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Determination method of sunscreen index of cosmetics
The purpose of this study is to establish a method for the determination of the SPF of cosmetics consistent with ISO by measuring the SPF of sunscreen ingredients and comparing the consistency of in vitro and in vivo detection methods. Research contents 1. Sun protection factor (SPF) test of 12 sunscreen cosmetic ingredients; 2. Long-wave UV protection index (PFA value) determination of 6 sunscreen cosmetic ingredients; 3. Applicability of testing according to ISO sunscreen function testing method. Test substance 1. The sunscreen agent is selected from 14 kinds of sunscreen agents limited in the 'Hygienic Standards for Cosmetics (2007 Edition)', and the concentration is set to the maximum allowable concentration. Among them, 12 kinds of SPF values were determined, and 6 kinds of PA values were determined. The relevant information is shown in Table 1. 2. Reference substance PA: S1 is 4.0 (ISO24442 reference value is 4.4±0.6); SPF: 4.0 for P7 (ISO24444 reference value is 4.4±0.4). Subjects All subjects are required to sign a written informed consent form after being informed of the relevant contents of the trial. All trials should comply with the basic principles of the International Declaration of Helsinki and national regulations on human trials. 1. Inclusion criteria 1.1 Select healthy volunteers aged 18~60 years old, both male and female. 1.2 SPF measurement Subject requirements: skin type II or III, that is, sensitive to sunlight or ultraviolet radiation, and prone to appear after exposure Those who are sunburned and less prone to hyperpigmentation; and the subject's skin colorimetric ITA°Value should be > 28°. 1.3 Subject requirements for PA determination: light skin type III or IV, that is, those with different degrees of pigmentation after the skin is irradiated by ultraviolet rays; and the subject's skin colorimetric ITA°value at 20°to 41°between. Exclusion criteria 2.1 Past history of photosensitivity disease or recent use of drugs or foods that affect skin photosensitivity 2.2 Immunosuppressive drugs used within the past month 2.3 Oral or topical use of anti-inflammatory drugs such as corticosteroids recently 2.4 Skin of the test site Pigmentation, inflammation, scars, pigmented moles, hirsutism, etc. 2.5 Lactating or pregnant women 2.6 Patients with immunodeficiency or autoimmune diseases, such as HIV-positive patients or patients who have undergone organ transplantation Cancer chemotherapy or radiotherapy 2.8 Those who cannot avoid frequent sun exposure at the test site 2.9 Those who have a highly sensitive constitution 2.10 Those who have undergone similar experiments in the past two months The number of subjects The number of subjects in each test should be no less than 10, and the maximum number of subjects is 25. Test method 1. Test method for sun protection factor (SPF) of sunscreen cosmetics 1.1 Selection of standard reference substance If the expected SPF value is less than 20, any of the following standard reference substances can be used: P2, P3 or P7. SPF as expected≥20. One of the following standard controls can be used: P2 or P3. If a high SPF standard reference substance is used, even if a low SPF value test sample is detected in the experiment, there is no need to use a low SPF value standard reference substance for control. 1.2 The artificial light source used for the light source must be a xenon arc lamp daylight simulator with a filter system. The UV heliostat should emit a continuous spectrum with no gaps or extreme emission peaks in the UV region. The light source output of the UV simulator should be stable and uniform over the entire beam cross-section, and must be equipped with an appropriate filtering system so that the spectral characteristics of the output meet acceptable limits. The spectral features are described by the cumulative erythema effect in the continuous waveband from 290nm to 400nm. The erythema effect of each band can be expressed as a percentage value of the total erythema effect at 290nm-400nm, that is, the relative cumulative erythema effect (%RCEE) (Relative Cumulative Erythemal Effectiveness).
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