CN113827660A - Traditional Chinese medicine composition for reducing blood sugar and blood fat and preparation method thereof - Google Patents

Traditional Chinese medicine composition for reducing blood sugar and blood fat and preparation method thereof Download PDF

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CN113827660A
CN113827660A CN202111338677.2A CN202111338677A CN113827660A CN 113827660 A CN113827660 A CN 113827660A CN 202111338677 A CN202111338677 A CN 202111338677A CN 113827660 A CN113827660 A CN 113827660A
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chinese medicine
traditional chinese
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medicine composition
component
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黄勇
郑林
张熊莉
李勇军
巩仔鹏
李月婷
迟明艳
何峰
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Guizhou Medical University
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/36Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/738Rosa (rose)
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8969Polygonatum (Solomon's seal)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
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    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
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    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention belongs to the technical field of biological medicines, and particularly relates to a traditional Chinese medicine composition for reducing blood sugar and blood fat and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-15 parts of kudzu roots, 5-10 parts of polygonatum sibiricum, 5-10 parts of rosa roxburghii and 2-10 parts of radix pseudostellariae. The invention has the advantages that: on the basis of a classical famous prescription, a plurality of medicinal and edible medicinal materials such as rhizoma polygonati, radix pseudostellariae, rosa roxburghii and the like are matched with the astragalus mongholicus and the radix puerariae, and the mutual complementary and mutual coordination effects of the medicinal and edible medicinal materials are utilized, so that the blood sugar reducing effect is improved, the immunity of the organism is improved, and the health level of a human body is improved. The health care product prepared from the medicinal and edible medicinal materials used in the invention has the advantages of definite curative effect, simple preparation process and convenient carrying and taking. The invention adopts an adsorption clarification technology to refine the decoction, removes protein, tannin and other impurities which affect the mouthfeel, and greatly improves the mouthfeel and clarity.

Description

Traditional Chinese medicine composition for reducing blood sugar and blood fat and preparation method thereof
Technical Field
The invention belongs to the technical field of biological medicines, and particularly relates to a traditional Chinese medicine composition for reducing blood sugar and blood fat and a preparation method thereof.
Background
Diabetes, cardiovascular and cerebrovascular diseases and cancer are one of three diseases which threaten human life and health at present. In recent years, the number of diabetics in China and even in the world is increasing, and according to data released in 2019 of the world diabetes alliance, 4.63 hundred million diabetics in the world currently exist, wherein 1.164 million diabetics exist in China and are located at the first position in the world, and in recent years, the incidence rate of diabetes is younger.
Diabetes is a series of metabolic diseases caused by high blood sugar due to absolute or relative insufficiency of insulin secretion. Diabetes is classified into type i diabetes, type ii diabetes, special type diabetes and gestational diabetes, wherein the proportion of type ii diabetes patients is more than 90%, type 1 diabetes mellitus (T1 DM) is also called insulin-dependent diabetes mellitus, and is an autoimmune disease caused by immune-mediated pancreatic cell destruction, which is regulated by the body's immune system, resulting in limited or complete cessation of insulin production and secretion, and type 2 diabetes mellitus (T2 DM) is also called non-insulin-dependent diabetes mellitus, mainly due to insulin hyposecretion and insulin resistance. The pathogenesis of diabetes is mainly common in heredity, obesity, environmental factors, insulin resistance, islet cell dysfunction and the like, and multiple factors often act together. At present, the diabetes is mainly treated by the western medicine through metformin, glimepiride, gliclazide, rosiglitazone and the like, the medicines have a good effect of reducing blood sugar, but have obvious toxic and side effects, the blood sugar needs to be monitored regularly in the taking process, the damage to the liver and kidney functions and the tolerance can be caused after the long-term use, if the dosage is too large, the blood sugar can be reduced to be below a normal value, the hypoglycemia is caused, even hypoglycemia shock and coma can be caused, and the serious patient can be killed.
Diabetes is called as diabetes by the theory of traditional Chinese medicine. Some ancient medical classics describe the name "diabetes". The Chinese medical literature, "jin Kui Yao L ü e" has been well documented for clinical symptoms of diabetes. Causes of diabetes usually include physical weakness, visceral weakness, improper diet control, emotional runaway, overstrain, excessive desire, etc. The traditional Chinese medicine is not only the national essence of China, but also the treasure of Chinese culture, has the obvious advantages of syndrome differentiation treatment, good long-term curative effect, small toxic and side effects and the like in the aspect of treating the diabetes, has wide application prospect, and has the advantages of definite curative effect, small toxic and side effects, parent price and the like in the aspect of preventing and treating the diabetes compared with western medicines.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for reducing blood sugar and blood fat.
A traditional Chinese medicine composition for reducing blood sugar and blood fat is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-15 parts of kudzu roots, 5-10 parts of polygonatum sibiricum, 5-10 parts of rosa roxburghii and 2-10 parts of radix pseudostellariae.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 15 parts of kudzu root, 10 parts of rhizoma polygonati, 5 parts of rosa roxburghii and 5 parts of radix pseudostellariae.
The invention also provides a method for preparing the traditional Chinese medicine composition, which comprises the following steps: according to the formula, astragalus, kudzuvine root, rhizoma polygonati, roxburgh rose and radix pseudostellariae are weighed, decocted by adding water, filtered and concentrated to obtain the traditional Chinese medicine.
Preferably, the amount of the water is 8-12 times of the weight of the traditional Chinese medicine composition; the decocting times are 1-5 times, and the time for each time of decocting is 1-5 hours.
The invention also provides a method for preparing the traditional Chinese medicine composition, which comprises the following steps: according to the formula, astragalus, kudzuvine root, rhizoma polygonati, roxburgh rose and heterophylly falsestarwort root are weighed, decocted by adding water, filtered, concentrated, clarified by adding a clarifying agent, stirred and filtered to obtain the traditional Chinese medicine.
Preferably, the amount of the water is 8-12 times of the weight of the traditional Chinese medicine composition; the decocting times are 1-5 times, and the time for each time of decocting is 1-5 hours; the clarifying agent comprises an A component and a B component; the clarifying temperature is 50-80 ℃; the stirring time is 30-90 minutes; the stirring speed is 80 r/min-120 r/min.
Particularly preferably, the preparation method of the A component comprises the following steps: weighing 5g of the component A, adding a small amount of water, stirring, adding water to 500mL, swelling for 24h, stirring, and filtering to obtain the composition; the preparation method of the component B comprises the following steps: weighing 5g of the component B, adding a small amount of 0.1% acetic acid solution for dissolving, stirring, adding 0.1% acetic acid solution to 500mL, stirring, and filtering to obtain the composition.
The invention also provides the traditional Chinese medicine composition, which further comprises pharmaceutically acceptable auxiliary materials.
The invention also provides the traditional Chinese medicine composition, and the dosage form of the traditional Chinese medicine composition is oral preparation, injection or inhalant; the oral preparation is tablet, capsule, granule, pill, decoction, oral liquid, unguent, powder, microcapsule, dispersible powder, distillate, dripping pill or liposome.
Preferably, the pharmaceutically acceptable adjuvants comprise one or more of filler, lubricant, sweetener, sour agent, edible essence, antiseptic, fruit powder, suspending agent, edible pigment, diluent, emulsifier, disintegrating agent or plasticizer.
The filler is auxiliary materials used for increasing the weight and the volume of the tablet and facilitating tabletting. The filler used as a tablet requires good flowability, compressibility and binding force. Preferably, the filler is one or a mixture of two or more of sucrose, starch, fructose, sugar alcohols, pregelatinized starch, microcrystalline cellulose, and dextrin. However, those skilled in the art will recognize that all possible disintegrants are within the scope of the present invention, and the type of filler is not limited thereto, and the present invention is not limited thereto.
The lubricant is an auxiliary material capable of reducing the friction force between the tablet and the die wall, so as to prevent difficult tabletting due to large friction force, ensure uniform pressure distribution during tabletting and uniform density of the tablet, and also improve the appearance of the tablet, so that the surface of the tablet is bright and flat. Preferably, the lubricant is one or a mixture of two or more of magnesium stearate, talc, silica and stearic acid. However, those skilled in the art will recognize that the possible lubricants are within the scope of the present invention, and the type of lubricant is not limited thereto, and the present invention is not limited thereto.
In order to increase the sweetness of the medicine and improve the taste, the medicine is easy to take. Preferably, the sweetener is one or a mixture of two of AK sugar, sucralose, aspartame or mogroside. However, those skilled in the art will recognize that any suitable sweetener is within the scope of the present invention, and that the type of sweetener is not limited thereto, and the present invention is not limited thereto.
Preferably, the sour agent is one or a mixture of two of malic acid, citric acid, lactic acid and citric acid. However, those skilled in the art will recognize that all possible acid agents are within the scope of the present invention, and the type of acid agent is not limited thereto, and the present invention is not limited thereto.
Preferably, the edible essence is one or a mixture of more than two of orange essence, lemon essence, orange essence, cherry essence, apple essence or coconut essence. However, those skilled in the art will recognize that the possible flavors are within the scope of the present invention, and the types of flavors are not limited thereto, and the present invention is not limited thereto.
Preferably, the preservative is one or a mixture of two or more of methyl sorbate, sodium benzoate, potassium benzoate, ethyl paraben and phenyl paraben. However, those skilled in the art will recognize that any preservatives are within the scope of the present invention, and the type of preservative is not limited thereto, and the present invention is not limited thereto. Preferably, the fruit powder is one or more of orange powder, lemon powder, orange powder, cherry powder, apple powder and coconut powder. However, those skilled in the art will recognize that the fruit powder is within the scope of the present invention, and the type of fruit powder is not limited thereto, and the present invention is not limited thereto.
Preferably, the suspending agent is one or a mixture of more than two of sodium carboxymethylcellulose, sodium alginate or beeswax. However, those skilled in the art will recognize that other possible suspending agents are within the scope of the present invention, and the type of suspending agent is not limited thereto, and the present invention is not limited thereto.
Preferably, the edible pigment is one or more of gardenia yellow, caramel pigment, curcumin and chlorophyll. However, those skilled in the art will recognize that the range of edible colors that are possible is within the scope of the present invention, and the type of edible color is not limited thereto, and the present invention is not limited thereto.
Preferably, the diluent is one or a mixture of more than two of edible vegetable oil, propylene glycol or polyethylene glycol with the molecular weight of 400-6000. However, those skilled in the art will recognize that all possible diluents are within the scope of the present invention, and the type of diluent is not limited thereto, and the present invention is not limited thereto.
Preferably, the emulsifier is one or a mixture of more than two of sodium/calcium stearoyl lactylate, diacetyl tartaric acid monoglyceride, sucrose fatty acid ester, polyethylene glycol with molecular weight of 400-6000 or distilled monoglyceride. However, the scope of the present invention is not limited to the examples, and the present invention is not limited thereto.
The main function of the disintegrant is to eliminate the binding force of the binder or the tablet formed by pressurization, so that the tablet disintegrates rapidly and can exert the drug effect rapidly. Preferably, the disintegrant is one or a mixture of two or more of starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, crospovidone, and sodium carboxymethyl cellulose. However, those skilled in the art will recognize that all possible disintegrants are within the scope of the present invention, and the type of filler is not limited thereto, and the present invention is not limited thereto.
Preferably, the plasticizer is one or a mixture of two or more of sodium carboxymethylcellulose, glycerol, sorbitol, and sodium oleamide sulfonate. However, the plasticizer is considered to be within the scope of the present invention by those skilled in the art, and the kind of plasticizer is not limited thereto, and the present invention is not limited thereto.
The formula Huangqi Kudzuvine root decoction (Huangqi Kudzuvine root decoction) is from syndrome treatment Hui Bu of pure essentials of Qing Dynasty Li, wherein the formula records that Huangqi is one or two, Kudzuvine root is five-money, and is used for treating alcohol depression, internal heat and aversion to cold, and is taken orally and cured by sweating, and is mainly used for treating symptoms of deficiency of both qi and yin such as diabetes and apoplexy sequela. The invention adds genuine medicinal materials of polygonatum, radix pseudostellariae, roxburgh rose and other Guizhou areas on the basis of the ancient formula, wherein astragalus in the formula has the functions of tonifying qi and invigorating yang, consolidating the constitution and consolidating the vitality, kudzuvine root has the functions of promoting the production of body fluid to quench thirst, clearing heat and removing toxicity, radix pseudostellariae has the functions of nourishing yin and promoting the production of body fluid, polygonatum has the functions of tonifying qi and nourishing yin, invigorating spleen and moistening lung, roxburgh rose improves the immunity of the organism, and the effects of tonifying kidney and strengthening spleen, tonifying qi and activating blood and nourishing yin and yang are achieved together by integrating the medicinal flavors.
Radix astragali is dried root of Astragalus membranaceus bge or Astragalus membranaceus bge of Leguminosae. Astragalus membranaceus is recorded in Shen nong Ben Cao Jing (Shennong's herbal), is named Astragalus membranaceus, Astragalus membranaceus and Astragalus membranaceus, has sweet taste and mild nature, enters lung and spleen channels, has the effects of tonifying qi, invigorating yang, consolidating superficial resistance, arresting sweating, inducing diuresis, relieving swelling, promoting the production of body fluid, nourishing blood, activating stagnancy, relieving arthralgia, expelling pus, healing sore and promoting tissue regeneration.
Kudzu root is the dry root of Pueraria lobata Ohwi of Leguminosae, and was recorded in Shen nong's herbal Jing of Han Dynasty: kudzuvine root, radix Puerariae, has the main effects of quenching thirst, body heat, vomiting, various kinds of arthralgia, yin qi generation and toxin elimination. It has sweet, pungent and cool taste, and has effects of expelling pathogenic factors from muscles, relieving fever, promoting salivation, quenching thirst, promoting eruption, invigorating yang, relieving diarrhea, dredging meridian passage, and relieving alcoholism.
Rhizoma Polygonati is dried rhizome of Polygonatum kingianum, Polygonatum kingianum or Polygonatum cyrtonema of Liliaceae, and is recorded in "Chinese pharmacopoeia". Beginning with the book Ming Yi Bie Lu: rhizoma polygonati is sweet in taste, flat and nontoxic, enters spleen channels, lung channels and kidney channels, and has the effects of tonifying qi and yin, strengthening spleen, moistening lung, tonifying kidney and the like.
Radix Pseudostellariae is dry root tuber of Caryophyllaceae plant, and is named as Pseudostellariae heterophylla, Tripterospermum heterophyllum, radix Tripterygii Wilfordii, and radix Ginseng Indici. It is sweet, slightly bitter and mild in taste. The ginseng tea has the effects of tonifying qi and spleen, promoting the production of body fluid and moistening lung, is commonly used for treating spleen deficiency and tiredness, inappetence, weakness after illness, deficiency of qi and yin, spontaneous perspiration and thirst, lung dryness and dry cough, and has the similar effect to the ginseng.
The roxburgh rose, also known as reeling silk flower, shinyleaf pricklyash fruit and Senchun angelica, is deciduous shrub of Rosa of Rosaceae, is rich in abundant nutrient substances, has high value for both medicine and food, and is rich in vitamin C, flavone, triterpene, amino acid, organic acid, polysaccharide, polyphenol and other substances. Fructus Rosae Normalis has effects in regulating immunity, clearing away toxic materials, tranquilizing mind, delaying aging, resisting tumor, invigorating stomach, resolving food stagnation, preventing and treating diabetes, and resisting mutation.
On the basis of a classical famous prescription, a plurality of medicinal and edible medicinal materials such as rhizoma polygonati, radix pseudostellariae, rosa roxburghii and the like are matched with the astragalus mongholicus and the radix puerariae, and the effects of mutual complementation and mutual coordination are utilized, so that the blood sugar reducing effect is improved, the immunity of the organism is improved, and the health level of a human body is improved. The health care product prepared from the medicinal and edible medicinal materials used in the invention has the advantages of definite curative effect, simple preparation process and convenient carrying and taking. The invention adopts an adsorption clarification technology to refine the decoction, removes protein, tannin and other impurities which affect the mouthfeel, and greatly improves the mouthfeel and clarity.
Detailed Description
In order to make the production process and technical effects of the present invention known in detail to those skilled in the art, the following is a specific production example to further describe the application and technical effects of the present invention.
Example one
Investigation of water decoction extraction Process
Determination of test objectives and investigation indicators
In the preparation method of the auxiliary hypoglycemic oral liquid, the optimal water extraction process combination is optimized through a multi-factor and multi-level orthogonal test. Taking the total polysaccharide extraction rate, the astragaloside IV and the puerarin transfer rate as investigation indexes, and selecting the optimal water extraction process parameters.
Design of orthogonal experiments
Factor, level and selection of orthogonal tables: the factors influencing water extraction include solvent multiple, extraction time and extraction frequency, 3 levels are designed for each factor on the basis of the 3 factors, the factor levels are shown in table 1, and L is selected9(34) The orthogonal table of (2) was designed for the experiment.
TABLE 1 Water extraction Process factor level table
Figure BDA0003351543650000061
Test methods and results: weighing the medicinal materials according to the prescription, paralleling 9 parts and randomly numbering 1-9 test numbers. According to the orthogonal table L9(34) The test is required to be carried out for each test number, the filtration is carried out, and the filtrates are combined for standby.
Determination of total polysaccharides: precisely sucking 0.5mL of each orthogonal test sample into a glass tube with a plug, adding distilled water to 2.0mL, adding 1.0mL of 5% phenol reagent, shaking up, rapidly adding 5.0mL of concentrated sulfuric acid, immediately shaking up, standing for 5min, placing in a water bath at 40 ℃ for 15min, taking out, placing in cold water for cooling to room temperature, taking distilled water as blank liquid in the same way, and measuring the absorbance at 490 nm.
Determination of astragaloside IV: precisely weighing 25mL of each orthogonal experiment decoction in an evaporating dish, extracting with water saturated n-butanol for 3 times (25 mL each time), mixing n-butanol, washing with ammonia test solution for 2 times (40 mL each time), discarding ammonia solution, evaporating n-butanol solution to dryness, dissolving residue with methanol, transferring to a 5mL measuring flask, adding methanol to scale, shaking, filtering, and collecting filtrate. Octadecylsilane chemically bonded silica is used as a filling agent; acetonitrile-water (36: 64) is used as a mobile phase; detecting with evaporative light scattering detector at column temperature of 40 deg.C and flow rate of 1.0ml/min, introducing sample 10ul, and analyzing.
Determination of puerarin: precisely sucking 1mL of each decoction liquid in an orthogonal test into a conical flask with a plug, adding 100mL of methanol, performing ultrasonic treatment for 30min, cooling to room temperature, complementing the weight loss amount with methanol, and filtering with a 0.45nm microporous filter membrane to obtain the final product. Octadecylsilane chemically bonded silica is used as a filling agent, methanol-water (25:75) is used as a mobile phase, the flow rate is 1.0ml/min, the column temperature is 30 ℃, and the detection wavelength is 250 nm. The number of theoretical plates is not less than 4000 calculated according to puerarin peak.
Table 2 water extraction process orthogonal test table
Figure BDA0003351543650000071
Note: the total polysaccharide extraction rate/maximum total polysaccharide extraction rate is multiplied by 0.40 multiplied by 100% + astragaloside transfer rate/maximum astragaloside transfer rate is multiplied by 0.30 multiplied by 100% + puerarin transfer rate/maximum puerarin transfer rate is multiplied by 0.30 multiplied by 100%.
Analysis of variance (table 3) shows that the number of extractions (B) has a significant effect on the experimental results (P <0.01), the extraction time (C) has a significant effect on the experimental results (P <0.05), the amount of water added (a) has no significant effect on the experimental results, and the order of the effects of each factor on the experimental results is B > C > a. Considering the actual situation, the optimal process is finally determined as A1B3C2, adding 8 times of water, decocting for 3 times, each time for 1.5 h.
TABLE 3 ANOVA TABLE
Source Sum of squares of class III Degree of freedom Mean square F Significance of
Correction model 1166.696a 6 194.449 70.821 0.014
Intercept of a beam 53505.858 1 53505.858 19487.541 0.000
A 13.843 2 6.922 2.521 0.284
B 900.760 2 450.380 164.034 0.006
C 252.092 2 126.046 45.908 0.021
Error of the measurement 5.491 2 2.746
Total of 54678.045 9
Corrected total 1172.187 8
Example two
Refining of extractive solution with ZTC1+1 II type clarifier
Weighing the medicinal materials according to the formula, adding 8 times of water, decocting for 3 times, each time for 1.5h, filtering, adding a solvent until the material-liquid ratio is 8 times, adding 4% of ZTC1+1 II clarifier B component, adding 2% of component A, heating the extract to 70 ℃, stirring for 60min at 100r/min, and filtering for later use.
The following are experiments relating to the adsorption clarification of the invention:
preparation of adsorption clarifying agent
The component A comprises: weighing 5g of the component A, adding a small amount of water, stirring, adding water to 500mL, and swelling for 24 h. Stirring and filtering to obtain the product.
And B component: weighing 5g of the component B, adding a small amount of 0.1% acetic acid solution for dissolving, stirring, adding 0.1% acetic acid solution to 500mL, stirring, and filtering to obtain the final product.
Examination of the use of clarifying Agents (fixed A, B ratio of Components 1:2)
Since the adsorbent clarifier contains A, B two components, the order of addition of the two components was screened. Weighing the medicinal materials according to the prescription proportion, decocting according to the optimal preferred extraction process, and concentrating to obtain the following medicinal materials: liquid medicine 1: 8. 100mL of the concentrated solution was measured out in two portions, heated to 70 ℃ and A, B portions were added at a stirring rate of 100r/min, each 10 mL. Sample 1 was added with component A first and then with component B, and sample 2 was reversed. The clarification effect of both addition sequences was examined. The results are shown in Table 4.
TABLE 4 clarification effect of the order of addition on the liquid medicine
Sample (I) Description of the precipitation Clarification effect
1 Small amount, small pieces on the surface of liquid Turbidity
2 Large amount of large lump precipitate Clarification
The results show (see Table 4) that ZTC1+1 II clarifier A, B was added in the order of component B first followed by component A.
Investigation of the amount of clarifying agent
The above experiment confirmed the order of addition of A, B two components, respectively measured the above concentrated solution 100mL four parts, according to the proportion of 2%, 4%, 6%, 8%, 10% add component B, heated to 70 ℃, with 100r/min stirring speed, stirring for 1h, according to the conditions of example 1 determination of polysaccharide, astragaloside IV, puerarin retention rate. The results are shown in Table 5.
TABLE 5 Effect of different amounts of absorbent clarifying agent on absorbent clarifying agent
Amount of clarifier B Polysaccharide Retention% Retention rate of astragaloside IV% Puerarin retention% Clarity of the solution
2% 87.62 90.57 86.78 Slight turbidity
4% 92.98 93.49 90.56 Clarification
6% 90.58 91.73 89.69 Is relatively clear
8% 80.47 81,14 79.47 Slightly turbid
10% 76.64 80.51 79.74 Turbidity
The results show (see Table 5) that the retention of the ingredients is maximized when the amount of the B component added is 4% and the A component is 2%.
Examination of concentration degree of extract
Respectively measuring the ratio of material to liquid as 1: 2. 1: 4. 1: 6. 1:8, adding 4% of component B and 2% of component A into 1 part of each extractive solution, heating to 70 deg.C, stirring at 100r/min for 1h, measuring the retention rate of polysaccharide, astragaloside IV and puerarin according to the conditions of example 1, and observing clarity. The results are shown in Table 6.
TABLE 6 influence of different feed-liquid ratios on the clarification effect of adsorption
Degree of concentration Polysaccharide Retention% Retention rate of astragaloside IV% Puerarin retention% Clarity of the product
1:2 75.78 74.56 73.98 Turbidity
1:4 80.93 78.85 79.63 Clarification
1:6 85.73 74.65 78.64 Is relatively clear
1:8 90.93 88.92 86.92 Clarification
The results show (see table 6) that when the feed is concentrated to 1: when 8, the retention rate of each index is maximized and the clarity is maximized.
Investigation of temperature of extract
Measuring 4 parts of extractive solution with material-to-liquid ratio of 1:8, adding 4% of component B and 2% of component A, stirring at 50 deg.C, 60 deg.C, 70 deg.C, and 80 deg.C at a stirring speed of 100r/min for 1 hr, measuring total polysaccharide extraction rate, astragaloside IV and puerarin retention rate according to the above conditions, and observing clarity. The results are shown in Table 7.
TABLE 7 Effect of different temperatures on the adsorption clarification Effect
Temperature of Polysaccharide Retention% Retention rate of astragaloside IV% Puerarin retention% Clarity of the product
50℃ 78.52 79.72 73.98 Turbidity
60℃ 83.61 82.57 77.63 Is relatively clear
70℃ 86.61 83.52 80.64 Clarification
80℃ 81.59 80.27 79.92 Is relatively clear
The results show (see table 7) that the retention of the respective indices is maximized and the clarity is maximized at a temperature of 70 ℃.
EXAMPLE III
Preparation of health product for reducing blood sugar and improving immunity
Weighing the medicinal materials according to the formula, adding 8 times of water, decocting for 3 times, each time for 1.5h, filtering, adding a solvent until the material-liquid ratio is 8 times, adding 4% of ZTC1+1 II clarifier B component, adding 2% of component A, heating the extract to 70 ℃, stirring at 100r/min for 60min, filtering, adding a proper amount of flavoring agent and preservative, stirring uniformly, canning, and sterilizing to obtain the finished product.
In the invention, the component A of the clarifying agent and the component B of the clarifying agent are both commercially available products, the component A of the clarifying agent is ZTC1+1 natural clarifying agent IIA, and the component B of the clarifying agent is ZTC1+1 natural clarifying agent IIB.
Example four
Pharmacodynamic study of the invention
Experimental Material
Medicine preparation: metformin tablets; astragalus root and kudzu root flavor-enhancing soup; astragalus root and kudzu root decoction
Reagent: tetraoxypyrimidines
High-fat feed: (lard 10%, sucrose 15%, yolk powder 15%, casein 5%, cholesterol 1.2%, sodium cholate 0.2%, calcium hydrogen phosphate 0.6%, stone powder 0.4%, basic feed 52.6%)
Animals: male SD mice, body weight 26. + -.2 g
An instrument; a rapid blood glucose meter; centrifugal machine
Experimental methods
Establishment of animal model
100 male SD mice are cultured for one week, 10 mice (a blank control group and a conventional feed) are randomly selected, the rest 90 mice are fed with high-fat feed for 4 weeks, the mice are fasted for 24 hours without water prohibition, 50mg/kg alloxan is injected into the abdominal cavity, the mice are fasted for 12 hours after 1 week, tail vein blood is taken, the blood sugar value is measured, the blood sugar value is more than or equal to 11.0mmol/L, the model building is considered to be successful, unqualified patients are discarded, and the mice are fed with the high-fat feed during the period. The 80 successfully molded rats are randomly divided into eight groups, namely a blank control group (normal saline), a model group, a western medicine control group (metformin), a traditional Chinese medicine control group (astragalus and kudzu root decoction), and astragalus and kudzu root flavor-enhancing decoction, namely high, medium and low dosage groups. Except for the blank group and the model group, the other groups all have 10mL/kg of corresponding tested medicine of ig, the blank control group and the model group ig have equal volume of distilled water, the continuous administration is carried out for 30d, and all the groups except the blank control group (common feed) during the administration period are fed with high-fat feed. After the administration, the animals in each group were fasted overnight and the fasting blood glucose, glucose tolerance, serum insulin, cholesterol and triglyceride levels were measured.
Measurement of fasting blood glucose, oral glucose tolerance test
After continuous administration for 30 days, rats of each group are fasted for 12 hours without water prohibition, fasting blood glucose is measured, 50% glucose solution is intraperitoneally injected at 2g/kg body weight, tail vein blood is respectively collected at 0min, 30min and 120min after injection, blood glucose value is measured, and area under the blood glucose curve (AUC) is calculated. The area under the blood glucose curve is 0.25 × 0min blood glucose level +0.5 × 30min blood glucose level +0.75 × 60min blood glucose level +0.5 × 120min blood glucose level.
TABLE 8 influence of hypoglycemic oral liquid on glucose tolerance of mice
Figure BDA0003351543650000101
Figure BDA0003351543650000111
Compared with the blank group, Tp is less than 0.001, Tp is less than 0.01, and Tp is less than 0.05; compared with the model group, the delta P is less than 0.001; compared with the model group, the delta P is less than 0.01; compared with the model group, the delta P is less than 0.05; n is 10.
The results show that the area under the curve of the model group mice is obviously increased compared with the blank group; compared with the model group, the area under the blood glucose curve of each administration group is lower than that of the model group. Compared with the model group, the metformin group, the radix astragali and radix puerariae group and the radix astragali and radix puerariae flavor-enhancing soup have the advantages that the fasting blood glucose of the model group is obviously increased, the high dose and the medium dose are obviously reduced, and the low dose group has no obvious difference.
Detection of blood lipid level of insulin resistant rat
The animals in each group are forbidden for 24 hours, tail vein blood sampling is carried out, serum cholesterol, triglyceride and other indexes are detected by an oxidase method, and the influence of the invention on the blood fat change of rats is examined. The results are shown in Table 9.
TABLE 9 Effect of hypoglycemic oral liquid on mouse triglyceride and total cholesterol
Group of Triglycerides Total Cholesterol
Blank group 0.88±0.32 4.56±0.61
Model set 1.34±0.48** 6.57±1.77***
Metformin hydrochloride 1.24±0.35 6.01±0.61
Radix astragali and radix Puerariae group 0.93±0.67△△ 5.09±0.84△△
High dose group 0.86±0.24△△ 4.76±0.54△△
Middle dose group 0.96±0.32△ 5.17±0.43△
Low dose group 0.99±0.31 6.01±1.11
Compared with the blank group, Tp is less than 0.001, Tp is less than 0.01, and Tp is less than 0.05; compared with the model group, the delta P is less than 0.001, the delta P is less than 0.01, and the delta P is less than 0.05; n is 10.
The results show (see table 9) that the effects on triglyceride and total cholesterol of the mice are obviously increased compared with the blank group, and triglyceride (P is less than 0.01) and total cholesterol (P is less than 0.001) of the model group mice are obviously increased; compared with the model group, the triglyceride and the total cholesterol of the high-dose group (P is less than 0.01) and the medium-dose group (P is less than 0.05) are all obviously lower than those of the model group, and the triglyceride and the total cholesterol of the high-dose group are both lower than those of the astragalus and kudzuvine root group.
Detection of insulin levels in insulin resistant rats
After each group of animals is fasted for 24h, serum insulin is detected, the insulin resistance conditions of the model control group and the test drug group are examined, and an insulin resistance index is calculated, and the result is shown in a table 10.
TABLE 10 Effect of hypoglycemic oral liquids on insulin resistance index in mice
Figure BDA0003351543650000112
Figure BDA0003351543650000121
Compared with the blank group, the delta P is less than 0.001, the delta P is less than 0.01, and the delta P is less than 0.001, the delta P is less than 0.01 and the delta P is less than 0.05; n is 10.
The results show that the insulin resistance level indexes of the mice in the model group are obviously increased (P is less than 0.001) compared with the blank group on the influence of the insulin resistance level of the mice; compared with the model group, the insulin resistance indexes of mice in the positive group, the high dose group, the medium dose group and the low dose group are all remarkably reduced (P is less than 0.001), which shows that the invention can effectively reduce the insulin resistance of the model rats with type II diabetes.
Finally, it should be noted that the above embodiments are only used for illustrating and not limiting the technical solutions of the present invention, and although the present invention has been described in detail with reference to the above embodiments, it should be understood by those skilled in the art that modifications or equivalent substitutions can be made to the present invention without departing from the spirit and scope of the present invention, and all modifications or partial substitutions should be covered by the scope of the claims of the present invention.

Claims (10)

1. A traditional Chinese medicine composition for reducing blood sugar and blood fat is characterized in that: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-30 parts of astragalus membranaceus, 5-15 parts of kudzu roots, 5-10 parts of polygonatum sibiricum, 5-10 parts of rosa roxburghii and 2-10 parts of radix pseudostellariae.
2. The traditional Chinese medicine composition for reducing blood sugar and blood fat according to claim 1, which is characterized in that: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30 parts of astragalus membranaceus, 15 parts of kudzu root, 10 parts of rhizoma polygonati, 5 parts of rosa roxburghii and 5 parts of radix pseudostellariae.
3. A method of preparing the traditional Chinese medicine composition of claim 1 or 2, characterized in that: the method comprises the following steps: according to the formula, astragalus, kudzuvine root, rhizoma polygonati, roxburgh rose and radix pseudostellariae are weighed, decocted by adding water, filtered and concentrated to obtain the traditional Chinese medicine.
4. The method of preparing a Chinese medicinal composition according to claim 3, wherein: the amount of the water is 8-12 times of the weight of the traditional Chinese medicine composition; the decocting times are 1-5 times, and the time for each time of decocting is 1-5 hours.
5. A method of preparing the traditional Chinese medicine composition of claim 1 or 2, characterized in that: the method comprises the following steps: according to the formula, astragalus, kudzuvine root, rhizoma polygonati, roxburgh rose and heterophylly falsestarwort root are weighed, decocted by adding water, filtered, concentrated, clarified by adding a clarifying agent, stirred and filtered to obtain the traditional Chinese medicine.
6. The method of preparing a Chinese medicinal composition according to claim 5, wherein: the amount of the water is 8-12 times of the weight of the traditional Chinese medicine composition; the decocting times are 1-5 times, and the time for each time of decocting is 1-5 hours; the clarifying agent comprises an A component and a B component; the clarifying temperature is 50-80 ℃; the stirring time is 30-90 minutes; the stirring speed is 80 r/min-120 r/min.
7. The method of preparing a Chinese medicinal composition according to claim 6, wherein: the preparation method of the component A comprises the following steps: weighing 5g of the component A, adding a small amount of water, stirring, adding water to 500mL, swelling for 24h, stirring, and filtering to obtain the composition; the preparation method of the component B comprises the following steps: weighing 5g of the component B, adding a small amount of 0.1% acetic acid solution for dissolving, stirring, adding 0.1% acetic acid solution to 500mL, stirring, and filtering to obtain the final product.
8. The traditional Chinese medicine composition according to any one of claims 1 to 7, wherein: the traditional Chinese medicine composition also comprises pharmaceutically acceptable auxiliary materials.
9. The traditional Chinese medicine composition according to any one of claims 1 to 8, wherein: the dosage form of the traditional Chinese medicine composition is oral preparation, injection or inhalant; the oral preparation is tablet, capsule, granule, pill, decoction, oral liquid, unguent, powder, microcapsule, dispersible powder, distillate, dripping pill or liposome.
10. The traditional Chinese medicine composition according to claim 8, wherein: the pharmaceutically acceptable adjuvants comprise one or more of filler, lubricant, sweetener, sour agent, edible essence, antiseptic, fruit powder, suspending agent, edible pigment, diluent, emulsifier, disintegrating agent or plasticizer.
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