WO2019085852A1 - 一种祛除萎缩纹的组合物 - Google Patents

一种祛除萎缩纹的组合物 Download PDF

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Publication number
WO2019085852A1
WO2019085852A1 PCT/CN2018/112342 CN2018112342W WO2019085852A1 WO 2019085852 A1 WO2019085852 A1 WO 2019085852A1 CN 2018112342 W CN2018112342 W CN 2018112342W WO 2019085852 A1 WO2019085852 A1 WO 2019085852A1
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essential oil
composition
skin
cream
oil
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PCT/CN2018/112342
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English (en)
French (fr)
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王国柱
罗惠敏
孙剑
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陕西慧康生物科技有限责任公司
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Priority to AU2018359924A priority Critical patent/AU2018359924B2/en
Publication of WO2019085852A1 publication Critical patent/WO2019085852A1/zh
Priority to AU2020100737A priority patent/AU2020100737A4/en

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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
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/64—Proteins; Peptides; Derivatives or degradation products 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
    • A61K8/92—Oils, fats or waxes; Derivatives thereof, e.g. hydrogenation products 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
    • A61K8/96—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
    • 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
    • A61Q19/08—Anti-ageing preparations

Definitions

  • the invention belongs to the technical field of skin care products, and in particular relates to a composition for removing atrophic lines.
  • the plant essential oil is produced from the aromatic plant containing the balm gland (Aromatic Herbst). It is a highly concentrated extract of aromatic plants. It is extracted from plant-specific aromatic substances such as flowers, leaves, roots, bark, fruits, seeds, resins, etc. Extracted by pressing. Most plant essential oils contain alcohols, aldehydes, acids, phenols, acetone, and terpenes. However, they actually contain more than one hundred components, and of course some are composed of thousands of components. In the case of rose essential oil, 86% is composed of more than 300 components and 14% is composed of many trace compounds. Because the essential oil has high volatility and small molecular weight, it is easily absorbed by the human body, and can quickly penetrate the human body and excrete excess components.
  • the whole process takes only a few minutes, and the fragrance of the plant itself directly stimulates the pituitary gland.
  • the secretion, enzymes and hormone secretion, etc. balance the body's functions, play a role in beauty and skin care. It is conceivable that the essential oil of the essential oil is extremely broad.
  • the shrinkage pattern (the general term for stretch marks/obesity lines) is the phenomenon of skin fiber breakage caused by the growth, pregnancy or weight gain of the human body.
  • the shrinkage lines caused by pregnancy are also called stretch marks. Its formation is mainly affected by hormones.
  • the growth or bulging of local tissues causes the elastic fibers and collagen fibers of the skin to be damaged or broken to varying degrees due to external force.
  • the skin becomes thinner and thinner, and some of the abdomen, buttocks or other parts will appear.
  • Some stretch marks are often accompanied by sagging skin, and even the skin exhibits "orange peel" changes.
  • Pregnancy is one of the things most women have. According to the survey, more than 75% of pregnant women have stretch marks after giving birth. When a woman is pregnant, the hormones in the body change greatly, including estrogen, progesterone, oxytocin, prolactin and corticosteroids. Among them, corticosteroids are secreted by the adrenal gland, and its increase causes pigmentation in the abdominal skin, increasing skin elasticity fibers and The brittleness of collagen fibers gradually increases with the growth of the abdomen. When the abdominal bulge exceeds the abdomen of the abdomen, the elastic fibers and collagen fibers of the skin break and produce stretch marks.
  • Unilateral essential oil is a simple plant essential oil, generally 100% pure, can not be directly used on the skin, generally added to cosmetics, usually combined with the base oil to be used.
  • the compound essential oil is prepared by mixing two or more kinds of single essential oil and base oil in a certain ratio, and can be directly used for skin care. It has the effect of complementing each other and enhancing the curative effect.
  • compound essential oils are widely used in skin care products because of their natural and safe properties.
  • the product efficacy of different formulas is quite different; most of them are aimed at promoting blood circulation, improving skin (need to cooperate with professional methods) and other single effects, and currently the compound to shrink lines
  • Most of the essential oils can be used for body massage, and the specific gravity of the essential oil is 2% to 5%. The use time is long and the effect is not obvious.
  • Cream as a matrix with a high safety factor and no preservative as a raw material source with the addition of essential oils, and most of the creams on the market have a low safety factor, and most of them are used to moisturize the skin, adding collagen to Claims that products that use long time but are less effective.
  • composition for eliminating the shrinkage pattern used to solve the above technical problems is composed of a compound essential oil and a cream, wherein the compound essential oil is composed of the following raw materials of a mass ratio:
  • the above-mentioned compound essential oil is preferably composed of the following raw materials of the mass ratio:
  • the above basic essential oil is a mixture of any one of rosehip oil, grape seed oil, macadamia nut oil and jojoba oil, preferably any one of rosehip oil, grape seed oil, macadamia nut oil and jojoba oil quality.
  • the ratio is a mixture of 1:1 to 2.
  • the above cream consists of the following raw materials with a mass ratio of:
  • the above-mentioned base cream is composed of the following raw materials of the mass ratio:
  • the above essential oil composition is composed of the following raw materials of the mass ratio:
  • the above essential oil composition is preferably composed of the following raw materials having a mass ratio of:
  • the preparation method of the above compound essential oil is as follows: according to the above-mentioned mass ratio, adding lavender essential oil, fragrant peach oil, frankincense essential oil, patchouli essential oil, zealand essential oil, carrot seed essential oil, rose grass essential oil and basil essential oil to the basic essential oil. , rosemary extract, to obtain mixed essential oil; the six peptides are uniformly dissolved in water, and then added to the C12-13 alkanol polyether-3, stirred at room temperature, uniformly mixed, and then poured into the mixed essential oil, stirred at room temperature and evenly mixed , sub-packaging, sealing, that is, get the compound essential oil.
  • the preparation method of the above cream is as follows: water, 1,3-butanediol, glycerin, betaine, hexanediol, carbomer are added to the emulsion tank according to the above mass ratio, and the mixture is heated and stirred to 85 ° C for 20 times.
  • octanoic acid/capric triglyceride, isodecyl isononanoate, dioctyl carbonate, cetearyl glucoside, polydimethylsiloxane, jojoba oil, cetyl alcohol Potassium phosphate is added to the oil phase tank, heated to 85 ° C for 20 minutes to obtain the oil phase; lavender essential oil, fragrant almond oil, frankincense oil, patchouli essential oil, vetiver essential oil, carrot seed oil, rose grass essential oil, basil The essential oil is mixed and stirred evenly to obtain the essential oil composition; the oil phase is added to the emulsion tank, stirred uniformly, and the temperature is lowered to 75 ° C for 2 minutes, the triethanolamine is added, the mixture is stirred for 15 minutes, the temperature is stirred and the vacuum is applied; 50 ° C is added to the mixture. Fresh ketone, continue to cool to 40 ° C, add essential oil composition, ethyl isononanoate, dio
  • the method for removing the atrophic pattern of the invention is as follows: the human skin has a shrinkage line and the surface is cleaned, and the water is removed, and the compound oil is applied to the atrophic portion, and the massage is heated to absorb or apply to the atrophic portion to cover with the plastic wrap. To absorb, then apply the cream and gently massage until absorbed.
  • the application amount of the compound essential oil is 0.05-0.1 mg/cm 2
  • the application amount of the cream is 0.1-0.5 mg/cm 2 .
  • Lavender essential oil is extracted from lavender flowers, which contain linalyl acetate, geraniol, linalool, eucalyptol, d-borneol, lemon thin, 1-decene, syringene, butyrate, shikimic acid, Coumarin can effectively tighten the skin of the epidermis, astringe pores, control the balance of water and oil, whitening the skin, wrinkle and rejuvenate, and promote the skin regeneration function of damaged tissue regeneration.
  • the essential oil of nectar is extracted from leaves and twigs, the main ingredient is eucalyptol, in addition to fragrant oleic acid, pine oil, geranol, linalool and decene, it is a particularly mild essential oil with antibacterial and astringent properties.
  • the characteristic is that it can purify the blocked skin and eliminate the protrusions. It can also dispel the congestion and improve the appearance of the dry and falling debris.
  • the frankincense oil is extracted from the mastic resin, which is composed of 1-decene, dipentene, water, decene, emulsified alcohol and various rosins. It exudes a warm, pure woody aroma with a hint of fruit, which makes you feel relaxed and soothed. It has antibacterial effect, promotes wound scarring, diminishes scars, wrinkles, enhances cell activity, calms skin, regulates dry, aging, dull skin, restores skin elasticity and tightens pores.
  • the patchouli essential oil is extracted from stems and leaves.
  • the main ingredients are musk alcohol, patchouli and Zhengbai musk, a small amount of eugenol, juniperene, carvone, etc. It can promote skin regeneration, reduce inflammation and converge pores. It tightens the skin and promotes the healing of the wound, which helps to improve the skin relaxation caused by excessive diet.
  • the vetiver essential oil is extracted from the roots and is mainly composed of kelanone, kelanol, lanylene and juniperene. It can regulate, astringe skin, anti-inflammatory, awaken cells, improve damaged skin, promote body cell regeneration and healing.
  • Carrot seed oil is extracted from carrot seeds.
  • the main chemical components are terpenes, terpenes, terpenes, myrcene, pine oil or terpinene, lemon olein, erythrophylline, geranyl acetate and carrotene alcohol. It stimulates and rejuvenates the skin, increases the elasticity of the skin, and the apparent effect of the epidermis on the skin is to eliminate wrinkles.
  • Rose grass essential oil is extracted from rose grass, its main component is citral (about 75% to 95%), as well as traces of citronellol, yttrium acetate, and farnesol. It balances sebum secretion and re-forms the natural water-retaining membrane on the skin surface, which provides excellent moisturizing effect and promotes epidermal cell regeneration, antibacterial, anti-viral and sterilization.
  • Basil essential oil is extracted from leaves and flowers. Basil is known as the 'king of vanilla'. It has a good protective effect on women. It has anti-aging, firming skin, nourish the skin, and improve the effect of loose and aging skin.
  • Six-peptide also known as the six-equivalent peptide (Areginine Essence) has an active hexapeptide, which effectively soothes and inhibits the contraction and activity of the wrinkles and surrounding muscles, helps the muscles relax, and restores the skin's elastic tissue to a smooth and smooth Lines. It has similar ability to inhibit nerve conduction substances, block the conduction function between nerves and muscles, avoid excessive muscle contraction, prevent fine lines from forming, reduce the occurrence of dynamic lines, and restore collagen elastic force to make skin smooth and firm.
  • the invention combines various natural plant essential oils which promote blood circulation, stimulate collagen regeneration, astringent and firm skin, improve skin roughness and reconstituted fibrous tissue structure, synergistically act on removing shrinkage lines, and is combined with cream containing essential oil components.
  • the two complement each other have synergistic effect, strong efficacy, can make the active ingredients quickly penetrate into the skin and be absorbed, remove or dilute the shrinkage lines, promote cell regeneration, improve skin dryness and relaxation, improve the shrinkage lines It can achieve the effect of moisturizing smooth skin while removing the shrinking lines, and the method of use is simple.
  • Figure 1 is a photograph of Ms. Wu's abdominal stretch marks before the trial.
  • Fig. 2 is a photograph of Ms. Wu's abdominal stretch mark test example 1 excluding the shrink wrinkle composition for 20 days.
  • Fig. 3 is a photograph of Ms. Wu's abdominal stretch mark test example 1 for removing the atrophic composition for 40 days.
  • Figure 4 is a photograph of Ms. Lei's back growth pattern before trial.
  • Fig. 5 is a photograph of the 15th day of the removal of the atrophic composition by the example 1 of the back growth pattern of Ms. Lei.
  • Figure 6 is a photograph of Ms. Wu's abdomen right stretch mark before trial.
  • Fig. 7 is a photograph of the 60th day of the removal of the atrophic composition of Example 1 of the right side stretch mark of Ms. Wu.
  • Figure 8 is a photograph of Ms. Li before the trial of the left stretch mark on the abdomen.
  • Fig. 9 is a photograph of the 60th day of the removal of the atrophic composition of Example 1 of the left side stretch mark of Ms. Li.
  • Figure 10 is a photograph of Ms. Liu's abdominal stretch marks before the trial.
  • Fig. 11 is a photograph of the 15th day of the removal of the atrophic composition of the sample of Example 1 of the abdomen stretch marks of Ms. Liu.
  • Figure 12 is a photograph of Ms. Zhao's abdominal stretch marks before the trial.
  • Fig. 13 is a photograph of the 11th day of the removal of the atrophic composition of the sample of the pregnant woman's abdominal stretch marks.
  • Figure 14 is a photograph of Ms. Jiang's leg growth pattern before trial.
  • Fig. 15 is a photograph of the 24th day of the removal of the atrophic composition of the example 1 of the leg growth pattern of Ms. Jiang.
  • Figure 16 is a photograph of Ms. Qin's back growth pattern before trial.
  • Fig. 17 is a photograph of the 38th day of the removal of the atrophic composition of the sample of the back growth pattern of Ms. Qin.
  • Figure 18 is a photograph of Ms. Feng's abdominal stretch marks before the trial.
  • Fig. 19 is a photograph of the tenth day of the removal of the atrophic composition of Example 1 of Ms. Feng's abdominal stretch marks.
  • Fig. 20 is a photograph of the 15th day of the removal of the atrophic composition of the sample of the pregnant woman's abdominal stretch marks.
  • Figure 21 is a photograph of Ms. Li's abdominal stretch marks before the trial.
  • Fig. 22 is a photograph of the 15th day of the removal of the atrophic composition by the example 1 of the test strip for the abdominal stretch marks of Ms. Li.
  • Figure 23 is a photograph of the 45th day of the removal of the atrophic composition of Example 1 of the test strip for the abdominal stretch marks of Ms. Li.
  • Figure 24 is a photograph of Ms. Han's leg growth pattern before trial.
  • Fig. 25 is a photograph of the 60th day of the removal of the atrophic composition by the example 1 of the leg growth pattern of Ms. Han.
  • Figure 26 is a photograph of Ms. Cui's leg growth pattern before trial.
  • Fig. 27 is a photograph of the 45th day of the removal of the atrophic composition by the example 1 of the Ms. Cui's leg growth pattern test.
  • Figure 28 is a photograph of Ms. Deng's abdominal stretch marks before the trial.
  • Figure 29 is a photograph of the 60th day of the removal of the atrophic composition of the example 1 of the abdomen stretch marks of Ms. Deng.
  • Figure 30 is a photograph of Ms. Shi's abdominal stretch marks before the trial.
  • Figure 31 is a photograph of the 60th day of the removal of the atrophic composition of the sample of the pregnant woman's abdominal stretch marks.
  • Fig. 32 is a clinical classification diagram of "area, number, and color of the atrophic pattern" on the 0th, 2nd, 4th, 6th, and 8th week.
  • Figure 33 is a histogram of the change in the clinical grade of the "atrophic area" at 0, 2, 4, 6, and 8 weeks.
  • Figure 34 is a histogram of the change in the clinical grade of the "atrophic pattern color" at 0, 2, 4, 6, and 8 weeks.
  • Figure 35 is a histogram of the change in the clinical grade of "number of atrophic lines" at 0, 2, 4, 6, and 8 weeks.
  • Fig. 36 is a graph showing the change in the average value of the "atrophic surface area" at 0, 2, 4, 6, and 8 weeks.
  • Figures 37-41 are the top five A-E users before the product is used (left side) and 8 weeks after product use (right side).
  • composition for removing the shrinkage pattern of the present embodiment is composed of a compound essential oil and a cream, and taking the preparation of the compound essential oil 100g as an example, the mass composition thereof is as follows:
  • the mass composition is as follows:
  • the mass percentage of the base cream is as follows:
  • the mass percentage composition of the essential oil composition is as follows:
  • the preparation method of the above compound essential oil is as follows: according to the above-mentioned mass composition, lavender essential oil, fragrant peach oil, frankincense essential oil, patchouli essential oil, zealand essential oil, carrot seed essential oil, rose grass essential oil, basil essential oil, fan are sequentially added to the basic essential oil.
  • the extract of rosemary is mixed to obtain the mixed essential oil; the six peptides are uniformly dissolved in water, and then added to the C12-13 alkanol polyether-3, and the mixture is uniformly stirred at room temperature, and then poured into the mixed essential oil, and uniformly mixed at room temperature. Packed and sealed to get the compound essential oil.
  • the above cream is prepared by adding water, 1,3-butanediol, glycerin, betaine, hexanediol, carbomer to an emulsifying tank, heating and stirring to 85 ° C for 20 minutes to obtain an aqueous phase; Caprylic/capric triglyceride, isodecyl isononanoate, dioctyl carbonate, cetearyl glucoside, polydimethylsiloxane, jojoba oil, potassium cetyl phosphate, added to the oil phase tank In the middle, heat to 85 ° C for 20 minutes to obtain the oil phase; lavender essential oil, fragrant almond oil, frankincense essential oil, patchouli essential oil, broccoli essential oil, carrot seed oil, rose grass essential oil, basil essential oil mixed and evenly, to obtain essential oil
  • the composition adding the oil phase to the emulsion tank, stirring evenly, homogenizing to cool to 75 ° C for 2 minutes, adding triethanolamine, stirring for 15 minutes, stirring
  • composition for removing the shrinkage pattern of the present embodiment is composed of a compound essential oil and a cream, and taking the preparation of the compound essential oil 100g as an example, the mass composition thereof is as follows:
  • the mass composition is as follows:
  • the mass percentage of the base cream is as follows:
  • the mass percentage composition of the essential oil composition is as follows:
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for removing the shrinkage pattern of the present embodiment is composed of a compound essential oil and a cream, and taking the preparation of the compound essential oil 100g as an example, the mass composition thereof is as follows:
  • the mass composition is as follows:
  • the mass percentage of the base cream is as follows:
  • the mass percentage composition of the essential oil composition is as follows:
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for removing the shrinkage pattern of the present embodiment is composed of a compound essential oil and a cream, and taking the preparation of the compound essential oil 100g as an example, the mass composition thereof is as follows:
  • the mass composition is as follows:
  • the mass percentage composition of the above base cream is the same as in Example 1, and the mass percentage composition of the essential oil composition is as follows:
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for removing the shrinkage pattern of the present embodiment is composed of a compound essential oil and a cream, and taking the preparation of the compound essential oil 100g as an example, the mass composition thereof is as follows:
  • composition of the cream was the same as in Example 1.
  • the preparation method of the compound essential oil and cream is also the same as in the first embodiment.
  • composition for removing the atrophic pattern of the present embodiment is composed of a compound essential oil and a cream, wherein the composition of the compound essential oil is the same as that of the first embodiment, and the preparation of the cream 100 g is taken as an example, and the mass composition thereof is as follows:
  • the mass percentage composition of the above base cream and essential oil composition was the same as in Example 1.
  • the preparation method of the compound essential oil and cream is also the same as in the first embodiment.
  • composition for eliminating the shrinkage pattern of this embodiment consisted of a combination essential oil and a cream, wherein the composition of the compound essential oil was the same as in Example 5, and the composition of the cream was the same as in Example 6.
  • the preparation method of the compound essential oil and cream is the same as in the first embodiment.
  • composition for eliminating the shrinkage pattern of this embodiment consists of a combination essential oil and a cream, wherein the composition of the compound essential oil is the same as in the first embodiment.
  • the mass composition is as follows:
  • the mass percentage composition of the base cream is the same as in Example 1, and the mass percentage composition of the essential oil composition is as follows:
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for removing the shrinkage pattern of this embodiment consisted of a combination essential oil and a cream, wherein the composition of the compound essential oil was the same as in Example 5. Taking 100g of the preparation cream as an example, the mass composition is as follows:
  • the mass percentage composition of the base cream was the same as in Example 1, and the mass percentage composition of the essential oil composition was the same as in Example 8.
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for eliminating the shrinkage pattern of this embodiment consists of a combination essential oil and a cream, wherein the composition of the compound essential oil is the same as in the first embodiment.
  • the mass composition is as follows:
  • the mass percentage composition of the base cream was the same as in Example 1, and the mass percentage composition of the essential oil composition was the same as in Example 8.
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • composition for removing the atrophic pattern of the present embodiment consisted of a compound essential oil and a cream, wherein the composition of the compound essential oil was the same as in Example 5, and the mass percentage composition of the cream was the same as in Example 10.
  • the preparation method of the above-mentioned compound essential oil and cream is the same as in the first embodiment.
  • the toxicology test was carried out on the cream in the composition of the atrophic pattern of Example 2, and the test was based on the 2015 edition of the "Technical Specifications for Cosmetics Safety", and the details are as follows:
  • test object (1), test object:
  • Feed Rabbit full-price pellet feed
  • source Xi'an Dilepu Biological Resources Open Co., Ltd.
  • Test conclusion The results of the multiple skin irritation test of the cream rabbits in the composition for removing the atrophic lines of Example 2 were non-irritating.
  • the toxicological test was carried out on the compound essential oil in the composition for removing the atrophic pattern of Example 2, and the test was based on the 2015 edition of the "Safety Technical Specification for Cosmetics", as follows:
  • test object (1), test object:
  • Feed Rabbit full-price pellet feed
  • source Xi'an Dilepu Biological Resources Open Co., Ltd.
  • Test conclusion The results of the multiple skin irritation test of the compound essential oil rabbit in the composition of the atrophic pattern of Example 2 were non-irritating.
  • mice 30 white guinea pigs, half male and half female, weighing 260-300 g. The animals were depilated on both sides of the spine with an electric razor 24 hours before the test, and the hair removal area on each side was 3 ⁇ 3 cm 2 .
  • Grouping of animals Guinea pigs were randomly divided into 3 groups according to gender and body weight, with 10 rats in each group, which were experimental group, positive control group and negative control group.
  • Test group Take 1cm 2 gauze block, soak it in compound essential oil for 5 minutes, as a patch, fix it semi-enclosed in the dorsal area of the animal for 6 hours, remove the patch, then apply cream, milk The amount of the paste applied was 0.5 g/cm 2 .
  • Positive control group Take 1cm 2 gauze block and soak it in formaldehyde solution with 0.1% mass fraction for 5 minutes. As a patch, fix it in the dorsal area of the animal for 6 hours to remove the patch. .
  • Negative control group 1 cm 2 gauze block was taken and soaked in physiological saline for 5 minutes. As a patch, it was semi-closed and fixed in the dorsal hair removal area of the animal for 6 hours to remove the patch.
  • the skin of each group of animals was observed and recorded for erythema and edema, and once a day for 6 consecutive days, the score was evaluated according to the standard, and the sensitization rate was calculated.
  • test results are expressed in terms of animal skin reaction intensity and sensitization positive rate.
  • the skin reaction intensity score is based on the following two criteria:
  • the total score is equal to the sum of the erythema and the edema, and in turn determines whether the animal has an allergic reaction.
  • the sensitization positive rate is the percentage of the ratio of the number of positive animals to the total number of animals, and the sensitization intensity of the chemical is classified according to the percentage. See Table 5 for sensitization intensity and Table 6 for test results.
  • Sensitization rate (%) grade Sensitization intensity 0-8 I Weak allergenicity 9-28 II Mild sensitivity 28-64 III Allergenicity 64-80 IV Strong allergenicity 81-100 V Extremely sensitizing
  • 1/3 1 / 3 in the table, that is, 3 with 1 point.
  • Example 1 Thirty people were randomly selected, and the compound essential oil and cream of Example 1 were applied to the inside of the arm of 30 persons for absorption. After 30 seconds, the person who applied the compound essential oil of Example 1 had a slight fever, and there was no discomfort. The person who applied the cream of Example 1 had no fever and no discomfort.
  • Example 1 of the present invention was applied once a day for 60 days, and the broken texture substantially disappeared, showing a normal skin condition (as shown in Fig. 7).
  • the composition for removing the atrophic pattern of the first embodiment of the present invention was applied once a day for 15 days, and the rough drying of the skin orange peel was remarkably improved, and the skin texture was fine and shortened (as shown in FIG. 11). ).
  • the growth pattern is formed for 2 years, and the leg has obvious and wide layered growth lines (see Fig. 24).
  • the atrophic pattern of the first embodiment of the present invention is removed every day. The composition was applied once for 60 days, and the white lines of the legs were narrowed and partially disappeared (see Figure 25).
  • the composition of the first embodiment of the present invention is used to smear the atrophic pattern according to the method of the above test 3. After four days of continuous use, some of the lines disappeared and some lines were significantly shortened (see Figure 27).
  • Example 1 of the present invention Ms. Deng, 35 years old, staff member, stretch marks for 6 years, the abdomen has more prominent lines, the texture is obviously larger, and there is pigmentation (see Figure 28).
  • the composition for removing the atrophic pattern of Example 1 of the present invention was applied once a day for 60 days for continuous use, and the texture was shortened and the pigmentation was lightened (see Fig. 29).
  • Example 1 of the present invention is used every day according to the method of Test 3 above.
  • the application was applied once for 60 days, the pigmentation was alleviated, and the left side lines were significantly improved (see Figure 31).
  • the product of the invention was commissioned by the Chinese Academy of Medical Sciences Dermatology Hospital to evaluate the efficacy and safety of the product. The details are as follows:
  • Exclusion criteria 1) Those who are known to be allergic to any component in the product, or those with allergies; 2) Those with obvious skin imperfections at the atrophic pattern may affect the evaluation of efficacy; 3) A history of severe heart disease, liver and kidney disease, high Patients with blood pressure; 4) patients with severe endocrine diseases, hematological diseases, neuropsychiatric diseases; 5) pregnant and lactating women; 6) taking or topical topical retinoic acid and glucocortico within 2 weeks before the start of the study Subjects of hormones; 7) Patients who are considered unsuitable for participation in the trial for other reasons.
  • the study must be withdrawn when the subjects enrolled in the study have any of the following conditions:
  • composition for removing the atrophic pattern of Example 2 consists of a compound essential oil and a cream
  • the study cycle was 8 weeks and each subject was followed up 5 times (0, 2, 4, 6, and 8 weeks).
  • the tester's shrinkage lines were evaluated by the investigator before use (0 weeks) and 2 weeks, 4 weeks, 6 weeks, and 8 weeks after use, respectively.
  • the photos were taken with a high-definition digital camera (the same light, distance, and shooting angle) to quantify the surface area of the shrinkage lines.
  • the subjects self-assessed to evaluate the improvement of the shrink lines.
  • the subjects After 76 weeks, the subjects returned to the clinic for clinical observation assessment and photographing, and filled out the self-assessment questionnaire. After 88 weeks, the subjects returned to the clinic for clinical observation assessment and photographing, and filled out a self-assessment questionnaire.
  • the surface area of the atrophic lines was quantified using Skin Surface Analyzer software.
  • Test samples were distributed to the subjects on the day of the start of the trial. After 8 weeks of continuous use, the samples were recorded and recovered.
  • the surface area of the atrophic pattern was quantitatively measured by SSA software, and objective quantitative parameters before and after use were obtained, combined with the evaluation of the researchers and subjects. Comprehensive evaluation of changes in the subject's shrinkage lines before and after product use.
  • the subjects were evaluated for photos before and after the atrophic pattern test, and the surface area of the atrophic lines was changed from the baseline percentage.
  • the quantitative indicator describes the number of cases, the mean value, and the standard deviation of the observed values.
  • the classification indicator describes the number and percentage of each category.
  • the quantitative analysis data of the shrinkage grain surface area did not conform to the normal distribution, and the validity analysis used the rank sum test to analyze the effects before and after the product was used.
  • the safety analysis list describes adverse events and adverse reactions, listing their causes and explanations. Refer to the “Technical Specifications for Cosmetics Safety” (2015 edition) issued by the State Food and Drug Administration to evaluate the safety of products.
  • the SSA analysis software (CK Company of Germany) was used to quantify the "surface area" index of the subject's shrinkage lines, combined with the doctor's clinical evaluation and the subject's self-assessment to evaluate the improvement of the shrinkage lines before and after the product was used. The results are as follows:
  • Figure 33 is a histogram of the change in the clinical grade of the "atrophic area" at 0, 2, 4, 6, and 8 weeks, where -3 indicates that the grade is reduced by three levels compared to the baseline value; -2 indicates: with baseline In comparison to the value, the grading is reduced by two levels; -1 means that the grading is reduced by one level compared to the baseline value; 0 means that the grading is unchanged compared to the baseline value.
  • Figure 34 is a histogram of the change in the clinical grade of the "atrophic pattern color" at 0, 2, 4, 6, and 8 weeks.
  • Figure 35 is a histogram of the change in the clinical grade of the "number of atrophic lines" at 0, 2, 4, 6, and 8 weeks.
  • the investigator's assessment of the grade, color, and surface area of the area of the atrophic pattern showed an improvement in 72% of subjects.
  • Table 8 shows that there was a statistically significant difference at p ⁇ 0.05 at 6 weeks and 8 weeks after use compared to the product before use.
  • Figure 36 shows that the surface area of the shrinkage grain has a downward trend before and after the product is used, and the statistics show that the surface area shrinks by more than 20%, accounting for 68.75% (see Annex 2 for the original data). It is suggested that the product has a certain improvement effect on the shrinkage lines.
  • Table 9 - Table 14 shows that 71.9% of the subjects believed that the number of shrink lines was reduced after using the product. 65.6% of the subjects thought that the area of the shrinkage pattern after using the product was reduced. 71.9% of the subjects thought that the color of the shrinking lines after the use of the product became lighter.
  • the effectiveness of the product including the quantitative analysis of the surface area of the shrinkage, clinical rating and the results of the self-evaluation of the subject, the product has an improvement effect on the shrinkage, the difference has statistical significane.

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Abstract

一种祛除萎缩纹的组合物，该组合物由复方精油和乳膏组成，其中复方精油包括基础精油、薰衣草精油、香桃木精油、乳香精油、广藿香精油、岩兰草精油、胡萝卜籽精油、玫瑰草精油、罗勒精油等，乳膏包括基础乳膏和精油组合物。将多种促进血液循环、刺激胶原蛋白再生、紧致肌肤、改善皮肤粗糙、重组纤维组织结构的天然植物精油与基础精油复配，配合多种滋润肌肤、促进吸收成分的乳膏使用，它们之间具有协同增效作用，功效性强，能够使有效成分迅速渗入皮肤而被吸收，达到祛除萎缩纹的同时滋润光滑肌肤的功效。

Description

一种祛除萎缩纹的组合物 技术领域
本发明属于护肤品技术领域，具体涉及一种祛除萎缩纹的组合物。
背景技术
植物精油产自含有香脂腺的芳香植物(Aromatic Herbst)，是芳香植物的高度浓缩提取物，是萃取自植物特有的芳香物质，如花、叶、根、树皮、果实、种子、树脂等以蒸馏、压榨方式提炼出来的。大多数植物精油都含有醇类、醛类、酸类、酚类、丙酮类、萜烯类。但它们实际所含成分是由一百多种以上构成，当然有些更高达数上千种成分构成。以玫瑰精油为例，86％是由三百多种成分组成，14％是由许多微量化合物组成。由于精油挥发性高，且分子小，很容易被人体吸收，并能迅速渗透人体内器官，将多余的成分排出体外，整个过程只需要几分钟，而植物本身的香味，也直接刺激脑下垂体的分泌，酵素及荷尔蒙分泌等，平衡体内机能，起到美容护肤的作用。可想而知精油对人体的奥秘是无比宽广的。
萎缩纹(妊娠纹/肥胖纹的总称)是人体在生长发育、怀孕或体重骤增过程当中产生的皮肤纤维断裂现象，由怀孕导致的萎缩纹又称妊娠纹。其形成主要是受荷尔蒙影响，局部组织的生长或膨隆使皮肤的弹力纤维与胶原纤维因外力牵拉而受到不同程度的损伤或断裂，皮肤变薄变细，腹部、臀部或其他部位会出现一些宽窄不同、长短不一的粉红色或***的波浪状花纹。一段时间后，这些花纹会逐渐消失，留下白色或银白色的有光泽的疤痕线纹，即萎缩纹。一些妊娠纹的患者往往还伴有腹部皮肤的松弛，甚至皮肤呈现出“橘皮样”的改变。
怀孕是大多数女性都会拥有的一件事情，据调查，有75％以上的怀孕女性在生育后会出现妊娠纹。女性怀孕时，体内激素发生巨大变化，包括***、孕激素、催产素、催乳素及皮质激素等，其中皮质激素由肾上腺分泌，它的增多会导致腹部皮肤出现色素沉着，增加皮肤弹力纤维和胶原纤维的脆性，随胎儿长大腹部逐渐增大，当腹部膨隆超出腹部皮肤的承受能力时，皮肤的弹力纤维和胶原纤维断裂，产生妊娠纹。但过于肥胖、突然增重或者受***激素影响，某些女性也会在未生育的情况下，出现类似于妊娠纹的肥胖纹，甚至一些病理性的因素，譬如肾上腺皮质功能减退、巨大卵巢肿瘤切除、大量腹水消退等等，也都可能出现类似的皮纹。
单方精油是单纯的一种植物精油，一般是100％纯度，不能直接用在皮肤上，一般加在化妆品中，通常要和基础油调合才能使用。复方精油是由两种以上的单方精油与基础油按照一定比例混合调配出来的，可直接用于皮肤护理。有相辅相成，增强疗效的作用。
复方精油作为以植物提取物为原料的产品，因其天然、安全的特性，被广泛应用于护肤品当中。但由于不同种类的精油存在协同拮抗作用，不同的配方组成得到的产品功效差异较大；大多针对促进血液循环，改善皮肤(需配合专业手法)等单一功效进行配比，目前去萎缩纹的复方精油大多数产品可用于全身按摩，且精油原液比重为2％～5％，使用时间长，效果不明显。 乳膏作为基质，多以安全性系数高且无防腐剂作为原料来源配合添加精油，而市面上大多数配合使用的乳膏安全性系数低，且大多数都是以滋润肌肤，添加胶原蛋白为宣称，使用时间长而效果却不太明显的产品。
发明内容
为了克服现有技术以及应用功效上的缺点与不足，本发明的目的在于提供一种能够有效改善并迅速被皮肤吸收、改善肌肤的松弛、滋润肌肤、祛除萎缩纹的组合物。
解决上述技术问题所采用的祛除萎缩纹的组合物由复方精油和乳膏组成，其中所述的复方精油由下述质量百分配比的原料组成：
Figure PCTCN2018112342-appb-000001
上述的复方精油优选由下述质量百分配比的原料组成：
Figure PCTCN2018112342-appb-000002
Figure PCTCN2018112342-appb-000003
上述的基础精油是玫瑰果油、葡萄籽油、澳洲坚果油中任意一种与荷荷巴油的混合物，优选玫瑰果油、葡萄籽油、澳洲坚果油中任意一种与荷荷巴油质量比为1:1～2的混合物。
上述的乳膏由下述质量百分配比的原料组成：
基础乳膏                    98.5％～99.5％
精油组合物                  0.5％～1.5％
上述的基础乳膏由下述质量百分配比的原料组成：
Figure PCTCN2018112342-appb-000004
上述的精油组合物由下述质量百分配比的原料组成：
Figure PCTCN2018112342-appb-000005
Figure PCTCN2018112342-appb-000006
上述的精油组合物优选由下述质量百分配比的原料组成：
Figure PCTCN2018112342-appb-000007
上述复方精油的制备方法为：按照上述质量百分配比，向基础精油中依次加入薰衣草精油、香桃木精油、乳香精油、广藿香精油、岩兰草精油、胡萝卜籽精油、玫瑰草精油、罗勒精油、迷迭香提取液，得到混合精油；将六胜肽均匀溶于水中，再加入到C12-13链烷醇聚醚-3中常温搅拌混合均匀，然后倒入混合精油中，常温搅拌混合均匀，分装、密封，即得到复方精油。
上述乳膏的制备方法为：按照上述质量百分配比，将水、1,3-丁二醇、甘油、甜菜碱、己二醇、卡波姆加入乳化罐中，加热搅拌至85℃保温20分钟，得到水相；将辛酸/癸酸甘油三酯、异壬酸异壬酯、碳酸二辛酯、鲸蜡硬脂基葡糖苷、聚二甲基硅氧烷、霍霍巴油、鲸蜡醇磷酸酯钾加入油相罐中，加热至85℃保温20分钟，得到油相；将薰衣草精油、香桃木精油、乳香精油、广藿香精油、岩兰草精油、胡萝卜籽精油、玫瑰草精油、罗勒精油混合搅拌均匀，得到精油组合物；将油相加入到乳化罐中，搅拌均匀，均质2分钟降温至75℃，加入三乙醇胺，保温搅拌15分钟，降温搅拌，抽真空；50℃加入馨鲜酮，继续降温至40℃，加入精油组合物、乙基己基甘油、六胜肽，继续抽真空缓慢搅拌冷却降温，灌装封存，即得到乳膏。
本发明祛除萎缩纹的组合物的使用方法为：将人皮肤有萎缩纹部位清洁后擦干水分，取复方精油涂于萎缩纹部位轻力按摩发热至吸收或涂抹于萎缩纹部位用保鲜膜覆盖至吸收，然后涂抹乳膏，轻轻按摩至吸收，其中复方精油的涂抹量为0.05～0.1mg/cm 2、乳膏的涂抹量为0.1～0.5mg/cm 2。
本发明各有效成分的功能如下：
薰衣草精油提取自薰衣草的花，其含有乙酸芳樟醚、牻牛儿醇、沉香醇、桉油醇、d-龙脑、柠檬稀、1-蒎烯、丁香烯、丁酸酯、缬草酸、香豆素，能有效紧致表皮肌肤，收敛毛孔，控制水油平衡，祛斑美白，祛皱嫩肤，还可促进受损组织再生恢复等护肤功能。
香桃木精油提取自叶子和细枝，主要成分桉油醇，另外还有香桃木醛、松油萜、牻牛儿醇、沉香醇和樟烯，它是一种特别温和的精油，具有抗菌和收敛的特性，能净化阻塞的皮肤进而消除突起物，也能驱散淤血，并改善干癣落屑的外观。
乳香精油萃取自乳香树脂，它的成分有1-蒎烯、二戊烯、水芹烯、樟烯、乳香醇及多种松香。散发着温馨清纯的木质香气，又透出淡淡的果香，可令人感受到从未有过的放松和舒缓。具有抗菌，促进伤口结疤，淡化疤痕、皱纹，增强细胞活性、镇静肌肤的作用，调理干燥、老化、暗沉的肌肤，恢复肌肤弹性、收紧毛孔。
广藿香精油提取自茎叶，主要成分有藿香醇、广藿香烯和正广藿香醇，少量的丁香酚、杜松烯、香芹酮等，它能够促进皮肤再生，减轻发炎现象，收敛毛孔，紧致肌肤，促进伤口愈结，有助于改善过分饮食造成的皮肤松弛。
岩兰草精油提取自根部，主要成分为岩兰酮、岩兰醇、岩兰烯和杜松烯。它能够调理、收敛皮肤，消炎杀菌，唤醒细胞，改善受损的肌肤，促进身体细胞再生及愈合。
胡萝卜籽精油提取自胡萝卜籽，主要化学成分为蒎烯、莰烯、桧烯、月桂烯、松油精或萜品烯、柠檬油精、红没药烯、乙酸香叶酯和胡萝卜烯醇。它使皮肤受到激励和恢复活力，能增加皮肤的弹力，在皮肤外表皮明显的作用是能消除皱纹。
玫瑰草精油提取自玫瑰草，它的主要成分是柠檬醛(约占75％～95％)，还有微量香茅醇、乙酸牻牛儿酯、金合欢醇等。它可以平衡皮脂分泌，重新形成肌肤表面的天然保水膜，起到了绝佳的保湿效果，也能够促进表皮细胞再生，抗菌、抗病毒、杀菌。
罗勒精油提取自叶子以及花朵，罗勒被称为‘香草之王’，对女性有很好的呵护作用，它具有抗老化，紧实皮肤，滋养皮肤，改善松垮、老化皮肤的作用。
六胜肽又称六元胜肽(Areginine Essence)，此物中具有活性的六角缩氨酸，有效舒缓并抑制额皱纹及周边肌肉的收缩与活动，帮助肌肉放松，使肌肤弹性组织恢复柔顺平滑的线条。它具有类似能抑制神经传导物质，阻断神经肌肉间的传导功能，避免肌肉过度收缩，就能防止细纹形成，减少动态纹的发生，能够重新恢复组织胶原弹力，使肌肤平滑紧致。
本发明将多种促进血液循环、刺激胶原蛋白再生、收敛紧致肌肤、改善皮肤粗糙、重组纤维组织结构的天然植物精油进行科学配伍，协同作用于祛除萎缩纹，并配合含有精油成分的乳膏使用，两者相辅相成，具有协同增效作用，功效性强，能够使有效成分迅速渗入皮肤而被吸收，祛除或淡化萎缩纹，促进细胞的再生，改善肌肤干燥松弛，对于萎缩纹有很好改善，达到祛除萎缩纹的同时滋润光滑肌肤的功效，且使用方法简单。
附图说明
图1是吴女士腹部妊娠纹试用前的照片。
图2是吴女士腹部妊娠纹试用实施例1祛除萎缩纹组合物20天的照片。
图3是吴女士腹部妊娠纹试用实施例1祛除萎缩纹组合物40天的照片。
图4是雷女士背部生长纹试用前的照片。
图5是雷女士背部生长纹试用实施例1祛除萎缩纹组合物第15天的照片。
图6是武女士腹部右侧妊娠纹试用前的照片。
图7是武女士腹部右侧妊娠纹试用实施例1祛除萎缩纹组合物第60天的照片。
图8是李女士腹部左侧妊娠纹试用前的照片。
图9是李女士腹部左侧妊娠纹试用实施例1祛除萎缩纹组合物第60天的照片。
图10是刘女士腹部妊娠纹试用前的照片。
图11是刘女士腹部妊娠纹试用实施例1祛除萎缩纹组合物第15天的照片。
图12是赵女士腹部妊娠纹试用前的照片。
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图14是江女士腿部生长纹试用前的照片。
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图16是秦女士背部生长纹试用前的照片。
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图24是韩女士腿部生长纹试用前的照片。
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图26是崔女士腿部生长纹试用前的照片。
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图28是邓女士腹部妊娠纹试用前的照片。
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图30是史女士腹部妊娠纹试用前的照片。
图31是史女士腹部妊娠纹试用实施例1祛除萎缩纹组合物第60天的照片。
图32是第0、2、4、6、8周“萎缩纹的面积、数量、颜色”临床分级图。
图33是第0、2、4、6、8周“萎缩纹面积”临床分级的变化值直方图。
图34是第0、2、4、6、8周“萎缩纹颜色”临床分级的变化值直方图。
图35是第0、2、4、6、8周“萎缩纹数量”临床分级的变化值直方图。
图36是第0、2、4、6、8周“萎缩纹表面积”平均值的变化线图。
图37-图41分别是A-E五位使用者在产品使用前(左侧的图)和产品使用后8周的情况(右侧的图)。
具体实施方式
下面结合附图和实施例对本发明做进一步详细说明，但本发明的保护范围不仅限于这些实施例。
实施例1
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，以制备复方精油100g为例，其质量组成如下：
Figure PCTCN2018112342-appb-000008
以制备乳膏100g为例，其质量组成如下：
基础乳膏                       99g
精油组合物                     1g。
上述乳膏中，基础乳膏的质量百分比组成如下：
Figure PCTCN2018112342-appb-000009
Figure PCTCN2018112342-appb-000010
上述乳膏中，精油组合物的质量百分比组成如下：
Figure PCTCN2018112342-appb-000011
上述复方精油的制备方法为：按照上述质量组成，向基础精油中依次加入薰衣草精油、香桃木精油、乳香精油、广藿香精油、岩兰草精油、胡萝卜籽精油、玫瑰草精油、罗勒精油、迷迭香提取液，得到混合精油；将六胜肽均匀溶于水中，再加入到C12-13链烷醇聚醚-3中常温搅拌混合均匀，然后倒入混合精油中，常温搅拌混合均匀，分装、密封，即得到复方精油。
上述乳膏的制备方法为：将水、1,3-丁二醇、甘油、甜菜碱、己二醇、卡波姆加入乳化罐中，加热搅拌至85℃保温20分钟，得到水相；将辛酸/癸酸甘油三酯、异壬酸异壬酯、碳酸二辛酯、鲸蜡硬脂基葡糖苷、聚二甲基硅氧烷、霍霍巴油、鲸蜡醇磷酸酯钾加入油相罐中，加热至85℃保温20分钟，得到油相；将薰衣草精油、香桃木精油、乳香精油、广藿香精油、岩兰草精油、胡萝卜籽精油、玫瑰草精油、罗勒精油混合搅拌均匀，得到精油组合物；将油相加入到乳化罐中，搅拌均匀，均质2分钟降温至75℃，加入三乙醇胺，保温搅拌15分钟，降温搅拌，抽真空；50℃加入馨鲜酮，继续降温至40℃，加入精油组合物、乙基己基甘油、六胜肽，继续抽真空缓慢搅拌冷却降温，灌装封存，即得到乳膏。
实施例2
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，以制备复方精油100g为例，其质量组成如下：
Figure PCTCN2018112342-appb-000012
Figure PCTCN2018112342-appb-000013
以制备乳膏100g为例，其质量组成如下：
基础乳膏                        99g
精油组合物                      1g。
上述乳膏中，基础乳膏的质量百分比组成如下：
Figure PCTCN2018112342-appb-000014
上述乳膏中，精油组合物的质量百分比组成如下：
Figure PCTCN2018112342-appb-000015
上述复方精油和乳膏的制备方法与实施例1相同。
实施例3
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，以制备复方精油100g为例，其质量组成如下：
Figure PCTCN2018112342-appb-000016
以制备乳膏100g为例，其质量组成如下：
基础乳膏                             99g
精油组合物                           1g。
上述乳膏中，基础乳膏的质量百分比组成如下：
Figure PCTCN2018112342-appb-000017
Figure PCTCN2018112342-appb-000018
上述乳膏中，精油组合物的质量百分比组成如下：
Figure PCTCN2018112342-appb-000019
上述复方精油和乳膏的制备方法与实施例1相同。
实施例4
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，以制备复方精油100g为例，其质量组成如下：
Figure PCTCN2018112342-appb-000020
Figure PCTCN2018112342-appb-000021
以制备乳膏100g为例，其质量组成如下：
基础乳膏                           99g
精油组合物                         1g。
上述基础乳膏的质量百分比组成与实施例1相同，精油组合物的质量百分比组成如下：
Figure PCTCN2018112342-appb-000022
上述复方精油和乳膏的制备方法与实施例1相同。
实施例5
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，以制备复方精油100g为例，其质量组成如下：
Figure PCTCN2018112342-appb-000023
Figure PCTCN2018112342-appb-000024
乳膏的组成与实施例1相同。复方精油和乳膏的制备方法也与实施例1相同。
实施例6
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例1相同，以制备乳膏100g为例，其质量组成如下：
基础乳膏                               99.5g
精油组合物                             0.5g
上述基础乳膏和精油组合物的质量百分比组成与实施例1相同。复方精油和乳膏的制备方法也与实施例1相同。
实施例7
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例5相同，乳膏的组成与实施例6相同。复方精油和乳膏的制备方法与实施例1相同。
实施例8
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例1相同。以制备乳膏100g为例，其质量组成如下：
基础乳膏                               99g
精油组合物                             1g。
上述乳膏中，基础乳膏的质量百分比组成与实施例1相同，精油组合物的质量百分比组成如下：
Figure PCTCN2018112342-appb-000025
上述复方精油和乳膏的制备方法与实施例1相同。
实施例9
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例5相同。以制备乳膏100g为例，其质量组成如下：
基础乳膏                                99g
精油组合物                              1g。
上述乳膏中，基础乳膏的质量百分比组成与实施例1相同，精油组合物的质量百分比组成与实施例8相同。
上述复方精油和乳膏的制备方法与实施例1相同。
实施例10
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例1相同。以制备乳膏100g为例，其质量组成如下：
基础乳膏                                 98.5g
精油组合物                               1.5g。
上述乳膏中，基础乳膏的质量百分比组成与实施例1相同，精油组合物的质量百分比组成与实施例8相同。
上述复方精油和乳膏的制备方法与实施例1相同。
实施例11
本实施例祛除萎缩纹的组合物由复方精油和乳膏组成，其中复方精油的组成与实施例5相同，乳膏的质量百分比组成与实施例10相同。
上述复方精油和乳膏的制备方法与实施例1相同。
为了证明本发明的有益效果，发明人采用实施例1的祛除萎缩纹的组合物进行了大量的研究试验，具体试验情况如下：
一、毒理学试验
对实施例2的祛除萎缩纹的组合物中的乳膏进行毒理学试验，检验依据为《化妆品安全技术规范》2015年版，具体内容如下：
1、材料和方法
(1)、受试物：
供试液的制备：原液
用量：每只动物用量为0.5ml
(2)、动物和饲养环境
动物：普通级新西兰家兔，4只，体重2.1kg-2.7kg，雌雄兼有，由西安市迪乐普生物资源开放有限公司提供。实验动物生产许可证号：SCXK(陕)2014-001。饲养环境：温度22℃-26℃， 相对湿度40％-70％，单笼饲养，自由饮水。实验动物使用许可证号：SYXK(陕)2013-001。动物相关信息如表1所示。
表1
动物编号 1 2 3 4
性别 雌 雌 雄 雄
体重(KG) 2.5 2.7 2.4 2.1
饲料：家兔全价颗粒饲料，来源：西安市迪乐普生物资源开放有限公司，饲料生产许可证号SCXK(陕)2014-004。
(3)、试验方法：
选用检疫合格的成年、健康、皮肤无损伤的家兔4只，试验前一天将家兔背部脊柱两侧被毛剪掉，去毛范围各为约3cm×3cm，表皮光滑无损。试验时取供试液0.5ml涂抹在左侧皮肤上，涂抹面积为2.5cm×2.5cm，右侧皮肤不作任何处理作为对照：每天涂抹1次，连续涂抹14d。从第二天开始，每次涂抹前剪毛并用温水清除残留受试物。1h后进行皮肤评分，按《化妆品安全技术规范》2015年版皮肤刺激性/腐蚀性试验有关规定进行皮肤刺激反应评分、判定皮肤刺激强度。
2、试验结果
试验期内，家兔试验区皮肤均未见红斑和水肿等皮肤刺激性反应，每只动物皮肤刺激反应积分均值为0.0，按《化妆品安全技术规范》2015年版皮肤刺激性/腐蚀性试验有关规定判定为无刺激性。
试验结果如表2所示。
表2 乳膏家兔多次皮肤刺激性试验结果
Figure PCTCN2018112342-appb-000026
Figure PCTCN2018112342-appb-000027
3、试验结论：实施例2的祛除萎缩纹的组合物中的乳膏家兔多次皮肤刺激性试验结果为无刺激性。
二、毒理学试验
对实施例2的祛除萎缩纹的组合物中的复方精油进行毒理学试验，检验依据为《化妆品安全技术规范》2015年版，具体如下：
1、材料和方法
(1)、受试物：
供试液的制备：原液
用量：每只动物用量为0.5ml
(2)、动物和饲养环境
动物：普通级新西兰家兔，4只，体重2.2kg-2.8kg，雌雄兼有，由西安市迪乐普生物资源开放有限公司提供。实验动物生产许可证号：SCXK(陕)2014-001。饲养环境：温度22℃-26℃，相对湿度40％-70％，单笼饲养，自由饮水。实验动物使用许可证号：SYXK(陕)2013-001。动物相关信息如表3所示。
表3
动物编号 1 2 3 4
性别 雌 雌 雄 雄
体重(KG) 2.3 2.2 2.6 2.8
饲料：家兔全价颗粒饲料，来源：西安市迪乐普生物资源开放有限公司，饲料生产许可证号SCXK(陕)2014-004。
(3)、试验方法：
选用检疫合格的成年、健康、皮肤无损伤的家兔4只，试验前一天将家兔背部脊柱两侧被毛剪掉，去毛范围各为约3cm×3cm，表皮光滑无损。试验时取供试液0.5ml涂抹在左侧皮肤上，涂抹面积为2.5cm×2.5cm，右侧皮肤不作任何处理作为对照：每天涂抹1次，连续涂抹14d。从第二天开始，每次涂抹前剪毛并用温水清除残留受试物。1h后进行皮肤评分，按《化妆品安全技术规范》2015年版皮肤刺激性/腐蚀性试验有关规定进行皮肤刺激反应评分、判定皮肤刺激强 度。
2、试验结果
试验期内，家兔试验区皮肤均未见红斑和水肿等皮肤刺激性反应，每只动物皮肤刺激反应积分均值为0.09，按《化妆品安全技术规范》2015年版皮肤刺激性/腐蚀性试验有关规定判定为无刺激性。
试验结果如表4所示。
表4 复方精油家兔多次皮肤刺激性试验结果
Figure PCTCN2018112342-appb-000028
3、试验结论：实施例2的祛除萎缩纹的组合物中的复方精油家兔多次皮肤刺激性试验结果为无刺激性。
三、皮肤过敏性试验
实验动物：白色豚鼠30只，雌雄各半，体重260～300g，试验前24小时用电动剃须刀将动物脊柱两侧去毛，每侧的去毛面积为3×3cm 2。
动物分组：将豚鼠按性别、体重随机分成3组，每组10只，分别为试验组、阳性对照组、阴性对照组。
试验组：取1cm 2纱布块，在复方精油中浸泡5分钟，作为斑贴物，将其半封闭固定在动物 背侧去毛区，持续6小时，去掉斑贴物，然后涂抹乳膏，乳膏的涂抹量为0.5g/cm 2。
阳性对照组：取1cm 2纱布块，在质量分数为0.1％的甲醛水溶液中浸泡5分钟，作为斑贴物，将其半封闭固定在动物背侧去毛区，持续6小时，去掉斑贴物。
阴性对照组：取1cm 2纱布块，在生理盐水中浸泡5分钟，作为斑贴物，将其半封闭固定在动物背侧去毛区，持续6小时，去掉斑贴物。
观察记录各组动物激发部位的皮肤有无红斑及水肿等现象，每天1次，连续6天，按标准进行评分，并算出致敏率。
结果判断与评价：试验结果以动物皮肤反应强度和致敏阳性率表示。皮肤反应强度评分按下列两种标准进行：
(1)形成很淡的红斑(勉强可见)为1分；轻度边界清晰的红斑为2分；中度红斑(鲜红-深红)为3分；重度红斑(深红-紫红，且有焦痂形成)为4分。
(2)形成很轻微的水肿(几乎观察不到)为1分；轻度水肿(边缘明显高出皮面)为2分；中度水肿(肿胀高出皮面约1mm)为3分；重度水肿(肿胀高出皮面1mm以上，范围超过斑贴区)为4分。
总积分等于红斑分与水肿分之和，并依次确定动物有无过敏反应。致敏阳性率是阳性动物数与合计动物数比值的百分率，根据此百分率对化学物质致敏强度进行分级。致敏强度分级见表5，试验结果见表6。
表5 致敏强度分级
致敏率(％) 等级 致敏强度
0-8 Ⅰ 弱致敏性
9-28 Ⅱ 轻致敏性
28-64 Ⅲ 中致敏性
64-80 Ⅳ 强致敏性
81-100 Ⅴ 极强致敏性
表6 致敏性试验结果表
Figure PCTCN2018112342-appb-000029
注：表中1/3＝1分/3只，即得1分者有3只。
从表6可以看出，试验组未出现1例致敏反应的动物，说明本发明去除萎缩纹的组合物中的复方精油和乳膏无致敏性。
四、刺激性测试
随机选取30名人员，采用实施例1的复方精油、乳膏在30名人员手臂内侧涂抹至吸收。30秒后，涂抹实施例1复方精油的人员有轻微发热现象，没有不适感，涂抹实施例例1乳膏的人员无发热现象，没有不适感。
五、功效测试
随机挑选30名志愿者进行试用实施例1的祛除萎缩纹的组合物，30名志愿者的年龄分布于25～50岁之间，均有不同程度的不同部位的萎缩纹症状，具体试用方法为：将人皮肤有萎缩纹部位清洁后擦干水分，取复方精油涂于萎缩纹部位轻力按摩发热至吸收，然后涂抹乳膏，轻轻按摩至吸收，其中复方精油的涂抹量为0.07mg/cm 2、乳膏的涂抹量为0.3mg/cm 2。试用持续6个月，试用结果以有功效作为指标，所述有功效为达到目标效果的志愿者人数占存在问题的志愿者总人数的百分比，试用结果如下：
试用1个月后：不论是身体的哪个部位，由于肥胖引起的肥胖纹或是怀孕引起的妊娠纹都在一定程度上有所淡化。试用结果显示30人都明显改善肌肤紧实度、萎缩纹纹路减轻的现象，有效率为100％；30名志愿者中有15人有因怀孕而导致的腹部、腿部等出现妊娠纹的现象，试用结果显示14人均有妊娠纹减轻且皮肤光滑透亮的现象，有效率为93.33％；30名志愿者中有15人是因为肥胖等其他原因导致的纹路，试用结果显示有14人纹路出现淡化，皮肤紧致细腻的现象有效率为93.33％；皮肤盈润透亮，紧致提升有效率为100％；综合来看，使用一个月后整体祛除萎缩纹的有效率为93.33％。
试用3个月后：30名志愿者由怀孕引起的妊娠纹的15人中，有13名出现身体部位九成的妊娠纹已经消失的现象并且肌肤柔嫩紧致，有效率为86.67％；而由于肥胖等因素引起的萎缩纹中有13名已经完全消失，1名九成纹路已经消失并且肌肤柔嫩紧致，有效率为93.33％。综合来看整体有效率为90％。
试用6个月后：30名志愿者由怀孕引起的妊娠纹的15人中，有14名出现身体部位全部的妊娠纹已经消失的现象并且肌肤柔嫩紧致，有效率为93.33％；而由于肥胖等因素引起的萎缩纹中15名志愿者的纹路已经完全消失，有效率为100％。综合来看整体有效率为96.65％。
六、典型案例
吴女士，33岁，职员，妊娠纹形成3年，腹部右侧有明显的妊娠纹，且纹路清晰，但面积不大(如图1所示)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用20天，纹路明显变短且部分已经褪去(见图2)，连续使用40天，之前妊娠纹的纹路成散乱的点状，有明显的褪去恢复的现象(见图3)。
雷女士，28岁，职员，前背部有明显的生长纹且呈长条状，纹路间隙较紧密(如图4所示)。 按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用15天，背部长条纹路基本呈现抚平的状态，凹凸的纹路已基本消失(如图5所示)。
武女士，33岁，职员，妊娠纹成形2年，腹部右侧有深色明显断裂的纹路，且有凹陷(如图6所示)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用60天，断裂的纹路基本消失，呈现出正常的皮肤状态(如图7所示)。
李女士，35岁，妊娠纹成形一年半，腹部左侧面呈现出层状的纹路，且手摸上去有明显的纹路感(如图8所示)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用60天，侧面的纹路已经消失，且手摸上去无明显纹路感，细腻柔和(如图9所示)。
刘女士，30岁，职员，腹部妊娠纹成形3年，腹部区域呈现橘皮波浪形纹路且纹路面积较大，纹路杂乱，皮肤干燥粗糙(如图10所示)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用15天，皮肤橘皮粗糙干燥现象明显改善，皮肤纹路细致且变短小(如图11所示)。
赵女士，35岁，妊娠纹形成4年，腹部有明显色素沉积圈，纹路面积较大且呈网状(如图12所示)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用11天，色素圈明显减小、颜色减弱，腹部下方和侧面纹路明显减轻(如图13所示)。
江女士，30岁，妊娠纹成形4年，腿部有较长似根状的纹路(如图14所示)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用24天，腿部纹路明显减短减轻(如图15所示)。
秦女士，28岁，职员，生长纹形成1年，背部生长纹较长且较深(如图16所示)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用38天，背部生长纹纹路长度变短，深度变浅(如图17所示)。
冯女士，31岁，职员，妊娠纹形成2年，腹部侧面有明显的皮肤断裂现象，断裂处有明显的***痕迹(如图18所示)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用10天，紫色纹路颜色淡化(如图19所示)，连续使用15天，皮肤纹路颜色恢复正常，纹路基本减退(如图20所示)。
李女士，32岁，职员，妊娠纹成形2年，左右两侧呈现出皮肤层有明显断裂现象(见图21)，断裂处有明显色素沉积(右侧较重)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用30天，有明显的纹路、色素淡化现象(见图22)；连续使用45天，两侧纹路基本淡化，断裂层呈现修复状态(右侧仍有轻微断裂)，如图23所示。
韩女士，27岁，职员，生长纹形成2年，腿部有明显、较宽的层状生长纹(见图24)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用60天，腿部白色纹路一部分变窄，一部分消失(见图25)。
崔女士，23岁，学生，生长纹形成5年，腿部内侧有明显的纹路现象(见图26)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用45天，部分纹路消失，部分纹路明显缩短(见图27)。
邓女士，35岁，职员，妊娠纹形成6年，腹部有较多突出的纹路，纹路明显面积较大，且带有色素沉积现象(见图28)。按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用60天，突出纹路减短，色素沉积淡化(见图29)。
史女士，36岁，职员，妊娠纹形成4年，腹部皮肤纹路突出且有严重的色素沉积现象(见图30)，按照上述试验3的方法每天用本发明实施例1的祛除萎缩纹的组合物涂抹1次，连续使用60天，色素沉积减轻，左侧纹路明显改善(见图31)。
七、功效评价试验
本发明的产品委托中国医学科学院皮肤病医院进行了功效评价试验，以评价该产品对萎缩纹的改善及安全性。具体内容如下：
1、研究目的与方法：通过一组受试者使用前及使用8周后萎缩纹的严重程度(包括萎缩纹表面积的量化分析)的对比，评价产品的改善萎缩纹的功效及安全性。本临床试验采用单中心、自身前后对照设计，对自愿参加、符合要求的萎缩纹受试者发放使用产品、完成临床观察。
(1)入选标准：1)年龄18-45岁身体健康女性；2)腹部，股内外侧，膝部或其他部位有明显萎缩纹；3)近三个月未参加其他临床研究；4)同意参加本研究并签署知情同意书；
(2)排除标准：1)已知产品中任何组分过敏者，或过敏体质者；2)萎缩纹处有明显皮肤瑕疵可能影响疗效评价者；3)严重的心脏病史，肝肾疾病，高血压患者；4)严重的内分泌疾病、血液病、神经精神疾病患者；5)妊娠期和哺乳期妇女；6)研究开始前2周内，服用过或局部外用过维A酸类药物和糖皮质激素的受试者；7)研究者认为由于其他原因不适合参加试验的患者。
(3)受试者退出和中止标准
在研究过程中，所有签署知情同意书并筛选合格进入临床研究的受试者，有权要求在任何时间无条件退出研究。无论何时因何种原因退出临床研究，只要受试者没有完成研究方案中安全性和有效性的观察，均视为中止研究，而中止研究的受试者为脱落病例。中止研究的时间和原因应记录在病例报告表中。
当入选本研究的受试者发生下列任一情况时，必须退出本研究：
1)受试者出现难以耐受的不良事件或者需要改变治疗策略而偏离临床研究方案；2)受试者主动要求退出研究；3)严重违背研究方案，并影响研究安全性和有效性评估；4)失访，与受试者失去联系；5)妊娠；6)出于安全性以及权益考虑，研究者认为受试者不适宜继续参加研究。
(4)研究产品：
实施例2的祛除萎缩纹的组合物，由复方精油和乳膏组成
产品使用方法：将复方精油涂抹于萎缩纹处、再涂抹乳膏，适当按摩帮助吸收。每天至少 使用1次，推荐2次/天。
研究流程周期为8周，每位受试者随访5次(第0、2、4、6、8周)。分别在使用前(0周)和使用后2周、4周、6周、8周后由研究者对受试的萎缩纹进行评估。第0、2、4、6、8周，用高清数码相机进行拍照(同样的光线、距离及拍摄角度)，对萎缩纹的表面积进行量化分析。第0、2、4、6、8周，受试者自我评估，来评价萎缩纹的改善情况。
①第0周，对受试者进行试验说明。②对参加试验的受试者按照试验要求进行筛选，入组35名合格受试者，签署知情同意书。③合格受试者填写自我评估问卷后进行临床观察评估和拍照。④对受试者进行使用说明，受试者听取说明后，发放产品，受试者在家连续8周使用试验样品。提醒受试者按照试验的指示在产品连用2周、4周、6周、8周后进行回访。⑤2周后，受试者回访，进行临床观察评估和拍照，并填写自我评估问卷。⑥4周后，受试者回访，进行临床观察评估和拍照，并填写自我评估问卷。⑦6周后，受试者回访，进行临床观察评估和拍照，并填写自我评估问卷。⑧8周后，受试者回访，进行临床观察评估和拍照，并填写自我评估问卷。用Skin Surface Analyzer软件量化分析萎缩纹的表面积。
在试验开始当天向受试者发放试验样品。连用8周后，记录并回收样品。
(5)受试者注意事项
①试验期间，禁止对被测部位进行影响测试的治疗。②试验期间，禁止在测试使用其他同类产品及其它影响测试的产品。
(6)有效性评价
1)评价指标
入组及每次随访时、通过高清数码相机拍照(相同光线、距离、角度)、用SSA软件定量测量萎缩纹的表面积，获得使用前后的客观量化参数，结合研究者和受试者的评价，综合评价受试者萎缩纹在产品使用前后的变化情况。
2)疗效指标
观察结束时，受试者萎缩纹试验前后照片评估、萎缩纹表面积较基线百分比的变化。
(7)安全性评价
参照《化妆品安全技术规范》2015版皮肤反应分级标准进行评判，其中，表7为人体使用试验皮肤反应分级标准。
表7
皮肤反应 分级
无反应 0
微弱红斑 1
红斑、浸润、丘疹 2
红斑、水肿、丘疹、水疱 3
红斑、水肿、大疱 4
(8)统计分析
样本量的估算《化妆品安全技术规范》2015版人体试用试验安全性评价要求按受试者入选标准选择自愿受试者至少30例，考虑到可能发生10-20％的脱落，确定入选样本量为35例。
所有的统计检验均采用双侧检验，除非特别说明，P≤0.05将被认为所检验的差异具有统计学意义。定量指标描述观察值的例数、均值、标准差。分类指标描述每一种类的例数及百分比。因萎缩纹表面积量化分析数据不符合正态分布，有效性分析采用秩和检验对使用产品前后的效果进行分析。安全性分析列表描述不良事件和不良反应，列出其原因和解释。参照国家食品药品监督管理总局印发的《化妆品安全技术规范》(2015年版)评价产品的安全性。
2、结果：
(1)受试者基本情况
本项试验共有35名符合入选标准的受试者自愿参加，签署知情同意书。年龄最小23岁，最大45岁，平均29.875岁。其中3例因出差不能按时随访脱落，其余32全部完成了8周的临床观察。
(2)有效性评价
利用SSA分析软件(德国CK公司)对受试者萎缩纹的“表面积”指标就行了量化分析，结合医生临床评估以及受试者自我评估来评价产品使用前后萎缩纹的改善情况。结果如下：
1)研究者对萎缩纹的临床评级
图32为第0、2、4、6、8周“萎缩纹的面积、数量、颜色”临床分级，其中，下降百分比*百分比＝(Wn-W0)/W0*100％。
图33为第0、2、4、6、8周“萎缩纹面积”临床分级的变化值直方图，其中，-3表示：与基线值相比，分级减少三级；-2表示：与基线值相比，分级减少两级；-1表示：与基线值相比，分级减少一级；0表示：与基线值相比，分级没有改变。图34为第0、2、4、6、8周“萎缩纹颜色”临床分级的变化值直方图。图35为第0、2、4、6、8周“萎缩纹数量”临床分级的变化值直方图。
研究者根据萎缩纹区域的颜色，数量及表面积的分级变化评估显示72％的受试者有所改善。
2)用SSA软件对产品使用前、后萎缩纹表面积的量化分析结果：见表8、图36，其中，表8为第0、2、4、6、8周“萎缩纹表面积”统计分析结果，图36为第0、2、4、6、8周“萎缩纹表面积”平均值的变化线图。
表8
时间 N 均值±标准差 P值
w0 32 6.1303±3.14995  
w2 32 5.5941±2.80466 0.417
w4 32 4.9769±2.33612 0.082
w6 32 4.5303±2.31075 0.016
w8 32 4.3616±2.46769 0.008
表8显示与产品使用前相比，在使用后第6周、8周，p＜0.05，有统计学显著性差异。
图36显示萎缩纹表面积在产品使用前后成下降趋势，且统计显示：表面积缩小大于20％以上者占68.75％(原始数据见附件2)。提示产品对萎缩纹有一定的改善作用。
3)受试者对产品功效的评价如表9-表14所示。
表9
Figure PCTCN2018112342-appb-000030
表10
Figure PCTCN2018112342-appb-000031
表11
Figure PCTCN2018112342-appb-000032
表12
Figure PCTCN2018112342-appb-000033
表13
Figure PCTCN2018112342-appb-000034
表14
Figure PCTCN2018112342-appb-000035
Figure PCTCN2018112342-appb-000036
表9-表14显示有71.9％的受试者认为使用产品后萎缩纹的数量减少。有65.6％的受试者认为使用产品后萎缩纹的面积减小。有71.9％的受试者认为使用产品后萎缩纹的颜色变淡。
4)照片评估部分受试者使用产品前、后的照片对比，具体如图37-图41所示，分别为A-E五位使用者在产品使用前(左侧的图)和产品使用后8周的情况(右侧的图)。
图37-图39所代表的A、B、C三位使用者的情况显示萎缩纹明显改善。图40、图41所代表的D、E两位使用者的情况显示萎缩纹基本消失。提示该产品对萎缩纹确实有改善作用。
(3)安全性评价
在使用产品的8周期间，研究者未见受试者皮肤有红斑、丘疹等明显不良反应。受试者在使用产品后8周随访的问卷结果见下表15：
表15
Figure PCTCN2018112342-appb-000037
从表15中可见，只有2名受试者报告局部有灼热感。93.7％的受试者无不良反应，说明产品的耐受性良好。
3、结论
综上所述，本次试验中，产品的有效性评价，包括对萎缩纹表面积的量化分析、临床评级以及受试者自我评价的结果综合来看，该产品对萎缩纹有改善作用，其差异具有统计学意义。在8周的观察中，绝大多数受试者(93.7％)无任何皮肤不良反应报告，产品的耐受性良好。

Claims (7)

  1. 一种祛除萎缩纹的组合物，其特征在于由复方精油和乳膏组成，所述的复方精油由下述质量百分配比的原料组成：
    Figure PCTCN2018112342-appb-100001
    所述的乳膏由下述质量百分配比的原料组成：
    基础乳膏                               98.5％～99.5％
    精油组合物                               0.5％～1.5％
    上述的精油组合物由下述质量百分配比的原料组成：
    Figure PCTCN2018112342-appb-100002
  2. 根据权利要求1所述的祛除萎缩纹的组合物，其特征在于所述的复方精油由下述质量百分配比的原料组成：
    Figure PCTCN2018112342-appb-100003
    Figure PCTCN2018112342-appb-100004
  3. 根据权利要求1或2所述的祛除萎缩纹的组合物，其特征在于：所述的基础精油是玫瑰果油、葡萄籽油、澳洲坚果油中任意一种与荷荷巴油的混合物。
  4. 根据权利要求1或2所述的祛除萎缩纹的组合物，其特征在于：所述的基础精油是玫瑰果油、葡萄籽油、澳洲坚果油中任意一种与荷荷巴油质量比为1:1～2的混合物。
  5. 根据权利要求3所述的祛除萎缩纹的组合物，其特征在于：所述的基础精油是玫瑰果油、葡萄籽油、澳洲坚果油中任意一种与荷荷巴油质量比为1:1～2的混合物。
  6. 根据权利要求1所述的祛除萎缩纹的组合物，其特征在于所述的基础乳膏由下述质量百分配比的原料组成：
    Figure PCTCN2018112342-appb-100005
    Figure PCTCN2018112342-appb-100006
  7. 根据权利要求1或6所述的祛除萎缩纹的组合物，其特征在于：所述的精油组合物由下述质量百分配比的原料组成：
    Figure PCTCN2018112342-appb-100007
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