CN116159088A - Propolis astragalus root and kudzuvine root soft capsule and preparation process thereof - Google Patents
Propolis astragalus root and kudzuvine root soft capsule and preparation process thereof Download PDFInfo
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- CN116159088A CN116159088A CN202310291724.5A CN202310291724A CN116159088A CN 116159088 A CN116159088 A CN 116159088A CN 202310291724 A CN202310291724 A CN 202310291724A CN 116159088 A CN116159088 A CN 116159088A
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- A61K35/64—Insects, e.g. bees, wasps or fleas
- A61K35/644—Beeswax; Propolis; Royal jelly; Honey
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- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
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- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
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Abstract
The invention discloses a propolis astragalus root and kudzuvine root soft capsule and a preparation process thereof, wherein the formula of the propolis astragalus root and kudzuvine root soft capsule is prepared into 1000 capsules, and the dosage of 0.6 g/capsule is calculated: 41-43g of propolis extract, 41-43g of astragalus extract, 95-97g of radix puerariae extract, 410-430g of polyethylene glycol, 110-130g of gelatin, 59-61g of glycerol, 1g of brown ferric oxide and 118-120g of purified water. Propolis extract for adjuvant treatment of hyperlipidemia and diabetes; radix astragali extract for treating chronic nephritis, albuminuria, and diabetes; the kudzuvine root extract is dry extract powder obtained by extracting, concentrating and drying kudzuvine root medicinal materials, has the efficacy of promoting the production of body fluid to quench thirst, and is clinically used for treating diabetes by single or compound medicines with obvious curative effect; the health food takes qi tonifying as a leading part, takes yin nourishing as a fundamental part, takes blood circulation promoting and blood stasis removing as a premise, achieves the aim of assisting in reducing blood sugar, has no toxic or side effect, plays the integral regulation advantage, improves the life quality of diabetics, and provides a safe, effective, reliable and low-cost health food for a plurality of diabetics.
Description
Technical Field
The invention belongs to the technical field of health care medicines, and in particular relates to a propolis astragalus root and kudzuvine root soft capsule and a preparation process thereof.
Background
It is counted that the mortality rate of diabetics caused by cardiovascular and cerebrovascular diseases is about 80%, the life expectancy of diabetics is reduced by 1/3, the blood lipid of diabetics is increased by more than 80%, and the blood viscosity of diabetics is increased by 90%. The death number caused by diabetes complications is the third place after cardiovascular and cerebrovascular diseases and cancers, and great importance is attached to all countries in the world, and researches on pathogenesis, medicine control, nutrition, health care and the like of diabetes are carried out in a dispute.
At present, no effective method for curing diabetes exists. Thus controlling blood glucose levels in patients, preventing complications is critical in the treatment of diabetes. As the method is a long-term process, compared with the application of synthetic medicaments, the natural hypoglycemic substance in the plant has the advantages of easy acceptance, adherence and small toxic and side effects. Therefore, research and development of natural hypoglycemic substances in various plants at home and abroad have been actively conducted in recent years. The health food is a long-term comprehensive behavior, and is necessary to eat on the basis of reasonable medication, attention to measures such as diet regulation, exercise, common sense education, self-monitoring and the like, so that the health food with the auxiliary blood sugar reducing function is also necessary.
At present, the SFDA approved health food with auxiliary blood sugar reducing function is more and the formula is various. The main steps are as follows: the composition comprises Sanshi Xiaokekang granule, tian XUENING tablet, pingchuan tablet Kang Daan sugar capsule, shuanggua Likang tablet, tianqu tablet Tangjingkang tablet, jin Yu tea bag, houde tablet Kuhaisantian granule, ajia Xiaokecha, enyu tablet Tang Mei tablet, yuan Zhengtang sugar pill, golden melon paste, qijian Qianli tablet, qili Ling powder, lizukang oral liquid, guyuxiaoke liquid, sanzhuangchan mycelium oral liquid, tongchun balsam pear buccal tablet, jin Liwang beverage, liwei Kanglishu capsule, borisi Xiaokekang tablet, zequan Yikang powder and the like.
The product plays a positive role in assisting in reducing blood sugar and maintaining physical health, and although the assisting blood sugar-reducing health-care food is continuously updated, the market demand of the product still cannot be met.
Disclosure of Invention
The invention aims to provide a propolis astragalus root and kudzuvine root soft capsule and a preparation process thereof, which are used for solving the problems in the prior art in the background technology.
In order to achieve the above purpose, the invention adopts the following technical scheme:
a formula of the propolis astragalus root and kudzuvine root soft capsule is prepared into 1000 capsules, and the dosage of the propolis astragalus root and kudzuvine root soft capsule is 0.6 g/capsule: 41-43g of propolis extract, 41-43g of astragalus extract, 95-97g of radix puerariae extract, 400410-430g of polyethylene glycol, 110-130g of gelatin, 59-61g of glycerol, 1g of brown ferric oxide and 118-120g of purified water.
Preferably, the formula of the propolis astragalus root and kudzuvine root soft capsule is prepared into 1000 granules, and the dosage of 0.6 g/granule is calculated: 41g of propolis extract, 41g of astragalus extract, 95g of radix puerariae extract, 400 g of polyethylene glycol, 110g of gelatin, 59g of glycerol, 1g of brown ferric oxide and 118g of purified water.
Preferably, the formula of the propolis astragalus root and kudzuvine root soft capsule is prepared into 1000 granules, and the dosage of 0.6 g/granule is calculated: 42g of propolis extract, 42g of astragalus extract, 96g of radix puerariae extract, 400 g of polyethylene glycol 420g, 120g of gelatin, 60g of glycerin, 1g of brown iron oxide and 119g of purified water.
Preferably, the formula of the propolis astragalus root and kudzuvine root soft capsule is prepared into 1000 granules, and the dosage of 0.6 g/granule is calculated: 43g of propolis extract, 43g of astragalus extract, 97g of kudzuvine root extract, 400 g of polyethylene glycol 430g, 130g of gelatin, 61g of glycerol, 1g of brown ferric oxide and 120g of purified water.
A preparation process of propolis astragalus root and kudzuvine root soft capsules comprises the following steps:
s1, preparing a content feed liquid, namely preparing propolis extract, astragalus extract and radix puerariae extract into fine powder, and then mixing the fine powder with polyethylene glycol 400 to prepare the content feed liquid;
s2, preparing capsule shell glue solution, and mixing gelatin, purified water, brown iron oxide and glycerol to obtain the capsule shell glue solution;
s3, injecting the content feed liquid and capsule shell glue liquid into a soft capsule manufacturing machine, pressing the capsule, and shaping the capsule;
s4, washing, drying and selecting the shaped capsules in sequence, and packaging the capsules;
s5, bottling and boxing.
Preferably, in preparing the content feed liquid, the method comprises:
taking the formula amount of propolis extract, astragalus extract and kudzuvine root extract, respectively sieving with a 100-mesh sieve, and uniformly mixing to obtain mixed fine powder for later use;
mixing polyethylene glycol 400 with the above mixed fine powder, stirring to mix uniformly, grinding with colloid mill for 2 times, homogenizing and emulsifying for 30min with a homogenizer, and vacuumizing and defoaming;
obtaining the content liquid.
Preferably, the vacuumizing temperature is 70-80 ℃ and the pressure is 0.06-0.08 Mpa.
Preferably, when preparing the capsule shell glue solution, the method comprises the following steps:
adding a proper amount of purified water into the gelatin of the formula amount to soak for 12 hours, so as to fully expand the gelatin to obtain expanded gelatin for standby;
sieving brown ferric oxide with 100 mesh sieve;
heating the formula amount of glycerol and the rest purified water to 70-80 ℃, uniformly mixing, adding the expanded gelatin and the fine iron oxide brown powder, stirring, preserving heat for 1-2 hours, completely melting, stirring, standing, vacuumizing, defoaming, filtering by a 100-mesh sieve to obtain capsule shell glue solution, and preserving heat at 60 ℃.
Preferably, the method comprises the following steps of: the material liquid of the content is conveyed into a storage tank of a soft capsule manufacturing machine by a conveying pipe; conveying the prepared capsule shell glue solution into a glue storage tank of a soft capsule manufacturing machine by using a conveying pipe, preserving heat, starting the soft capsule manufacturing machine, pressing capsules, wherein each capsule contains 0.6g, and the room temperature is kept between 20 and 24 ℃ and the relative humidity is kept below 30 to 50 percent; and shaping and drying the pressed capsules for 3-4 hours by using a shaping rotary cage machine, cooling the capsules, removing surface moisture, shaping the capsules and primarily drying the capsules.
Preferably, when washing, drying and selecting pills, the method comprises the following steps: washing the shaped capsule with 95% ethanol, and cleaning oil on the surface of the capsule; the washed capsule is sent into a drying chamber, and is dried for 24 to 30 hours, the room temperature of the drying chamber is 26 to 30 ℃, and the relative humidity is below 40 percent; when the softness of the capsule is proper, stopping drying, selecting the dried capsule, removing unqualified products, and selecting the capsule room temperature to be 18-26 ℃ and the relative humidity to be below 60%.
The invention has the technical effects and advantages that: the propolis astragalus root and kudzuvine root soft capsule and the preparation process thereof provided by the invention have the following advantages compared with the prior art:
the propolis astragalus root and kudzuvine root soft capsule provided by the invention is mainly composed of propolis extract, astragalus root extract, kudzuvine root extract and other components, and the propolis extract is dry extract powder obtained by extracting, concentrating and drying propolis, is used for the auxiliary treatment of hyperlipidemia and diabetes, has good effects of sterilizing, diminishing inflammation, resisting oxidation, purifying blood, removing toxins, strengthening immunity, and has obvious effects of reducing blood fat, reducing blood sugar, softening blood vessels and the like; the astragalus extract is dry extract powder obtained by extracting, concentrating and drying astragalus medicinal materials, and is used for qi deficiency and hypodynamia, loose stool, sinking of middle qi, chronic diarrhea and rectocele, hematochezia and metrorrhagia, spontaneous perspiration due to exterior deficiency, qi deficiency and edema, carbuncle and ulcer difficult to be ulcerated, chronic ulcer difficult to be healed, blood deficiency and flaccidity yellow, internal heat and diabetes; chronic nephritis proteinuria, diabetes; the kudzuvine root extract is dry extract powder obtained by extracting, concentrating and drying kudzuvine root medicinal materials, has the efficacy of promoting the production of body fluid to quench thirst, and is clinically used for treating diabetes by single or compound medicines with obvious curative effect; the health food has the advantages of taking qi tonifying as a leading part, nourishing yin as a fundamental part, promoting blood circulation to remove blood stasis as a precondition, and achieving the aim of assisting in reducing blood sugar by simultaneous application, has definite functions, lasting effect, no toxic or side effect, plays the integral regulation role, improves the life quality of diabetics, and provides a safe, effective, reliable and low-cost health food for a plurality of diabetics.
Drawings
Fig. 1 is a flow chart of the preparation of the propolis astragalus root and kudzuvine root soft capsule.
Detailed Description
The following description of the embodiments of the present invention will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present invention, but not all embodiments. The specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Example 1
The embodiment of the invention provides a propolis astragalus root and kudzuvine root soft capsule, which is prepared from 1000 capsules according to the formula of 0.6 g/capsule: 41g of propolis extract, 41g of astragalus extract, 95g of radix puerariae extract, 400 g of polyethylene glycol, 110g of gelatin, 59g of glycerol, 1g of brown ferric oxide and 118g of purified water.
As shown in fig. 1, when preparing the propolis astragalus root and kudzuvine root soft capsule, the steps are as follows:
s1, preparing a content feed liquid, namely taking the formula amount of propolis extract, astragalus extract and kudzuvine root extract, respectively sieving the propolis extract, the astragalus extract and the kudzuvine root extract by a 100-mesh sieve, and uniformly mixing to obtain mixed fine powder for later use; mixing polyethylene glycol 400 with the above mixed fine powder, stirring to mix uniformly, grinding with colloid mill for 2 times, homogenizing and emulsifying for 30min with a homogenizer, and vacuumizing and defoaming; obtaining the content liquid. The room temperature should be kept between 20 ℃ and 28 ℃ and the relative humidity should be below 60%, the vacuumizing temperature is 70 ℃ to 80 ℃ and the pressure is 0.06 Mpa to 0.08Mpa;
s2, preparing capsule shell glue solution, soaking a formula amount of gelatin in a proper amount of purified water for 12 hours to fully expand the gelatin to obtain expanded gelatin for later use; sieving brown ferric oxide with 100 mesh sieve; heating the formula amount of glycerol and the rest purified water to 70-80 ℃, uniformly mixing, adding the expanded gelatin and the fine iron oxide brown powder, stirring, preserving heat for 1-2 hours, completely melting, stirring, standing, vacuumizing and defoaming (the temperature is 70-80 ℃ and the pressure is 0.06-0.08 Mpa), filtering by a 100-mesh sieve to obtain capsule shell glue solution, and preserving heat at 60 ℃;
s3, injecting the content feed liquid and capsule shell glue liquid into a soft capsule manufacturing machine, pressing the capsule, and shaping the capsule; the material liquid of the content is conveyed into a storage tank of a soft capsule manufacturing machine by a conveying pipe; conveying the prepared capsule shell glue solution into a glue storage tank of a soft capsule manufacturing machine by using a conveying pipe, preserving heat, starting the soft capsule manufacturing machine, pressing capsules, wherein each capsule contains 0.6g, and the room temperature is kept between 20 and 24 ℃ and the relative humidity is kept below 30 to 50 percent; and shaping and drying the pressed capsules for 3-4 hours by using a shaping rotary cage machine, cooling the capsules, removing surface moisture, shaping the capsules and primarily drying the capsules.
S4, washing, drying and selecting the shaped capsules in sequence; washing the shaped capsule with 95% ethanol, and cleaning oil on the surface of the capsule; the washed capsule is sent into a drying chamber, and is dried for 24 to 30 hours, the room temperature of the drying chamber is 26 to 30 ℃, and the relative humidity is below 40 percent; when the softness of the capsule is proper, stopping drying, selecting the dried capsule, removing unqualified products, and selecting the capsule room temperature to be 18-26 ℃ and the relative humidity to be below 60%.
And packaging.
S5, packaging, namely bottling (60 grains/bottle) firstly, then boxing (6 bottles/box), and marking the batch number on the outer box according to the batch number issued by the instruction book.
S6, checking finished products, randomly extracting each batch of products, and checking according to the method and requirements of enterprise standards in the health food reporting material.
S7, warehousing the finished product, and placing the finished product in a ventilated and dried warehouse after the finished product is inspected to be qualified, wherein the finished product cannot be mixed with toxic, easy-to-pollute and bad-smell articles. The warehouse should be kept clean and sanitary, and the special personnel should be responsible for keeping.
Example two
The formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 42g of propolis extract, 42g of astragalus extract, 96g of radix puerariae extract, 400 g of polyethylene glycol 420g, 120g of gelatin, 60g of glycerin, 1g of brown iron oxide and 119g of purified water.
When the propolis astragalus root and kudzuvine root soft capsules are prepared, the steps are as follows:
s1, preparing a content feed liquid, namely taking the formula amount of propolis extract, astragalus extract and kudzuvine root extract, respectively sieving the propolis extract, the astragalus extract and the kudzuvine root extract by a 100-mesh sieve, and uniformly mixing to obtain mixed fine powder for later use; mixing polyethylene glycol 400 with the above mixed fine powder, stirring to mix uniformly, grinding with colloid mill for 2 times, homogenizing and emulsifying for 30min with a homogenizer, and vacuumizing and defoaming; obtaining the content liquid. The room temperature should be kept between 20 ℃ and 28 ℃ and the relative humidity should be below 60%, the vacuumizing temperature is 70 ℃ to 80 ℃ and the pressure is 0.06 Mpa to 0.08Mpa;
s2, preparing capsule shell glue solution, soaking a formula amount of gelatin in a proper amount of purified water for 12 hours to fully expand the gelatin to obtain expanded gelatin for later use; sieving brown ferric oxide with 100 mesh sieve; heating the formula amount of glycerol and the rest purified water to 70-80 ℃, uniformly mixing, adding the expanded gelatin and the fine iron oxide brown powder, stirring, preserving heat for 1-2 hours, completely melting, stirring, standing, vacuumizing and defoaming (the temperature is 70-80 ℃ and the pressure is 0.06-0.08 Mpa), filtering by a 100-mesh sieve to obtain capsule shell glue solution, and preserving heat at 60 ℃;
s3, injecting the content feed liquid and capsule shell glue liquid into a soft capsule manufacturing machine, pressing the capsule, and shaping the capsule; the material liquid of the content is conveyed into a storage tank of a soft capsule manufacturing machine by a conveying pipe; conveying the prepared capsule shell glue solution into a glue storage tank of a soft capsule manufacturing machine by using a conveying pipe, preserving heat, starting the soft capsule manufacturing machine, pressing capsules, wherein each capsule contains 0.6g, and the room temperature is kept between 20 and 24 ℃ and the relative humidity is kept below 30 to 50 percent; and shaping and drying the pressed capsules for 3-4 hours by using a shaping rotary cage machine, cooling the capsules, removing surface moisture, shaping the capsules and primarily drying the capsules.
S4, washing, drying and selecting the shaped capsules in sequence; washing the shaped capsule with 95% ethanol, and cleaning oil on the surface of the capsule; the washed capsule is sent into a drying chamber, and is dried for 24 to 30 hours, the room temperature of the drying chamber is 26 to 30 ℃, and the relative humidity is below 40 percent; when the softness of the capsule is proper, stopping drying, selecting the dried capsule, removing unqualified products, and selecting the capsule room temperature to be 18-26 ℃ and the relative humidity to be below 60%.
And packaging.
S5, packaging, namely bottling (60 grains/bottle) firstly, then boxing (6 bottles/box), and marking the batch number on the outer box according to the batch number issued by the instruction book.
S6, checking finished products, randomly extracting each batch of products, and checking according to the method and requirements of enterprise standards in the health food reporting material.
S7, warehousing the finished product, and placing the finished product in a ventilated and dried warehouse after the finished product is inspected to be qualified, wherein the finished product cannot be mixed with toxic, easy-to-pollute and bad-smell articles. The warehouse should be kept clean and sanitary, and the special person is responsible for keeping
Example III
The formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 43g of propolis extract, 43g of astragalus extract, 97g of kudzuvine root extract, 400 g of polyethylene glycol 430g, 130g of gelatin, 61g of glycerol, 1g of brown ferric oxide and 120g of purified water.
When the propolis astragalus root and kudzuvine root soft capsules are prepared, the steps are as follows:
s1, preparing a content feed liquid, namely taking the formula amount of propolis extract, astragalus extract and kudzuvine root extract, respectively sieving the propolis extract, the astragalus extract and the kudzuvine root extract by a 100-mesh sieve, and uniformly mixing to obtain mixed fine powder for later use; mixing polyethylene glycol 400 with the above mixed fine powder, stirring to mix uniformly, grinding with colloid mill for 2 times, homogenizing and emulsifying for 30min with a homogenizer, and vacuumizing and defoaming; obtaining the content liquid. The room temperature should be kept between 20 ℃ and 28 ℃ and the relative humidity should be below 60%, the vacuumizing temperature is 70 ℃ to 80 ℃ and the pressure is 0.06 Mpa to 0.08Mpa;
s2, preparing capsule shell glue solution, soaking a formula amount of gelatin in a proper amount of purified water for 12 hours to fully expand the gelatin to obtain expanded gelatin for later use; sieving brown ferric oxide with 100 mesh sieve; heating the formula amount of glycerol and the rest purified water to 70-80 ℃, uniformly mixing, adding the expanded gelatin and the fine iron oxide brown powder, stirring, preserving heat for 1-2 hours, completely melting, stirring, standing, vacuumizing and defoaming (the temperature is 70-80 ℃ and the pressure is 0.06-0.08 Mpa), filtering by a 100-mesh sieve to obtain capsule shell glue solution, and preserving heat at 60 ℃;
s3, injecting the content feed liquid and capsule shell glue liquid into a soft capsule manufacturing machine, pressing the capsule, and shaping the capsule; the material liquid of the content is conveyed into a storage tank of a soft capsule manufacturing machine by a conveying pipe; conveying the prepared capsule shell glue solution into a glue storage tank of a soft capsule manufacturing machine by using a conveying pipe, preserving heat, starting the soft capsule manufacturing machine, pressing capsules, wherein each capsule contains 0.6g, and the room temperature is kept between 20 and 24 ℃ and the relative humidity is kept below 30 to 50 percent; and shaping and drying the pressed capsules for 3-4 hours by using a shaping rotary cage machine, cooling the capsules, removing surface moisture, shaping the capsules and primarily drying the capsules.
S4, washing, drying and selecting the shaped capsules in sequence; washing the shaped capsule with 95% ethanol, and cleaning oil on the surface of the capsule; the washed capsule is sent into a drying chamber, and is dried for 24 to 30 hours, the room temperature of the drying chamber is 26 to 30 ℃, and the relative humidity is below 40 percent; when the softness of the capsule is proper, stopping drying, selecting the dried capsule, removing unqualified products, and selecting the capsule room temperature to be 18-26 ℃ and the relative humidity to be below 60%.
And packaging.
S5, packaging, namely bottling (60 grains/bottle) firstly, then boxing (6 bottles/box), and marking the batch number on the outer box according to the batch number issued by the instruction book.
S6, checking finished products, randomly extracting each batch of products, and checking according to the method and requirements of enterprise standards in the health food reporting material.
S7, warehousing the finished product, and placing the finished product in a ventilated and dried warehouse after the finished product is inspected to be qualified, wherein the finished product cannot be mixed with toxic, easy-to-pollute and bad-smell articles. The warehouse should be kept clean and sanitary, and the special personnel should be responsible for keeping.
Table 1, the compositions in examples 1-3:
| example 1 (g) | Example 2 (g) | Example 3 (g) | |
| Propolis extract | 41 | 42 | 43 |
| Astragalus mongholicus extract | 41 | 42 | 43 |
| Radix Puerariae extract | 95 | 96 | 97 |
| Polyethylene glycol 400 | 410 | 420 | 430 |
| Gelatin | 110 | 120 | 130 |
| Glycerol | 59 | 60 | 61 |
| Brown iron oxide | 1 | 1 | 1 |
| Purified water | 118 | 119 | 120 |
The raw and auxiliary materials are as follows:
polyethylene glycol 400 is in accordance with the regulations of the pharmacopoeia of the people's republic of China.
Gelatin, purified water and glycerol should meet the requirements of the pharmacopoeia of the people's republic of China.
The brown ferric oxide accords with the regulations of the pharmacopoeia of the people's republic of China.
The propolis extract should meet the specification of GB/T24283 propolis.
The astragalus extract and the kudzuvine root extract meet the requirements of annex A.
Appendix A.1 Astragalus membranaceus extract should conform to the table
Propolis extract is dry extract powder obtained by extracting propolis, concentrating, and drying. Fragrant smell, bitter taste, and pungent taste. Antibacterial, antiinflammatory, immunity regulating, antioxidant, and tissue healing accelerating effects. Can be used for the adjuvant treatment of hyperlipidemia and diabetes. Propolis is a biochemical active substance, and contains flavonoids, terpenes, quinones, esters, alcohols, phenols, ethers, organic acids, and a large number of substances with physiological and pharmacological activities such as amino acids, enzymes, VB1, VB2, VB6, VE, VA, polysaccharide, trace elements, etc. The propolis not only has good effects of sterilizing, diminishing inflammation, resisting oxidation, purifying blood, removing toxins and enhancing immunity, but also has obvious effects of reducing blood fat, reducing blood sugar, softening blood vessels and the like.
The effect of propolis soft capsules on regulating blood sugar is studied. Healthy female mice are selected, the abdominal cavity is injected with tetraoxapyrimidine (100 mg/kg body weight), the mice are fasted for 16 hours after 10d after injection, free drinking water is carried out, tail blood is taken for measuring the fasting blood glucose value, 50 mice with fasting blood glucose higher than 10mmol/L are selected, and the mice are randomly divided into 5 groups according to the blood glucose level, namely a hyperglycemia model control group, low, medium and high 3 dosage groups of the tested substances and a propolis astragalus root and kudzuvine root soft capsule group. The dosage of the tested substances is designed to be 12.5, 125.0, 375.0mg/kg body weight (1 time, 10 times and 30 times of the recommended amount of human body respectively) of 10 animals in each group, the solvent (salad oil) is given to the hyperglycemia model control group, and the propolis radix astragali and radix Puerariae soft capsule group is given to the propolis radix astragali and radix Puerariae soft capsule of 50.0mg/kg body weight. The method comprises the steps of 1 time of stomach filling every day, continuously administering for 14 days, fasted for 16 hours at 15 days, freely drinking water, taking inner canthus blood to measure fasting blood glucose value, immediately performing stomach filling after blood taking, administering 20% glucose solution (the stomach filling amount is 0.1ml/10g body weight), removing eyeballs to take blood to measure glucose tolerance after 2 hours, and observing the influence of a test object on fasting blood glucose and glucose tolerance of a hyperglycemic model mouse caused by tetraoxypyrimidine. The results showed that there was no statistically significant difference in fasting blood glucose values for each group prior to dosing. Compared with the hyperglycemia model control group, the fasting blood glucose of the medium dose group and the high dose group is obviously reduced after glucose is given for 2 hours, and the difference has significance and high significance through statistical test. Meanwhile, the two indexes of the propolis astragalus root and kudzuvine root soft capsule group are obviously reduced, and the differences are highly significant through inspection. The propolis soft capsule is suggested to have obvious regulation effects on the fasting blood glucose increase and the sugar tolerance of mice caused by tetraoxypyrimidine.
The 72 SD rats replicating the diabetes model were randomly divided into model groups, a low-dose group and a high-dose group of propolis aqueous extract, a low-dose group and a high-dose group of propolis alcoholic extract, and a positive control group (Bai Tang Ping), and 12 normal groups were taken. Each group was given a different test drug in addition to the normal and model groups, respectively. During the administration, blood was taken once a week, fasting blood glucose was measured, and after 7 weeks of administration, blood was taken to measure fasting blood glucose and fructosamine. The test results show that both the propolis aqueous extract and the alcohol aqueous extract can control the rise of fasting blood sugar of diabetic rats, and the effect is more and more obvious along with the extension of time.
The effect of propolis in the comprehensive treatment of diabetes is studied, and the clinical curative effect observation is carried out for 2 years. Propolis treatment group: patients with type 2 diabetes, initially or not regularly treated, are subjected to simple diet control for more than 1 month, or patients with type 1 and type 2 diabetes with a history of diabetes of more than 2 years, on the basis of the original treatment scheme (insulin injection or oral hypoglycemic agent) treatment, the fasting blood glucose is still higher than 7.8mmol/L, the postprandial blood glucose (PPBG) is still higher than 11.1mmol/L, and glycosylated hemoglobin (HbAlc) is more than 7%. Control group: and (3) observing the conditions of blood sugar, blood fat and glycosylated hemoglobin before and after taking the propolis by adopting a self-contrast method. The results show that: (1) After propolis is added, the blood sugar is obviously reduced after fasting and 2 hours after meal, and the dosage of insulin is reduced to different degrees for patients who are treated by the original insulin. Compared with the effect of reducing blood sugar, the propolis group has higher effective rate, and particularly has better curative effect of reducing blood sugar after 2 hours after meal. (2) Glycosylated hemoglobin changes and effects on insulin secretion: there was no significant difference in the magnitude of HbAlc reduction in the two groups. The serum insulin levels before and after propolis treatment were observed and compared with the control group, and the serum insulin levels before and after propolis administration did not change significantly, and the results were not statistically significant. Propolis has no effect of stimulating insulin secretion, and does not cause hyperinsulinemia.
The astragalus extract is dry extract powder obtained by extracting, concentrating and drying astragalus medicinal materials. Sweet in nature and warm in nature, enter lung and spleen meridians. Has effects in invigorating qi, consolidating superficial resistance, promoting urination, removing toxic substances, expelling pus, healing sore, and promoting granulation. Can be used for treating qi deficiency debilitation, loose stool, sinking of middle-jiao, chronic diarrhea and rectocele, hematochezia metrorrhagia, exterior deficiency spontaneous perspiration, qi deficiency edema, carbuncle, hard ulcer, chronic ulcer, blood deficiency flaccidity, internal heat and diabetes; chronic nephritis proteinuria and diabetes. Astragalus contains astragalosides, polysaccharides, flavonoids, amino acids, microelements, choline, folic acid, etc.
She Shi the rule of the prescription of the Chinese patent medicine for treating diabetes is counted, the highest use frequency is qi tonifying and yin nourishing, wherein the highest use frequency of astragalus accounts for 76.9%. Is closely related to the function of astragalus root in tonifying qi, reinforcing deficiency and promoting the production of body fluid. "it is known as" it is quenching thirst and tonifying Qi "from Bie Ji". The astragalus root has the effects of supplementing qi, promoting the production of body fluid without damaging yin, supplementing qi without rigid and dry, and meets the pathogenesis characteristics of deficiency of both qi and yin. Astragalus root has various functions in treating diabetes, and can strengthen body resistance and tonify deficiency, strengthen body resistance to eliminate evil and treat both principal and secondary aspects of the disease; it can treat both qi and blood, and treat water and remove blood stasis.
The effect of astragaloside on glucagon-like peptide-1 was studied using radioimmunoassay. Three different concentrations of astragaloside solutions were used to intraperitoneally inject Wistar rats and blood was taken after 3, 4, 5w to determine the astragaloside content in the rat plasma. The results were statistically processed to find that, under the action of astragaloside, the glucagon-like peptide-1 content in the plasma of rats was significantly different (P < 0.05) from that of the control group, and the secretion was increased with the prolonged action time. The result shows that the astragaloside IV has the effect of promoting the secretion of glucagon-like peptide-1
38 cases of type 2 diabetes mellitus are treated by astragalus polysaccharide granules. The results show that: (1) The total effective rate of astragalus polysaccharide granule for treating non-insulin dependent diabetes mellitus is 65.79%, the effective rate of diabetes pill control group is 73.68%, and the two groups of statistical analysis have no obvious difference. (2) Has obvious improvement effect on the three more and one less symptoms of type 2 diabetes, and the improvement degree is better than that of a diabetes pill control group. (3) Has obvious effects of reducing blood sugar and urine sugar, the effective rate is more than 70 percent, and the effect is similar to that of a diabetes pill control group. The curative effect of the astragalus polysaccharide granule taken for two courses of treatment is obviously better than that of the diabetes pill. (4) Has obvious improving effect on clinical symptoms of diabetics, especially on symptoms such as mental fatigue, hypodynamia, palpitation, insomnia and the like, the effective rate is more than 90 percent, and the effective rate is obviously different from that of a control group. The astragalus polysaccharide granule has obvious hypoglycemic effect, and retains the effects of tonifying qi and deficiency of the original medicine.
The radix Puerariae extract is dry extract powder obtained by extracting radix Puerariae, concentrating, and drying. Has effects in relieving fever, promoting salivation, promoting eruption, and invigorating yang, and can be used for treating fever, headache, thirst, diabetes, measles, dysentery, and diarrhea; high blood pressure and strong pain in the neck. The main component of radix Puerariae contains isoflavone, puerarin, triterpene saponin, alkaloid and other compounds. Pueraria is sweet and cool in nature, has the efficacy of promoting the production of body fluid to quench thirst, and is often used for treating diabetes singly or in a compound way clinically, and has obvious curative effect.
The action mechanism of the kudzuvine root decoction on the blood sugar reduction of diabetic rats is observed. The high-energy feed plus streptozotocin is injected to replicate a diabetes rat model, and after the treatment of kudzuvine root decoction, the contents of fasting blood sugar, insulin, glucagon, C-peptide, free fatty acid, TNF-alpha and the like are measured, and the glucose tolerance and insulin sensitivity index are calculated. Results: the radix Puerariae decoction can remarkably reduce fasting blood glucose, free fatty acid and TNF-alpha content of diabetic rats, and improve insulin sensitivity index. The kudzuvine root decoction has the effect of reducing blood sugar of diabetic rats, and improves insulin resistance by reducing free fatty acid, TNF-alpha and the like.
The hypoglycemic effect of the radix puerariae extract and the influence on hemodynamics are observed. STZ induction establishes DM rat model, radix Puerariae extract is administered by intragastric administration, blood is taken after administration for 30d, blood sugar, hbA1C and hemodynamic index are detected, and group comparison is carried out. The results show that: the radix Puerariae extract can obviously reduce blood sugar, hbA1C, blood viscosity and hematocrit of DM rats. As the high cut blood viscosity mainly reflects the deformability of red blood cells, the low cut blood viscosity mainly reflects the aggregation capability of red blood cells, the kudzuvine root extract has the pharmacological effects of reducing blood viscosity and improving local blood circulation, and can be used for preventing and treating diabetes and chronic complications and improving the life quality of diabetics.
The blood sugar and blood fat reducing effect of the compound kudzuvine root capsule of the traditional Chinese medicine preparation prepared by treating the puerarin and glucose tolerance factor is observed. The 107 cases of type 2 diabetics are randomly divided into 76 cases of compound kudzuvine root capsule experimental groups and 31 cases of diabetes pill control groups, and the compound kudzuvine root capsule experimental groups and the diabetes pill control groups are treated by corresponding medicaments respectively, so that the two groups of curative effects and safety are observed. Results: the total effective rate of the experimental group is 96.1%, the total effective rate of the control group is 80.6%, and the two groups are obviously different (P < 0.05); in the aspects of improvement of main symptoms and comparison of physical and chemical indexes, the experimental group is obviously superior to the control group (P < 0.01); in the aspect of safety evaluation, the compound kudzuvine root capsules have no obvious clinical side effect or adverse reaction and have good safety. Conclusion: the compound kudzuvine root capsule has the effects of reducing blood sugar and blood fat and improving blood viscosity, and has no obvious toxic or side effect.
The screening process of the formula shows that all the raw materials have definite blood sugar reducing effect through modern pharmacological experiments and clinical practices. The compatibility of the whole formula of the propolis astragalus root and kudzuvine root soft capsule is a formula according to the traditional Chinese medicine treatment rules of diabetes mellitus, and the formula comprises the following compatibility relations of tonifying qi and nourishing yin, strengthening spleen and tonifying kidney, wherein the formula has the effects of resisting bacteria and diminishing inflammation, regulating immunity, resisting oxidation and accelerating tissue healing. Is mainly used for the adjuvant treatment of hyperlipidemia and diabetes; astragalus root has the functions of invigorating qi, strengthening the body resistance and tonifying qi to invigorate the spleen; radix Puerariae nourishes yin of spleen and stomach, and promote fluid production. The raw materials are mutually matched, the qi supplementing is dominant, the yin nourishing is fundamental, and the effects of promoting the production of body fluid and moistening dryness are achieved. So that primordial qi is abundant, yin fluid is distributed, qi and blood are mixed, and immunity of the machine can be improved, thereby achieving the function of assisting in reducing blood sugar.
Finally, it should be noted that: the foregoing description is only illustrative of the preferred embodiments of the present invention, and although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that modifications may be made to the embodiments described, or equivalents may be substituted for elements thereof, and any modifications, equivalents, improvements or changes may be made without departing from the spirit and principles of the present invention.
Claims (10)
1. A propolis astragalus root and kudzuvine root soft capsule is characterized in that: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 41-43g of propolis extract, 41-43g of astragalus extract, 95-97g of radix puerariae extract, 410-430g of polyethylene glycol, 110-130g of gelatin, 59-61g of glycerol, 1g of brown ferric oxide and 118-120g of purified water.
2. The propolis astragalus root-kudzuvine root soft capsule according to claim 1, which is characterized in that: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 41g of propolis extract, 41g of astragalus extract, 95g of radix puerariae extract, 400410g of polyethylene glycol, 110g of gelatin, 59g of glycerol, 1g of brown ferric oxide and 118g of purified water.
3. The propolis astragalus root-kudzuvine root soft capsule according to claim 1, which is characterized in that: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 42g of propolis extract, 42g of astragalus extract, 96g of radix puerariae extract, 400420g of polyethylene glycol, 120g of gelatin, 60g of glycerin, 1g of brown iron oxide and 119g of purified water.
4. The propolis astragalus root-kudzuvine root soft capsule according to claim 1, which is characterized in that: the formula of the propolis astragalus root and kudzuvine root soft capsule is 1000 granules, and the dosage of 0.6 g/granule is calculated: 43g of propolis extract, 43g of astragalus extract, 97g of kudzuvine root extract, 400430g of polyethylene glycol, 130g of gelatin, 61g of glycerol, 1g of brown iron oxide and 120g of purified water.
5. A preparation process of propolis astragalus root and kudzuvine root soft capsules is characterized by comprising the following steps:
s1, preparing a content feed liquid, namely preparing propolis extract, astragalus extract and radix puerariae extract into fine powder, and then mixing the fine powder with polyethylene glycol 400 to prepare the content feed liquid;
s2, preparing capsule shell glue solution, and mixing gelatin, purified water, brown iron oxide and glycerol to obtain the capsule shell glue solution;
s3, injecting the content feed liquid and capsule shell glue liquid into a soft capsule manufacturing machine, pressing the capsule, and shaping the capsule;
s4, washing, drying and selecting the shaped capsules in sequence, and packaging the capsules;
s5, bottling and boxing.
6. The preparation process according to claim 5, characterized in that: in preparing a content feed solution, comprising:
taking the formula amount of propolis extract, astragalus extract and kudzuvine root extract, respectively sieving with a 100-mesh sieve, and uniformly mixing to obtain mixed fine powder for later use;
mixing polyethylene glycol 400 with the above mixed fine powder, stirring to mix uniformly, grinding with colloid mill for 2 times, homogenizing and emulsifying for 30min with a homogenizer, and vacuumizing and defoaming;
obtaining the content liquid.
7. The preparation process according to claim 6, characterized in that: the vacuumizing temperature is 70-80 ℃ and the pressure is 0.06-0.08 Mpa.
8. The manufacturing process according to claim 7, characterized in that: when preparing the capsule shell glue solution, the method comprises the following steps:
adding a proper amount of purified water into the gelatin of the formula amount to soak for 12 hours, so as to fully expand the gelatin to obtain expanded gelatin for standby;
sieving brown ferric oxide with 100 mesh sieve;
heating the formula amount of glycerol and the rest purified water to 70-80 ℃, uniformly mixing, adding the expanded gelatin and the fine iron oxide brown powder, stirring, preserving heat for 1-2 hours, completely melting, stirring, standing, vacuumizing, defoaming, filtering by a 100-mesh sieve to obtain capsule shell glue solution, and preserving heat at 60 ℃.
9. The manufacturing process according to claim 8, characterized in that: the preparation method comprises the following steps of: the material liquid of the content is conveyed into a storage tank of a soft capsule manufacturing machine by a conveying pipe; conveying the prepared capsule shell glue solution into a glue storage tank of a soft capsule manufacturing machine by using a conveying pipe, preserving heat, starting the soft capsule manufacturing machine, pressing capsules, wherein each capsule contains 0.6g, and the room temperature is kept between 20 and 24 ℃ and the relative humidity is kept below 30 to 50 percent; and shaping and drying the pressed capsules for 3-4 hours by using a shaping rotary cage machine, cooling the capsules, removing surface moisture, shaping the capsules and primarily drying the capsules.
10. The manufacturing process according to claim 9, characterized in that: during washing, drying and selecting pills, the method comprises the following steps: washing the shaped capsule with 95% ethanol, and cleaning oil on the surface of the capsule; after washing
The capsule is sent into a drying chamber, and is dried for 24 to 30 hours, the room temperature of the drying chamber is 26 to 30 ℃, and the relative humidity is below 40 percent;
stopping drying when the softness of the capsule is proper, selecting the dried capsule, removing unqualified products,
the room temperature between the pills is 18-26 ℃ and the relative humidity is below 60%.
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