting to obtain the finished tablets.

Preferably, the screening and processing of the traditional Chinese medicines in the step (1) specifically comprise the following steps:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.5-1 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 2-3 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

Preferably, the traditional Chinese medicine extraction in the step (2) specifically comprises the following steps:

A. weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, putting the three plant medicinal materials into a frying vat, adding 8-12 times of water, soaking for 40-120 minutes, starting heating and decocting, and taking out soup after boiling for 40-120 minutes;

B. adding 6-8 times of water, decocting for 40-120 min, and collecting decoction;

C. mixing the two decoctions, sieving with 200 mesh sieve, and concentrating to obtain soft extract with a liquid-solid ratio of 1-1.1;

D. adding 6-8 kg/ton sodium dehydroacetate and 0.5-1 kg/ton sodium cyclamate, standing for 5-8 hr, and directly adding 0.4-0.6 kg/ton sodium D-isoascorbate when the temperature is reduced to below 30 deg.C to obtain Chinese medicinal concentrated thick paste; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving;

preferably, the granulation in step (3) specifically comprises the following steps:

a. pulverizing Trichosanthis radix and calyx kaki respectively, and sieving with 120-mesh and 200-mesh sieve;

b. pulverizing corn flour, sieving with 120 mesh sieve, sieving fish meal with 80 mesh sieve, and removing large bone;

c. weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 4-10 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

Preferably, the drying and granulating in the step (4) specifically comprises the following steps:

(A) drying the prepared granules in a high-efficiency boiling dryer at 100 ℃ for 20-25 minutes;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

Preferably, the step (5) of totally mixing the wafer comprises the following steps:

(a) weighing magnesium stearate with the mass of 0.4-0.7% of the mass of the granules, and then putting the sized semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 10-20 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablets once every 10-20 minutes in the tabletting process, ensuring that the difference of the tablet weights is within the allowable range of +/-5 percent, and observing the appearance of the tablets at any time;

(e) and subpackaging the tablets as required.

Has the advantages that: firstly, mulberry leaves, potentilla discolor, rhizoma anemarrhenae, trichosanthes roots, kaki calyx and the like are used as raw materials to prepare the mulberry grass hypoglycemic tablet, the drug effects of all the components can be fully exerted, and the hypoglycemic tablet capable of effectively treating the diabetes of dogs and cats is obtained. The folium Mori has effects of lowering blood pressure, reducing blood lipid, resisting pathogenic microorganism, and resisting inflammation. Folium Mori is rich in folium Mori polysaccharide and 1-deoxynojirimycin, and can be used for treating animal diabetes. The potentilla discolor is used as a hypoglycemic drug and is acted together with the mulberry leaves to be used as a monarch drug of the prescription; rhizoma anemarrhenae (rhizoma anemarrhenae) is used as a yin nourishing medicine, can clear away the fire of lung and stomach, and eliminate the symptoms of thirst and phlegm retention caused by diabetes, and is a ministerial medicine in the process formula; the trichosanthes root has good effects of moistening lung and stomach and relieving phlegm-fluid retention constipation symptom of diabetes, and is used as an adjuvant drug in the formula of the process; kaki calyx has the functions of lowering qi and stopping hiccup, can relieve nausea and vomiting symptoms caused by pancreatitis of diabetes, and is used as a guiding drug in the formula of the process. Through the mutual matching and the combined action of all the components, the effects of reducing the blood sugar of animals such as dogs and cats, slowing down the emaciation of four limbs and prolonging the life of the animals can be achieved. In addition, the corn flour, the starch, the imported fish meal and other components are added, so that the prepared product can be used as a health-care blood sugar-reducing daily feed for diabetic animals, and the effect of reducing the blood sugar of the animals can be achieved by daily feeding, so that the dependence use of the insulin of the animals can be reduced, and the social and humanistic harmony is promoted.

Secondly, according to the preparation method of the mulberry grass hypoglycemic tablet, disclosed by the application, fresh mulberry leaves, rhizoma anemarrhenae and persimmon calyx are naturally and thoroughly aired and processed, so that the drug effect loss and environmental pollution caused by drying the medicinal materials are avoided; by extraction process, high-efficiency blood sugar lowering compound Chinese medicinal components such as folium Mori polysaccharide, DNJ (1-deoxynojirimycin), rutin, etc. can be extracted; the tablet preparation with stable drug effect is prepared by the processes of granulation, tabletting and the like, is convenient to take and use, and has good development prospect. The process product is from the green and environment-friendly perspective, and the process extraction needs a large amount of fresh mulberry leaves, potentilla discolor and the like, and can promote the rapid development of GAP Chinese herbal medicine planting. The preparation method is simple and easy to implement, is beneficial to promoting health-care feed enterprises for reducing blood sugar, and is beneficial to pulling development of ecological traditional Chinese medicine extraction of veterinary drug enterprises.

Detailed Description

The present invention will be described in detail with reference to specific examples

Example 1

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 3Kg of mulberry leaf, 2Kg of potentilla discolor, 1Kg of rhizoma anemarrhenae, 2Kg of trichosanthes root, 1Kg of calyx kaki, 6Kg of fish meal, 9Kg of white dextrin, 18Kg of corn flour, 4Kg of starch, 5Kg of zeolite powder and 0.6Kg of beef essence.

A preparation process of a mulberry leaf hypoglycemic tablet specifically comprises the following steps:

(1) screening and processing the traditional Chinese medicines:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 1 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 2 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

(2) Traditional Chinese medicine extraction:

weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, putting the three plant medicinal materials into a frying vat, adding 8 times of water, soaking for 120 minutes, starting heating and decocting, and taking out soup after the boiling is started and the timing is 120 minutes;

adding 6 times of water into the decoction, and decocting for 40 minutes to obtain decoction;

c, merging the two decoctions, sieving by a 200-mesh sieve, and concentrating to obtain thick paste with the liquid-solid ratio of 1.0;

d, 6 kilograms of sodium dehydroacetate and 1 kilogram of sodium cyclamate are added, the mixture is placed for 5 hours, and when the temperature is reduced to be below 30 ℃, 0.4 kilogram of D-sodium erythorbate is directly added, so that the traditional Chinese medicine condensed thick paste is obtained; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving;

(3) and (3) granulating:

a, independently crushing trichosanthes root and kaki calyx respectively, and sieving with a 120-mesh sieve;

b, independently crushing the corn flour, sieving the corn flour with a 120-mesh sieve, and sieving the fish meal with a 80-mesh sieve to remove larger bone blocks;

and c, weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 4 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

(4) Drying and finishing granules:

(A) drying the prepared granules in a high-efficiency boiling dryer at 100 ℃ for 20 minutes;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

(5) Total mixed pressing sheet:

(a) weighing magnesium stearate with the mass of 0.4% of the mass of the granules, and then putting the granulated semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 20 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) in the tabletting process, the tablet weight is weighed once every 10 minutes, the difference of the tablet weight is ensured to be within the allowable range of +/-5 percent, and the appearance of the tablet is observed at any time;

(e) and subpackaging the tablets as required.

Example 2

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 5Kg of mulberry leaf, 4Kg of potentilla discolor, 3Kg of rhizoma anemarrhenae, 5Kg of trichosanthes root, 3Kg of persimmon calyx, 9Kg of fish meal, 5Kg of white dextrin, 12Kg of corn flour, 2Kg of starch, 2Kg of zeolite powder and 0.4Kg of beef essence.

A preparation process of a mulberry leaf hypoglycemic tablet specifically comprises the following steps:

(1) screening and processing the traditional Chinese medicines:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.5 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 3 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

(2) Traditional Chinese medicine extraction:

weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, then putting the three plant medicinal materials into a frying vat, adding 12 times of water, soaking for 40 minutes, starting heating and decocting, starting timing when boiling, and taking out soup after 40 minutes;

adding 8 times of water into the decoction, and decocting for 120 minutes to obtain decoction;

c, merging the two decoctions, sieving by a 200-mesh sieve, and concentrating to obtain thick paste with the liquid-solid ratio of 1.1;

d, adding 8 kg/ton of sodium dehydroacetate and 0.5 kg/ton of sodium cyclamate, standing for 8 hours, and directly adding 0.6 kg/ton of D-sodium erythorbate when the temperature is reduced to be below 30 ℃ to obtain a traditional Chinese medicine concentrated thick paste solution; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving;

(3) and (3) granulating:

a, independently crushing trichosanthes root and kaki calyx respectively, and sieving with a 200-mesh sieve;

b, independently crushing the corn flour, sieving the corn flour with a 120-mesh sieve, and sieving the fish meal with a 80-mesh sieve to remove larger bone blocks;

c, weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator to be mixed for 10 minutes, and then pouring the concentrated thick paste into the granulator to start the granulator to granulate.

(4) Drying and finishing granules:

(A) drying the prepared particles in a high-efficiency boiling dryer for 25 minutes at 100 ℃;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

(5) Total mixed pressing sheet:

(a) weighing magnesium stearate with the mass of 0.7 percent of the mass of the granules, and then putting the granulated semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 10 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablets once every 20 minutes in the tabletting process, ensuring that the difference of the tablet weights is within the allowable range of +/-5 percent, and observing the appearance of the tablets at any time;

(e) and subpackaging the tablets as required.

Example 3

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 4Kg of mulberry leaf, 3Kg of potentilla discolor, 2Kg of anemarrhena asphodeloides bunge, 3Kg of trichosanthes root, 1Kg of kaki calyx, 6Kg of fish meal, 5Kg of white dextrin, 14Kg of corn flour, 4Kg of starch, 3Kg of zeolite powder and 004Kg of beef essence.

A preparation process of a mulberry leaf hypoglycemic tablet specifically comprises the following steps:

(1) screening and processing the traditional Chinese medicines:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.6 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 3 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

(2) Traditional Chinese medicine extraction:

weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, then putting the three plant medicinal materials into a frying vat, adding 10 times of water, soaking for 60 minutes, starting heating and decocting, starting timing when boiling, and taking out soup after 90 minutes;

adding 7 times of water into the decoction B, and decocting for 60 minutes to obtain decoction;

c, merging the two decoctions, sieving by a 200-mesh sieve, and concentrating to obtain thick paste with the liquid-solid ratio of 1.05;

d, adding 7 kg/ton of sodium dehydroacetate and 0.6 kg/ton of sodium cyclamate, standing for 6 hours, and directly adding 0.5 kg/ton of D-sodium erythorbate when the temperature is reduced to be below 30 ℃ to obtain a traditional Chinese medicine concentrated thick paste solution; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving;

(3) and (3) granulating:

a, independently crushing trichosanthes root and kaki calyx respectively, and sieving with a 150-mesh sieve;

b, independently crushing the corn flour, sieving the corn flour with a 120-mesh sieve, and sieving the fish meal with a 80-mesh sieve to remove larger bone blocks;

and c, weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 6 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

(4) Drying and finishing granules:

(A) drying the prepared particles in a high-efficiency boiling dryer at 100 ℃ for 22 minutes;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

(5) Total mixed pressing sheet:

(a) weighing magnesium stearate with the mass of 0.4% of the mass of the granules, and then putting the granulated semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 15 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablets once every 16 minutes in the tabletting process, ensuring that the difference of the tablet weights is within the allowable range of +/-5 percent, and observing the appearance of the tablets at any time;

(e) and subpackaging the tablets as required.

Example 4

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 3Kg of mulberry leaf, 2.5Kg of potentilla discolor, 2.5Kg of rhizoma anemarrhenae, 3Kg of trichosanthes root, 1.5Kg of persimmon calyx, 7.5Kg of fish meal, 8Kg of white dextrin, 16Kg of corn meal, 2.5Kg of starch, 3.5Kg of zeolite powder and 0.6Kg of beef flavor.

A preparation process of a mulberry leaf hypoglycemic tablet specifically comprises the following steps:

(1) screening and processing the traditional Chinese medicines:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.8 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 2.5 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

(2) Traditional Chinese medicine extraction:

weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, then putting the three plant medicinal materials into a frying vat, adding 9 times of water, soaking for 72 minutes, starting heating and decocting, starting timing when boiling, and taking out soup after 80 minutes;

adding 8 times of water into the decoction, and decocting for 90 minutes to obtain decoction;

c, merging the two decoctions, sieving by a 200-mesh sieve, and concentrating to obtain thick paste with the liquid-solid ratio of 1.02;

d, adding 7 kg/ton of sodium dehydroacetate and 0.5 kg/ton of sodium cyclamate, standing for 6 hours, and directly adding 0.4 kg/ton of D-sodium erythorbate when the temperature is reduced to be below 30 ℃ to obtain a traditional Chinese medicine concentrated thick paste solution; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving;

(3) and (3) granulating:

a, independently crushing trichosanthes root and kaki calyx respectively, and sieving with a 180-mesh sieve;

b, independently crushing the corn flour, sieving the corn flour with a 120-mesh sieve, and sieving the fish meal with a 80-mesh sieve to remove larger bone blocks;

and c, weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 7 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

(4) Drying and finishing granules:

(A) drying the prepared particles in a high-efficiency boiling dryer for 24 minutes at 100 ℃;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

(5) Total mixed pressing sheet:

(a) weighing magnesium stearate with the mass of 0.6 percent of the mass of the granules, and then putting the granulated semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 18 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablet weight every 15 minutes in the tabletting process, ensuring that the difference of the tablet weight is within the allowable range of +/-5 percent, and observing the appearance of the tablet at any time;

(e) and subpackaging the tablets as required.

Example 5

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 4Kg of mulberry leaf, 3Kg of potentilla discolor, 2Kg of rhizoma anemarrhenae, 3.5Kg of trichosanthes root, 1.88Kg of persimmon calyx, 7.5Kg of fish meal, 6.6Kg of white dextrin, 15.2Kg of corn meal, 2.8Kg of starch, 3.8Kg of zeolite powder and 0.5Kg of beef flavor.

A preparation process of a mulberry leaf hypoglycemic tablet specifically comprises the following steps:

(1) screening and processing the traditional Chinese medicines:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of large-dish persimmon is adopted as the persimmon calyx, no mildew or insect damage is required, and the persimmon calyx is sieved to remove dust and impurities are picked out;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.7 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 2.5 cm sections, and removing impurities; removing hair and skin from the surface of rhizoma anemarrhenae, keeping rhizoma anemarrhenae meat, cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

(2) Traditional Chinese medicine extraction:

D. weighing folium Mori, herba Potentillae Discoloris and rhizoma anemarrhenae according to the above formula, adding 8 times of water into a decocting jar, soaking for 1 hr, decocting, boiling for a certain time, and collecting decoction after 1 hr;

E. adding 6 times of water, decocting for 1 hr, and collecting decoction;

F. mixing the two decoctions, filtering with 200 mesh sieve, and concentrating to obtain soft extract with a liquid-solid ratio of 1.1;

D. adding 8 kg/ton sodium dehydroacetate and 1 kg/ton sodium cyclamate, standing for 5-8 hours, and directly adding 0.5 kg/ton sodium D-erythorbate when the temperature is reduced to below 30 ℃ to obtain a traditional Chinese medicine concentrated thick paste; when in use, the sodium dehydroacetate and the sodium cyclamate are dissolved by a small amount of hot water, and when the D-sodium erythorbate is used, the D-sodium erythorbate is dissolved by boiled water;

(3) and (3) granulating:

a. pulverizing Trichosanthis radix and calyx kaki respectively, and sieving with 120-mesh and 200-mesh sieve;

b. independently crushing the corns, sieving the crushed corns with a 120-mesh sieve, and sieving the Peru imported fish meal with a 80-mesh sieve to remove larger bone blocks;

c. weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 5 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

(4) Drying and finishing granules:

(A) drying the prepared particles in a high-efficiency boiling dryer for 25 minutes at 100 ℃;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

(5) Total mixed pressing sheet:

(a) weighing magnesium stearate with the mass of 0.5 percent of the mass of the granules, and then putting the granulated semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 15 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablet weight every 15 minutes in the tabletting process, ensuring that the difference of the tablet weight is within the allowable range of +/-5 percent, and observing the appearance of the tablet at any time;

(e) and subpackaging the tablets as required.

Comparative example 1

The mulberry leaf hypoglycemic tablet comprises the following components in parts by weight: 2Kg of mulberry leaf, 1.5Kg of potentilla discolor, 1Kg of rhizoma anemarrhenae, 1.75Kg of trichosanthes root, 0.94Kg of persimmon calyx, 7.5Kg of fish meal, 6.6Kg of white dextrin, 15.2Kg of corn flour, 2.8Kg of starch, 3.8Kg of zeolite powder and 0.5Kg of beef flavor.

A preparation process of SANGCAO JIANGTANG tablet is the same as in example 5.

The sugar-reducing tablets prepared in the above examples 1 to 5 were subjected to pharmacodynamic and toxicological tests.

1. Pharmacodynamic assay

(1) And (3) detecting animals: 200 mice;

(2) and (3) detecting the medicine: the mulberry grass hypoglycemic tablets prepared in the embodiments 1-5 of the invention are respectively named as No. 1, No. 2, No. 3, No. 4 and No. 5; the existing dog and cat chromium element blood sugar-reducing tablets on the market are used as a positive control group.

(3) Test method

Randomly selecting 10 mice as a blank control group; and (3) other mice are subjected to intraperitoneal injection of alloxan and then are fasted for 3 to 5 weeks, tail blood is collected in the morning the next day, fasting blood glucose is measured, and the mice with the blood glucose value exceeding 16.7mol/L are diabetes model mice, and 160 diabetes model mice are obtained in total.

(4) Grouping

Diabetes model mice were randomly divided into: blank control group (10, 1 ml/day of normal saline), model control group (10, 1 ml/day of normal saline), comparative example 1 control group (10, comparative example 1, measurement of 0.5 tablet/day), hypoglycemic tablets No. 1 low dose group (10, 0.1 tablet/day), hypoglycemic tablets No. 1 medium dose group (10, 0.5 tablet/day), hypoglycemic tablets No. 1 high dose group (10, 1 tablet/day), hypoglycemic tablets No. 2 low dose group (10, 0.1 tablet/day), hypoglycemic tablets No. 2 medium dose group (10, 0.5 tablet/day), hypoglycemic tablets No. 2 high dose group (10, 1 tablet/day), hypoglycemic tablets No. 3 low dose group (10, 0.1 tablet/day), hypoglycemic tablets No. 3 medium dose group (10, 0.5 tablet/day), hypoglycemic tablets No. 3 high dose group (10, 1 tablet/day), The composition comprises a hypoglycemic tablet No. 4 low dose group (10 tablets, 0.1 tablet/day), a hypoglycemic tablet No. 4 medium dose group (10 tablets, 0.5 tablet/day), a hypoglycemic tablet No. 4 high dose group (10 tablets, 1 tablet/day), a hypoglycemic tablet No. 5 low dose group (10 tablets, 0.1 tablet/day), a hypoglycemic tablet No. 5 medium dose group (10 tablets, 0.5 tablet/day) and a hypoglycemic tablet No. 5 high dose group (10 tablets, 1 tablet/day).

Collecting tail artery blood before administration and at 1, 2, 3 and 4 weeks after administration, and detecting blood glucose value.

(5) Results

The blood glucose measurement results are shown in table 1, and the blood glucose values are shown as the average blood glucose value (mol/L) of each group of mice during the statistical process.

The results show that:

the blood glucose of the model control group was significantly increased compared to the blank control group; compared with a model control group at the same time, the control group and the blood glucose reducing tablet metering group in the comparative example 1 can stably reduce the blood glucose, the blood glucose value is obviously improved after one week of injection, and the blood glucose value is obviously improved after two weeks of injection.

Compared with a control group of a comparative example 1 in the same period, the blood sugar reducing tablet No. 5 has more obvious blood sugar reducing effect; the blood glucose levels were substantially the same after 4 weeks of administration in the high dose group of Jiangtang tablets No. 5, compared to the blank control group.

The results show that the mulberry grass hypoglycemic tablet disclosed by the invention has an obvious effect of treating diabetes.

2. Toxicology testing

(1) Acute toxicity test

After the white mice are continuously observed for 14 days, the indexes of the white mice, such as weight, hair color state, motion state, excrement condition and the like, are not abnormal, the weight is normally increased, and the death condition does not occur. After 14 days, no obvious pathological changes are observed in the main organs of all the surviving animals by dissection and visual observation.

(2) Long term toxicity test

a. The mulberry leaf hypoglycemic tablets are administrated by rat gavage in a high dose group of 1 tablet/day, a medium dose group of 0.5 tablet/day and a low dose group of 0.1 tablet/day. After the three metering groups are continuously administrated for 13 weeks, male and female rats generally have good physical signs, normal behavior activity, urination, defecation and drinking water, and no obvious difference exists in weight increase and food intake compared with a control group.

b. Only individual rat animal protein shows positive reaction in urine routine examination 13 weeks after administration of the high, medium and low dosage groups of male and female rats. The result is not related to drug toxicity by combining hematology and academic biochemistry index analysis.

c. After the mulberry grass blood glucose reducing tablet is administrated to male and female rats in high, medium and low measurement groups for 13 weeks, only the liver weight of individual female rats is different from that of a control group, but the coefficient of the liver weight of individual female rats is not different, and the liver weight of individual female rats is considered to be caused by the difference of animal body weights and is not related to animal toxicity reaction. The medicine has no influence on liver in the middle stage of the test.

d. No drug-related toxic reactions were found in the histopathological examination.

Combining the above results, under the present experimental conditions, no significant toxic reaction related to the drug was found after 13 weeks of administration of the mulberry grass hypoglycemic agent tablets by the gavage route of rats.

3. Clinical feedback was as follows:

one example of the Langqing dog, originally used as a breed, is stopped to use at present, and is 9 years old, and shows polydipsia, polyphagia, emaciation in the day, vomiting and nausea symptoms occasionally, diuresis and urine with fruity flavor in half a year. The weight is 10.3 kg. Blood glucose concentration was 38.2mmol/L (normal value was 4.11-7.95mmol/L) as determined by blood drawing. Urine was routinely tested as severe urine glucose. Ketone bodies were detected as ketonuria. The oral mulberry grass hypoglycemic tablet is taken 5-6 tablets/day at 8-10 am and directly mixed into dog food for eating for 14 days continuously. The blood glucose concentration was measured to be 8.37 mmol/L.

One example of a mini poodle, 5 years old, shows frequent vomiting, polyphagia, polyuria, dry stools, and eye secretions. The blood glucose concentration was measured to be 15.36 mmol/L. Diagnosing pancreatitis as the complication of diabetes. The mulberry leaf hypoglycemic tablet is taken 2 tablets per day and is directly mixed into feed for eating for 12 days continuously. The blood glucose concentration was measured to be 10.26 mmol/L. The vomiting disappeared and the feces were not dry.

The following are practical data:

according to the observation of the blood sugar reducing effect of the mulberry grass blood sugar reducing tablet eaten by practical cases, statistics is as follows:

animal(s) production	Quantity (only)	Dosage form	Time of practice	Effective rate of reducing blood sugar	Total blood sugar reduction range
						Dog	58	0.5 tablet/kg body weight	12-14 days	94.83％	30.1-79.2％
Cat (cat)	22	0.5 tablet/kg body weight	12-21 days	95.46％	27.3-56.8％

The above is only a preferred embodiment of the present invention, and the protection scope of the present invention is not limited to the examples shown herein, and all technical solutions belonging to the idea of the present invention belong to the protection scope of the present invention. It should be noted that several modifications and decorations within the scope of the invention are possible to those skilled in the art without departing from the principle of the invention.

Claims (7)

1. The mulberry grass hypoglycemic tablet is characterized by comprising the following raw materials in parts by weight: 3-5 parts of mulberry leaf, 4-6 parts of potentilla discolor, 1-4 parts of rhizoma anemarrhenae, 2-5 parts of trichosanthes root, 1-3 parts of persimmon calyx, 7-8 parts of fish meal, 6-7 parts of white dextrin, 14-16 parts of corn flour, 2-4 parts of starch, 3-4 parts of zeolite powder and 0.4-0.6 part of beef flavor.

2. The preparation process of the mulberry grass hypoglycemic tablet according to claim 1, which is characterized by comprising the following specific steps:

(1) screening and processing the traditional Chinese medicines: firstly, screening qualified mulberry leaves, potentilla discolor, rhizoma anemarrhenae, trichosanthes roots and persimmon calyx, and then respectively processing the medicinal materials;

(2) traditional Chinese medicine extraction: weighing the mulberry leaves, the discolor cinquefoil herbs and the rhizoma anemarrhenae prepared in the step (1) according to a formula, and extracting the components to obtain a traditional Chinese medicine concentrated thick paste solution;

(3) and (3) granulating: respectively crushing the trichosanthes root, the persimmon calyx and the corn flour, sieving the fish meal, weighing all the powder except the mulberry leaves, the potentilla discolor and the rhizoma anemarrhenae according to the formula, and adding all the powder except the mulberry leaves, the potentilla discolor and the rhizoma anemarrhenae and the concentrated traditional Chinese medicine paste prepared in the step (2) into a granulator for granulation;

(4) drying and finishing granules: drying the granules prepared in the step (3) by using a dryer, and granulating the dried granules by using a granulator to obtain a semi-finished product;

(5) total mixed pressing sheet: putting the semi-finished product prepared in the step (4) and magnesium stearate into a mixer for mixing; and then adding the mixed particles into a tabletting machine for tabletting to obtain the finished tablets.

3. The preparation process of the mulberry grass hypoglycemic tablet according to claim 2, wherein the screening and processing of the traditional Chinese medicines in the step (1) specifically comprise the following steps:

screening medicinal materials: selecting fresh folium Mori, naturally air drying to obtain semi-dry folium Mori with water content of less than 15%, sieving, removing dust, and removing impurities; herba Potentillae Discoloris, selecting whole plant without mildew or pesticide, sieving for removing dust, and selecting out impurities; rhizoma anemarrhenae adopts first-class decoction pieces, requires no mildew or pesticide, is sieved and dedusted, and impurities are picked out; radix Trichosanthis, adopting first-class decoction pieces, sieving to remove dust and impurities, wherein the first-class decoction pieces are required to have no mildew, no insect pest and no sulfur; calyx of persimmon is covered with calyx of persimmon, no mildew or insect damage is required, and the calyx is sieved to remove dust and remove impurities;

processing: cutting the half-dried mulberry leaves into strips with the width of 0.5-1 cm, and picking out unqualified leaves and impurities; cutting herba Potentillae Discoloris into 2-3 cm sections, and removing impurities; removing hair and skin from rhizoma anemarrhenae surface, and keeping rhizoma anemarrhenae pulp; cleaning radix Trichosanthis, slicing, and naturally drying in the sun; calyx kaki, air-dried in the semiyin area.

4. The preparation process of the mulberry grass hypoglycemic tablet according to claim 2, wherein the Chinese medicine extraction in the step (2) specifically comprises the following steps:

A. weighing mulberry leaves, discolor cinquefoil herbs and rhizoma anemarrhenae according to a formula, putting the three plant medicinal materials into a frying vat, adding 8-12 times of water, soaking for 40-120 minutes, starting heating and decocting, timing when boiling, and taking out soup after 40-120 minutes;

B. adding 6-8 times of water, decocting for 40-120 min, and collecting decoction;

C. mixing the two decoctions, sieving with 200 mesh sieve, and concentrating to obtain soft extract with a liquid-solid ratio of 1-1.1;

D. adding 6-8 kg/ton sodium dehydroacetate and 0.5-1 kg/ton sodium cyclamate, standing for 5-8 hr, and directly adding 0.4-0.6 kg/ton sodium D-isoascorbate when the temperature is reduced to below 30 deg.C to obtain Chinese medicinal concentrated thick paste; when the sodium dehydroacetate and the sodium cyclamate are added, a small amount of hot water is firstly used for dissolving, and when the D-sodium erythorbate is used, the cold boiled water is firstly used for dissolving.

5. The preparation process of the mulberry grass hypoglycemic tablet according to claim 2, wherein the granulation in the step (3) is specifically as follows:

a. pulverizing Trichosanthis radix and calyx kaki respectively, and sieving with 120-mesh and 200-mesh sieve;

b. pulverizing corn flour, sieving with 120 mesh sieve, sieving fish meal with 80 mesh sieve, and removing large bone; c. weighing the solid materials according to the formula, then pouring all the weighed powdery materials into a granulator, mixing for 4-10 minutes, pouring the concentrated thick paste, and starting the granulator to granulate.

6. The preparation process of the mulberry grass hypoglycemic tablet according to claim 2, wherein the drying and granulating in the step (4) are specifically as follows:

(A) drying the prepared granules in a high-efficiency boiling dryer at 100 ℃ for 20-25 minutes;

(B) and (4) granulating the dried granules by using a granulator, wherein the mesh number of the selected sieve is 12.

7. The preparation process of mulberry grass hypoglycemic tablet according to claim 2, wherein the total step of mixing and pressing the tablet in step (5) is as follows:

(a) weighing magnesium stearate with the mass of 0.4-0.7% of the mass of the granules, and then putting the sized semi-finished product and the weighed magnesium stearate into a two-dimensional mixer to stir for 10-20 minutes;

(b) selecting the specification of a stamping die according to the process specification, loading the stamping die, wiping the surface with 75% ethanol for cleaning and disinfection, carrying out no-load test, and carrying out the next working procedure after the normal operation;

(c) the filling amount is adjusted according to the weight of the tablets, and then the pressure is adjusted, so that the weight, the hardness, the friability, the appearance and the like of the extruded plain tablets meet the quality requirements;

(d) weighing the tablets once every 10-20 minutes in the tabletting process, ensuring that the difference of the tablet weights is within the allowable range of +/-5 percent, and observing the appearance of the tablets at any time;

(e) and (5) subpackaging the tablets.