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 PDFInfo
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- 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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Abstract
本发明提供了一种用于辅助治疗糖尿病、高血压的组合物,包括氯化钾40~60份、卵磷脂80~120份、糖240~360份以及氯化镁2.4~3.6份,所述组合物还可以包括二甲双胍24~36份;本发明还提供了用所述组合物制成的制剂,所述制剂为口香糖或舌下片或硬糖。本发明提供的用于辅助治疗高血压、糖尿病的组合物能对体内钾离子的代谢进行调节,以治疗因钾代谢失衡导致的糖尿病并发症,同时维持机体内环境的稳定;并且本发明所用原料的品种少,因此副作用小,并能够实现各有效成分的相辅相成、协同发挥疗效的目的;制成口香糖或舌下片或硬糖后,服用及携带更加方便,通过咀嚼或含服,可以刺激唾液分泌,有助于将有效成分充分吸收,并且能够充分发挥组合物的疗效。The invention provides a composition for auxiliary treatment of diabetes and hypertension, comprising 40-60 parts of potassium chloride, 80-120 parts of lecithin, 240-360 parts of sugar and 2.4-3.6 parts of magnesium chloride. It can also include 24-36 parts of metformin; the present invention also provides a preparation made from the composition, and the preparation is chewing gum, sublingual tablet or hard candy. The composition for auxiliary treatment of hypertension and diabetes provided by the present invention can regulate the metabolism of potassium ions in the body to treat diabetic complications caused by imbalance of potassium metabolism while maintaining the stability of the internal environment of the body; and the raw materials used in the present invention There are few varieties, so the side effects are small, and the active ingredients can complement each other and play a synergistic effect; after making chewing gum, sublingual tablets or hard candy, it is more convenient to take and carry, and can stimulate saliva by chewing or swallowing Secretion helps to fully absorb the active ingredients and fully exert the curative effect of the composition.
Description
技术领域technical field
本发明属于保健食品领域,具体涉及一种用于辅助治疗高血压、糖尿病的组合物及其制剂。The invention belongs to the field of health food, and in particular relates to a composition for auxiliary treatment of hypertension and diabetes and a preparation thereof.
背景技术Background technique
糖尿病是一组以高血糖为特征的代谢性疾病,高血糖则是由于胰岛素分泌缺陷或其生物功能受损,或两者兼有引起。人体经过千百万年的进化形成了一套完整的代谢糖分的系统,但这套系统并不完美,人体在糖分代谢失衡或大量运动后容易出现机体缺钾,此时这套系统出现弊端,不能快速平衡体内钾的含量,此时也会导致血压调节失衡,导致高血压的发生。糖尿病长期伴随高血糖,导致各种组织,特别是眼、肾、心脏、血管、神经的慢性损害和功能障碍,即俗称的并发症。长期以来人们普遍采用注射胰岛素的方式调节血糖、控制糖尿病,但此种方式对治疗糖尿病并发症并没有起到显著的效果。究其原因,糖尿病的并发症大多是由于钾代谢的异常导致的,与胰岛素的含量没有显著相关性。例如,进餐前血钾处于正常状态,此时细胞内钾含量不足;进餐后,胰岛素将糖和钾同时代谢,使人体进入低钾状态,出现无力、消化不良、心律不齐等症状缺钾会引起高血钠症,导致血压升高;同时血钠过高会引起细胞膨胀、细胞功能受损,特别是毛细血管更容易引起堵塞,严重时可能导致糖尿病眼病、肾病的发生;肾压的升高会导致尿酸升高,从而导致血管硬化和全身或局部血压升高,引起四肢末端的麻木、胀痛。此时除了补充钾,还可以补充适当的磷,通过磷和钾的共同作用,达到缓解症状的作用;同时,还可以通过补充适量的镁,调节血管收缩和舒张、维持细胞离子通道的正常功能,以调节血压、防止细胞内钾离子的流失。授权公告号为CN102894249A的发明专利公开了一种缓解体力疲劳的营养液,包括氯化钾、卵磷脂、蔗糖、花生多肽、水解乳清蛋白以及多种成分,能够快速补充人体所需的营养物质,以迅速恢复代谢平衡,维持内环境稳定。因此,通过适时补充钾、磷元素,并保证糖分的供应,对糖尿病并发症也可以起到一定的治疗作用。Diabetes mellitus is a group of metabolic diseases characterized by hyperglycemia caused by defective insulin secretion or impaired biological function, or both. After millions of years of evolution, the human body has formed a complete system for metabolizing sugar, but this system is not perfect. The human body is prone to potassium deficiency after sugar metabolism is out of balance or after a lot of exercise. At this time, this system has disadvantages. Failure to quickly balance the potassium content in the body will also lead to an imbalance in blood pressure regulation at this time, leading to the occurrence of high blood pressure. Diabetes is accompanied by high blood sugar for a long time, leading to chronic damage and dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, and nerves, which are commonly known as complications. For a long time, people have generally used insulin injections to regulate blood sugar and control diabetes, but this method has no significant effect on the treatment of diabetic complications. The reason is that most of the complications of diabetes are caused by the abnormality of potassium metabolism, and there is no significant correlation with the content of insulin. For example, blood potassium is in a normal state before a meal, and the potassium content in the cells is insufficient at this time; after a meal, insulin metabolizes sugar and potassium at the same time, causing the body to enter a low potassium state, and symptoms such as weakness, indigestion, and arrhythmia appear. Cause hypernatremia, leading to high blood pressure; at the same time, too high blood sodium will cause cell expansion and cell function damage, especially capillaries are more likely to cause blockage, which may lead to diabetic eye disease and kidney disease in severe cases; High levels will lead to increased uric acid, which will lead to hardening of the arteries and increased systemic or local blood pressure, causing numbness and pain at the extremities. At this time, in addition to supplementing potassium, appropriate phosphorus can also be supplemented. Through the joint action of phosphorus and potassium, the symptoms can be relieved; at the same time, an appropriate amount of magnesium can be added to regulate vasoconstriction and relaxation, and maintain the normal function of cell ion channels. , to regulate blood pressure and prevent the loss of intracellular potassium ions. The invention patent with the authorized notification number CN102894249A discloses a nutrient solution for relieving physical fatigue, including potassium chloride, lecithin, sucrose, peanut polypeptide, hydrolyzed whey protein and various ingredients, which can quickly supplement the nutrients needed by the human body , to quickly restore metabolic balance and maintain internal environment stability. Therefore, by timely supplementing potassium and phosphorus elements and ensuring the supply of sugar, it can also play a certain role in the treatment of diabetic complications.
发明内容Contents of the invention
为了解决上述技术问题,本发明提供了一种用于辅助治疗糖尿病、高血压的组合物及其制剂。In order to solve the above technical problems, the present invention provides a composition and preparation thereof for auxiliary treatment of diabetes and hypertension.
本发明具体技术方案如下:Concrete technical scheme of the present invention is as follows:
本发明一方面提供了一种用于辅助治疗糖尿病、高血压的组合物,包括如下重量份数的成分:氯化钾40~60份、卵磷脂80~120份、糖240~360份以及氯化镁2.4~3.6份,所述糖选自葡萄糖、果糖、麦芽糖或蔗糖中的至少一种。One aspect of the present invention provides a composition for auxiliary treatment of diabetes and hypertension, comprising the following ingredients in parts by weight: 40-60 parts of potassium chloride, 80-120 parts of lecithin, 240-360 parts of sugar and magnesium chloride 2.4 to 3.6 parts, the sugar is at least one selected from glucose, fructose, maltose or sucrose.
进一步地,所述组合物还包括重量份数为24~36份的二甲双胍。Further, the composition also includes 24-36 parts by weight of metformin.
本发明提供的组合物能补充人体所需的钾、磷元素和糖分,同时对体内钾离子的代谢进行调节,以治疗因钾代谢失衡导致的糖尿病并发症,同时维持机体内环境的稳定,改善健康状况。The composition provided by the invention can supplement the potassium, phosphorus and sugar required by the human body, and at the same time regulate the metabolism of potassium ions in the body to treat diabetic complications caused by imbalanced potassium metabolism, while maintaining the stability of the internal environment of the body, improving the State of health.
为了使用方便,本发明提供了一种用于辅助治疗高血压、糖尿病的制剂,包括前述的组合物,所述制剂选自口香糖、舌下片、硬糖、喷剂或合剂。For the convenience of use, the present invention provides a preparation for auxiliary treatment of hypertension and diabetes, including the aforementioned composition, and the preparation is selected from chewing gum, sublingual tablet, hard candy, spray or mixture.
本发明一方面提供了一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括如下重量份数的成分:所述组合物15~25份、胶基20~35份、增塑剂5~10份。One aspect of the present invention provides a chewing gum for auxiliary treatment of hypertension and diabetes. The chewing gum includes the following ingredients in parts by weight: 15-25 parts of the composition, 20-35 parts of gum base, 5 parts of plasticizer ~10 servings.
进一步地,所述胶基为魔芋胶、聚醋酸乙烯酯以及杜仲胶的混合物,所述魔芋胶、聚醋酸乙烯酯以及杜仲胶的重量份数比为:1~2:2:1。Further, the gum base is a mixture of konjac gum, polyvinyl acetate and Eucommia gum, and the ratio of parts by weight of konjac gum, polyvinyl acetate and Eucommia gum is 1-2:2:1.
将魔芋胶、聚醋酸乙烯酯以及杜仲胶联合使用,可以显著提升胶基的粘性和弹性,大大改善口香糖咀嚼的口感。The joint use of konjac gum, polyvinyl acetate and Eucommia gum can significantly improve the viscosity and elasticity of the gum base, and greatly improve the chewing taste of the chewing gum.
进一步地,所述增塑剂为蜜蜡、小烛树蜡以及乙酰基蓖麻酸甲酯的混合物,所述蜜蜡、小烛树蜡以及乙酰基蓖麻酸甲酯的重量份数比为1:1:1~2。Further, the plasticizer is a mixture of beeswax, candelilla wax and acetyl ricinoleic acid methyl ester, and the weight and number ratio of the beeswax, candelilla wax and acetyl ricinoleic acid methyl ester is 1:1:1~2.
将蜜蜡、小烛树蜡以及乙酰基蓖麻酸甲酯联合使用,可以显著增强口香糖的可塑性,并进一步提升口香糖的柔软和润滑程度,改善口香糖的质地和口感。The combined use of beeswax, candelilla wax and methyl acetyl ricinoleate can significantly enhance the plasticity of the chewing gum, further enhance the softness and lubricity of the chewing gum, and improve the texture and mouthfeel of the chewing gum.
本发明另一方面提供了一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括如下重量份数的组分:所述组合物20~30份、填充剂50~70份以及润滑剂0.6~1份。Another aspect of the present invention provides a sublingual tablet for auxiliary treatment of hypertension and diabetes, the sublingual tablet includes the following components in parts by weight: 20-30 parts of the composition, 50-70 parts of the filler parts and lubricant 0.6 to 1 part.
进一步地,所述填充剂为异麦芽糖醇、山梨糖醇、α-乳糖以及微晶纤维素的混合物,所述异麦芽糖醇、山梨糖醇、α-乳糖以及微晶纤维素的重量份数比为1:1:2:2~4。Further, the filler is a mixture of isomalt, sorbitol, α-lactose and microcrystalline cellulose, and the ratio of parts by weight of isomalt, sorbitol, α-lactose and microcrystalline cellulose 1:1:2:2~4.
将异麦芽糖醇、山梨糖醇、α-乳糖以及微晶纤维素联合使用,舌下片的抗张强度和成形性均显著好于只使用单一成分的稀释剂时的效果。When isomalt, sorbitol, α-lactose and microcrystalline cellulose are used in combination, the tensile strength and formability of sublingual tablets are significantly better than those of diluents with only one component.
进一步地,所述润滑剂为硬脂酸镁、山嵛酸甘油酯以及月桂醇硫酸镁的混合物,所述硬脂酸镁、山嵛酸甘油酯以及月桂醇硫酸镁的重量份数比为1~3:1:1。Further, the lubricant is a mixture of magnesium stearate, glyceryl behenate and magnesium lauryl sulfate, and the ratio of parts by weight of magnesium stearate, glyceryl behenate and magnesium lauryl sulfate is 1 ~3:1:1.
将硬脂酸镁、山嵛酸甘油酯以及月桂醇硫酸镁联合使用,其润滑性能显著提高,能显著提升制粒压片过程的效率,提高片剂的硬度。The combined use of magnesium stearate, glyceryl behenate and magnesium lauryl sulfate can significantly improve the lubricating performance, significantly improve the efficiency of the granulation and tabletting process, and increase the hardness of the tablet.
本发明另一方面还提供了一种用于辅助治疗高血压、糖尿病的硬糖,所述硬糖包括如下重量份数的组分:所述组合物20~30份、蜂蜜10~15份、甜菊糖甙10~15份、薄荷3~5份、浓缩柠檬汁3~5份以及复合微量元素0.01份,所述复合微量元素包括皮考啉酸铬、葡萄糖酸锌、柠檬酸铁、硫酸锰、硫酸铜以及硫酸钴。Another aspect of the present invention also provides a hard candy for auxiliary treatment of hypertension and diabetes, the hard candy includes the following components in parts by weight: 20-30 parts of the composition, 10-15 parts of honey, 10-15 parts of steviol glycoside, 3-5 parts of mint, 3-5 parts of concentrated lemon juice and 0.01 part of compound trace elements, which include chromium picolinate, zinc gluconate, iron citrate, manganese sulfate , copper sulfate and cobalt sulfate.
蜂蜜、甜菊糖甙可以为硬糖提供甜味,并使服用者减少糖分的摄入;薄荷与浓缩柠檬汁可以改善硬糖口感,减少甜腻感;向硬糖中添加复合微量元素,服用者可以以此补充多种元素,以维持机体的正常生理功能。Honey and steviol glycosides can provide sweetness to hard candies and reduce sugar intake for users; mint and concentrated lemon juice can improve the taste of hard candies and reduce the feeling of sweetness; adding compound trace elements to hard candies, users Various elements can be added to maintain the normal physiological functions of the body.
本发明还提供了所述用于辅助治疗高血压、糖尿病的组合物在制备用于辅助治疗高血压、糖尿病的药物中的应用The present invention also provides the application of the composition for auxiliary treatment of hypertension and diabetes in the preparation of medicines for auxiliary treatment of hypertension and diabetes
本发明的有益效果是:本发明提供的用于辅助治疗高血压、糖尿病的组合物能补充人体所需的钾、磷元素和糖分,同时通过添加镁离子对体内钾离子的代谢进行调节,以治疗因钾代谢失衡导致的糖尿病并发症,并能维持机体内环境的稳定,调节血压;同时,通过治疗糖尿病并发症、调节血压,可以缓解伴随出现的心脏不适症状,达到辅助治疗心脏疾病的效果,从而从整体上改善患者的健康状况;并且本发明所用原料的品种少,因此副作用小,并能够实现各有效成分的相辅相成、协同发挥疗效的目的;制成口香糖或舌下片或硬糖后,服用及携带更加方便,通过咀嚼或含服,可以刺激唾液分泌,有助于将有效成分充分吸收,并且能够充分发挥组合物的疗效;通过舌下含服使舌下毛细血管将有效成分快速吸收,并且这种吸收的速率与糖吸收速率、胰岛素释放速率一致,可以保证安全有效;各种助剂的添加使所述复方中药组合物性质更稳定,有助于保持其治疗效果,并能提供良好的口感,服用更加方便。The beneficial effects of the present invention are: the composition provided by the present invention for auxiliary treatment of hypertension and diabetes can supplement the potassium, phosphorus and sugar required by the human body, and at the same time, the metabolism of potassium ions in the body can be regulated by adding magnesium ions, so that Treat diabetic complications caused by potassium metabolism imbalance, maintain the stability of the body's internal environment, and regulate blood pressure; at the same time, by treating diabetic complications and regulating blood pressure, it can relieve the accompanying symptoms of heart discomfort and achieve the effect of adjuvant treatment of heart diseases , thereby improving the health status of the patient as a whole; and the kind of raw materials used in the present invention is few, so side effects are small, and can realize that each active ingredient complements each other and synergistically exerts the purpose of curative effect; after making chewing gum or sublingual tablet or hard candy , it is more convenient to take and carry. By chewing or swallowing, it can stimulate saliva secretion, help to fully absorb the active ingredients, and can give full play to the curative effect of the composition; through sublingual administration, the sublingual capillaries can quickly absorb the active ingredients Absorption, and the absorption rate is consistent with the sugar absorption rate and insulin release rate, which can ensure safety and effectiveness; the addition of various auxiliary agents makes the compound Chinese medicine composition more stable in nature, helps to maintain its therapeutic effect, and can Provides a good taste and is more convenient to take.
具体实施方式detailed description
实施例1Example 1
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾40份、卵磷脂80份、葡萄糖120份、麦芽糖120份以及氯化镁2.4份。A composition for auxiliary treatment of hypertension and diabetes, comprising 40 parts of potassium chloride, 80 parts of lecithin, 120 parts of glucose, 120 parts of maltose and 2.4 parts of magnesium chloride.
实施例2Example 2
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份、果糖150份、蔗糖150份以及氯化镁3份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin, 150 parts of fructose, 150 parts of sucrose and 3 parts of magnesium chloride.
实施例3Example 3
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾60份、卵磷脂120份、葡萄糖140份、果糖140份、麦芽糖100份、氯化镁3.6份以及二甲双胍36份。A composition for auxiliary treatment of hypertension and diabetes, comprising 60 parts of potassium chloride, 120 parts of lecithin, 140 parts of glucose, 140 parts of fructose, 100 parts of maltose, 3.6 parts of magnesium chloride and 36 parts of metformin.
实施例4Example 4
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份、葡萄糖150份、蔗糖150份、氯化镁3份以及二甲双胍30份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin, 150 parts of glucose, 150 parts of sucrose, 3 parts of magnesium chloride and 30 parts of metformin.
实施例5Example 5
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括实施例1所述组合物15份、胶基20份以及增塑剂5份,所述胶基包括魔芋胶5份、聚醋酸乙烯酯10份以及杜仲胶5份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 15 parts of the composition described in Example 1, 20 parts of gum base and 5 parts of plasticizer, said gum base comprising 5 parts of konjac gum, polyacetic acid 10 parts of vinyl ester and 5 parts of Eucommia gum.
实施例6Example 6
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括实施例2所述组合物25份、胶基35份以及增塑剂10份,所述胶基包括魔芋胶14份、聚醋酸乙烯酯14份以及杜仲胶7份,所述增塑剂包括蜜蜡2.5份、小烛树蜡2.5份以及乙酰基蓖麻酸甲酯5份。A chewing gum for the auxiliary treatment of hypertension and diabetes, said chewing gum comprising 25 parts of the composition described in Example 2, 35 parts of gum base and 10 parts of plasticizer, said gum base comprising 14 parts of konjac gum, polyacetic acid 14 parts of vinyl ester and 7 parts of Eucommia gum, the plasticizer includes 2.5 parts of beeswax, 2.5 parts of candelilla wax and 5 parts of methyl acetyl ricinoleate.
实施例7Example 7
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括实施例3所述组合物25份、胶基35份以及增塑剂10份,所述增塑剂包括蜜蜡3.33份、小烛树蜡3.33份以及乙酰基蓖麻酸甲酯3.33份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 25 parts of the composition described in Example 3, 35 parts of gum base and 10 parts of a plasticizer, said plasticizer including 3.33 parts of beeswax, a small amount of 3.33 parts of candelabra wax and 3.33 parts of methyl acetyl ricinoleate.
实施例8Example 8
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括实施例4所述组合物15份、胶基20份以及增塑剂5份,所述胶基包括魔芋胶6份、聚醋酸乙烯酯6份以及杜仲胶3份,所述增塑剂包括蜜蜡1.25份、小烛树蜡1.25份以及乙酰基蓖麻酸甲酯2.5份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 15 parts of the composition described in Example 4, 20 parts of gum base and 5 parts of plasticizer, said gum base comprising 6 parts of konjac gum, polyacetic acid 6 parts of vinyl ester and 3 parts of Eucommia gum, the plasticizer includes 1.25 parts of beeswax, 1.25 parts of candelilla wax and 2.5 parts of methyl acetyl ricinoleate.
实施例9Example 9
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括实施例1所述组合物20份、填充剂50份以及润滑剂0.6份,所述填充剂包括异麦芽糖醇8.33份、山梨糖醇8.33份、α-乳糖16.66份以及微晶纤维素16.66份。A sublingual tablet for the auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 20 parts of the composition described in Example 1, 50 parts of a filler and 0.6 parts of a lubricant, said filler including isomalt 8.33 8.33 parts of sorbitol, 16.66 parts of α-lactose and 16.66 parts of microcrystalline cellulose.
实施例10Example 10
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括实施例2所述组合物30份、填充剂70份以及润滑剂1份,所述填充剂包括异麦芽糖醇8.75份、山梨糖醇8.75份、α-乳糖17.5份以及微晶纤维素35份,所述润滑剂包括硬脂酸镁0.6份、山嵛酸甘油酯0.2份以及月桂醇硫酸镁0.2份。A sublingual tablet for the auxiliary treatment of hypertension and diabetes, the sublingual tablet includes 30 parts of the composition described in Example 2, 70 parts of a filler and 1 part of a lubricant, and the filler includes isomalt 8.75 8.75 parts of sorbitol, 17.5 parts of α-lactose and 35 parts of microcrystalline cellulose. The lubricant includes 0.6 parts of magnesium stearate, 0.2 parts of glyceryl behenate and 0.2 parts of magnesium lauryl sulfate.
实施例11Example 11
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括实施例3所述组合物30份、填充剂70份以及润滑剂1份,所述润滑剂包括硬脂酸镁0.33份、山嵛酸甘油酯0.33份以及月桂醇硫酸镁0.33份。A sublingual tablet for the auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 30 parts of the composition described in Example 3, 70 parts of filler and 1 part of lubricant, said lubricant comprising magnesium stearate 0.33 parts, 0.33 parts of glyceryl behenate and 0.33 parts of magnesium lauryl sulfate.
实施例12Example 12
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括实施例4所述组合物20份、填充剂50份以及润滑剂0.6份,所述填充剂包括异麦芽糖醇6.25份、山梨糖醇6.25份、α-乳糖12.5份以及微晶纤维素25份,所述润滑剂包括硬脂酸镁0.2份、山嵛酸甘油酯0.2份以及月桂醇硫酸镁0.2份。A sublingual tablet for auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 20 parts of the composition described in Example 4, 50 parts of a filler and 0.6 parts of a lubricant, said filler including isomalt 6.25 6.25 parts of sorbitol, 12.5 parts of α-lactose and 25 parts of microcrystalline cellulose, the lubricant includes 0.2 parts of magnesium stearate, 0.2 parts of glyceryl behenate and 0.2 parts of magnesium lauryl sulfate.
实施例13Example 13
一种用于辅助治疗高血压、糖尿病的硬糖,所述硬糖包括所述组合物20份、蜂蜜10份、甜菊糖甙10份、薄荷3份、浓缩柠檬汁3份以及复合微量元素0.01份,所述复合微量元素包括皮考啉酸铬、葡萄糖酸锌、柠檬酸铁、硫酸锰、硫酸铜以及硫酸钴。A hard candy for auxiliary treatment of hypertension and diabetes, the hard candy includes 20 parts of the composition, 10 parts of honey, 10 parts of stevioside, 3 parts of mint, 3 parts of concentrated lemon juice and 0.01 parts of compound trace elements The composite trace elements include chromium picolinate, zinc gluconate, iron citrate, manganese sulfate, copper sulfate and cobalt sulfate.
实施例14Example 14
一种用于辅助治疗高血压、糖尿病的硬糖,所述硬糖所述组合物30份、蜂蜜15份、甜菊糖甙15份、薄荷5份、浓缩柠檬汁5份以及复合微量元素0.01份,所述复合微量元素包括皮考啉酸铬、葡萄糖酸锌、柠檬酸铁、硫酸锰、硫酸铜以及硫酸钴。A hard candy for auxiliary treatment of hypertension and diabetes, comprising 30 parts of the hard candy composition, 15 parts of honey, 15 parts of stevioside, 5 parts of mint, 5 parts of concentrated lemon juice and 0.01 part of compound trace elements , the composite trace elements include chromium picolinate, zinc gluconate, ferric citrate, manganese sulfate, copper sulfate and cobalt sulfate.
对照例1Comparative example 1
一种辅助治疗高血压、糖尿病的组合物,包括卵磷脂100份、果糖150份、蔗糖150份以及氯化镁3份。A composition for auxiliary treatment of hypertension and diabetes, comprising 100 parts of lecithin, 150 parts of fructose, 150 parts of sucrose and 3 parts of magnesium chloride.
对照例2Comparative example 2
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、葡萄糖150份、麦芽糖150份以及氯化镁3份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 150 parts of glucose, 150 parts of maltose and 3 parts of magnesium chloride.
对照例3Comparative example 3
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份以及氯化镁3份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin and 3 parts of magnesium chloride.
对照例4Comparative example 4
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份、葡萄糖150份以及果糖150份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin, 150 parts of glucose and 150 parts of fructose.
对照例5Comparative example 5
一种辅助治疗高血压、糖尿病的组合物,包括卵磷脂100份、葡萄糖200份、氯化镁3份以及二甲双胍30份。A composition for auxiliary treatment of hypertension and diabetes, comprising 100 parts of lecithin, 200 parts of glucose, 3 parts of magnesium chloride and 30 parts of metformin.
对照例6Comparative example 6
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、葡萄糖300份、氯化镁3份以及二甲双胍30份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 300 parts of glucose, 3 parts of magnesium chloride and 30 parts of metformin.
对照例7Comparative example 7
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份、氯化镁3份以及二甲双胍30份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin, 3 parts of magnesium chloride and 30 parts of metformin.
对照例8Comparative example 8
一种辅助治疗高血压、糖尿病的组合物,包括氯化钾50份、卵磷脂100份、葡萄糖200份以及二甲双胍30份。A composition for auxiliary treatment of hypertension and diabetes, comprising 50 parts of potassium chloride, 100 parts of lecithin, 200 parts of glucose and 30 parts of metformin.
对照例9Comparative example 9
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括对照例1所述的组合物25份、胶基35份以及增塑剂10份,所述胶基为聚醋酸乙烯酯,所述增塑剂包括蜜蜡5份以及乙酰基蓖麻酸甲酯5份。A kind of chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprises 25 parts of the composition described in Comparative Example 1, 35 parts of gum base and 10 parts of plasticizer, said gum base is polyvinyl acetate, so Said plasticizer comprises 5 parts of beeswax and 5 parts of methyl acetyl ricinoleate.
对照例10Comparative example 10
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括对照例2所述的组合物25份、胶基35份以及增塑剂10份,所述胶基包括杜仲胶14份以及聚醋酸乙烯酯21份,所述增塑剂为蜜蜡2.5份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 25 parts of the composition described in Comparative Example 2, 35 parts of gum base and 10 parts of plasticizer, said gum base including 14 parts of Eucommia gum and poly 21 parts of vinyl acetate, and described plasticizer is 2.5 parts of beeswax.
对照例11Comparative Example 11
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括对照例4所述的组合物25份、胶基35份以及增塑剂10份,所述胶基包括魔芋胶14份以及聚醋酸乙烯酯21份,所述增塑剂包括蜜蜡5份以及乙酰基蓖麻酸甲酯5份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 25 parts of the composition described in Comparative Example 4, 35 parts of gum base and 10 parts of plasticizer, said gum base comprising 14 parts of konjac gum and poly 21 parts of vinyl acetate, and the plasticizer includes 5 parts of beeswax and 5 parts of methyl acetyl ricinoleate.
对照例12Comparative example 12
一种用于辅助治疗高血压、糖尿病的口香糖,所述口香糖包括对照例5所述的组合物25份、胶基35份以及增塑剂10份,所述胶基包括杜仲胶14份以及聚醋酸乙烯酯21份,所述增塑剂包括小烛树蜡5份以及乙酰基蓖麻酸甲酯5份。A chewing gum for auxiliary treatment of hypertension and diabetes, said chewing gum comprising 25 parts of the composition described in Comparative Example 5, 35 parts of gum base and 10 parts of plasticizer, said gum base comprising 14 parts of Eucommia gum and poly 21 parts of vinyl acetate, and the plasticizer includes 5 parts of candelilla wax and 5 parts of methyl acetyl ricinoleate.
对照例13Comparative example 13
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括对照例1所述组合物30份、填充剂70份以及润滑剂1份,所述填充剂包括异麦芽糖醇35份以及山梨糖醇35份,所述润滑剂包括硬脂酸镁0.6份以及月桂醇硫酸镁0.4份。A sublingual tablet for auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 30 parts of the composition described in Comparative Example 1, 70 parts of filler and 1 part of lubricant, said filler including isomalt 35 parts part and 35 parts of sorbitol, and the lubricant includes 0.6 part of magnesium stearate and 0.4 part of magnesium lauryl sulfate.
对照例14Comparative example 14
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括对照例2所述组合物30份、填充剂70份以及润滑剂1份,所述填充剂包括α-乳糖35份以及微晶纤维素35份,所述润滑剂包括硬脂酸镁0.6份以及山嵛酸甘油酯0.4份。A sublingual tablet for auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 30 parts of the composition described in Comparative Example 2, 70 parts of filler and 1 part of lubricant, said filler including 35 parts of α-lactose part and 35 parts of microcrystalline cellulose, and the lubricant includes 0.6 part of magnesium stearate and 0.4 part of glyceryl behenate.
对照例15Comparative Example 15
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括对照例4组所述组合物30份、填充剂70份以及润滑剂1份,所述填充剂包括异麦芽糖醇20份、α-乳糖20份以及微晶纤维素30份,所述润滑剂包括山嵛酸甘油酯0.5份以及月桂醇硫酸镁0.5份。A sublingual tablet for auxiliary treatment of high blood pressure and diabetes, said sublingual tablet comprising 30 parts of the composition of Control Example 4, 70 parts of filler and 1 part of lubricant, said filler including isomalt 20 parts, 20 parts of α-lactose and 30 parts of microcrystalline cellulose, the lubricant includes 0.5 part of glyceryl behenate and 0.5 part of magnesium lauryl sulfate.
对照例16Comparative Example 16
一种用于辅助治疗高血压、糖尿病的舌下片,所述舌下片包括对照例5组所述组合物30份、填充剂70份以及润滑剂1份,所述填充剂包括山梨糖醇30份以及微晶纤维素40份,所述润滑剂为硬脂酸镁。A sublingual tablet for the auxiliary treatment of hypertension and diabetes, said sublingual tablet comprising 30 parts of the composition of the control group 5, 70 parts of filler and 1 part of lubricant, said filler including sorbitol 30 parts and 40 parts of microcrystalline cellulose, the lubricant is magnesium stearate.
实验例1Experimental example 1
口香糖咀嚼口感评价试验Chewing gum chewing taste evaluation test
以实施例5-8中提供的口香糖作为实验组1-4,以对照例9-12中提供的口香糖作为对照组1-4。分别请十位评价员对各组口香糖进行品尝,并对各组鲜鹅汁的软硬程度和弹性进行评分,每项满分50分,总计100分,同时记录各组口香糖的咀嚼时间。各评价员单独进行评分,相互不进行交流,两次品尝之间间隔一小时,用水漱口并用补充口腔水分。The chewing gums provided in Examples 5-8 were used as experimental groups 1-4, and the chewing gums provided in Comparative Examples 9-12 were used as control groups 1-4. Ten evaluators were invited to taste each group of chewing gums, and scored the softness, hardness and elasticity of fresh goose juice in each group. The full score for each item was 50 points, and the total score was 100 points. At the same time, the chewing time of each group of chewing gums was recorded. Each assessor scored independently without communicating with each other, and there was an hour interval between two tastings, gargling with water and supplementing oral moisture with water.
表1各组口香糖感官评价结果Table 1 Sensory evaluation results of chewing gum in each group
由表1可知,实验组1-4的口感得分均显著高于对照组1-4,同时咀嚼时间也均显著高于对照组1-4,表明实验组各组的口香糖在咀嚼时的口感更好,同时咀嚼时间更长也可以使口香糖里有效成分的吸收利用率更高,更好地发挥效力。由此可知,将魔芋胶+聚醋酸乙烯酯+杜仲胶联合作为胶基,再辅以蜜蜡+小烛树蜡+乙酰基蓖麻酸甲酯联合作为增塑剂,可以赋予口香糖良好的质地和口感,并且这种效果显著好于只使用其中一种或个别几种时的效果。As can be seen from Table 1, the mouthfeel scores of the experimental group 1-4 were significantly higher than those of the control group 1-4, and the chewing time was also significantly higher than that of the control group 1-4, indicating that the chewing gums of the experimental groups had a better mouthfeel when chewed. Well, at the same time, chewing for a longer time can also make the active ingredients in the chewing gum absorb and utilize more efficiently, and play a better role. It can be seen that the combination of konjac gum + polyvinyl acetate + Eucommia gum as the gum base, and the combination of beeswax + candelilla wax + acetyl ricinoleic acid methyl ester as the plasticizer can give chewing gum a good texture and taste, and this effect is significantly better than the effect of using only one or several of them.
实验例2Experimental example 2
舌下片溶出度对比试验Dissolution test of sublingual tablets
以实施例9~12提供的舌下片作为实验例1~4,以对照例13~16提供的舌下片作为实验例1~4,根据《中华人民共和国药典》2010版记载的片剂溶出度测定法之一的“转篮法”对各组舌下片的溶出度进行测定,具体测定方法如下:The sublingual tablets provided by Examples 9-12 are used as Experimental Examples 1-4, and the sublingual tablets provided by Comparative Examples 13-16 are used as Experimental Examples 1-4. "Turning Basket Method", one of the drug testing methods, measures the dissolution rates of each group of sublingual tablets, and the specific testing methods are as follows:
以去离子水作为溶出介质,加热至约41℃,并在真空条件下不断搅拌5min以上,得到脱气溶出介质;分别量取经脱气处理的去离子水,置于8个溶出杯中,每杯500mL,待溶出介质温度恒定在37℃±0.5℃后,每组样品取6片,分别投入6个干燥的转篮内,将转篮降入溶出杯中,注意供试品表面上不要有气泡,启动溶出度仪并调至100r/min,记录每片样品完全溶出的时间,并比较各组样品的溶出速度。Use deionized water as the dissolution medium, heat to about 41°C, and stir continuously for more than 5 minutes under vacuum conditions to obtain a degassed dissolution medium; measure the deionized water that has been degassed, and place it in 8 dissolution cups. After the temperature of the dissolution medium is constant at 37°C±0.5°C, take 6 pieces of samples from each group, put them into 6 dry baskets, and lower the baskets into the dissolution cups. Be careful not to have any Bubbles, start the dissolution apparatus and adjust to 100r/min, record the time for each sample to dissolve completely, and compare the dissolution rate of each group of samples.
表2各组舌下片的完全溶出时间The complete dissolution time of each group sublingual tablet of table 2
由表2可知,实验组1-4的溶出时间均显著低于对照组1-4,表明实验组各组的溶出速率均显著高于对照组各组。舌下片在使用时应当在舌下迅速溶化,药物经舌下粘膜毛细血管吸收,并由血液输送至全身以达到治疗效果。《中国药典》2010版规定,舌下片除另有规定外,应在5min内全部溶解。由此可见,实验组1~4中的舌下片溶出时间均符合国家标准。因此,异麦芽糖醇+山梨糖醇+α-乳糖+微晶纤维素的填充剂组合使用,能使舌下片具有良好的溶出效果,并且这种溶出效果显著好于只使用其中一种或个别几种时的效果。As can be seen from Table 2, the dissolution times of the experimental groups 1-4 were significantly lower than those of the control groups 1-4, indicating that the dissolution rates of the experimental groups were significantly higher than those of the control groups. Sublingual tablets should dissolve quickly under the tongue when used, and the drug is absorbed through the sublingual mucosal capillaries and transported to the whole body by the blood to achieve therapeutic effect. "Chinese Pharmacopoeia" 2010 edition stipulates that unless otherwise specified, sublingual tablets should be completely dissolved within 5 minutes. It can be seen that the dissolution time of the sublingual tablets in the experimental groups 1-4 all met the national standard. Therefore, the combined use of fillers of isomalt + sorbitol + α-lactose + microcrystalline cellulose can make the sublingual tablet have a good dissolution effect, and this dissolution effect is significantly better than using only one of them or individually The effect of several times.
实验例3Experimental example 3
糖尿病并发症临床实验Clinical Trials of Diabetic Complications
1.试验病例1. Test case
选取160名年龄在30~60岁之间的糖尿病患者,随机分成8组,每组20人,所有患者中无妊娠期或哺乳期患者。A total of 160 diabetic patients aged between 30 and 60 were selected and randomly divided into 8 groups, 20 people in each group. None of the patients were pregnant or lactating.
2.用药剂量2. Dosage
以实施例1-4中提供的组合物为实验组1-4,以对照例5-8中提供的组合物为对照组5-8,让8组患者分别服用以上8组产品,每12小时1次,每次1g,同时按照医嘱用量注射胰岛素,每12小时1次,连续治疗60天。Take the composition provided in Example 1-4 as experimental group 1-4, take the composition provided in Comparative Example 5-8 as control group 5-8, let 8 groups of patients take the above 8 groups of products respectively, every 12 hours 1 time, 1g each time, at the same time, inject insulin according to the amount prescribed by the doctor, once every 12 hours, and treat continuously for 60 days.
3.评价指标3. Evaluation indicators
临床表现:四肢无力、手脚麻木、蛋白尿、眼睛干涩、视力模糊、心律不齐Clinical manifestations: weakness of limbs, numbness of hands and feet, proteinuria, dry eyes, blurred vision, arrhythmia
生理生化指标:糖尿病患者尿微量白蛋白含量>20mg/L。Physiological and biochemical indicators: urinary microalbumin content of diabetic patients >20mg/L.
显著有效:治疗后病情体征明显改善,尿微量白蛋白降至正常范围(<18.14mg/L);Significantly effective: After treatment, the symptoms of the disease were significantly improved, and the urine microalbumin dropped to the normal range (<18.14mg/L);
有效:治疗后病情体征有所改善,尿微量白蛋白显著降低并且维持在较稳定状态;Effective: After treatment, the symptoms of the disease were improved, and the urine microalbumin was significantly reduced and maintained at a relatively stable state;
无效:治疗前后无明显改变。Ineffective: no significant changes before and after treatment.
4.数据处理4. Data processing
对患者临床资料进行整理分析,通过t检验对实验组和对照组的治疗效果进行比较。The clinical data of the patients were collated and analyzed, and the treatment effects of the experimental group and the control group were compared by t test.
5.实验结果5. Experimental results
表3各组患者治疗情况Table 3 Treatment of patients in each group
实验组与对照组差异显著(p<0.05)。There was a significant difference between the experimental group and the control group (p<0.05).
6.分析与结论6. Analysis and conclusion
由表3可知,实验组的有效率均不低于85%,而对照组各组有效率均不超过65%,表明实验组的疗效显著高于对照组。并且经后续跟踪调查表明,对照组部分患者服药后一年内出现视力模糊、手脚麻木等复发迹象,而实验组所有患者用药后一年内均未出现不良反应或复发迹象,表明本发明实施例提供的组合物对糖尿病并发症具有良好的治疗效果,并且效力持久、无毒副作用,适宜进行推广。It can be seen from Table 3 that the effective rate of the experimental group is not less than 85%, while the effective rate of each group of the control group is not more than 65%, indicating that the curative effect of the experimental group is significantly higher than that of the control group. And the follow-up investigation shows that some patients in the control group have recurrence signs such as blurred vision and numbness of hands and feet within one year after taking the medicine, while all patients in the experimental group have no adverse reactions or signs of recurrence within one year after taking the medicine, which shows that the drug provided by the embodiments of the present invention The composition has good therapeutic effect on diabetic complications, has long-lasting effect and no toxic or side effect, and is suitable for popularization.
实验例4Experimental example 4
高血压临床实验Hypertension Clinical Trials
1.试验病例1. Test case
选取160名年龄在30~60岁之间的高血压患者,随机分成八组,每组20人,所有患者中无妊娠期或哺乳期患者。A total of 160 hypertensive patients aged between 30 and 60 were selected and randomly divided into eight groups, 20 people in each group. None of the patients were pregnant or lactating.
2.用药剂量2. Dosage
以实施例1-4中提供的组合物为实验组1-4,以对照例1-4中提供的组合物为对照组1-4,让八组患者分别服用以上八组产品,每12小时1次,每次1g,连续服用30天。Take the composition provided in Example 1-4 as experimental group 1-4, take the composition provided in Comparative Example 1-4 as control group 1-4, let eight groups of patients take the above eight groups of products respectively, every 12 hours 1 time, 1g each time, for 30 consecutive days.
3.评价指标3. Evaluation indicators
临床表现:头晕、头痛、精神紧张、注意力不集中、记忆力减退、肢体麻木、心悸、胸闷、乏力等。Clinical manifestations: dizziness, headache, nervousness, inattention, memory loss, limb numbness, palpitations, chest tightness, fatigue, etc.
生理生化指标:高血压患者收缩压≥140mmHg,舒张压≥90mmHg。Physiological and biochemical indicators: systolic blood pressure ≥ 140mmHg and diastolic blood pressure ≥ 90mmHg in hypertensive patients.
显著有效:治疗后病情体征明显改善,血压值降至正常范围;Significantly effective: After treatment, the symptoms of the disease improved significantly, and the blood pressure dropped to the normal range;
有效:治疗后病情体征有所改善,血压值显著降低并且维持在较稳定状态;Effective: After treatment, the symptoms of the disease improved, and the blood pressure value was significantly reduced and maintained at a relatively stable state;
无效:治疗前后无明显改变。Ineffective: no significant changes before and after treatment.
4.数据处理4. Data processing
对患者临床资料进行整理分析,通过t检验对实验组和对照组的治疗效果进行比较。The clinical data of the patients were collated and analyzed, and the treatment effects of the experimental group and the control group were compared by t test.
5.实验结果5. Experimental results
表4各组患者治疗情况Table 4 Treatment of patients in each group
实验组与对照组差异显著(p<0.05)。There was a significant difference between the experimental group and the control group (p<0.05).
6.分析与结论6. Analysis and conclusion
由表4可知,实验组的有效率均不低于90%,而对照组各组有效率均不超过70%,表明实验组的疗效显著高于对照组。并且经后续跟踪调查表明,对照组部分患者服药后半年内出现头晕、胸闷、肢体麻木、血压升高等复发迹象,而实验组所有患者用药后半年内均未出现不良反应或复发迹象,表明本发明实施例提供的组合物对高血压具有良好的治疗效果,对于并且效力持久、无毒副作用,适宜进行推广。It can be seen from Table 4 that the effective rate of the experimental group is not less than 90%, while the effective rate of each group of the control group is not more than 70%, indicating that the curative effect of the experimental group is significantly higher than that of the control group. And the follow-up investigation shows that some patients in the control group have recurrence signs such as dizziness, chest tightness, limb numbness, and elevated blood pressure within half a year after taking the medicine, while all patients in the experimental group have no adverse reactions or signs of recurrence within half a year after taking the medicine, which shows that the present invention The composition provided in the example has a good therapeutic effect on hypertension, has a long-lasting effect and no side effects, and is suitable for popularization.
以上所述实施例仅表达了本发明的几种实施方式,其描述较为具体和详细,但并不能因此而理解为对本发明专利范围的限制。应当指出的是,对于本领域的普通技术人员来说,在不脱离本发明构思的前提下,还可以做出若干变形和改进,这些都属于本发明的保护范围。因此,本发明专利的保护范围应以所附权利要求为准。The above-mentioned embodiments only express several implementation modes of the present invention, and the description thereof is relatively specific and detailed, but should not be construed as limiting the patent scope of the present invention. It should be pointed out that those skilled in the art can make several modifications and improvements without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent for the present invention should be based on the appended claims.
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