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CN118021803A - Anti-aging and anti-inflammatory composition containing ergothioneine, and preparation method and application thereof - Google Patents

Anti-aging and anti-inflammatory composition containing ergothioneine, and preparation method and application thereof Download PDF

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CN118021803A
CN118021803A CN202410223518.5A CN202410223518A CN118021803A CN 118021803 A CN118021803 A CN 118021803A CN 202410223518 A CN202410223518 A CN 202410223518A CN 118021803 A CN118021803 A CN 118021803A
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ergothioneine
aging
preparation
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CN118021803B (en
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赵玲玲
张华�
陈蕾
黄靖雅
王莲婧
李思韵
梁绮莹
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Health And Happiness H&h Hong Kong Ltd
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Biostime Guangzhou Health Product Co ltd
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Abstract

The invention provides an ergothioneine-containing composition for delaying aging and resisting inflammation, which comprises the following components in parts by weight: 0.5-10 parts by weight of ergothioneine and 0.5-10 parts by weight of component a; the component a is at least one of beta-carotene or astaxanthin; the components have obvious synergistic effect, can delay aging, resist skin photoaging, resist skin inflammation, and improve dermatitis and skin sensitivity redness.

Description

一种含麦角硫因的延缓衰老、抗炎的组合物和制备方法及其 用途An anti-aging and anti-inflammatory composition containing ergothioneine, a preparation method and its use

技术领域Technical Field

本发明涉及医药技术领域,具体涉及一种含麦角硫因的延缓衰老、抗炎的组合物和制备方法及其用途。The invention relates to the technical field of medicines, and in particular to an ergothioneine-containing composition for delaying aging and resisting inflammation, a preparation method and use thereof.

背景技术Background technique

衰老是表现为人体机能变缓的自然过程。衰老的外观主要表现为皮肤老化、干燥、皱纹、松弛等。衰老是不可逆转的,但是可以延缓衰老的进程。皮肤老化主要包括内源性老化和外源性老化。外源性老化是指皮肤受环境因素影响而引起的衰老变化,因以紫外线(Ultraviolet,UV)辐射的影响为主,故又称为光老化。与内源性老化不同,光老化可以在一定程度上得到控制,因为它是外部因素的结果。光老化会影响暴露在阳光下的区域,临床特征是细纹和粗皱纹、粗糙、干燥、松弛和色素沉着变化。在过去几十年里,已经开发了对抗皮肤老化迹象和功能障碍的抗衰老策略。Aging is a natural process characterized by a slowdown in human functions. The appearance of aging is mainly manifested in skin aging, dryness, wrinkles, sagging, etc. Aging is irreversible, but the aging process can be slowed down. Skin aging mainly includes intrinsic aging and exogenous aging. Exogenous aging refers to aging changes in the skin caused by environmental factors. Because it is mainly affected by ultraviolet (UV) radiation, it is also called photoaging. Unlike intrinsic aging, photoaging can be controlled to a certain extent because it is the result of external factors. Photoaging affects areas exposed to the sun, and its clinical characteristics are fine and coarse wrinkles, roughness, dryness, sagging, and changes in pigmentation. In the past few decades, anti-aging strategies have been developed to combat the signs and functional disorders of skin aging.

敏感性皮肤特指皮肤在生理或病理条件下发生的一种高反应状态,主要发生于面部,临床表现为受到物理、化学、精神等因素刺激时皮肤易出现灼热、刺痛、瘙痒及紧绷感等主观症状,伴或不伴红斑、鳞屑、毛细血管扩张等客观体征。熬夜、压力大、化妆品使用不当是造成敏感肌的主要因素,敏感肌形成的机理主要有皮肤屏障受损、神经系统介导不适感、免疫反应引发多种症状、血管功能障碍等,作用机理复杂,且各机制之间并非孤立,牵一发而动全身。Sensitive skin refers specifically to a highly reactive state of the skin under physiological or pathological conditions, mainly occurring on the face. Clinically, the skin is prone to subjective symptoms such as burning, stinging, itching, and tightness when stimulated by physical, chemical, mental and other factors, with or without objective signs such as erythema, scaling, and capillary dilation. Staying up late, high stress, and improper use of cosmetics are the main factors causing sensitive skin. The mechanism of sensitive skin formation mainly includes damaged skin barrier, discomfort mediated by the nervous system, immune response causing multiple symptoms, vascular dysfunction, etc. The mechanism of action is complex, and each mechanism is not isolated, and one move affects the whole body.

发明内容Summary of the invention

因此,本发明要解决的技术问题在于提供一种含麦角硫因的延缓衰老、抗炎的组合物和制备方法及其用途。Therefore, the technical problem to be solved by the present invention is to provide an anti-aging and anti-inflammatory composition containing ergothioneine, a preparation method and use thereof.

为此,本发明提供了如下的技术方案:To this end, the present invention provides the following technical solutions:

一种含麦角硫因的延缓衰老、抗炎的组合物,包括如下重量份组分:麦角硫因0.5-10重量份,组分a 0.5-10重量份;组分a为β-胡萝卜素和虾青素中的至少一种。An ergothioneine-containing anti-aging and anti-inflammatory composition comprises the following components in parts by weight: 0.5-10 parts by weight of ergothioneine and 0.5-10 parts by weight of component a; component a is at least one of beta-carotene and astaxanthin.

可选的,包括如下重量份组分:麦角硫因1.6重量份,组分a 1.7重量份。Optionally, the following components in parts by weight are included: 1.6 parts by weight of ergothioneine and 1.7 parts by weight of component a.

可选的,还包括如下重量份的组分:胶原蛋白肽50-1000重量份,神经酰胺2-200重量份,透明质酸钠5-500重量份中至少一种。Optionally, the composition further comprises the following components in parts by weight: at least one of 50-1000 parts by weight of collagen peptide, 2-200 parts by weight of ceramide, and 5-500 parts by weight of sodium hyaluronate.

可选的,还包括如下重量份的组分:维生素E 0.5-100重量份,维生素C 0.5-200重量份,生物素5-30重量份,烟酰胺2-200重量份中至少一种。Optionally, the composition further comprises the following components in parts by weight: at least one of 0.5-100 parts by weight of vitamin E, 0.5-200 parts by weight of vitamin C, 5-30 parts by weight of biotin, and 2-200 parts by weight of niacinamide.

可选的,还包括如下重量份的组分:氧化铜0.01-1重量份,柠檬酸锌2-15重量份中至少一种。Optionally, the invention further comprises the following components in parts by weight: at least one of 0.01-1 parts by weight of copper oxide and 2-15 parts by weight of zinc citrate.

可选的,还包括如下重量份的组分:谷胱甘肽100-500重量份。Optionally, the invention further comprises the following components in parts by weight: 100-500 parts by weight of glutathione.

可选的,包括如下重量份的组分:Optionally, the following components are included in parts by weight:

麦角硫因1.6重量份,β-胡萝卜素1.7重量份,神经酰胺20重量份;1.6 parts by weight of ergothioneine, 1.7 parts by weight of beta-carotene, and 20 parts by weight of ceramide;

或,麦角硫因0.5重量份,虾青素5重量份,胶原蛋白肽635重量份,谷胱甘肽265重量份;Or, 0.5 parts by weight of ergothioneine, 5 parts by weight of astaxanthin, 635 parts by weight of collagen peptide, and 265 parts by weight of glutathione;

或,麦角硫因10重量份,β-胡萝卜素0.5重量份,神经酰胺200重量份,维生素E 100重量份;Or, 10 parts by weight of ergothioneine, 0.5 parts by weight of beta-carotene, 200 parts by weight of ceramide, and 100 parts by weight of vitamin E;

或,麦角硫因10重量份,β-胡萝卜素10重量份,胶原蛋白肽50重量份,谷胱甘肽500重量份;Or, 10 parts by weight of ergothioneine, 10 parts by weight of beta-carotene, 50 parts by weight of collagen peptide, and 500 parts by weight of glutathione;

或,麦角硫因5重量份,虾青素5重量份,透明质酸钠5重量份,维生素E为0.5重量份,生物素30重量份;Or, 5 parts by weight of ergothioneine, 5 parts by weight of astaxanthin, 5 parts by weight of sodium hyaluronate, 0.5 parts by weight of vitamin E, and 30 parts by weight of biotin;

或,麦角硫因1重量份,虾青素0.5重量份,神经酰胺2重量份,维生素C 200重量份,生物素5重量份;Or, 1 part by weight of ergothioneine, 0.5 part by weight of astaxanthin, 2 parts by weight of ceramide, 200 parts by weight of vitamin C, and 5 parts by weight of biotin;

或,麦角硫因3.2重量份,虾青素5.36重量份,神经酰胺2.6重量份,柠檬酸锌15重量份,氧化铜1重量份;Or, 3.2 parts by weight of ergothioneine, 5.36 parts by weight of astaxanthin, 2.6 parts by weight of ceramide, 15 parts by weight of zinc citrate, and 1 part by weight of copper oxide;

或,麦角硫因1.69重量份,β-胡萝卜素1.482重量份,胶原蛋白肽834重量份,透明质酸钠42.1重量份,维生素C27.78重量份,维生素E1.69重量份,氧化铜0.227重量份;Or, 1.69 parts by weight of ergothioneine, 1.482 parts by weight of beta-carotene, 834 parts by weight of collagen peptide, 42.1 parts by weight of sodium hyaluronate, 27.78 parts by weight of vitamin C, 1.69 parts by weight of vitamin E, and 0.227 parts by weight of copper oxide;

或,麦角硫因8.5重量份,虾青素10重量份,胶原蛋白肽1000重量份,透明质酸钠126.5重量份,谷胱甘肽100重量份;Or, 8.5 parts by weight of ergothioneine, 10 parts by weight of astaxanthin, 1000 parts by weight of collagen peptide, 126.5 parts by weight of sodium hyaluronate, and 100 parts by weight of glutathione;

或,麦角硫因0.5重量份,β-胡萝卜素0.5重量份,透明质酸钠500重量份,维生素C0.5重量份,烟酰胺200重量份,柠檬酸锌2重量份,氧化铜0.01重量份。Or, 0.5 weight part of ergothioneine, 0.5 weight part of beta-carotene, 500 weight parts of sodium hyaluronate, 0.5 weight part of vitamin C, 200 weight parts of niacinamide, 2 weight parts of zinc citrate, and 0.01 weight part of copper oxide.

一种所述的含麦角硫因的延缓衰老、抗炎的组合物的制备方法,包括:按照配方称取原料,混合。A method for preparing the ergothioneine-containing anti-aging and anti-inflammatory composition comprises: weighing raw materials according to a formula and mixing them.

一种制剂,含有所述的含麦角硫因的延缓衰老、抗炎的组合物,以及制剂允许的载体;A preparation comprising the anti-aging and anti-inflammatory composition containing ergothioneine and a carrier allowed by the preparation;

可选的,所述制剂形式包括液体制剂和固体制剂;Optionally, the preparation form includes liquid preparation and solid preparation;

可选的,所述药物制剂的形式包括注射剂、片剂、胶囊剂、颗粒剂或膏剂。Optionally, the pharmaceutical preparation is in the form of injection, tablet, capsule, granule or paste.

可选的,在所述片剂中,包括片芯和设置在所述片芯表面的包衣层;所述片芯中含有所述的延缓衰老、抗炎的组合物;所述包衣层从由内至外依次包括透明包衣层和有色包衣层;所述透明包衣层的原料包括羟丙基甲基纤维素90-100重量份和中链甘油三酯0-10重量份;优选的,所述有色包衣层为粉色包衣层,原料为OPADRY IIPINK包衣液。Optionally, the tablet comprises a tablet core and a coating layer arranged on the surface of the tablet core; the tablet core contains the anti-aging and anti-inflammatory composition; the coating layer comprises a transparent coating layer and a colored coating layer from the inside to the outside; the raw materials of the transparent coating layer include 90-100 parts by weight of hydroxypropyl methylcellulose and 0-10 parts by weight of medium-chain triglycerides; preferably, the colored coating layer is a pink coating layer, and the raw material is OPADRY IIPINK coating solution.

所述的含麦角硫因的延缓衰老、抗炎的组合物、所述的制备方法制备得到的含麦角硫因的延缓衰老、抗炎的组合物或所述的制剂在制备延缓衰老、抗炎的药物或食品中的用途;The anti-aging and anti-inflammatory composition containing ergothioneine, the anti-aging and anti-inflammatory composition containing ergothioneine prepared by the preparation method, or the use of the preparation in preparing anti-aging and anti-inflammatory drugs or foods;

可选的,在制备抗皮肤光老化的药物或食品中的用途;Optionally, use in the preparation of drugs or foods for resisting skin photoaging;

可选的,在制备抗皮炎的药物或食品中的用途;Optionally, use in the preparation of anti-dermatitis drugs or foods;

可选的,在制备抗皮肤敏感泛红的药物或食品中的用途。Optionally, the invention is used for preparing medicines or foods for preventing skin allergy and redness.

本发明技术方案,具有如下优点:The technical solution of the present invention has the following advantages:

1.本发明提供的含麦角硫因的延缓衰老、抗炎的组合物,包括如下重量份组分:麦角硫因0.5-10重量份,组分a 0.5-10重量份;组分a为β-胡萝卜素和虾青素中的任意一种;上述组方之间具有显著的协同增效作用,可以延缓衰老,抗皮肤光老化,同时还具有抗皮肤过敏,改善皮炎和皮肤敏感泛红的作用。1. The anti-aging and anti-inflammatory composition containing thioneine provided by the present invention comprises the following components in parts by weight: thioneine 0.5-10 parts by weight, component a 0.5-10 parts by weight; component a is any one of beta-carotene and astaxanthin; the above-mentioned prescriptions have a significant synergistic effect, can delay aging, resist skin photoaging, and also have anti-skin allergy, improve dermatitis and skin sensitive redness.

2.本发明提供的含麦角硫因的延缓衰老、抗炎的组合物,还包括如下重量份的组分:维生素E 0.5-100重量份,维生素C 0.5-200重量份,生物素5-30重量份,烟酰胺2-200重量份中至少一种;本发明研究发现,经添加上述任一组分后,上述组分具有维持和保障机体正常功能,和组合物中的组分组合具有显著的协同增效作用,达到更好的延缓衰老和抗皮肤过敏的作用。2. The anti-aging and anti-inflammatory composition containing ergothioneine provided by the present invention also includes the following components in parts by weight: at least one of 0.5-100 parts by weight of vitamin E, 0.5-200 parts by weight of vitamin C, 5-30 parts by weight of biotin, and 2-200 parts by weight of nicotinamide; the present invention has found that after adding any of the above components, the above components have the function of maintaining and ensuring the normal function of the body, and have a significant synergistic effect with the combination of components in the composition, thereby achieving better anti-aging and anti-skin allergy effects.

3.本发明提供的含麦角硫因的延缓衰老、抗炎的组合物,还包括如下重量份的组分:胶原蛋白肽50-1000重量份,神经酰胺2-200重量份,透明质酸钠5-500重量份中至少一种;本发明研究发现,经添加上述任一组分后,上述组分为肌肤基础组成物质原料,和组合物中的组分组合具有显著的协同增效作用,可以进一步的起到更好的延缓衰老和抗皮肤过敏的作用。3. The anti-aging and anti-inflammatory composition containing ergothioneine provided by the present invention also includes the following components in parts by weight: at least one of 50-1000 parts by weight of collagen peptide, 2-200 parts by weight of ceramide, and 5-500 parts by weight of sodium hyaluronate; the present invention has found that after adding any of the above components, the above components are raw materials for the basic components of the skin, and the combination with the components in the composition has a significant synergistic effect, which can further play a better role in delaying aging and resisting skin allergies.

4.本发明提供的含麦角硫因的延缓衰老、抗炎的组合物,还包括如下重量份的组分:氧化铜0.01-1重量份,柠檬酸锌2-15重量份中至少一种;上述组分具有维持和保障机体正常功能,和组合物中的组分组合具有显著的协同增效作用,达到更好的延缓衰老和抗皮肤过敏的作用。4. The anti-aging and anti-inflammatory composition containing ergothioneine provided by the present invention also includes the following components in parts by weight: 0.01-1 parts by weight of copper oxide, at least one of 2-15 parts by weight of zinc citrate; the above components have the function of maintaining and ensuring the normal function of the body, and have a significant synergistic effect with the combination of components in the composition, thereby achieving better anti-aging and anti-skin allergy effects.

5.本发明提供的含麦角硫因的延缓衰老、抗炎的组合物,还包括如下重量份的组分:谷胱甘肽100-500重量份;上述组分和组合物中的组分组合具有显著的协同增效作用,达到更好的延缓衰老和抗皮肤过敏的作用。5. The anti-aging and anti-inflammatory composition containing ergothioneine provided by the present invention also includes the following components in parts by weight: 100-500 parts by weight of glutathione; the combination of the above components and the components in the composition has a significant synergistic effect, achieving better anti-aging and anti-skin allergy effects.

6、本发明提供的一种制剂,含有所述的含麦角硫因的延缓衰老、抗炎的组合物,以及制剂允许的载体,所述制剂为片剂,所述片剂包括片芯和设置在所述片芯表面的包衣层;所述片芯中含有所述的含麦角硫因的延缓衰老、抗炎的组合物;所述包衣层从由内至外依次包括透明包衣层和有色包衣层;所述透明包衣层的原料包括羟丙基甲基纤维素90-100重量份和中链甘油三酯0-10重量份;优选的,所述有色包衣层为粉色包衣层,原料为OPADRYIIPINK包衣液;本发明研究发现,本发明的含麦角硫因的延缓衰老、抗炎的组合物压成片芯后进行常规的有色包衣,制备成的片剂中有黑色斑点透出,影响外观,而本发明进一步研究发现,在进行有色包衣层包衣之前,先在片芯上包覆原料包括羟丙基甲基纤维素90-100重量份和中链甘油三酯0-10重量份组成的透明包衣层,所述透明包衣层可以隔绝氧气和水分,可以阻碍原料发生反应,减少了生成黑色的物质,然后再进行常规的有色包衣,获得的片剂中无黑色斑点透出。6. A preparation provided by the present invention comprises the anti-aging and anti-inflammatory composition containing ergothioneine, and a carrier allowed by the preparation, wherein the preparation is a tablet, and the tablet comprises a core and a coating layer arranged on the surface of the core; the core contains the anti-aging and anti-inflammatory composition containing ergothioneine; the coating layer comprises a transparent coating layer and a colored coating layer from the inside to the outside in sequence; the raw material of the transparent coating layer comprises 90-100 parts by weight of hydroxypropyl methylcellulose and 0-10 parts by weight of medium-chain triglycerides; preferably, the colored coating layer is a pink coating layer, and the raw material is OPADRYIIPINK package The present invention has found that after the anti-aging and anti-inflammatory composition containing ergothioneine is pressed into a tablet core, conventional colored coating is performed, and black spots are visible in the prepared tablets, affecting the appearance. The present invention has further found that before the colored coating layer is coated, a transparent coating layer composed of 90-100 parts by weight of hydroxypropyl methylcellulose and 0-10 parts by weight of medium-chain triglycerides is first coated on the tablet core, and the transparent coating layer can isolate oxygen and moisture, hinder the reaction of the raw materials, and reduce the generation of black substances. Then, conventional colored coating is performed, and no black spots are visible in the obtained tablets.

附图说明BRIEF DESCRIPTION OF THE DRAWINGS

为了更清楚地说明本发明具体实施方式或现有技术中的技术方案,下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图是本发明的一些实施方式,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

图1是本发明实施例10中制备的片剂的图片;FIG1 is a picture of a tablet prepared in Example 10 of the present invention;

图2是本发明对比例1中制备的片剂的图片。FIG. 2 is a picture of the tablets prepared in Comparative Example 1 of the present invention.

具体实施方式Detailed ways

提供下述实施例是为了更好地进一步理解本发明,并不局限于所述最佳实施方式,不对本发明的内容和保护范围构成限制,任何人在本发明的启示下或是将本发明与其他现有技术的特征进行组合而得出的任何与本发明相同或相近似的产品,均落在本发明的保护范围之内。The following examples are provided for a better understanding of the present invention, but are not intended to limit the best mode of implementation, nor to limit the content and protection scope of the present invention. Any product identical or similar to the present invention obtained by anyone under the inspiration of the present invention or by combining the features of the present invention with other prior arts shall fall within the protection scope of the present invention.

实施例中未注明具体实验步骤或条件者,按照本领域内的文献所描述的常规实验步骤的操作或条件即可进行。所用试剂或仪器未注明生产厂商者,均为可以通过市购获得的常规试剂产品。If no specific experimental steps or conditions are specified in the examples, the conventional experimental steps or conditions described in the literature in the field can be used. If no manufacturer is specified for the reagents or instruments used, they are all conventional reagent products that can be purchased commercially.

表1Table 1

注:上述原料均为粉体。Note: The above raw materials are all powders.

实施例本实施例提供了实施例1-实施例11的配方如下表:Embodiment This embodiment provides the formula of embodiment 1-embodiment 11 as follows:

表2、配方Table 2. Formulation

上述实施例的制备方法:The preparation method of the above embodiment:

按照上述表格称取所需原料,混合均匀。Weigh the required raw materials according to the above table and mix them evenly.

实施例11Embodiment 11

本实施例提供了一种制剂,包括如下步骤:This embodiment provides a preparation, comprising the following steps:

(1)、以实施例1-实施例10中任意的所述的延缓衰老、抗炎的组合物为活性成分,采用常规工艺,加入或不加入常规辅料制备成片芯,备用。(1) Using any of the anti-aging and anti-inflammatory compositions described in Examples 1 to 10 as active ingredients, a conventional process is used with or without conventional auxiliary materials to prepare a tablet core for later use.

(2)、按照如下配方配制透明包衣液:包衣粉:羟丙基甲基纤维素(HPMC)95g和中链甘油三酯(MCT)5g;将上述包衣粉与纯化水按照质量比1:5.25混合,制备得到透明包衣液。粉色包衣液选择OPADRY IIPINK包衣液(市售)。(2) Prepare a transparent coating liquid according to the following formula: Coating powder: 95 g of hydroxypropyl methylcellulose (HPMC) and 5 g of medium chain triglyceride (MCT); mix the above coating powder with purified water at a mass ratio of 1:5.25 to prepare a transparent coating liquid. The pink coating liquid is OPADRY IIPINK coating liquid (commercially available).

(3)、采用包衣机(包衣机BGB-350F万申),先将透明包衣液均匀喷涂在步骤(1)中的片芯表面,然后再喷涂粉色包衣液,喷涂的工艺参数为设定包衣锅转速在2转/分-8转/分;设定进风温度50℃-100℃;设定滚筒内保持喷枪压力0.3Mpa-0.5Mpa;设定雾化压力0.3Mpa-0.6Mpa;设定扁化压力0.3Mpa-0.5Mpa,最终获得片剂,所述片剂的结构为包括片芯和设置在所述片芯表面的包衣层;所述片芯中含有所述的延缓衰老、抗炎的组合物;所述包衣层从由内至外依次包括透明包衣层和有色包衣层。(3) Using a coating machine (coating machine BGB-350F Wanshen), firstly spray the transparent coating liquid evenly on the surface of the tablet core in step (1), and then spray the pink coating liquid. The spraying process parameters are as follows: setting the coating pan speed at 2 rpm-8 rpm; setting the air inlet temperature at 50°C-100°C; setting the spray gun pressure in the drum to 0.3 MPa-0.5 MPa; setting the atomization pressure at 0.3 MPa-0.6 MPa; and setting the flattening pressure at 0.3 MPa-0.5 MPa. Finally, tablets are obtained. The tablets have a structure comprising a tablet core and a coating layer arranged on the surface of the tablet core; the tablet core contains the anti-aging and anti-inflammatory composition; and the coating layer comprises a transparent coating layer and a colored coating layer from the inside to the outside.

上述获得的片剂中,片芯重量为1040mg,在片芯上设置一层透明包衣层后重量为1053mg,在该基础上再设置一层粉色包衣层后重量为1078mg。以活性成分为实施例1中的组合物为代表,制备的片剂如图1所示,由图1中可以看到,片剂表面无黑色斑点透出。In the tablets obtained above, the weight of the tablet core is 1040 mg, the weight after a transparent coating layer is provided on the tablet core is 1053 mg, and the weight after a pink coating layer is provided on the basis is 1078 mg. Taking the active ingredient as the composition in Example 1 as a representative, the prepared tablet is shown in Figure 1, and it can be seen from Figure 1 that there are no black spots on the surface of the tablet.

实施例12Example 12

本实施例与实施例11的区别在于,包衣粉:羟丙基甲基纤维素(HPMC)90g和中链甘油三酯(MCT)10g。制备的片剂表面无黑色斑点透出。The difference between this example and Example 11 is that the coating powder includes 90 g of hydroxypropyl methylcellulose (HPMC) and 10 g of medium chain triglyceride (MCT). No black spots are visible on the surface of the prepared tablets.

实施例13Example 13

本实施例与实施例11的区别在于,包衣粉:羟丙基甲基纤维素(HPMC)100g。制备的片剂表面无黑色斑点透出。The difference between this example and Example 11 is that the coating powder is 100 g of hydroxypropyl methylcellulose (HPMC). No black spots are visible on the surface of the prepared tablets.

对比例1Comparative Example 1

本实施例提供了一种制剂,包括如下步骤:This embodiment provides a preparation, comprising the following steps:

(1)、以实施例1-实施例10中任意的所述的延缓衰老、抗炎的组合物为活性成分,采用常规工艺,加入或不加入常规辅料制备成片芯,备用。(1) Using any of the anti-aging and anti-inflammatory compositions described in Examples 1 to 10 as active ingredients, a conventional process is used with or without conventional auxiliary materials to prepare a tablet core for later use.

(2)、粉色包衣液选择OPADRY IIPINK包衣液,备用。(2) Select OPADRY IIPINK coating solution as the pink coating solution and set aside.

(3)、采用包衣机(包衣机BGB-350F万申),先将透明包衣液均匀喷涂在步骤(1)中的片芯表面,然后再喷涂粉色包衣液,喷涂的工艺参数为设定包衣锅转速在2转/分-8转/分;设定进风温度50℃-100℃;设定滚筒内保持喷枪压力0.3Mpa-0.5Mpa;设定雾化压力0.3Mpa-0.6Mpa;设定扁化压力0.3Mpa-0.5Mpa,最终获得片剂,所述片剂的结构为包括片芯和设置在所述片芯表面的包衣层;所述片芯中含有所述的延缓衰老、抗炎的组合物;所述包衣层仅包括一层有色包衣层;在获得的片剂中,片芯重量为1040mg,在片芯上设置一层粉色包衣层后重量为1078mg。以活性成分为实施例1中的组合物为代表,制备的片剂如图2所示。由图2中可以看到,片剂表面有黑色斑点透出。(3) A coating machine (coating machine BGB-350F Wanshen) is used to evenly spray the transparent coating liquid on the surface of the tablet core in step (1), and then spray the pink coating liquid. The spraying process parameters are as follows: setting the coating pan speed at 2 rpm-8 rpm; setting the air inlet temperature at 50°C-100°C; setting the spray gun pressure in the drum to 0.3Mpa-0.5Mpa; setting the atomization pressure at 0.3Mpa-0.6Mpa; setting the flattening pressure at 0.3Mpa-0.5Mpa, and finally obtaining a tablet, wherein the tablet comprises a tablet core and a coating layer disposed on the surface of the tablet core; the tablet core contains the anti-aging and anti-inflammatory composition; the coating layer comprises only a colored coating layer; in the obtained tablet, the tablet core weighs 1040 mg, and the weight after a pink coating layer is disposed on the tablet core is 1078 mg. Taking the active ingredient as the composition in Example 1 as a representative, the prepared tablet is shown in FIG2 . As can be seen from Figure 2, black spots are visible on the surface of the tablet.

实验例1抗光老化实验Experimental Example 1 Anti-light aging experiment

本实验例考察了本发明实施例的组合物在抗光老化中的作用This experimental example investigates the effect of the composition of the present invention on anti-light aging

1.检测材料1. Test materials

1.1.样品配制信息1.1. Sample preparation information

实施例均用超纯水配制成20.0mg/mL母液,-20℃储存。All the examples were prepared with ultrapure water to a 20.0 mg/mL stock solution and stored at -20°C.

阳性对照:白藜芦醇,白色粉末,批号为F2121344,上海阿拉丁生化科技股份有限公司,-20℃储存。用DMSO配制成20.0mg/mL母液,-20℃储存。Positive control: Resveratrol, white powder, batch number F2121344, Shanghai Aladdin Biochemical Technology Co., Ltd., stored at -20°C. Prepared into 20.0 mg/mL stock solution with DMSO, stored at -20°C.

1.2.实验动物1.2. Experimental animals

斑马鱼均饲养于28℃的养鱼用水中(水质:每1L反渗透水中加入200mg速溶海盐,电导率为450~550μS/cm;pH为6.5~8.5;硬度为50~100mg/LCaCO3),由本公司养鱼中心繁殖提供,实验动物使用许可证号为:SYXK(浙)2022-0004,饲养管理符合国际AAALAC认证(认证编号:001458)的要求,IACUC伦理审查号:IACUC-2023-3719-2-01。Zebrafish were raised in fish farming water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450-550 μS/cm; pH was 6.5-8.5; hardness was 50-100 mg/LCaCO3), bred and provided by our company's fish farming center, the experimental animal use license number is: SYXK (Zhejiang) 2022-0004, and the breeding management complies with the requirements of the international AAALAC certification (certification number: 001458), and the IACUC ethics review number is: IACUC-2023-3719-2-01.

野生型AB品系斑马鱼,以自然成对交配繁殖方式进行。年龄为受精后2天(2dpf)的斑马鱼用于样品抗光老化功效的功效评价。Wild-type AB strain zebrafish were bred in natural pairs. Zebrafish aged 2 days post fertilization (2 dpf) were used for the efficacy evaluation of the samples' anti-photoaging efficacy.

1.3.仪器、耗材与试剂1.3. Instruments, consumables and reagents

解剖显微镜(SZX7,OLYMPUS,日本);CCD相机(VertA1,上海土森视觉科技有限公司,中国);精密电子天平(CP214,OHAUS,美国);多功能酶标仪(SPARK,TECAN,奥地利);模拟太阳光(SOL500,Hoenle,德国);96孔酶标板(Costar,中国);6孔板(浙江贝兰伯生物科技有限公司,中国)。Dissecting microscope (SZX7, OLYMPUS, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); multifunctional microplate reader (SPARK, TECAN, Austria); simulated sunlight (SOL500, Hoenle, Germany); 96-well microplate (Costar, China); 6-well plate (Zhejiang Bellanbo Biotechnology Co., Ltd., China).

CM-H2DCFDA(批号2456929,Invitrogen,USA);二甲基亚砜(DMSO,批号BCCD8942,Sigma,奥地利);甲基纤维素(批号C2004046,上海阿拉丁生化科技股份有限公司,中国)。CM-H2DCFDA (lot number 2456929, Invitrogen, USA); dimethyl sulfoxide (DMSO, lot number BCCD8942, Sigma, Austria); methylcellulose (lot number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China).

2.检测方法2. Detection Method

随机选取2dpf野生型AB品系斑马鱼于6孔板中,每孔(实验组)均处理30尾斑马鱼。分别水溶给予样品(浓度见表2),阳性对照白藜芦醇10.0μg/mL浓度,同时设置正常对照组和模型对照组,每孔容量为3mL。除正常对照组外,其余各实验组均用太阳光照射诱导建立紫外损伤模型。28℃处理3天后,每个实验组随机选取8尾斑马鱼置于解剖显微镜下拍照,用NIS-Elements D 3.20高级图像处理软件分析并采集数据,分析斑马鱼尾鳍面积,以该指标的统计学分析结果评价样品抗光老化功效。统计学处理结果采用mean±SE表示。用SPSS26.0软件进行统计学分析,p<0.05表明差异具有统计学意义,具体统计方法如下:样品与模型对照组比较,使用参数检验中的独立样本T检验进行统计分析;样品与样品比较,使用参数检验-单因素ANOVA分析-LSD(选项中勾选描述、固定和随机效应、平均值图)进行统计分析。2dpf wild-type AB strain zebrafish were randomly selected in a 6-well plate, and 30 zebrafish were treated in each well (experimental group). The samples were given water-soluble (concentrations are shown in Table 2), and the positive control resveratrol concentration was 10.0μg/mL. At the same time, a normal control group and a model control group were set up, and the capacity of each well was 3mL. Except for the normal control group, the remaining experimental groups were irradiated with sunlight to induce the establishment of ultraviolet damage models. After 3 days of treatment at 28℃, 8 zebrafish were randomly selected from each experimental group and placed under a dissecting microscope for photography. The data were analyzed and collected using NIS-Elements D 3.20 advanced image processing software, and the zebrafish tail fin area was analyzed. The statistical analysis results of this indicator were used to evaluate the anti-photoaging efficacy of the samples. The statistical analysis results are expressed as mean±SE. SPSS26.0 software was used for statistical analysis, and p<0.05 indicated that the difference was statistically significant. The specific statistical methods were as follows: when the samples were compared with the model control group, the independent sample T test in the parameter test was used for statistical analysis; when the samples were compared with each other, the parameter test-one-way ANOVA analysis-LSD (description, fixed and random effects, and mean value graph were checked in the options) was used for statistical analysis.

3.检测结果3. Test results

表3、抗光老化的功效Table 3. Anti-photoaging effect

*、**、***分别表示与模型对照组相比,分别表示p<0.05,p<0.01,p<0.001。不同的字母a~f之间具有显著差异p<0.05。*, **, *** respectively indicate p<0.05, p<0.01, p<0.001 compared with the model control group. Different letters a to f have significant differences p<0.05.

由上表的结果可以看出,模型对照组的抗光老化尾鳍面积显著低于正常对照组,说明模型对照组构建成功。阳性对照组、实施例组和单独的原料麦角硫因、虾青素、神经酰胺、烟酰胺、谷胱甘肽等的抗光老化尾鳍面积显著高于模型对照组(p<0.05或p<0.01),说明阳性对照组、实施例组和单独的原料麦角硫因、虾青素、神经酰胺、烟酰胺、谷胱甘肽具有抗光老化的作用。在相同浓度下,实施例组的抗光老化尾鳍面积显著高于单独的原料,说明本发明的组合物中各组分之间具有显著的协同抗光老化的作用,更进一步的,实施例1-10之间比较,实施例8的抗光老化的作用最优,实施例2-7、9-10次之,实例例1再次之。As can be seen from the results of the above table, the anti-photoaging tail fin area of the model control group is significantly lower than that of the normal control group, indicating that the model control group is successfully constructed. The anti-photoaging tail fin area of the positive control group, the embodiment group and the independent raw material ergothioneine, astaxanthin, ceramide, nicotinamide, glutathione, etc. is significantly higher than that of the model control group (p < 0.05 or p < 0.01), indicating that the positive control group, the embodiment group and the independent raw material ergothioneine, astaxanthin, ceramide, nicotinamide, glutathione have the effect of anti-photoaging. At the same concentrations, the anti-photoaging tail fin area of the embodiment group is significantly higher than that of the independent raw material, indicating that there is a significant synergistic anti-photoaging effect between each component in the composition of the present invention, and further, compared between embodiments 1-10, the anti-photoaging effect of embodiment 8 is optimal, and embodiments 2-7, 9-10 are second, and example 1 is again.

实验例2皮肤抗炎实验Experimental Example 2 Skin Anti-Inflammation Experiment

本实验例考察了本发明实施例的组合物在皮肤抗炎中的作用This experimental example investigates the effect of the composition of the present invention on skin anti-inflammatory effects.

1.检测材料1. Test materials

1.1.样品配制信息1.1. Sample preparation information

实施例均用超纯水配制成20.0mg/mL母液,-20℃储存。All the examples were prepared with ultrapure water to a 20.0 mg/mL stock solution and stored at -20°C.

阳性对照:地塞米松,白色粉末,批号为C2110208,上海阿拉丁生化科技股份有限公司,4℃储存。用DMSO配制成3.92mg/mL母液,现配现用。Positive control: dexamethasone, white powder, batch number C2110208, Shanghai Aladdin Biochemical Technology Co., Ltd., stored at 4°C. Prepared into 3.92 mg/mL stock solution with DMSO, ready for use.

1.2.实验动物1.2. Experimental animals

斑马鱼均饲养于28℃的养鱼用水中(水质:每1L反渗透水中加入200mg速溶海盐,电导率为450~550μS/cm;pH为6.5~8.5;硬度为50~100mg/LCaCO3),由本公司养鱼中心繁殖提供,实验动物使用许可证号为:SYXK(浙)2022-0004,饲养管理符合国际AAALAC认证(认证编号:001458)的要求,IACUC伦理审查号:IACUC-2023-3719-2-01。Zebrafish were raised in fish farming water at 28°C (water quality: 200 mg of instant sea salt was added to every 1 L of reverse osmosis water, the conductivity was 450-550 μS/cm; pH was 6.5-8.5; hardness was 50-100 mg/LCaCO3), bred and provided by our company's fish farming center, the experimental animal use license number is: SYXK (Zhejiang) 2022-0004, and the breeding management complies with the requirements of the international AAALAC certification (certification number: 001458), and the IACUC ethics review number is: IACUC-2023-3719-2-01.

转基因中性粒细胞绿色荧光斑马鱼(MPX),以自然成对交配繁殖方式进行。年龄为2dpf的斑马鱼用于样品皮肤抗炎功效的功效评价。Transgenic neutrophil green fluorescent zebrafish (MPX) were bred by natural pair mating. Zebrafish aged 2dpf were used for the efficacy evaluation of the sample's skin anti-inflammatory effect.

野生型AB品系斑马鱼,以自然成对交配繁殖方式进行。年龄为2dpf的斑马鱼用于样品皮肤抗炎功效基因相对表达量测定。Wild-type AB strain zebrafish were bred in natural pairs. Zebrafish aged 2 dpf were used to measure the relative expression of genes with anti-inflammatory effects in the skin of the samples.

1.3.仪器、耗材与试剂1.3. Instruments, consumables and reagents

解剖显微镜(SZX7,OLYMPUS,日本);电动聚焦连续变倍荧光显微镜(AZ100,Nikon,日本);CCD相机(VertA1,上海土森视觉科技有限公司,中国);精密电子天平(CP214,OHAUS,美国);全自动样品快速研磨仪(JXFSTPRP-24L,上海净信实验设备科技部,中国);高速冷冻离心机(Heraeus Fresco17,ThermoFisher,德国);全自动核酸提取仪(Auto-Pure32A,杭州奥盛仪器有限公司,中国);普通PCR扩增仪(T100,BIO-RAD,新加坡);荧光定量PCR仪(CFXConnect,BIO-RAD,新加坡);紫外-可见光分光光度计(Nanodrop2000,Thermo,USA);微孔板迷你离心机(BE-6100,海门市其林贝尔仪器制造有限公司,中国);光学粘性封膜B(MSB1001,Bio-rad,USA);低位裙边96孔板(透明)(HSP9601,Bio-rad,USA);6孔板(浙江贝兰伯生物科技有限公司,中国)。Dissecting microscope (SZX7, OLYMPUS, Japan); motorized focusing and continuously variable magnification fluorescence microscope (AZ100, Nikon, Japan); CCD camera (VertA1, Shanghai Tusen Vision Technology Co., Ltd., China); precision electronic balance (CP214, OHAUS, USA); fully automatic sample rapid grinding machine (JXFSTPRP-24L, Shanghai Jingxin Experimental Equipment Technology Department, China); high-speed refrigerated centrifuge (Heraeus Fresco17, ThermoFisher, Germany); fully automatic nucleic acid extractor (Auto-Pure32A, Hangzhou Aosheng Instrument Co., Ltd., China); ordinary PCR amplifier (T100, BIO-RAD, Singapore); fluorescence quantitative PCR instrument (CFXConnect, BIO-RAD, Singapore); UV-visible spectrophotometer (Nanodrop2000, Thermo, USA); microplate mini centrifuge (BE-6100, Haimen Qilin Bell Instrument Manufacturing Co., Ltd., China); optical adhesive sealing film B (MSB1001, Bio-rad, USA); low-skirt 96-well plate (transparent) (HSP9601, Bio-rad, USA); 6-well plate (Zhejiang Belanbo Biotechnology Co., Ltd., China).

十二烷基磺酸钠(批号L212807,上海阿拉丁生化科技股份有限公司,中国);甲醇(批号20220514,国药集团化学试剂有限公司,中国);二甲基亚砜(DMSO,批号BCCD8942,Sigma,瑞士);甲基纤维素(批号C2004046,上海阿拉丁生化科技股份有限公司,中国);ChamQ Universal SYBR qPCR Master Mix(批号027E2201CD,Vazyme,中国);FastKingcDNA第一链合成试剂盒(去基因组)(批号Y1712,天根生化科技(北京)有限公司,中国);Universal RNA Extraction TL Kit C(货号TL2204001643C,佛山奥维生物科技有限公司,中国)。Sodium dodecyl sulfate (lot number L212807, Shanghai Aladdin Biochemical Technology Co., Ltd., China); methanol (lot number 20220514, Sinopharm Chemical Reagent Co., Ltd., China); dimethyl sulfoxide (DMSO, lot number BCCD8942, Sigma, Switzerland); methylcellulose (lot number C2004046, Shanghai Aladdin Biochemical Technology Co., Ltd., China); ChamQ Universal SYBR qPCR Master Mix (lot number 027E2201CD, Vazyme, China); FastKing cDNA First Strand Synthesis Kit (Genomic DNA-free) (lot number Y1712, Tiangen Biochemical Technology (Beijing) Co., Ltd., China); Universal RNA Extraction TL Kit C (catalog number TL2204001643C, Foshan Aowei Biotechnology Co., Ltd., China).

2.检测方法2. Detection Method

随机选取2dpf野生型AB品系斑马鱼于6孔板中,每孔(实验组)均处理30尾斑马鱼。分别水溶给予样品,阳性对照地塞米松3.92μg/mL浓度,同时设置正常对照组和模型对照组,每孔容量为3mL。除正常对照组外,其余各实验组均水溶给予十二烷基磺酸钠(终浓度为60μg/ml)建立斑马鱼皮肤炎症模型。平行设置三次实验。28℃处理16h后,使用UniversalRNA Extraction TL Kit C提取各组斑马鱼总RNA,利用紫外-可见光分光光度计对总RNA浓度和纯度进行测定。取2.00μg斑马鱼样品总RNA,按照cDNA第一链合成试剂盒说明操作,合成20.0μL cDNA,通过q-PCR检测β-actin、il-17a/f3基因的表达。用β-actin作为基因表达的内参,计算il-17a的RNA相对表达量。统计学处理结果采用mean±SE表示。用SPSS26.0软件进行统计学分析,p<0.05表明差异具有统计学意义,具体统计方法如下:样品与模型对照组比较,使用参数检验-单因素ANOVA分析-图基或邓尼特进行统计分析;样品与样品比较,使用参数检验-单因素ANOVA分析-LSD(选项中勾选描述、固定和随机效应、平均值图)进行统计分析。2dpf wild-type AB strain zebrafish were randomly selected in a 6-well plate, and 30 zebrafish were treated in each well (experimental group). The samples were given water-soluble, and the positive control dexamethasone was 3.92μg/mL. At the same time, a normal control group and a model control group were set up, and the volume of each well was 3mL. Except for the normal control group, the rest of the experimental groups were given water-soluble sodium dodecyl sulfate (final concentration of 60μg/ml) to establish a zebrafish skin inflammation model. Three experiments were set up in parallel. After treatment at 28℃ for 16h, the total RNA of each group of zebrafish was extracted using UniversalRNA Extraction TL Kit C, and the total RNA concentration and purity were determined using a UV-visible spectrophotometer. 2.00μg of total RNA from zebrafish samples was taken, and 20.0μL cDNA was synthesized according to the instructions of the cDNA first-strand synthesis kit, and the expression of β-actin and il-17a/f3 genes was detected by q-PCR. β-actin was used as an internal reference for gene expression to calculate the relative RNA expression of il-17a. The statistical results were expressed as mean ± SE. SPSS 26.0 software was used for statistical analysis. p < 0.05 indicated that the difference was statistically significant. The specific statistical methods were as follows: the sample was compared with the model control group, and the parameter test-one-way ANOVA analysis-Tukey or Dunnett was used for statistical analysis; the sample was compared with the sample, and the parameter test-one-way ANOVA analysis-LSD (description, fixed and random effects, and mean value graph were checked in the options) was used for statistical analysis.

3.检测结果3. Test results

表4、抗炎功效Table 4. Anti-inflammatory effect

*、**、***分别表示与模型对照组相比,分别表示p<0.05,p<0.01,p<0.001。a、b、c、d、e、f表示彼此之间具有统计学差异p<0.05。*, **, *** respectively indicate p < 0.05, p < 0.01, p < 0.001 compared with the model control group. a, b, c, d, e, f indicate statistical differences between each other at p < 0.05.

由于IL-17炎症因子,皮肤免疫细胞分泌的IL-17会促进炎症加速皮肤衰老,因此il-17a基因的表达量高低将反映皮肤炎症的情况,il-17a基因的表达量高反映皮肤炎症因子含量高即组合物抗炎效果差,il-17a基因的表达量低反映皮肤炎症因子含量低即组合物抗炎效果优。从上述结果可以看出,模型对照组的il-17a基因的相对表达量显著高于正常对照组,说明模型对照组构建成功。与模型对照组相比,阳性对照和实施例组以及单独的原料的il-17a基因的相对表达量显著低于模型对照组,说明阳性对照、实施例和单独的原料均具有显著的皮肤抗炎作用,实施例组的il-17a基因的相对表达量显著低于单独的原料,说明实施例组的组方中的各组分之间具有显著的协同增效作用,能够显著的抗皮肤炎症,更进一步的,实施例1-10之间比较,实施例8的抗皮肤炎症的作用最优,实施例2-7、9-10次之,实例例1再次之。Due to the IL-17 inflammatory factor, the IL-17 secreted by skin immune cells will promote inflammation and accelerate skin aging, so the expression of the il-17a gene will reflect the situation of skin inflammation. The high expression of the il-17a gene reflects the high content of skin inflammatory factors, that is, the poor anti-inflammatory effect of the composition, and the low expression of the il-17a gene reflects the low content of skin inflammatory factors, that is, the excellent anti-inflammatory effect of the composition. From the above results, it can be seen that the relative expression of the il-17a gene in the model control group is significantly higher than that in the normal control group, indicating that the model control group is successfully constructed. Compared with the model control group, the relative expression of the il-17a gene in the positive control and the embodiment group and the raw material alone is significantly lower than that in the model control group, indicating that the positive control, the embodiment and the raw material alone have significant skin anti-inflammatory effects, and the relative expression of the il-17a gene in the embodiment group is significantly lower than that in the raw material alone, indicating that there is a significant synergistic effect between the components in the prescription of the embodiment group, which can significantly resist skin inflammation. Further, compared between embodiments 1-10, the anti-skin inflammation effect of embodiment 8 is the best, followed by embodiments 2-7, 9-10, and example 1 is the best.

实验例3皮肤敏感泛红实验Experimental Example 3: Skin Sensitivity and Redness Experiment

本实验例考察了本发明实施例的组合物在皮肤敏感泛红中的作用This experimental example investigates the effect of the composition of the present invention on skin sensitivity and redness.

1.检测材料1. Test materials

1.1.样品信息1.1. Sample information

将各实施例的组合物按照配方混合均匀相关原料后压片服用或单独的原料压片服用,每片含药物1g,片重1078mg。压片所采用的辅料为常规辅料微晶纤维素、硬脂酸镁、交联聚维酮或交联羧甲基纤维素钠,采用常规工艺压片。The composition of each embodiment is mixed with the relevant raw materials according to the formula and then tableted or taken separately. Each tablet contains 1g of the drug and weighs 1078mg. The excipients used for tableting are conventional excipients such as microcrystalline cellulose, magnesium stearate, cross-linked polyvinylpyrrolidone or cross-linked sodium carboxymethyl cellulose, and the tablets are tableted using conventional processes.

2.检测方法2. Detection Method

受试者均年龄介于30~55岁的中国健康女性(为社会招募的志愿者),面颊皮肤有泛红现象是医生判断的入组标准。每组五人进行试食,每次剂量是3片,每日1次,服用28天。其中第0天及28天分别检测一次,记为D0和D28。The subjects were all healthy Chinese women aged between 30 and 55 (volunteers recruited from the society). The inclusion criteria were determined by doctors to be red on the cheeks. Five people in each group took the test, with each dose of 3 tablets, once a day, for 28 days. The test was conducted once on day 0 and day 28, recorded as D0 and D28.

皮肤泛红程度参数是通过Visia-CR进行面部图像采集,然后使用Image-Pro-Plus图像分析软件对交叉偏振光光源下的红色区图片进行面颊区域皮肤a*值分析所得,该数值越小,表示皮肤泛红程度越轻。各组的皮肤敏感泛红程度=D28对应的面颊区域皮肤a*值-D0对应的面颊区域皮肤a*值。The skin redness parameter was obtained by collecting facial images using Visia-CR, and then using Image-Pro-Plus image analysis software to analyze the cheek area skin a* value of the red area image under the cross-polarized light source. The smaller the value, the lighter the skin redness. The skin sensitivity redness of each group = the cheek area skin a* value corresponding to D28 - the cheek area skin a* value corresponding to D0.

数据处理方法为:用SPSS26.0软件进行统计学分析,p<0.05表明差异具有统计学意义,具体统计方法如下:样品与空白对照组比较,使用参数检验-单因素ANOVA分析-图基或邓尼特进行统计分析;样品与样品比较,使用参数检验-单因素ANOVA分析-LSD(选项中勾选描述、固定和随机效应、平均值图)进行统计分析。The data processing method is: SPSS26.0 software is used for statistical analysis, p<0.05 indicates that the difference is statistically significant. The specific statistical methods are as follows: the samples are compared with the blank control group, and the parameter test-one-way ANOVA analysis-Tukey or Dunnett's statistical analysis is used; the samples are compared with each other, and the parameter test-one-way ANOVA analysis-LSD (check the description, fixed and random effects, and mean value graph in the options) is used for statistical analysis.

3.检测结果见下表。3.The test results are shown in the table below.

表5、皮肤敏感泛红功效Table 5. Effect on sensitive skin and redness

皮肤敏感泛红Sensitive skin with redness sdsd P值P-value 空白对照Blank control 0.70.7 0.360.36 实施例1Example 1 -0.8-0.8 0.40.4 ****** cc 实施例2Example 2 -1-1 0.310.31 ****** bb 实施例3Example 3 -0.98-0.98 0.320.32 ****** bb 实施例4Example 4 -0.92-0.92 0.340.34 ****** bb 实施例5Example 5 -0.92-0.92 0.30.3 ****** bb 实施例6Example 6 -0.93-0.93 0.370.37 ****** bb 实施例7Example 7 -0.95-0.95 0.430.43 ****** bb 实施例8Example 8 -1.23-1.23 0.310.31 ****** aa 实施例9Example 9 -0.93-0.93 0.440.44 ****** bb 实施例10Example 10 -0.96-0.96 0.320.32 ****** bb 麦角硫因Ergothioneine 0.550.55 0.320.32 VaV 0.340.34 0.320.32 虾青素Astaxanthin 0.30.3 0.530.53 胶原蛋白肽Collagen Peptides -0.32-0.32 0.640.64 透明质酸钠Sodium hyaluronate -0.05-0.05 0.260.26 神经酰胺Ceramide 0.10.1 0.450.45 VcVc -0.26-0.26 0.590.59 VeVe 0.130.13 0.640.64 BiotinBiotin -0.25-0.25 0.370.37 烟酰胺Nicotinamide 0.280.28 0.690.69 氧化铜Copper oxide -0.24-0.24 0.590.59 柠檬酸锌Zinc Citrate -0.16-0.16 0.190.19 谷胱甘肽Glutathione 0.690.69 0.190.19

注:*、**、***分别表示与空白对照组相比,分别表示p<0.05,p<0.01,p<0.001。a、b、c表示彼此之间具有统计学差异p<0.05。Note: *, **, *** respectively indicate p<0.05, p<0.01, p<0.001 compared with the blank control group. a, b, c indicate statistical differences between each other at p<0.05.

由上述表格可以看出,实施例组的皮肤敏感泛红程度显著低于空白对照组,说明实施例组具有显著的抗皮肤敏感泛红的作用,而单独的原料组与空白对照没有显著性差异,说明单独的原料组没有明显的抗皮肤敏感泛红的作用,同时也说明实施例组的组方中的各组分之间具有显著的协同增效作用,能够显著的抗皮肤敏感泛红。更进一步的,实施例1-10之间比较,实施例8的抗皮肤炎症的作用最优,实施例2-7、9-10次之,实例例1再次之。As can be seen from the above table, the skin sensitivity and redness of the embodiment group is significantly lower than that of the blank control group, indicating that the embodiment group has a significant effect on anti-skin sensitivity and redness, while there is no significant difference between the raw material group and the blank control, indicating that the raw material group alone has no significant effect on anti-skin sensitivity and redness, and it also shows that the components in the formula of the embodiment group have a significant synergistic effect and can significantly resist skin sensitivity and redness. Furthermore, compared with Examples 1-10, Example 8 has the best effect on anti-skin inflammation, followed by Examples 2-7, 9-10, and Example 1.

显然,上述实施例仅仅是为清楚地说明所作的举例,而并非对实施方式的限定。对于所属领域的普通技术人员来说,在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本发明创造的保护范围之中。Obviously, the above embodiments are merely examples for the purpose of clear explanation, and are not intended to limit the implementation methods. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the implementation methods here. The obvious changes or modifications derived therefrom are still within the protection scope of the invention.

Claims (10)

1. An anti-aging and anti-inflammatory composition containing ergothioneine is characterized by comprising the following components in parts by weight: 0.5-10 parts by weight of ergothioneine and 0.5-10 parts by weight of component a; the component a is at least one of beta-carotene and astaxanthin.
2. An anti-aging and anti-inflammatory composition containing ergothioneine according to claim 1, which is characterized by comprising the following components in parts by weight: ergothioneine 1.6 parts by weight, component a 1.7 parts by weight.
3. An anti-aging and anti-inflammatory composition containing ergothioneine according to claim 1 or 2, further comprising the following components in parts by weight: 50-1000 parts of collagen peptide, 2-200 parts of ceramide and 5-500 parts of sodium hyaluronate.
4. An anti-aging and anti-inflammatory composition containing ergothioneine according to claim 3, further comprising the following components in parts by weight: 0.5-100 parts by weight of vitamin E, 0.5-200 parts by weight of vitamin C, 5-30 parts by weight of biotin and 2-200 parts by weight of nicotinamide.
5. An anti-aging and anti-inflammatory composition containing ergothioneine according to claim 3, further comprising the following components in parts by weight: 0.01-1 part by weight of copper oxide and 2-15 parts by weight of zinc citrate.
6. An anti-aging and anti-inflammatory composition containing ergothioneine according to claim 3, further comprising the following components in parts by weight: 100-500 parts of glutathione.
7. An anti-aging, anti-inflammatory composition containing ergothioneine according to any of claims 1-6, characterized by comprising the following components in parts by weight:
1.6 parts of ergothioneine, 1.7 parts of beta-carotene and 20 parts of ceramide;
Or, 0.5 parts by weight of ergothioneine, 5 parts by weight of astaxanthin, 635 parts by weight of collagen peptide, and 265 parts by weight of glutathione;
Or, 10 parts by weight of ergothioneine, 0.5 part by weight of beta-carotene, 200 parts by weight of ceramide and 100 parts by weight of vitamin E;
Or, 10 parts by weight of ergothioneine, 10 parts by weight of beta-carotene, 50 parts by weight of collagen peptide and 500 parts by weight of glutathione;
Or 5 parts by weight of ergothioneine, 5 parts by weight of astaxanthin, 5 parts by weight of sodium hyaluronate, 0.5 part by weight of vitamin E and 30 parts by weight of biotin;
or, ergothioneine 1 weight part, astaxanthin 0.5 weight part, ceramide 2 weight parts, vitamin C200 weight parts, biotin 5 weight parts;
or 3.2 parts by weight of ergothioneine, 5.36 parts by weight of astaxanthin, 2.6 parts by weight of ceramide, 15 parts by weight of zinc citrate and 1 part by weight of copper oxide;
Or, ergothioneine 1.69 parts by weight, beta-carotene 1.482 parts by weight, collagen peptide 834 parts by weight, sodium hyaluronate 42.1 parts by weight, vitamin C27.78 parts by weight, vitamin E1.69 parts by weight, and copper oxide 0.227 parts by weight;
Or 8.5 parts by weight of ergothioneine, 10 parts by weight of astaxanthin, 1000 parts by weight of collagen peptide, 126.5 parts by weight of sodium hyaluronate and 100 parts by weight of glutathione;
Or 0.5 part by weight of ergothioneine, 0.5 part by weight of beta-carotene, 500 parts by weight of sodium hyaluronate, 0.5 part by weight of vitamin C, 200 parts by weight of nicotinamide, 2 parts by weight of zinc citrate and 0.01 part by weight of copper oxide.
8. A process for the preparation of an anti-aging, anti-inflammatory composition comprising ergothioneine according to any of claims 1 to 7, comprising: weighing the raw materials according to the formula, and mixing.
9. A formulation comprising an anti-aging, anti-inflammatory composition comprising ergothioneine according to any of claims 1-7, and a formulation-approved carrier;
Optionally, the preparation forms comprise liquid preparation and solid preparation;
optionally, the pharmaceutical preparation comprises injection, tablet, capsule, granule or paste;
Optionally, in the tablet, a tablet core and a coating layer disposed on a surface of the tablet core are included; the tablet core contains the anti-aging and anti-inflammatory composition; the coating layer sequentially comprises a transparent coating layer and a colored coating layer from inside to outside; the transparent coating layer comprises 90-100 parts by weight of hydroxypropyl methyl cellulose and 0-10 parts by weight of medium chain triglyceride; preferably, the colored coating layer is a pink coating layer, and the raw material is OPADRY IIPINK coating liquid.
10. Use of a composition comprising ergothioneine for the delay of aging, anti-inflammatory according to any one of claims 1 to 7, a composition comprising ergothioneine for the delay of aging, anti-inflammatory prepared by the method of preparation according to claim 8, or a formulation according to claim 9 for the preparation of a medicament or food for the delay of aging, anti-inflammatory;
Optionally, in the preparation of a medicament or food for combating skin photoaging;
Optionally, in the preparation of an anti-dermatitis medicament or food;
optionally, in the preparation of a medicament or food for combating sensitive reddening of the skin.
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