CN106361768A - Composition and preparation thereof for adjuvant therapy of hypertension and diabetes - Google Patents

Composition and preparation thereof for adjuvant therapy of hypertension and diabetes Download PDF

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Publication number
CN106361768A
CN106361768A CN201610755215.3A CN201610755215A CN106361768A CN 106361768 A CN106361768 A CN 106361768A CN 201610755215 A CN201610755215 A CN 201610755215A CN 106361768 A CN106361768 A CN 106361768A
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parts
diabetes
preparation
assisting
compositionss
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宋延军
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/14Alkali metal chlorides; Alkaline earth metal chlorides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/683Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols
    • A61K31/685Diesters of a phosphorus acid with two hydroxy compounds, e.g. phosphatidylinositols one of the hydroxy compounds having nitrogen atoms, e.g. phosphatidylserine, lecithin
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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    • A61K47/46Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
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    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A61K9/0058Chewing gums
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    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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Abstract

The invention provides a composition for adjuvant therapy of hypertension and diabetes. The composition consists of 40-60 parts of potassium chloride, 80-120 parts of lecithin, 240-360 parts of saccharides and 2.4-3.6 parts of magnesium chloride, and the composition can further consist of 24-36 parts of metformin. The invention also provides a preparation which is prepared from the composition, wherein the preparation is in the form of chewing gum, sublingual tablets or hard candies. The composition for the adjuvant therapy of the hypertension and the diabetes provided by the invention can regulate the metabolism of in-vivo potassium ions, so as to treat diabetes complications caused by potassium metabolism imbalance, and simultaneously to keep an in-vivo environment stable; in addition, the composition, which is prepared from a few varieties of raw materials, is low in side effects, and the purpose that various active ingredients supplement each other to develop a synergistic curative effect can be achieved; the preparation, which is prepared into the form of the chewing gum, the sublingual tablets or the hard candies, is more convenient to take and carry, and the preparation, when chewed or kept under a tongue, can stimulate the secretion of saliva, so as to bring benefits for the full absorption of the active ingredients, and in addition, the curative effect of the composition can be fully developed.

Description

A kind of for assisting in treating hypertension, the compositionss of diabetes and its preparation
Technical field
The invention belongs to field of health care food is and in particular to a kind of compositionss for assisting in treating hypertension, diabetes And its preparation.
Background technology
Diabetes are one group of metabolic diseases being characterized with hyperglycemia, hyperglycemia be then due to defect of insulin secretion or Its biological function is impaired, or both have concurrently and cause.Human body defines the metabolism sugar of complete set through the evolution of millions upon millions of years System, but this set system imperfect, human body sugar metabolic imbalance or a large amount of move after body potassium deficiency easily occurs, now This set system drawback occurs it is impossible in Fast-Balance body potassium content, it is unbalance now to also result in blood pressure regulating, leads to hypertension Generation.Diabetes, for a long time with hyperglycemia, lead to various tissues, particularly eye, kidney, heart, blood vessel, the chronic lesion of nerve And dysfunction, that is, the complication being commonly called as.The mode of the commonly used insulin injection of people adjusts blood glucose, controls sugar for a long time Urine disease, but this kind of mode does not play significant effect to treatment diabetic complication.Trace it to its cause, the complication of diabetes It is because the exception of Potassium Metabolism leads to mostly, do not have significant correlation with the content of insulin.For example, enter blood potassium before the meal to be in Normal condition, now intracellular potassium content is not enough;Enter after the meal, insulin, by sugar and potassium metabolism simultaneously, makes human body enter low potassium shape State, appearance is powerless, the symptom potassium deficiency such as dyspepsia, arrhythmia can cause hypernatremia, leads to blood pressure to raise;Blood sodium mistake simultaneously Height can cause cell expansion, cell function impaired, and particularly blood capillary is easier to cause blocking, may lead to glycosuria when serious Sick oculopathy, the generation of nephropathy;The rising of kidney pressure can lead to uric acid to raise, thus leading to sclerosis of blood vessels and whole body or localised blood pressure liter Height, causes numbness, the distending pain of limb end.Now except supplementing potassium, supplemented with suitable phosphorus, common by phosphorus and potassium Effect, reaches the effect of relief of symptoms;At the same time it can also the magnesium appropriate by supplement, adjust vasoconstriction and diastole, remain thin The normal function of born of the same parents' ion channel, to adjust blood pressure, to prevent the loss of intracellular potassium ion.Authorization Notice No. is The patent of invention of cn102894249a discloses a kind of physical fatigue relieving nutrient liquid, including potassium chloride, lecithin, sucrose, Peanut Polypeptide, lact albumin hydrolysate and Multiple components, can quickly supplement the nutrient substance of needed by human body, recover generation with rapid Thank to balance, maintain homeostasis.Therefore, by supplementing potassium, P elements in good time, and ensure the supply of sugar, to diabetes simultaneously Send out disease and can also play certain therapeutical effect.
Content of the invention
In order to solve above-mentioned technical problem, the invention provides a kind of combination for auxiliary treatment diabetes, hypertension Thing and its preparation.
Concrete technical scheme of the present invention is as follows:
One aspect of the present invention provides a kind of compositionss for auxiliary treatment diabetes, hypertension, including following weight The composition of number: 40~60 parts of potassium chloride, 80~120 parts of lecithin, sugared 240~360 parts and 2.4~3.6 parts of magnesium chloride, institute State at least one in glucose, Fructose, maltose or sucrose for the sugar.
Further, described compositionss also include the metformin that parts by weight are 24~36 parts.
The compositionss that the present invention provides can supplement potassium, P elements and the sugar of needed by human body, simultaneously to internal potassium ion Metabolism is adjusted, and to treat the diabetic complication leading to because Potassium Metabolism is unbalance, maintains stablizing of organismic internal environment simultaneously, changes Kind health status.
In order to easy to use, the invention provides a kind of preparation for assisting in treating hypertension, diabetes, including aforementioned Compositionss, described preparation is selected from chewing gum, Sublingual tablet, hard sugar, spray or mixture.
One aspect of the present invention provides a kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum bag Include the composition of following parts by weight: 15~25 parts of described compositionss, 20~35 parts of gum base, 5~10 parts of plasticizer.
Further, described gum base is the mixture of Konjac glucomannan, polyvinyl acetate and gutta-percha, described Konjac glucomannan, The ratio of weight and number of polyvinyl acetate and gutta-percha is: 1~2:2:1.
Konjac glucomannan, polyvinyl acetate and gutta-percha are used in combination, viscosity and the elasticity of gum base can be obviously improved, Substantially improve the mouthfeel of chewing-gum chewing.
Further, described plasticizer is the mixture of Apis cerana Fabriciuss, candelilla wax and acetyl group methyl ricinoleate, described honey The ratio of weight and number of wax, candelilla wax and acetyl group methyl ricinoleate is 1:1:1~2.
Apis cerana Fabriciuss, candelilla wax and acetyl group methyl ricinoleate are used in combination, the plastic of chewing gum can be significantly increased Property, and the softness of lifting chewing gum and degree of lubrication further, improve quality and the mouthfeel of chewing gum.
Another aspect of the present invention provides a kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet Component including following parts by weight: 20~30 parts of described compositionss, 50~70 parts of filler and 0.6~1 part of lubricant.
Further, described filler is hydroxyl isomaltulose, the mixing of Sorbitol, alpha-lactose and Microcrystalline Cellulose Thing, the ratio of weight and number of described hydroxyl isomaltulose, Sorbitol, alpha-lactose and Microcrystalline Cellulose is 1:1:2:2~4.
Hydroxyl isomaltulose, Sorbitol, alpha-lactose and Microcrystalline Cellulose are used in combination, the tensile strength of Sublingual tablet and Formability is all considerably better than the effect during diluent only using single component.
Further, described lubricant is the mixture of magnesium stearate, Glyceryl Behenate and magnesium laurylsulfate, institute The ratio of weight and number stating magnesium stearate, Glyceryl Behenate and magnesium laurylsulfate is 1~3:1:1.
Magnesium stearate, Glyceryl Behenate and magnesium laurylsulfate are used in combination, its greasy property significantly improves, energy It is obviously improved the efficiency of pelletizing press sheet process, improve the hardness of tablet.
Another aspect of the present invention additionally provides a kind of hard sugar for assisting in treating hypertension, diabetes, described hard sugar bag Include the component of following parts by weight: 20~30 parts of described compositionss, 10~15 parts of Mel, 10~15 parts of steviol glycosides, Herba Menthae 3~ 5 parts, 3~5 parts of concentrated lemon juice and 0.01 part of compound microelement, described compound microelement includes picolinic acid chromium, Portugal Grape saccharic acid zinc, ferric citrate, manganese sulfate, copper sulfate and cobaltous sulfate.
Mel, steviol glycosides can provide sweet taste for hard sugar, and make user reduce the absorption of sugar;Herba Menthae and concentration lemon Lemon juice can improve hard sugar mouthfeel, reduces sweet sense;Add compound microelement in hard sugar, user can supplement many with this Plant element, to maintain the normal physiological function of body.
Present invention also offers the described compositionss for assisting in treating hypertension, diabetes are used for auxiliary treatment in preparation Application in hypertension, the medicine of diabetes
The invention has the beneficial effects as follows: the compositionss provided by the present invention for assisting in treating hypertension, diabetes can be mended Fill potassium, P elements and the sugar of needed by human body, by adding magnesium ion, the metabolism of internal potassium ion is adjusted, to control simultaneously Treat the diabetic complication leading to because Potassium Metabolism is unbalance, and stablizing of organismic internal environment can be maintained, adjust blood pressure;Meanwhile, pass through Treatment diabetic complication, regulation blood pressure, can alleviate the heart malaise symptoms with appearance, reach auxiliary treatment heart disease Effect, thus improving the health status of patient on the whole;And the raw materials used kind of the present invention is few, therefore side effect Little, and it is capable of complementing each other, working in coordination with the purpose playing curative effect of each effective ingredient;Make chewing gum or Sublingual tablet or hard sugar Afterwards, take and carry convenient, by chewing or buccal, can contribute to fully inhaling effective ingredient with exciting salivary secretion Receive, and the curative effect of compositionss can be given full play to;Sublingual blood capillary is made quickly to absorb effective ingredient by sublingual administration, And the speed of this absorption and sugared absorption rate, insulin releasing speed consistent it is ensured that safe and effective;Various auxiliary agents Adding makes described compound traditional Chinese medicine composite property more stable, helps to maintain its therapeutic effect, and is provided that good mouthfeel, clothes With convenient.
Specific embodiment
Embodiment 1
A kind of assisting in treating hypertension, the compositionss of diabetes, including 40 parts of potassium chloride, 80 parts of lecithin, glucose 120 Part, 120 parts of maltose and 2.4 parts of magnesium chloride.
Embodiment 2
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin, Fructose 150 Part, 150 parts of sucrose and 3 parts of magnesium chloride.
Embodiment 3
A kind of assisting in treating hypertension, the compositionss of diabetes, including 60 parts of potassium chloride, 120 parts of lecithin, glucose 140 parts, 140 parts of Fructose, 100 parts of maltose, 3.6 parts of magnesium chloride and 36 parts of metformin.
Embodiment 4
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin, glucose 150 parts, 150 parts of sucrose, 3 parts of magnesium chloride and 30 parts of metformin.
Embodiment 5
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes compositionss described in embodiment 1 15 parts, 20 parts of gum base and 5 parts of plasticizer, described gum base includes 5 parts of Konjac glucomannan, 10 parts of polyvinyl acetate and gutta-percha 5 Part.
Embodiment 6
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes compositionss described in embodiment 2 25 parts, 35 parts of gum base and 10 parts of plasticizer, described gum base includes 14 parts of Konjac glucomannan, 14 parts of polyvinyl acetate and gutta-percha 7 parts, described plasticizer includes 2.5 parts of Apis cerana Fabriciuss, 2.5 parts of candelilla wax and 5 parts of acetyl group methyl ricinoleate.
Embodiment 7
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes compositionss described in embodiment 3 25 parts, 35 parts of gum base and 10 parts of plasticizer, described plasticizer includes 3.33 parts of Apis cerana Fabriciuss, 3.33 parts of candelilla wax and acetyl group 3.33 parts of methyl ricinoleate.
Embodiment 8
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes compositionss described in embodiment 4 15 parts, 20 parts of gum base and 5 parts of plasticizer, described gum base includes 6 parts of Konjac glucomannan, 6 parts of polyvinyl acetate and gutta-percha 3 Part, described plasticizer includes 1.25 parts of Apis cerana Fabriciuss, 1.25 parts of candelilla wax and 2.5 parts of acetyl group methyl ricinoleate.
Embodiment 9
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in embodiment 1 20 parts, 50 parts of filler and 0.6 part of lubricant, described filler include 8.33 parts of hydroxyl isomaltulose, 8.33 parts of Sorbitol, 16.66 parts of alpha-lactose and 16.66 parts of Microcrystalline Cellulose.
Embodiment 10
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in embodiment 2 30 parts, 70 parts of filler and 1 part of lubricant, described filler include 8.75 parts of hydroxyl isomaltulose, 8.75 parts of Sorbitol, α- 17.5 parts of Lactose and 35 parts of Microcrystalline Cellulose, described lubricant include 0.6 part of magnesium stearate, 0.2 part of Glyceryl Behenate with And 0.2 part of magnesium laurylsulfate.
Embodiment 11
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in embodiment 3 30 parts, 70 parts of filler and 1 part of lubricant, described lubricant includes 0.33 part of magnesium stearate, 0.33 part of Glyceryl Behenate And 0.33 part of magnesium laurylsulfate.
Embodiment 12
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in embodiment 4 20 parts, 50 parts of filler and 0.6 part of lubricant, described filler include 6.25 parts of hydroxyl isomaltulose, 6.25 parts of Sorbitol, 12.5 parts of alpha-lactose and 25 parts of Microcrystalline Cellulose, described lubricant includes 0.2 part of magnesium stearate, 0.2 part of Glyceryl Behenate And 0.2 part of magnesium laurylsulfate.
Embodiment 13
A kind of hard sugar for assisting in treating hypertension, diabetes, described hard sugar includes 20 parts of described compositionss, Mel 10 Part, 10 parts of steviol glycosides, 3 parts of Herba Menthae, 3 parts of concentrated lemon juice and 0.01 part of compound microelement, described compound microelement Including picolinic acid chromium, zinc gluconate, ferric citrate, manganese sulfate, copper sulfate and cobaltous sulfate.
Embodiment 14
A kind of hard sugar for assisting in treating hypertension, diabetes, 30 parts of compositionss described in described hard sugar, 15 parts of Mel, 15 parts of steviol glycosides, 5 parts of Herba Menthae, 5 parts of concentrated lemon juice and 0.01 part of compound microelement, described compound microelement includes Picolinic acid chromium, zinc gluconate, ferric citrate, manganese sulfate, copper sulfate and cobaltous sulfate.
Reference examples 1
A kind of assisting in treating hypertension, the compositionss of diabetes, including 100 parts of lecithin, 150 parts of Fructose, 150 parts of sucrose And 3 parts of magnesium chloride.
Reference examples 2
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 150 parts of glucose, maltose 150 parts and 3 parts of magnesium chloride.
Reference examples 3
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin and chlorination 3 parts of magnesium.
Reference examples 4
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin, glucose 150 parts and 150 parts of Fructose.
Reference examples 5
A kind of assisting in treating hypertension, the compositionss of diabetes, including 100 parts of lecithin, 200 parts of glucose, magnesium chloride 3 Part and 30 parts of metformin.
Reference examples 6
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 300 parts of glucose, magnesium chloride 3 Part and 30 parts of metformin.
Reference examples 7
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin, magnesium chloride 3 Part and 30 parts of metformin.
Reference examples 8
A kind of assisting in treating hypertension, the compositionss of diabetes, including 50 parts of potassium chloride, 100 parts of lecithin, glucose 200 parts and 30 parts of metformin.
Reference examples 9
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes the combination described in reference examples 1 25 parts of thing, 35 parts of gum base and 10 parts of plasticizer, described gum base is polyvinyl acetate, described plasticizer include 5 parts of Apis cerana Fabriciuss with And 5 parts of acetyl group methyl ricinoleate.
Reference examples 10
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes the combination described in reference examples 2 25 parts of thing, 35 parts of gum base and 10 parts of plasticizer, described gum base includes 14 parts of gutta-percha and 21 parts of polyvinyl acetate, described Plasticizer is 2.5 parts of Apis cerana Fabriciuss.
Reference examples 11
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes the combination described in reference examples 4 25 parts of thing, 35 parts of gum base and 10 parts of plasticizer, described gum base includes 14 parts of Konjac glucomannan and 21 parts of polyvinyl acetate, described Plasticizer includes 5 parts of Apis cerana Fabriciuss and 5 parts of acetyl group methyl ricinoleate.
Reference examples 12
A kind of chewing gum for assisting in treating hypertension, diabetes, described chewing gum includes the combination described in reference examples 5 25 parts of thing, 35 parts of gum base and 10 parts of plasticizer, described gum base includes 14 parts of gutta-percha and 21 parts of polyvinyl acetate, described Plasticizer includes 5 parts of candelilla wax and 5 parts of acetyl group methyl ricinoleate.
Reference examples 13
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in reference examples 1 30 parts, 70 parts of filler and 1 part of lubricant, described filler includes 35 parts of hydroxyl isomaltulose and 35 parts of Sorbitol, institute State lubricant and include 0.6 part of magnesium stearate and 0.4 part of magnesium laurylsulfate.
Reference examples 14
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes compositionss described in reference examples 2 30 parts, 70 parts of filler and 1 part of lubricant, described filler includes 35 parts of alpha-lactose and 35 parts of Microcrystalline Cellulose, described Lubricant includes 0.6 part of magnesium stearate and 0.4 part of Glyceryl Behenate.
Reference examples 15
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes combination described in 4 groups of reference examples 30 parts of thing, 70 parts of filler and 1 part of lubricant, described filler includes 20 parts of hydroxyl isomaltulose, 20 parts of alpha-lactose and micro- 30 parts of crystalline cellulose, described lubricant includes 0.5 part of Glyceryl Behenate and 0.5 part of magnesium laurylsulfate.
Reference examples 16
A kind of Sublingual tablet for assisting in treating hypertension, diabetes, described Sublingual tablet includes combination described in 5 groups of reference examples 30 parts of thing, 70 parts of filler and 1 part of lubricant, described filler includes 30 parts of Sorbitol and 40 parts of Microcrystalline Cellulose, Described lubricant is magnesium stearate.
Experimental example 1
Chewing-gum chewing mouthfeel evaluation test
The chewing gum being provided using in embodiment 5-8 as experimental group 1-4, the chewing gum that provided using in reference examples 9-12 as Matched group 1-4.Ask ten valuation officers that each group chewing gum is tasted respectively, and the soft or hard degree to each group fresh goose juice and elasticity Scored, 50 points of each full marks, amount to 100 points, record the chew time of each group chewing gum simultaneously.Each valuation officer is individually carried out Scoring, is not mutually exchanged, between tasting twice between every other hour, gargle and use supplement oral cavity moisture with water.
Table 1 each group chewing gum Analyses Methods for Sensory Evaluation Results
As shown in Table 1, the mouthfeel score of experimental group 1-4 is all remarkably higher than matched group 1-4, and chew time is also all notable simultaneously Higher than matched group 1-4, show the chewing gum of the experimental group each group mouthfeel when chewing more preferably, chew time is longer simultaneously can also Make the absorption rate of effective ingredient in chewing gum higher, preferably play effect.It follows that by Konjac glucomannan+poly-vinegar acid second Alkene ester+gutta-percha is combined as gum base, then is aided with Apis cerana Fabriciuss+candelilla wax+acetyl group methyl ricinoleate and combines as plasticizer, can To give the good quality of chewing gum and mouthfeel, and this effect is significant be better than only use one of which or several individually when Effect.
Experimental example 2
Sublingual tablet dissolution contrast test
Using the Sublingual tablet of embodiment 9~12 offer as experimental example 1~4, made with the Sublingual tablet that reference examples 13~16 provide For experimental example 1~4, one of Dissolution of Tablet algoscopys according to 2010 editions records of the Pharmacopoeia of the People's Republic of China " turn basket Method " is measured to the dissolution of each group Sublingual tablet, and concrete assay method is as follows:
Using deionized water as dissolution medium, it is heated to about 41 DEG C, and is stirred continuously more than 5min under vacuum, obtain To degassing dissolution medium;Measure the deionized water of degassed process respectively, be placed in 8 stripping rotors, every glass of 500ml, treat dissolution Medium temperature is constant, and after 37 DEG C ± 0.5 DEG C, every group of sample takes 6, respectively put into 6 dryings turn in basket, basket will be turned and fall into In stripping rotor, note must not having bubble on test sample surface, start dissolution instrument and be adjusted to 100r/min, record every sample complete The time of full dissolution, and compare the dissolution rate of each group sample.
The complete dissolution time of table 2 each group Sublingual tablet
As shown in Table 2, the dissolution time of experimental group 1-4 is all substantially less than matched group 1-4, shows the dissolution of experimental group each group Speed is all remarkably higher than matched group each group.Sublingual tablet should dissolve rapidly in Sublingual when using, and medicine is through hypoglossis mucous membrane capillary Blood vessel absorbs, and is delivered to whole body to reach therapeutic effect by blood." Chinese Pharmacopoeia " 2010 editions regulations, Sublingual tablet is except as otherwise rule Fixed outer, all should dissolve in 5min.As can be seen here, the Sublingual tablet dissolution time in experimental group 1~4 all meets national standard. Therefore, the filler of hydroxyl isomaltulose+Sorbitol+alpha-lactose+Microcrystalline Cellulose is applied in combination, and Sublingual tablet can be made to have well Result of extraction, and this result of extraction be considerably better than only use one of which or several individually when effect.
Experimental example 3
Diabetic complication clinical experiment
1. test case
Choose diabeticss between 30~60 years old for 160 ages, be randomly divided into 8 groups, every group of 20 people, all patients Middle no trimester of pregnancy or patient's age of sucking.
2. dosage
The compositionss being provided with embodiment 1-4 are experimental group 1-4, and the compositionss being provided with reference examples 5-8 are for comparison Group 5-8, allows 8 groups of patients take above 8 set products respectively, every 12 hours 1 time, each 1g, simultaneously according to doctor's advice consumption injection pancreas Island element, every 12 hours 1 time, continuous treatment 60 days.
3. evaluation index
Clinical manifestation: myasthenia of limbs, numbness of hands and feet, albuminuria, eyes are dry and astringent, blurred vision, arrhythmia
Physiological and biochemical index: diabeticss microdose urine protein content > 20mg/l.
Significantly effective: after treatment, state of an illness sign is obviously improved, microdose urine protein is down to normal range (< 18.14mg/l);
Effective: after treatment, state of an illness sign makes moderate progress, microdose urine protein significantly reduces and maintains compared with steady statue;
Invalid: no substantially to change before and after treatment.
4. data processing
Finishing analysis are carried out to patient clinical data, by t inspection, the therapeutic effect of experimental group and matched group is compared Relatively.
5. experimental result
Table 3 each group patient's treatment
Experimental group and matched group significant difference (p < 0.05).
6. analysis and conclusion
As shown in Table 3, the effective percentage of experimental group is all not less than 85%, and matched group each group effective percentage is all less than 65%, Show experimental group evident in efficacy higher than matched group.And show through follow-up follow-up investigation, one after the medication of matched group some patientss Year in the recurrence signs such as blurred vision, numbness of hands and feet occur, and 1 year after all patient medication of experimental group in all do not occur bad Reaction or recurrence sign, show that compositionss provided in an embodiment of the present invention have good therapeutic effect to diabetic complication, And effect persistently, have no toxic side effect, suitably promoted.
Experimental example 4
Hypertension clinical experiment
1. test case
Choose hyperpietic between 30~60 years old for 160 ages, be randomly divided into eight groups, every group of 20 people, all trouble No trimester of pregnancy or age of sucking patient in person.
2. dosage
The compositionss being provided with embodiment 1-4 are experimental group 1-4, and the compositionss being provided with reference examples 1-4 are for comparison Group 1-4, allows eight groups of patients take above eight set products respectively, every 12 hours 1 time, and each 1g continuously takes 30 days.
3. evaluation index
Clinical manifestation: dizziness, headache, psychentonia, absent minded, hypomnesis, numb limbs and tense tendons, cardiopalmus, breast Vexed, weak etc..
Physiological and biochemical index: hyperpietic's systolic pressure >=140mmhg, diastolic pressure >=90mmhg.
Significantly effective: after treatment, state of an illness sign is obviously improved, and pressure value is down to normal range;
Effective: after treatment, state of an illness sign makes moderate progress, pressure value significantly reduces and maintains compared with steady statue;
Invalid: no substantially to change before and after treatment.
4. data processing
Finishing analysis are carried out to patient clinical data, by t inspection, the therapeutic effect of experimental group and matched group is compared Relatively.
5. experimental result
Table 4 each group patient's treatment
Experimental group and matched group significant difference (p < 0.05).
6. analysis and conclusion
As shown in Table 4, the effective percentage of experimental group is all not less than 90%, and matched group each group effective percentage is all less than 70%, Show experimental group evident in efficacy higher than matched group.And show through follow-up follow-up investigation, the medication of matched group some patientss is later half Dizzy, uncomfortable in chest, numb limbs and tense tendons, the blood pressure high recurrence sign of liter occurs in year, and in experimental group all patient medication later six months all Untoward reaction or recurrence sign do not occur, shows that compositionss provided in an embodiment of the present invention have to hypertension and good control curative effect Really, for and effect persistently, have no toxic side effect, suitably promoted.
Embodiment described above only have expressed the several embodiments of the present invention, and its description is more concrete and detailed, but simultaneously Therefore the restriction to the scope of the claims of the present invention can not be interpreted as.It should be pointed out that for those of ordinary skill in the art For, without departing from the inventive concept of the premise, some deformation can also be made and improve, these broadly fall into the guarantor of the present invention Shield scope.Therefore, the protection domain of patent of the present invention should be defined by claims.

Claims (10)

1. a kind of for assisting in treating hypertension, diabetes compositionss it is characterised in that described compositionss include following weight The composition of number: 40~60 parts of potassium chloride, 80~120 parts of lecithin, sugared 240~360 parts and 2.4~3.6 parts of magnesium chloride, institute State at least one in glucose, Fructose, maltose or sucrose for the sugar.
2. the compositionss being used for as claimed in claim 1 assisting in treating hypertension, diabetes are it is characterised in that described combination Thing also includes the metformin that parts by weight are 24~36 parts.
3. a kind of preparation for assisting in treating hypertension, diabetes, including the compositionss described in claim 1 or 2, its feature It is, described preparation is selected from chewing gum, Sublingual tablet, hard sugar, spray or mixture.
4. it is used for assisting in treating hypertension, the preparation of diabetes as claimed in claim 3 it is characterised in that described preparation is Chewing gum, described chewing gum includes the composition of following parts by weight: 15~25 parts of described compositionss, 20~35 parts of gum base, plasticising 5~10 parts of agent.
5. it is used for assisting in treating hypertension, the preparation of diabetes as claimed in claim 4 it is characterised in that described gum base is The mixture of Konjac glucomannan, polyvinyl acetate and gutta-percha, the weight of described Konjac glucomannan, polyvinyl acetate and gutta-percha Portion rate is: 1~2:2:1.
6. the preparation being used for as claimed in claim 4 assisting in treating hypertension, diabetes is it is characterised in that described plasticizer For the mixture of Apis cerana Fabriciuss, candelilla wax and acetyl group methyl ricinoleate, described Apis cerana Fabriciuss, candelilla wax and acetyl group ricinoleic acid The ratio of weight and number of methyl ester is 1:1:1~2.
7. it is used for assisting in treating hypertension, the preparation of diabetes as claimed in claim 3 it is characterised in that described preparation is Sublingual tablet, described Sublingual tablet includes the composition of following parts by weight: 20~30 parts of described compositionss, 50~70 parts of filler and 0.6~1 part of lubricant.
8. the preparation being used for as claimed in claim 7 assisting in treating hypertension, diabetes is it is characterised in that described filler For the mixture of hydroxyl isomaltulose, Sorbitol, alpha-lactose and Microcrystalline Cellulose, described hydroxyl isomaltulose, Sorbitol, α- The ratio of weight and number of Lactose and Microcrystalline Cellulose is 1:1:2:2~4;Preferably, described lubricant is magnesium stearate, behenic acid Glyceride and the mixture of magnesium laurylsulfate, the weight of described magnesium stearate, Glyceryl Behenate and magnesium laurylsulfate Amount portion rate is 1~3:1:1.
9. it is used for assisting in treating hypertension, the preparation of diabetes as claimed in claim 3 it is characterised in that described preparation is Hard sugar, described hard sugar includes the component of following parts by weight: 20~30 parts of described compositionss, 10~15 parts of Mel, steviol glycosides 10~15 parts, 3~5 parts of Herba Menthae, 3~5 parts of concentrated lemon juice and 0.01 part of compound microelement, described compound microelement bag Include picolinic acid chromium, zinc gluconate, ferric citrate, manganese sulfate, copper sulfate and cobaltous sulfate.
10. the compositionss for assisting in treating hypertension, diabetes described in claim 1 or 2 are used for auxiliary treatment in preparation Application in hypertension, the medicine of diabetes.
CN201610755215.3A 2016-08-29 2016-08-29 Composition and preparation thereof for adjuvant therapy of hypertension and diabetes Pending CN106361768A (en)

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