WO2021163915A1 - 含接近饱和、饱和、或超饱和活性成分的温和洁净组合物及其制备方法 - Google Patents

含接近饱和、饱和、或超饱和活性成分的温和洁净组合物及其制备方法 Download PDF

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WO2021163915A1
WO2021163915A1 PCT/CN2020/075824 CN2020075824W WO2021163915A1 WO 2021163915 A1 WO2021163915 A1 WO 2021163915A1 CN 2020075824 W CN2020075824 W CN 2020075824W WO 2021163915 A1 WO2021163915 A1 WO 2021163915A1
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cleansing composition
mild cleansing
mild
skin
active ingredient
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PCT/CN2020/075824
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English (en)
French (fr)
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黄尧焜
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黄尧焜
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Priority to CA3171372A priority Critical patent/CA3171372A1/en
Priority to CN202080096376.0A priority patent/CN115867257A/zh
Priority to KR1020227030252A priority patent/KR20220145840A/ko
Priority to AU2020430275A priority patent/AU2020430275A1/en
Priority to PCT/CN2020/075824 priority patent/WO2021163915A1/zh
Priority to JP2022549369A priority patent/JP2023516566A/ja
Priority to US17/799,784 priority patent/US20230091703A1/en
Priority to EP20919388.7A priority patent/EP4108229A4/en
Publication of WO2021163915A1 publication Critical patent/WO2021163915A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9789—Magnoliopsida [dicotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/345—Alcohols containing more than one hydroxy group
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/40—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing nitrogen
    • A61K8/44—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof
    • A61K8/442—Aminocarboxylic acids or derivatives thereof, e.g. aminocarboxylic acids containing sulfur; Salts; Esters or N-acylated derivatives thereof substituted by amido group(s)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/46—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur
    • A61K8/466—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing sulfur containing sulfonic acid derivatives; Salts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/84—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds obtained by reactions otherwise than those involving only carbon-carbon unsaturated bonds
    • A61K8/86—Polyethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9728—Fungi, e.g. yeasts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q17/00—Barrier preparations; Preparations brought into direct contact with the skin for affording protection against external influences, e.g. sunlight, X-rays or other harmful rays, corrosive materials, bacteria or insect stings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/007—Preparations for dry skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A61Q19/10—Washing or bathing preparations
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/40—Chemical, physico-chemical or functional or structural properties of particular ingredients
    • A61K2800/59—Mixtures
    • A61K2800/596—Mixtures of surface active compounds

Definitions

  • the present invention relates to a mild cleansing composition containing active ingredients close to saturation, saturation, or supersaturation, and a preparation method thereof, and in particular to a kind of composition containing at least one surfactant and at least one close to saturation, saturation, or supersaturation and A cleansing and maintenance composition with active ingredients capable of improving skin texture and a preparation method thereof.
  • the skin is the largest natural barrier between the human body and the outside world.
  • the goal of skin cleansing is to remove foreign objects in the human environment and the sebum and sweat produced by the human body. Therefore, skin cleansing is the first step to maintain skin health. Take facial cleansing as an example.
  • the cleaning principle of detergents can be roughly divided into two types: dissolving and emulsifying dirt (Physicochemical and Engineering Aspects, 74, 169-215 (1993)).
  • the cleaning agent used to remove dirt by using the principle of dissolution is difficult to avoid excessive washing of the skin surface, which will damage the skin barrier and cause rough and dry skin after cleaning (Clinics in Dermatology, Volume 14, Issue 1, January-February 1996, Pages 29 -33), it even leads to excessive sebum secretion; the detergents and emulsifiers used to remove the dirt by the principle of emulsification are not easy to completely remove the dirt, so a small amount of small emulsion droplets that are not washed off after emulsification are accumulated on the skin surface On the pores and sweat glands, resulting in unclean feeling, clogged pores, and acne proliferation.
  • the timing and method of skin care after cleansing is also a challenge in the lives of ordinary people.
  • the timing of personal skin care varies from person to person, but the evaluation of skin care products can be analyzed from two aspects: First, the formula combination of skin care products mainly includes water, oil, emulsifier, stabilizer, various bases and even solvents, etc., due to the basic It is composed of two insoluble oil and water phases and the maximum composition ratio. Therefore, emulsifiers, stabilizers, etc. are required. If other active ingredients are required, they often face various challenges in physical and chemical stability, and the active ingredients The proportion is usually quite low, and it is difficult to improve the aesthetic or clinical effects.
  • the absorption of topical skin preparations is mainly affected by the barrier formed by the stratum corneum, which results in limited effects.
  • TDDS transdermal delivery system
  • the problems to be overcome in the first way of absorption mainly include the acid mantle of the skin (Current Pharmaceutical Design, 2015, Vol. 21, No. 00), and the stratum corneum that causes absorption barriers, both of which block drugs and cosmetics.
  • the main obstacle to the absorption of active ingredients is also the main factor that makes it difficult for consumers to achieve the expected maintenance effect when using various skin care products.
  • the present invention intends to improve the previous technology that is difficult to clean the skin with a gentle formula and the difficult-to-fit method to maintain the skin, so as to clean the skin at the same time, prevent excessive cleaning, and achieve the initial maintenance effect to enhance the skin function.
  • the gentle cleansing composition is provided.
  • the active ingredient is combined with a mild surfactant formula in a manner close to saturation, saturation or supersaturation, and a simple manufacturing process is used to make a composition that can clean, avoid excessive cleaning and maintain the skin at the same time, wherein the active ingredient contains Angelica dahurica Extracts of one or more of, Atractylodes, Atractylodes, Bletilla striata, Poria, Aconite, and Comfrey; and surfactants include long-chain betaine, sodium lauroyl sarcosinate, and lauroyl hydroxymethyl A combination of one or more of sodium ethanesulfonate and potassium cocoylglycinate.
  • the mild cleansing composition containing active ingredients of the present invention can be used on any skin part of the human body to directly clean the skin and achieve maintenance effects at the same time. Its effect on the skin can be one of the following or a combination of effects, such as: whitening, promoting collagen Protein synthesis, anti-inflammatory, avoiding dry and cracked skin, anti-itch, anti-allergic, anti-aging, anti-oxidation, immune regulation, anti-fibrosis, etc.
  • the mild cleansing composition of the present invention containing nearly saturated, saturated, or supersaturated active ingredients
  • its individual active ingredients are referenced in the composition of the present invention as landmark and representative ingredients (especially fat-soluble, highly physiologically active
  • the saturation of its aqueous solution is Angelica dahurica ⁇ 0.01%, Baiji ⁇ 0.003%, Baizhu ⁇ 0.004%, Bletilla ⁇ 0.006%, Poria ⁇ 0.05%, Aconite ⁇ 0.0002%, and Lithospermum ⁇ 0.01%; therefore, its total saturation concentration About not more than 0.1%.
  • the active ingredient extraction preparation method of the mild clean composition containing close to saturated, saturated or supersaturated active ingredients can be one of general high-temperature aqueous solution extraction, organic solvent extraction, ultrasonic extraction, or supercritical fluid extraction. One or more extraction combinations.
  • the active ingredients of the mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients are based on the US Food and Drug Administration's Cosmetics Laws & Regulations: it can meet the definitions of cosmetics and drugs at the same time. It means that the present invention is any ingredient that has any function that can affect humans or other animals according to the purpose of scientific journals and intended use; and is used for human body cleaning, beauty, etc.
  • the mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients has active ingredients that are intended to be used for rubbing, pouring, spraying or sprinkling, introducing or wiping onto the human body for cleansing, beautifying, and tightening.
  • active ingredients that are intended to be used for rubbing, pouring, spraying or sprinkling, introducing or wiping onto the human body for cleansing, beautifying, and tightening.
  • the mild cleansing composition containing nearly saturated, saturated, or super-saturated active ingredients means that its active ingredient means that its effect on the skin can be one of the following or a combination of effects, such as: whitening, promoting collagen synthesis , Anti-inflammatory, avoid skin dryness, anti-itch, anti-allergic, anti-aging, anti-oxidation, immune regulation, anti-fibrosis, etc.
  • the mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients has O/W microemulsions (American Journal of Pharmtech Research, 2012), emulsions, or micelles (Cancers, July 2018) and other different dosage forms.
  • liquid dosage forms containing fat-soluble and high physiological activity such as paclitaxel, paclitaxel, European paclitaxel and other drugs, which are effective for such needs.
  • the therapeutic dose and the active ingredients that minimize the total volume of administration should be as close as possible to the solubility saturation of the active ingredients in the dosage form design; relatively, the active ingredients are nearly saturated, saturated, and supersaturated due to the characteristics of the active ingredients after being mixed with water. Disadvantages that are easy to precipitate.
  • the present invention utilizes the near-saturated, saturated, and super-saturated characteristics of the active ingredients to convert this shortcoming into the advantages of external preparations, and achieves the precipitation and absorption of the effective ingredients after mixing with water, avoids being dissolved and washed out by detergents, and more
  • the hydration effect of the cleanser on the skin is further added to increase the absorption and effect of the active ingredient.
  • the present invention uses a mild surfactant combination, which mainly uses the principle of emulsification cleansing method to clean the skin and produce the stratum corneum hydration phenomenon. In this state, the stratum corneum not only increases Penetration also increases the capacity between the stratum corneum.
  • the present invention uses this hydration phenomenon to increase the adhesion and penetration of the active ingredients to the stratum corneum at an appropriate time (The Journal of Investigative Dermatology, Vol. 101, No. 3, September 1993); At the same time, the concentration of active ingredients is close to saturation, saturation, or supersaturation (Pharmaceutical Research, July 2001, Volume 18, Issue 7, pp 1006-1011) to facilitate the deposition and adhesion of active ingredients and the difference in concentration Absorption produces protection and maintenance effects on the skin, and because of this novel design principle, it can also eliminate the possibility of excessive skin cleansing.
  • Long-chain betaines (Handbook for Cleaning/Decontamination of Surfaces), sodium lauroyl sarcosinate (Cosmetic Ingredient Review, September 2016), sodium lauroyl hydroxymethyl ethanesulfonate ( Sodium lauroyl methyl isethionate) (Cosmetic Ingredient Review, September 2013) and potassium cocoyl glycinate (Cosmetic Ingredient Review, September 2013) are considered mild to the skin or eyes in various studies and scientific literature.
  • a low-irritant surfactant The invention of a mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients is to apply this mild cleansing surfactant combination to gently cleanse the skin, and then according to the invention. Dissolve the active ingredients to a concentration close to saturation, saturation, or supersaturation, and at the same time achieve the effects of skin cleansing and skin care.
  • the present invention provides a mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients, which includes at least one surfactant and at least one nearly saturated active ingredient.
  • the surfactant is composed of long-chain betaines, sodium lauroyl sarcosinate, sodium lauroyl methyl isethionate, and potassium cocoyl glycinate (potassium cocoyl glycinate) any combination of one or more of them and accounted for 5.00wt% to 70.00wt% of the composition of the invention;
  • the active ingredient consists of Angelica dahurica, Baiji, Atractylodes macrocephala, Bletilla striata, Poria cocos, Aconite, and comfrey.
  • composition of the invention may further include an appropriate amount of water, which accounts for 15.00wt% to 85.00% of the composition of the invention;
  • composition of the invention may further contain appropriate cosmetic excipients, such as diluents, thickeners, stabilizers, fragrances, preservatives, cosurfactants, etc., and the excipients account for 0 wt of the composition of the invention. % To 15.00wt%.
  • the surfactant of the composition of the invention is long-chain betaines, sodium lauroyl sarcosinate, sodium lauroyl methyl isethionate , And potassium cocoyl glycinate (potassium cocoyl glycinate) in the composition of the invention are respectively 0wt% to 25.00wt%, 0wt% to 20.00wt%, 0wt% to 25.00wt%, 0wt% to 20.00wt%, and the sum thereof Must not be zero.
  • the surfactant of the composition of the invention consists of long-chain betaines, sodium lauroyl sarcosinate, sodium lauroyl methyl isethionate ), and any combination of one or more of potassium cocoyl glycinate (potassium cocoyl glycinate) and account for 10.00 wt% to 65.00 wt% of the composition of the present invention.
  • the surfactant of the composition of the invention consists of long-chain betaines, sodium lauroyl sarcosinate, sodium lauroyl methyl isethionate ), and any combination of one or more of potassium cocoyl glycinate (potassium cocoyl glycinate) and account for 20.00 wt% to 60.00 wt% of the composition of the present invention.
  • the active ingredients of the composition of the invention are Angelica dahurica, Baiji, Baizhu, Bletilla striata, Poria cocos, aconite, and comfrey, which account for 0wt% to 8.00wt%, 0wt% to 8.00wt%, and 0wt% of the composition of the invention, respectively.
  • the sum thereof must not be zero.
  • the active ingredient of the composition of the invention is any combination of one or more of Angelica dahurica, Baiji, Baizhu, Bletilla striata, Poria cocos, aconite, and comfrey, and accounts for 0.10wt% to 8.00wt of the composition of the invention. %.
  • the active ingredient of the composition of the invention is any combination of one or more of Angelica dahurica, Baiji, Atractylodes macrocephala, Bletilla striata, Poria cocos, aconite, and comfrey, and accounts for 0.20wt% to 6.00wt of the composition of the invention. %.
  • the active ingredient of the composition of the invention is any combination of one or more of Angelica dahurica, Baiji, Baizhu, Bletilla striata, Poria cocos, aconite, and comfrey, and accounts for 0.40wt% to 4.00wt of the composition of the invention %.
  • the composition of the invention may further comprise an appropriate amount of water, accounting for 20.00% to 80.00% by weight of the composition of the invention; more preferably, accounting for 25.00% to 75.00% of the composition of the invention; most preferably, accounting for the composition of the invention.
  • the inventive composition is 30.00wt% to 70.00wt%.
  • the composition of the invention may further include an appropriate amount of cosmetic excipients, which may be diluents, thickeners, stabilizers, fragrances, preservatives, or cosurfactants, etc.
  • Excipients account for 0.50 wt% to 10.00 wt% of the inventive composition.
  • the excipient accounts for 1.00% to 8.00% by weight of the composition of the invention. More preferably, the excipient accounts for 2.00% to 6.00% by weight of the composition of the invention. Most preferably, the excipient accounts for 4.00% to 6.00% by weight of the composition of the invention.
  • the present invention provides a mild cleansing composition containing near-saturated, saturated, or super-saturated active ingredients, which includes at least one surfactant and at least one near-saturated, saturated, or super-saturated active ingredient that can improve skin texture.
  • a maintenance composition wherein the mild cleansing composition is prepared by the following preparation method, the preparation method comprising the following steps: (i) adding the at least one active ingredient into a mixing container and adding an appropriate amount of water; and (ii) Add the at least one surfactant to the mixing container of step (i) and mix uniformly, if necessary, heat to dissolve and mix uniformly; (iii) if necessary, add appropriate excipients, such as diluents, thickeners, and stabilizers Agents, fragrances, or preservatives, etc., continue to mix well and return to room temperature.
  • the mild clean composition containing nearly saturated, saturated, or supersaturated active ingredients and the active ingredients of the preparation method thereof can be obtained through general high-temperature aqueous solution extraction methods, organic solvent extraction methods, ultrasonic extraction methods, Or any combination of one or more of the supercritical fluid extraction methods.
  • Figure 1 is a schematic diagram illustrating that the present invention utilizes surfactants and water to hydrate the stratum corneum, and the effective ingredients are implemented in a nearly saturated or saturated or supersaturated form to facilitate skin absorption.
  • Figure 2 is a series of micrographs magnified at different magnifications, showing that the composition of the present invention is presented in different dosage forms.
  • Figure 3 is a series of magnified microscope photographs at different magnifications, showing the precipitation state of Example 12 of the composition of the present invention before being mixed with water.
  • Fig. 4 is a series of magnified micrographs of different magnifications, showing the precipitation state of Example 12 of the composition of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 10 minutes.
  • Fig. 5 is a series of magnified micrographs of different magnifications, showing the precipitation state of Example 12 of the composition of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 60 minutes.
  • Fig. 6 is a series of micrographs magnified at different magnifications, showing the precipitation state of Example 12 of the composition of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 360 minutes.
  • Figure 7 is a series of magnified micrographs of different magnifications, showing the precipitation state of Example 12 of the composition of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 720 minutes.
  • Fig. 8 is a micrograph of a magnified 200 times magnification, showing the state of the skin before being cleaned with a general cleanser.
  • Fig. 9 is a micrograph of a magnified 200 times magnification, showing the state of the skin before washing in Example 10 of the composition of the present invention.
  • Figure 10 is a 30-fold magnification microscope photograph showing the state of the skin being washed 20 times continuously with a general cleanser.
  • Fig. 11 is a 30-fold magnification micrograph of a photomicrograph showing a state where the skin was washed 20 times continuously in Example 10 of the composition of the present invention.
  • Figure 12 is a micrograph of a magnified 200 times magnification, showing the state of the skin being washed 20 times continuously with a general cleanser.
  • FIG. 13 is a micrograph of a magnified 200 times magnification, showing a state where the skin was washed 20 times in Example 10 of the composition of the present invention.
  • Figure 14 is a moisture retention test diagram illustrating the moisture retention of the skin in Example 11 of the composition of the present invention immediately after cleansing and 10 minutes after cleansing.
  • Fig. 15 is a gloss detection graph, illustrating the gloss of the skin in Example 11 of the composition of the present invention immediately after cleansing and 10 minutes after cleansing.
  • Fig. 16 is a series of magnified micrographs of different magnifications, showing the precipitation state of the composition of Comparative Example 13 of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 10 minutes.
  • Fig. 17 is a series of magnified micrographs of different magnifications, showing the precipitation state of the composition of Comparative Example 13 of the present invention and water at a weight ratio of 1:1 after being uniformly mixed at a time point of 60 minutes.
  • Fig. 18 is a 30-fold magnification microscope photograph showing the state of the skin before cleaning in Comparative Example 13 of the composition of the present invention.
  • Fig. 19 is a 30-fold magnification micrograph, showing a state where the skin was washed 20 times continuously in Comparative Example 13 of the composition of the present invention.
  • FIG. 20 is a micrograph of a magnified 200 times magnification, showing the state of the skin before cleaning in Comparative Example 13 of the composition of the present invention.
  • FIG. 21 is a micrograph of a magnified 200 times magnification, showing a state where the skin was washed 20 times continuously in Comparative Example 13 of the composition of the present invention.
  • the present invention provides a mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients.
  • the composition contains one or more active ingredients. More than one active ingredient; and one or more than one surfactant; the inventive composition may further include an appropriate amount of water; the inventive composition may further include an appropriate amount of cosmetic excipients.
  • FIG. 1 illustrate that the present invention utilizes surfactants and water to hydrate the stratum corneum 100, and the active ingredients are implemented in a nearly saturated, saturated, or supersaturated form in the combination of the present invention to make the active ingredients 200 easy to the surface of the stratum corneum. Precipitation is conducive to the absorption of active ingredients.
  • the so-called having at least one surfactant is selected from the group consisting of long-chain betaines, sodium lauroyl sarcosinate, sodium lauroyl hydroxymethyl ethanesulfonate (sodium lauroyl sarcosinate). lauroyl methyl isethionate), and potassium cocoyl glycinate (potassium cocoyl glycinate), one or more of the above combinations.
  • the so-called having at least one active ingredient is an extract selected from Angelica dahurica, Baiji, Atractylodes macrocephala, Bletilla striata, Poria cocos, Aconite, or Comfrey, one or more of them in any combination of the above.
  • the embodiment of the present invention can have different dosage forms such as O/W microemulsion (American Journal of Pharmtech Research, 2012), emulsion, or micellar (Cancers, July 2018) according to different formulation combinations.
  • O/W microemulsion American Journal of Pharmtech Research, 2012
  • emulsion emulsion
  • micellar micellar
  • Example 1 Formulation 1 of a mild cleansing composition containing active ingredients and its manufacturing method
  • every 1000 grams of the final product contains 5 grams of active ingredients.
  • the manufacturing method is as follows: extract the active ingredients with a mixed extract of equal weight ratio of alcohol and water, wherein the mixed extract and each active ingredient
  • the weight ratio of the ingredients of the raw materials is 10:1 to 50:1
  • the extraction temperature is 50 to 100°C
  • the extraction time is 1 hour to 10 hours.
  • the extracted content contains 1000 mg each of Angelica dahurica, Baiji and Atractylodes striata, Bletilla striata, 500 mg extracts of Poria, Aconite, and Lithospermum erythrorhizon.
  • Lauroyl methyl isethionate potassium cocoyl glycinate (potassium cocoyl glycinate) each 50 grams mixed with appropriate amount of water, if necessary, heat to a uniform state and add PEG-7 glyceryl cocoate (PEG-7 glyceryl cocoate), PEG-200 10 grams of PEG-200 hydrogenated glyceryl palmate (PEG-200 hydrogenated glyceryl palmate) are mixed uniformly, and then 10 grams of sodium chloride are added and mixed until uniform. After cooling to room temperature, it is obtained.
  • Table 1 is the composition table of the formulation of Example 1.
  • Examples 2 to 12 Formulations 2 to 12 of the mild cleansing composition containing active ingredients, the manufacturing method of which is similar to that of Example 1, but the different formulation composition and extraction method are also shown in Table 2.
  • Table 2 is Examples 1 to 12 Formulation composition composition table, Table 3 shows the extraction methods of the active ingredients of the formulation compositions of Examples 1 to 12, and Table 4 shows the extraction conditions of each extraction method.
  • the present invention provides a mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients, the test results of which are as follows:
  • Example 12 Microscopically observe the composition of the present invention in Example 12 with a microscope, and mix the water and the composition of the present invention at a weight ratio of 1:1 uniformly, and observe with a microscope at the time points of 10, 60, 360, and 720 minutes.
  • the saturated precipitation situation is shown in Figure 3 to Figure 7.
  • the results showed that the composition of the present invention did not produce precipitation (Figure 3); water and the composition of the present invention were mixed uniformly in a weight ratio of 1:1, and a trace amount of precipitation visible under an optical microscope was generated at the time point of 10 minutes (Figure 4).
  • Example 10 of the composition of the present invention were separately washed, wiped dry and then washed on the inner thigh for 20 consecutive cleaning procedures.
  • the results are shown in Table 5 and Figures 8 to 13 to avoid excessive cleaning. The experiment shows.
  • the experiment uses gloss and microscopy as observation tools to simulate general washing methods for cleaning.
  • the results show that the skin surface is damaged after repeated cleaning with general detergents in a short period of time.
  • the microscopy results also show that the stratum corneum is damaged and white peeling.
  • the microscopic results of this microscopic examination also show a decrease in the macroscopic gloss detection results; on the contrary, the skin surface is not only not damaged after repeated washing in a short period of time using the composition of the present invention.
  • Observing the results of microscopy the difference between before and after washing cannot be distinguished, but the improvement of skin smoothness can be seen from the results of gloss. Based on this, it can be expected that long-term use of the composition of the present invention will make the skin more delicate and smooth, and further lead to a large gloss. Raised to the point where the human eye can discern the difference.
  • the use of cleansing agents to clean the skin easily damages the stratum corneum and causes the skin surface to be rough, and then based on the use of skin care products such as creams on the damaged skin; relatively, the composition of the present invention Utilizing a design that is close to saturation, saturation, or supersaturation, the effective ingredients can be precipitated, absorbed and protected from damage during the process of cleansing the skin.
  • Example 11 the standard steps are one decontamination and one cleaning and maintenance every time you wash your face. Every time you clean your face, it is measured with a commercially available skin detector (RUNVE Skin Analyzer).
  • This detector contains three measurement values: humidity, Oil content and fine roughness, of which oil content and fine roughness can be tested with skin gloss; moisture content is represented by the average value of three-point detection of forehead and left and right cheekbones.
  • the composition of the present invention is used to clean the skin for more than 4 weeks in accordance with the above-mentioned standard use steps. It can be seen from its moisture retention test chart ( Figure 14). Whether it was just after cleansing or 10 minutes after cleansing, the moisture retention index showed a significant improvement after two weeks.
  • the moisturizing degree of cleansing products after cleaning is about 40 to 42, and the degree of moisturizing after drying is about 34 to 38.
  • Table 6 referring to the classification of moisturizing degree in the instruction manual, it can be seen that it falls in the normal skin area after cleansing, 10 minutes The moisture is lost to the dry skin area; relatively, after using the composition of the present invention for about two weeks, the moisturizing degree after cleansing is about 43 to 48, and the moisturizing degree after drying is about 38 to 44.
  • the skin test According to the classification of the moisturizing degree of the device manual, it can be known that after cleansing, it falls in the range of skin full of suitable humidity, and the water is lost to the range of normal skin in 10 minutes.
  • the general dermatologist’s perception of skin gloss is that the oil secreted by the sebaceous glands and other substances in the environment will increase the gloss of the skin (Biomedical Optics Express). This environment produced on the skin can easily lead to acne and seborrhoea.
  • skin diseases such as dermatitis; relatively, when the skin is cleaned without the interference of the above-mentioned sebum, the skin still shows obvious gloss is due to the long-term healthy skin composition, such as reducing skin roughness (Skin Research and Technology), wrinkle reduction, and better moisturizing performance for delicate and healthy skin.
  • Such performance can be promoted by, for example, epidermal growth factor or collagen proliferation (WO2005037270A1).
  • the composition of the present invention is rich in active ingredients enough to promote healthier skin, thereby reducing wrinkles, etc., thereby increasing the gloss of the skin after cleansing (International Journal of Research in Pharmacy and Chemistry).
  • the standard steps are one decontamination and one cleaning and maintenance every time you wash your face. After cleaning every day, use BYK Micro-Gloss to detect the skin glossiness of the forehead in the flattest area of the face. After about 3 weeks of cleaning (Dermisa Brightening Bar) with general facial cleansing products, cleaning and testing, and then cleaning the skin with the composition of the present invention in accordance with the above-mentioned standard use steps for more than 4 weeks, according to the gloss test chart ( Figure 15), you can see the cleansing Whether it was just after cleaning or 10 minutes after cleaning, the gloss index showed a significant improvement after two weeks.
  • the gloss of sebum-containing people's face is about 2GU (Gloss Unit). After cleansing or the roughness of the skin will decrease to about 1GU, it will also increase to 2.5GU with the increase of skin fineness or the use of maintenance cosmetics. Left and right (Optical Review).
  • the composition of the present invention can reach a gloss of about 3GU to 5GU after long-term use and before using various skin care products, so that the human eye can distinguish the difference in gloss (the human eye can distinguish the difference of about 3GU), so generally The user can also clearly feel the skin's fineness and see the increase in gloss. After cleansing, the hydrated skin is not yet dry and the stratum corneum has not returned to its original state, so the gloss is about 3GU. After 10 minutes of recovery, the gloss can normally appear to about 5GU.
  • Comparative Example 13 Formula 13 of a mild cleansing composition containing unsaturated active ingredients and its manufacturing method
  • every 1000 grams contains 0.83 grams of active ingredients.
  • the manufacturing method is as follows: extract the extracts with equal proportions of alcohol and water respectively, containing 100 mg of Angelica dahurica, Baiji and Atractylodes macrocephala, Bletilla striata, Poria cocos , Aconite, and comfrey each 50 mg extract, and cocamidopropyl betaine (cocamidopropyl betaine), sodium lauroyl sarcosinate (sodium lauroyl sarcosinate), sodium lauroyl hydroxymethyl ethanesulfonate (sodium Lauroyl methyl isethionate), potassium cocoyl glycinate (potassium cocoyl glycinate), 50 grams each, mixed with an appropriate amount of water, if necessary, heat to a uniform state and add PEG-7 glyceryl cocoate (PEG-7 glyceryl cocoate), PEG-200 10 grams of PEG-200 hydrogenated g
  • This comparative example provides a mild cleansing composition containing unsaturated active ingredients.
  • the comparative test results are as follows:
  • the experiment used gloss and microscope inspection as observation tools to simulate general washing methods for cleaning.
  • the results showed that the skin surface of Comparative Example 13 did not change significantly after repeated washing in a short period of time; although the gloss result (washing) 1.4GU before and 1.4GU after washing) showed that the skin smoothness did not change significantly, and the microscopic examination results failed to see a significant difference in the cell types before and after washing, but under the microscope: the gloss after washing was still higher than Lower before cleaning.
  • the saturated example 10 not only has the function of avoiding excessive cleansing and protection of the skin, but also can increase the smoothness of the skin; on the contrary, no The function of Saturated Example 13 to avoid excessive cleansing and protection of the skin is not significant.
  • This experiment shows that the invention of the mild cleansing composition containing nearly saturated, saturated, or supersaturated active ingredients has its special novelty and progress.

Abstract

一种含有接近饱和、饱和、或超饱和活性成分的温和洁净组合物，其组合物包含一或多种界面活性剂、一或多种活性成分。此温和洁净组合物可以同时清洁并改善皮肤的质地，例如光泽度与皱纹等。

Description

含接近饱和、饱和、或超饱和活性成分的温和洁净组合物及其制备方法 技术领域
本发明涉及一种含接近饱和、饱和、或超饱和的活性成分的温和洁净组合物及其制备方法，且特别涉及一种包含至少一界面活性剂及至少一接近饱和、饱和、或超饱和且可改善皮肤质地的活性成分的清洁保养组合物及其制备方法。
背景技术
皮肤作为人体与外界间面积最大的天然屏障，为保持皮肤处于良好卫生状态(即干净与健康的状态)，皮肤清洗的目标乃去除人体所处环境的外来物及人体本身所产生的皮脂、汗液，故皮肤的清洁为维护皮肤健康的首要步骤。以脸部清洁为例，于以一般清洁用品洗脸后容易未洗干净而导致毛细孔阻塞或过度清洁而导致皮肤天然屏障损害等现象(Indian J Dermatol.2011 Jan-Feb；56(1):2-6)；对于洗脸的水温、时间、清洁用品选择、清洁方式再地影响着清洁效能与皮肤功能的维持，如何同时完整清洁并保持皮肤功能的正常发挥、甚至增加皮肤的审美程度，即为相关研究者所难以突破之处。
清洁剂的清洁原理大致可概分为：溶解与乳化脏污等两种(Physicochemical and Engineering Aspects,74,169-215(1993))。利用溶解原理去除脏污所使用的清洁剂，难以避免过度清洗皮肤表面，因而造成损害皮肤屏障与导致清洁后肌肤粗糙、干涩(Clinics in Dermatology,Volume 14,Issue 1,January-February 1996,Pages 29-33)，甚者反而导致皮脂过度分泌；利用乳化原理去除脏污所使用的清洁剂、乳化剂又不易完全去除脏污，因而留下少量乳化后未洗去的微小乳滴积聚于肌肤表面与毛孔、汗腺上，从而导致未洁净感、毛孔阻塞、与粉刺增生。
另外，皮肤清洁后的保养时机、方式也是一般民众生活中的一项挑战。 个人保养皮肤时机因人而异，但保养品的评估可以从两方面解析：首先，保养品的配方组合主要有水、油脂、乳化剂、安定剂、各种基剂甚至溶剂等等，由于基本组成为二不相互溶的油水两相、且为最大组成比例，因此需要乳化剂、安定剂等等，若须搭配其他活性成分时，于物理化学安定性上经常面临各种挑战，且活性成分所占有的比例通常相当低，而难以达成审美或临床效果的改善；其次，影响外用皮肤制剂的吸收主要在于角质层所形成的屏障而导致效果有限。无论是药物或化妆品经皮吸收传递系统(transdermal delivery system，TDDS)的途径大致上有以下两种方式：一、直接穿透角质层、或经由角质细胞间隙的脂质双层穿透，此为穿透皮肤的主要途径；二、通过毛囊、皮脂腺或汗腺等皮肤附属器，而其仅占皮肤0.1至1.0％，故极少量活性成分透过此途径吸收)。第一种吸收方式尚待克服的问题主要有皮肤的酸性屏蔽(acid mantle)(Current Pharmaceutical Design,2015,Vol.21,No.00)、与造成吸收障碍的角质层，均为阻挡药品与化妆品活性成分吸收的主要障碍，这也是消费者在使用各种保养品难以达到预期保养效果的主要因素。
发明内容
有鉴于现有清洁与保养技术的缺点，本发明欲针对先前技术难以温和配方清洁皮肤及难以适合方式保养皮肤加以改良，成为同时清洁皮肤、并且预防过度清洁、同时达成初步保养功效以增强皮肤功能的温和洁净组合物。本发明藉由将活性成分以接近饱和、饱和或超饱和的方式佐以温和界面活性剂配方，利用简易制程制作成一种可以同时清洁、避免过度清洁与保养皮肤的组合物，其中活性成分包含白芷、白蔹、白术、白芨、茯苓、附子、及紫草中的一种或多种以上的萃取物；而界面活性剂则包含长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中的一种或多种以上的组合物。本发明的含活性成分的温和洁净组合物可使用于人体任何皮肤部位，直接清洁皮肤并同时达成保养功效，其对皮肤的功效可以为下列其一或 其组合的功效，如：美白、促进胶原蛋白合成、抗发炎、避免皮肤干裂、止痒、抗过敏、抗老化、抗氧化、免疫调节、抗纤维化等。
依本发明的含接近饱和、饱和、或超饱和活性成分的温和洁净组合物，其个别活性成分于本发明组合物所引用具标志性、代表性成分(特别是指脂溶性、具高生理活性物)其水溶液饱和度分别为白芷≦0.01％、白蔹≦0.003％、白术≦0.004％、白芨≦0.006％、茯苓≦0.05％、附子≦0.0002％、紫草≦0.01％；因此其总饱和浓度约不大于0.1％。
该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物其活性成分萃取制备方法可为一般高温水性溶液萃取法、有机溶媒萃取法、超声波萃取法、或超临界流体萃取法其中的一种或多种以上的萃取组合。
该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物其活性成分依据美国食品药物管理局Cosmetics Laws&Regulations的说明：可以同时为符合化妆品和药品的定义。意指本发明根据科学期刊及预定使用的目的为具有可影响人或其他动物的任何功能的任何成分；以及使用于人体清洁、美容等。
较佳的，该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物其活性成分为预定用于搓揉、浇灌、喷洒或洒上、引入或擦拭于人体以清洁、美容、提升紧致度或改变外表的物质。
更佳的，该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物其活性成分意指其对皮肤的功效可以为下列其一或其组合的功效，如：美白、促进胶原蛋白合成、抗发炎、避免皮肤干裂、止痒、抗过敏、抗老化、抗氧化、免疫调节、抗纤维化等。
该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物依据其不同配方组合而具有O/W的微乳剂(American Journal of Pharmtech Research,2012)、乳剂、或胶束剂(Cancers,July 2018)等不同剂型。
在药理学领域中经常需要将有效成分极大化于剂型设计上，特别是含有脂溶性、高生理活性的液体剂型，例如：紫杉醇类的太平洋紫杉醇、欧洲紫 杉醇等药品，对于此类需要达到有效治疗剂量、尽可能减少给药总容量的活性成分，皆尽可能在剂型设计上接近活性成分的溶解饱和度；相对地，由于活性成分近饱和、饱和、超饱和的特性反而造成与水混合后容易沉淀的缺点。本发明即利用活性成分的近饱和、饱和、超饱和的特性将此缺点转化为外用制剂的优点，在与水混合后达成有效成分的析出与吸收，避免受到清洁剂溶解、清洗殆尽，更进一步配合清洁剂对皮肤的水合作用增加活性成分的吸收及作用。
皮肤脏污及酸性屏障可以经由清洁剂清洗去除以增加活性成分的吸收，但是角质层的穿透则需要经过药妆传递系统(cosmeceutical delivery system)的设计，才足以克服角质细胞间与角质细胞直接穿透的障碍(Skin Pharmacol Physiol 2006:19:106-21)。本发明藉由温和的界面活性剂组合，此界面活性剂组合主要以乳化清洁法(emulsification method)的原理对皮肤进行清洁并产生角质层的水合(Hydration)现象，于此状态下角质层不仅增加穿透度，也同时增加角质层间的容量(Capacitance)，本发明即利用此水合现象于此适当时机增加活性成分的附着与穿透角质层(The Journal of Investigative Dermatology,Vol.101,No.3,September 1993)；同时利用活性成分的浓度接近饱和、饱和、或超饱和(Pharmaceutical Research,July 2001,Volume 18,Issue 7,pp 1006–1011)现象以利于活性成分的沉积附着与经由浓度差吸收从而产生对皮肤的保护与保养功效，且因为此新颖的设计原理亦可同时杜绝皮肤过度清洁的可能性。
长链甜菜碱(Long-chain betaines)(Handbook for Cleaning/Decontamination of Surfaces)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)(Cosmetic Ingredient Review,September 2016)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)(Cosmetic Ingredient Review,September 2013)及椰油酰甘氨酸钾(potassium cocoyl glycinate)(Cosmetic Ingredient Review,September 2013)在各项研究以及科学文献中无论对皮肤或眼睛都是属于温和、低刺激性的界面活性剂， 本含接近饱和、饱和、或超饱和活性成分的温和洁净组合物发明即应用此温和洁净的界面活性剂组合，一则据以温和洗净皮肤，再者据以溶解活性成分至接近饱和、饱和、或超饱和浓度，同时达成清洁皮肤与保养皮肤的功效。
为达到上述可以同时清洁、避免过度清洁与保养皮肤的目的，本发明提供一种含接近饱和、饱和、或超饱和活性成分的温和洁净组合物，其中包括至少一界面活性剂及至少一接近饱和、或饱和、或超饱和且可改善皮肤质地的活性成分的清洁保养组合物及其制备方法。该界面活性剂由长链甜菜碱(long-chain betaines)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、及椰油酰甘氨酸钾(potassium cocoyl glycinate)其中的一种或多种的任意组合且占该发明组合物5.00wt％至70.00wt％；该活性成分由白芷、白蔹、白术、白芨、茯苓、附子、及紫草其中的一种或多种的任意组合的萃取物且占该发明组合物0.1wt％至10.00wt％；该发明组合物可进一步包含适量水，其占该发明组合物15.00wt％至85.00wt％；该发明组合物可进一步包含适量化妆品赋形剂，如稀释剂、增稠剂、安定剂、香味剂、防腐剂、助界面活性剂(cosurfactant)等等，该赋形剂占该发明组合物0wt％至15.00wt％。
较佳地，该发明组合物的界面活性剂长链甜菜碱(long-chain betaines)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、及椰油酰甘氨酸钾(potassium cocoyl glycinate)占该发明组合物分别为0wt％至25.00wt％、0wt％至20.00wt％、0wt％至25.00wt％、0wt％至20.00wt％，且其总和不得为零。
更佳地，该发明组合物的界面活性剂由长链甜菜碱(long-chain betaines)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、及椰油酰甘氨酸钾(potassium cocoyl glycinate)其中的一种或多种的任意组合且占该发明组合物10.00wt％至65.00wt％。
最佳地，该发明组合物的界面活性剂由长链甜菜碱(long-chain betaines)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、及椰油酰甘氨酸钾(potassium cocoyl glycinate)其中的一种或多种的任意组合且占该发明组合物20.00wt％至60.00wt％。
较佳地，该发明组合物的活性成分白芷、白蔹、白术、白芨、茯苓、附子、及紫草占该发明组合物分别为0wt％至8.00wt％、0wt％至8.00wt％、0wt％至8.00wt％、0wt％至4.00wt％、0wt％至4.00wt％、0wt％至4.00wt％、0wt％至4.00wt％，且其总和不得为零。
较佳地，该发明组合物的活性成分由白芷、白蔹、白术、白芨、茯苓、附子、及紫草其中的一种或多种的任意组合且占该发明组合物0.10wt％至8.00wt％。
更佳地，该发明组合物的活性成分由白芷、白蔹、白术、白芨、茯苓、附子、及紫草其中的一种或多种的任意组合且占该发明组合物0.20wt％至6.00wt％。
最佳地，该发明组合物的活性成分由白芷、白蔹、白术、白芨、茯苓、附子、及紫草其中的一种或多种的任意组合且占该发明组合物0.40wt％至4.00wt％。
较佳地，该发明组合物可进一步包含适量水，占该发明组合物20.00wt％至80.00wt％；更佳地，占该发明组合物25.00wt％至75.00wt％；最佳地，占该发明组合物30.00wt％至70.00wt％。
较佳地，该发明组合物可进一步包含适量化妆品赋形剂，该赋形剂可为稀释剂、增稠剂、安定剂、香味剂、防腐剂、或助界面活性剂(cosurfactant)等，该赋形剂占该发明组合物0.50wt％至10.00wt％。较佳地，该赋形剂占该发明组合物1.00％重量百分比至8.00％重量百分比。更佳的，该赋形剂占该发明组合物2.00％重量百分比至6.00％重量百分比。最佳的，该赋形剂占该发明组合物4.00％重量百分比至6.00％重量百分比。
本发明提供一种含接近饱和、饱和、或超饱和活性成分的温和洁净组合物，其中包括至少一界面活性剂及至少一接近饱和、饱和、或超饱和且可改善皮肤质地的活性成分的清洁保养组合物，其中该温和洁净组合物是透过下列制备方法制得，该制备方法包括下列步骤：(i)将该至少一活性成分加入至一混合容器内并加入适量水；以及(ii)将该至少一界面活性剂加入至步骤(i)的混合容器内混合均匀，若有需要加热至溶解混合均匀；(iii)若有需要加入适当赋形剂，如稀释剂、增稠剂、安定剂、香味剂、或防腐剂等，持续混合均匀、回复至室温。
依据本发明，较佳地，该含接近饱和、饱和、或超饱和活性成分的温和洁净组合物及其制备方法的活性成分可经由一般高温水性溶液萃取法、有机溶媒萃取法、超声波萃取法、或超临界流体萃取法其中的一种或多种的任意萃取组合。
为让本发明的上述特征和优点能更明显易懂，下文特举实施例，并配合附图式作详细说明如下。
附图说明
图1为一示意图，说明本发明利用界面活性剂及水对角质层水合作用、以及有效成分以接近饱和或饱和或超饱和形态实施利于皮肤吸收。
图2为一系列不同倍率放大的显微镜照片图，呈现本发明组合物以不同剂型呈现。
图3为一系列不同倍率放大的显微镜照片图，呈现本发明组合物实施例12与水混合前的沉淀状态。
图4为一系列不同倍率放大的显微镜照片图，呈现本发明组合物实施例12与水以重量比1：1的比例混合均匀后于时间点10分钟的沉淀状态。
图5为一系列不同倍率放大的显微镜照片图，呈现本发明组合物实施例12与水以重量比1：1的比例混合均匀后于时间点60分钟的沉淀状态。
图6为一系列不同倍率放大的显微镜照片图，呈现本发明组合物实施例 12与水以重量比1：1的比例混合均匀后于时间点360分钟的沉淀状态。
图7为一系列不同倍率放大的显微镜照片图，呈现本发明组合物实施例12与水以重量比1：1的比例混合均匀后于时间点720分钟的沉淀状态。
图8为一200倍倍率放大的显微镜照片图，呈现皮肤于一般清洁剂清洗前的状态。
图9为一200倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物实施例10清洗前的状态。
图10为一30倍倍率放大的显微镜照片图，呈现皮肤于一般清洁剂连续清洗20次的状态。
图11为一30倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物实施例10连续清洗20次的状态。
图12为一200倍倍率放大的显微镜照片图，呈现皮肤于一般清洁剂连续清洗20次的状态。
图13为一200倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物实施例10连续清洗20次的状态。
图14为一保湿度检测图，说明皮肤于本发明组合物实施例11刚清洁后与清洁后10分钟的保湿度。
图15为光泽度检测图，说明皮肤于本发明组合物实施例11刚清洁后与清洁后10分钟的光泽度。
图16为一系列不同倍率放大的显微镜照片图，呈现本发明组合物比较实施例13与水以重量比1：1的比例混合均匀后于时间点10分钟的沉淀状态。
图17为一系列不同倍率放大的显微镜照片图，呈现本发明组合物比较实施例13与水以重量比1：1的比例混合均匀后于时间点60分钟的沉淀状态。
图18为一30倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物比较实施例13清洗前的状态。
图19为一30倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物比较实施例13连续清洗20次的状态。
图20为一200倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物比较实施例13清洗前的状态。
图21为一200倍倍率放大的显微镜照片图，呈现皮肤于本发明组合物比较实施例13连续清洗20次的状态。
具体实施方式
为了同时清洁皮肤、并且预防过度清洁、同时达成初步保养功效以增强皮肤功能，本发明提供一种含接近饱和、饱和、或超饱和活性成分的温和洁净组合物，该组合物包含一种或多种以上的活性成分；以及一种或多种以上的界面活性剂；该发明组合物可进一步包含适量水；该发明组合物可进一步包含适量化妆品赋形剂。
请参照图1，说明本发明利用界面活性剂及水对角质层100水合作用、以及有效成分于本发明组合中以接近饱和、饱和、或超饱和形态实施以使有效成分200易于角质层表面沉淀而利于有效成分的吸收。
下列实施例用于示范说明本发明。这些实施例不以任何方式意欲限制本发明的范围，但用于指示如何实施本发明的材料及方法。
本发明实施例中所谓具有至少一种界面活性剂乃选自长链甜菜碱(long-chain betaines)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、及椰油酰甘氨酸钾(potassium cocoyl glycinate)，其中的一种或多种以上任意组合的组合物。
本发明实施例中所谓具有至少一种活性成份乃选自白芷、白蔹、白术、白芨、茯苓、附子、或紫草的萃取物，其中的一种或或多种以上任意组合的组合物。
如图2所示，本发明实施例可依据其不同配方组合而具有O/W的微乳剂 (American Journal of Pharmtech Research,2012)、乳剂、或胶束剂(Cancers,July 2018)等不同剂型。
实施例1：含活性成分的温和洁净组合物配方1及其制造方法
本实施例中每1000公克最终产物含有相当于5公克的活性成分，其制造方法如下：分别将以酒精与水等重量比例的混合萃取液进行各活性成分的萃取，其中混合萃取液与各活性成分的原料的重量比为10：1至50：1，萃取温度为50至100℃，萃取时间为1小时至10小时，萃取后的内容物含有白芷、白蔹、白术各1000毫克与白芨、茯苓、附子、紫草各500毫克的萃取物，并与椰油酰胺丙基甜菜碱(cocamidopropyl betaine)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、椰油酰甘氨酸钾(potassium cocoyl glycinate)各50公克与适量水混合，若有需要加热至均匀态加入PEG-7甘油椰油酸酯(PEG-7 glyceryl cocoate)、PEG-200氢化甘油棕榈油酸酯(PEG-200 hydrogenated glyceryl palmate)各10公克混合均匀，再加入10公克氯化钠搅拌混合至均匀，冷却至室温即得，表1为实施例1配方组合物组成表。
表1、实施例1配方组合物组成表
Figure PCTCN2020075824-appb-000001
Figure PCTCN2020075824-appb-000002
实施例2至12：含活性成分的温和洁净组合物配方2到12，其制造方法与实施例1相似而不同的配方组成与萃取方法亦于表2中显示，表2为实施例1至12配方组合物组成表，表3为实施例1至12配方组合物其活性成份的萃取方法，表4为各萃取方法的萃取条件。
表2、实施例1至12配方组合物组成表
Figure PCTCN2020075824-appb-000003
表3、实施例1至12配方组合物其活性成份之萃取方法
Figure PCTCN2020075824-appb-000004
Figure PCTCN2020075824-appb-000005
表4、各萃取方法的萃取条件
Figure PCTCN2020075824-appb-000006
Figure PCTCN2020075824-appb-000007
本发明提供一种含接近饱和、饱和、或超饱和活性成分的温和洁净组合物，其各项试验结果如下所示：
〈接近饱和、饱和、超饱和实验〉
在微观上将本发明组合物实施例12以显微镜观察，另外将水与本发明组合物以重量比1：1的比例混合均匀，于时间点10、60、360、720分钟以显微镜观察，检视其饱和沉淀情形如图3到图7。结果显示本发明组合物并未有沉淀产生(图3)；水与本发明组合物以重量比1：1的比例混合均匀，于时间点10分钟即产生光学显微镜可见的微量沉淀物(图4)、60分钟产生少量的沉淀物(图5)、360分钟产生凝聚的沉淀物(图6)、720分钟产生多量的沉淀物(图7)；反之，一般在宏观的角度观察临界饱和实验则以安定性试验进行，由于能量的降低经过长时间静置储存后会缓慢产生凝集。此试验显示本发明组合物在饱和临界值附近的优异设计(Journal of Pharmaceutical Sciences,January 2012)；证明本发明组合物经由“质量是设计而得的(Quality by Design)”的概念下，在实际清洁皮肤时足以对皮肤产生保护、保养的功效。
〈避免过度清洁及保护实验〉
分别将市售清洁用品(Dermisa Brightening Bar)与本发明组合物实施例10对大腿内侧分别进行清洗、擦干再清洗的连续20次清洁程序，结果如表5、图8至13之避免过度清洁实验所示。
实验以光泽度与显微镜镜检为观察工具，模拟一般洗涤方式进行清洁，结果显示一般清洁剂于短时间内重复清洗后其皮肤表面即有损伤，镜检结果也显示角质层受损、白色剥离片状、甚至呈现卷起状态，此一镜检微观结果亦显现在宏观性的光泽度检测结果呈现下降；反之，使用本发明组合物于短时间内重复清洗后其皮肤表面不仅仅没有损伤，观察镜检结果亦无法分辨出 清洗前后的差异，但由光泽度结果可以看出皮肤光滑度的提升，依此即可预期长期使用本发明组合物将使皮肤更加细致光滑，进一步导致光泽度大幅提升至人眼可辨认出差异的程度。
表5、避免过度清洁实验
Figure PCTCN2020075824-appb-000008
综上，基于现有技术与一般知识及认知，使用清洁剂清洗肌肤容易损伤角质层造成皮肤表面粗糙，再基于对损伤的皮肤进行乳霜等保养品的使用；相对地，本发明组合物利用接近饱和、饱和、或超饱和的设计，使得有效成分能够在清洁肌肤的过程中析出、吸收并保护皮肤不至于受损。
〈保湿度实验〉
将实施例11以每回洗脸一次去污、一次清洁保养为标准步骤，每回清洁完毕皆以市售皮肤检测器测量(RUNVE Skin Analyzer)，此检测器包含三种测量数值分别为含湿度、含油度、细致粗糙度，其中含油度、细致粗糙度可搭配皮肤光泽度检测；含湿度则以额头、左右颧骨三点检测的平均值表示。经过约3周的一般洗脸清洁用品清洁(Dermisa Brightening Bar)清洗并检测，接着再以本发明组合物依照上述标准使用步骤清洁肌肤4周以上，由其保湿度检测图(图14)可以看到无论是刚刚清洁后或是清洁后10分钟，保湿度指标在两周后都呈现大幅改善。
一般洗脸清洁用品其清洁后保湿度约在40至42之间、干燥后保湿度约在34至38之间，如表6参考使用说明书保湿度的分类可知清洁后落在正常肌肤区间，10分钟水份散失至干性肌肤区间；相对地，使用本发明组合物约 两周后，其清洁后保湿度约在43至48之间、干燥后保湿度约在38至44之间，参考皮肤检测器说明书其保湿度的分类，可以知道清洁后落在饱含适合湿度肌肤区间，10分钟水份散失至正常肌肤区间。
表6、保湿度说明
数位格数 1 2 3 4 5
含水百分比 ≦33％ 34％～37％ 38％～42％ 43％～46％ ≧47％
保湿度 干燥 轻微干燥 正常保湿 保湿良好 极度保湿
〈光泽度实验〉
一般皮肤科学家对皮肤光泽度的认知为皮脂腺分泌的油脂及环境中其他物质沾附而导致皮肤光泽度的增加(Biomedical Optics Express)，皮肤上产生的这种环境容易导致如青春痘、脂漏性皮肤炎等皮肤疾病的发生；相对地，当皮肤完成清洁后无上述皮脂等干扰情形下，皮肤仍然显现出明显的光泽度则是由于长期性的健康皮肤构成，例如减少皮肤粗糙度(Skin Research and Technology)、减少皱纹、较佳的保湿度之细致健康皮肤的表现，此种表现可以由例如表皮生长因子或胶原蛋白增生加以促成(WO2005037270A1)。而本发明组合物由于富含有效成分足以促使皮肤更加健康，因而减少皱纹等进而增加皮肤清洁后的光泽度(International Journal of Research in Pharmacy and Chemistry)。
以每回洗脸一次去污、一次清洁保养为标准步骤，每天清洁完毕后以光泽度器测量(BYK Micro-Gloss)检测脸部最平坦区额头的皮肤光泽度。经过约3周的一般洗脸清洁用品清洁(Dermisa Brightening Bar)清洗并检测，接着再以本发明组合物依照上述标准使用步骤清洁肌肤4周以上，由其光泽度检测图(图15)清洗可以看到无论是刚刚清洁后或是清洁后10分钟，光泽度指标在两周后都呈现大幅改善。
一般含皮脂的人脸部光泽度约在2GU(Gloss unit)左右，随着清洁后或皮肤粗糙程度会下降至1GU左右，亦会随着皮肤细致度的增加或使用保养化妆品而增加至2.5GU左右(Optical Review)。而本发明组合物经长时间使用后且在尚未使用各项保养品之前即可达到光泽度3GU到5GU左右，达到人眼可以辨别光泽度差异(人眼可辨别差异为3GU左右)，因此一般使用者亦可清楚感受到肌肤细致度以及看见光泽度的增加。由于清洁后经水合的肌肤尚未干燥、角质层还没恢复原状态，因此光泽度落在3GU左右，经过10分钟的恢复后、光泽度即可正常显现到5GU左右。
比较实施例13：含不饱和活性成分的温和洁净组合物配方13及其制造方法
本比较实施例中每1000公克含有相当于0.83公克的活性成分，其制造方法如下：分别将以酒精、水等比例萃取液进行萃取，内含白芷、白蔹、白术各100毫克与白芨、茯苓、附子、紫草各50毫克的萃取物，并与椰油醯胺丙基甜菜鹼(cocamidopropyl betaine)、月桂酰肌氨酸钠(sodium lauroyl sarcosinate)、月桂酰羟甲基乙磺酸钠(sodium lauroyl methyl isethionate)、椰油酰甘氨酸钾(potassium cocoyl glycinate)各50公克与适量水混合，若有需要加热至均匀态加入PEG-7甘油椰油酸酯(PEG-7 glyceryl cocoate)、PEG-200氢化甘油棕榈油酸酯(PEG-200 hydrogenated glyceryl palmate)各10公克混合均匀，再加入10公克氯化钠搅拌混合至均匀，冷却至室温即得，表7为比较实施例13配方组合物组成表。
表7、比较实施例13配方组合物组成表
Figure PCTCN2020075824-appb-000009
Figure PCTCN2020075824-appb-000010
本比较实施例提供一种含不饱和活性成分的温和洁净组合物，其各项比较试验结果如下所示：
〈接近饱和、饱和、超饱和实验〉
在微观上将比较实施例13与水以重量比等比例混合均匀，于时间点10、60分钟以显微镜观察，检视其不饱和是否有沉淀情形发生，如图16、17。结果显示本不饱和比较实施例13并未有沉淀产生。
〈避免过度清洁及保护比较实验〉
将本比较实施例13对大腿内侧进行清洗、擦干再清洗连续20次的清洁程序，结果如表8与图18至21之避免过度清洁比较实验所示。
表8、避免过度清洁实验
Figure PCTCN2020075824-appb-000011
实验以光泽度与显微镜镜检为观察工具，模拟一般洗涤方式进行清洁， 结果显示本比较实施例13于短时间内重复清洗后其皮肤表面并未有显着变化；虽然由光泽度结果(清洗前1.4GU、清洗后1.4GU)得出皮肤光滑度并无明显变化，且观察镜检结果未能看出清洗前后细胞型态并之显着差异，但是显微镜下观察：清洗后光泽度仍然比清洗前降低。
基于饱和实施例10与不饱和比较实施例13在避免过度清洁及保护实验结果显示，饱和实施例10除了具有避免皮肤过度清洁及保护功能之外，亦可增加皮肤光滑度的提升；反之，不饱和实施例13对于避免皮肤过度清洁及保护的功能并不显着。此实验显示本含有接近饱和、饱和、或超饱和活性成份的温和洁净组合物的发明有其特殊新颖性、进步性。
虽然本发明已以实施例揭露如上，然其并非用以限定本发明，任何所属技术领域中具有通常知识者，在不脱离本发明之精神和范围内，当可作些许之更动与润饰，故本发明之保护范围当视后附之申请专利范围所界定者为准。

Claims (20)

  1. 一种温和洁净组合物，其特征在于：包括：
    至少一种界面活性剂；以及
    至少一接近饱和、饱和、或超饱和且可改善皮肤质地的活性成分。
  2. 根据权利要求1所述的温和洁净组合物，其特征在于：所述界面活性剂含有长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中至少一者，且所述界面活性剂占所述温和洁净组合物5wt％至70wt％。
  3. 根据权利要求1所述的温和洁净组合物，其特征在于：所述界面活性剂含有长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中至少一者，且所述界面活性剂占所述温和洁净组合物10wt％至65wt％。
  4. 根据权利要求1所述的温和洁净组合物，其特征在于：所述活性成分含有白芷、白蔹、白术、白芨、茯苓、附子、及紫草中至少一者的萃取物，且所述活性成分占所述温和洁净组合物0.1wt％至10wt％。
  5. 根据权利要求1所述的温和洁净组合物，其特征在于：所述活性成分含有白芷、白蔹、白术、白芨、茯苓、附子、及紫草中至少一者的萃取物，且所述活性成分占所述温和洁净组合物0.2wt％至6wt％。
  6. 根据权利要求1所述的温和洁净组合物，其特征在于：还包括水。
  7. 根据权利要求6所述的温和洁净组合物，其特征在于：所述适量水占所述温和洁净组合物20wt％至80wt％。
  8. 根据权利要求1所述的温和洁净组合物，其特征在于：还包括化妆品赋形剂。
  9. 根据权利要求8所述的温和洁净组合物，其特征在于：所述化妆品赋形剂占所述温和洁净组合物0.50wt％至10.00wt％。
  10. 根据权利要求1所述的温和洁净组合物，其特征在于：所述活性成分的萃取物的制备方法为一般高温水性溶液萃取法、有机溶媒萃取法、超音波萃取法、或超临界流体萃取法。
  11. 一种温和洁净组合物，其特征在于,包括：
    至少一界面活性剂，选自长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中至少一种；以及
    至少一接近饱、饱和、或超饱和且可改善皮肤质地的活性成分，选自白芷、白蔹、白术、白芨、茯苓、附子、及紫草中至少一种的萃取物。
  12. 根据权利要求11所述的温和洁净组合物，其特征在于：选自长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中至少二者，且所述界面活性剂占所述温和洁净组合物5wt％至70wt％。
  13. 根据权利要求11所述的温和洁净组合物，其特征在于：所述界面活性剂含有长链甜菜碱、月桂酰肌氨酸钠、月桂酰羟甲基乙磺酸钠、及椰油酰甘氨酸钾中至少二者，且所述界面活性剂占所述温和洁净组合物10wt％至65wt％。
  14. 根据权利要求11所述的温和洁净组合物，其特征在于：所述活性成分含有白芷、白蔹、白术、白芨、茯苓、附子、及紫草中至少二者的萃取物，且所述活性成分占所述温和洁净组合物0.1wt％至10wt％。
  15. 根据权利要求11所述的温和洁净组合物，其特征在于：所述活性成分含有白芷、白蔹、白术、白芨、茯苓、附子、及紫草中至少二者的萃取物，且所述活性成分占所述温和洁净组合物0.2wt％至6wt％。
  16. 根据权利要求11所述的温和洁净组合物，其特征在于：还包括水。
  17. 根据权利要求16所述的温和洁净组合物，其特征在于：所述水占所述温和洁净组合物20wt％至80wt％。
  18. 根据权利要求11所述的温和洁净组合物，其特征在于：还包括化妆品赋形剂。
  19. 根据权利要求18所述的温和洁净组合物，其特征在于：所述化妆品赋形剂占所述温和洁净组合物0.50wt％至10.00wt％。
  20. 根据权利要求11所述的温和洁净组合物，其特征在于：所述活性成分的萃取物的制备方法为一般高温水性溶液萃取法、有机溶媒萃取法、超音波萃取法、或超临界流体萃取法。
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