Measurement method for determining protection factor and protection factor evaluation system

Abstract

The present invention describes a method for determining a protection factor, which includes spectroscopic measurement comprising the following steps: emitting radiation from a beam source, the emitted radiation including light with an irradiation wavelength between 280 nm and 2000 nm; irradiating a measurement body with the emitted radiation; detecting radiation diffusely reflected by the irradiated measurement body at a detection wavelength; and evaluating the protection factor of the protective measure at the evaluation wavelength from the diffusely reflected radiation and the transmission spectrum, using transmission spectrum data used for evaluating the protection factor of the protective measure, an evaluation wavelength different from the wavelength range of the irradiation wavelength and / or detection wavelength, and transmission spectrum data that is in silico data.The present invention also describes an SPF evaluation system for determining the protection factor of a protective measure, which comprises the following components: a measuring device having a beam source device including a beam source, a detector unit, a control unit for controlling the measuring device, and an evaluation unit.

Description

[Technical Field]

[0001] The present invention relates to a method for determining a protection factor, the method steps including: emitting radiation from a beam source, the emitted radiation including light with an irradiation wavelength between 280 nm and 2000 nm; irradiating a measurement body with the emitted radiation; detecting radiation diffusely reflected by the irradiated measurement body at a detection wavelength; and evaluating the protection factor of a protective measure at an evaluation wavelength and transmission spectrum from the diffusely reflected radiation using transmission spectrum data used for evaluating the protection factor of the protective measure, an evaluation wavelength different from the wavelength range of the irradiation wavelength and / or detection wavelength, and transmission spectrum data that is in silico data. The present invention also describes an SPF evaluation system for determining the protection factor of a protective measure, comprising the following components: a measuring device having a beam source device including a beam source, a detector unit, a control unit for controlling the measuring device, and an evaluation unit. [Background technology]

[0002] All of the methods for determining SPF (Sun Protection Factor) previously approved by the European Community (EU) and the U.S. Food and Drug Administration (FDA) (COLI PA-15 European Cosmetic, Toiletry and Perfumery Association: Colipa SPF Test Method 94 / 289, 1994, ISO Standards 24442, 24443, 24444) are harmful to participating subjects by causing erythema, i.e., a photoinduced inflammatory skin reaction. Therefore, both the FDA and the EU have repeatedly pointed out that future research efforts should be directed toward new methods for characterizing the protective efficacy of sunscreen products to avoid long-term effects on subjects (European Commission, 20 Standardization Mangate Assigned to CEN Concerning Methods for Testing Efficacy of Sunscreen Products, M / 389EN, Brussels, July 12, 2006). Summary of the Invention

[0003] The present invention is intended to achieve this goal.Existing procedures are defined in a variety of sources.

[0004] The procedures specified in the standards and regulations are as follows:

[0005] a. ISO 24444 specifies a method for determining SPF in vivo. This method is based on the occurrence of erythema on the skin of subjects exposed to UVB radiation. Therefore, this method is harmful to the subjects.

[0006] b. ISO 24443 specifies an in vitro method for determining the UVA protection factor (UVAPF). The protection measure is applied to a plastic plate, which allows the transmission spectrum of the protection measure to be measured. Due to uncontrollable variations in the procedure, the transmission spectrum is adapted to the results of the erythema test according to ISO 24444 by scaling and is therefore implementation dependent. The plastic plate used has a rough surface and is an unrealistic skin model.

[0007] c. ISO 24442 defines an in vivo method in which the UVA protection factor is determined using the minimum UVA dose required to produce irreversible pigmentation (tanning) of the skin. This method also produces changes in the skin of subjects.

[0008] CROSS-REFERENCE TO RELATED APPLICATIONS DE 19828497 A1 describes a method in which, like ISO 24444, erythema is induced in subjects by UV irradiation of the skin. In contrast to ISO 24444, the erythema is detected by reflectance spectroscopy. This method therefore also produces damage. The optical effect of the protective measures (protection) is not recorded by direct optical measurements, but by the biological response of the body.

[0009] DE 10 2004 020 644 A1 describes a method for quantitatively measuring the generation of radicals due to UV exposure in vivo using electron spin resonance (ESR). Here, too, the optical effect of the protective measures is only indirectly recorded. Furthermore, ESR measurements are technically complex and require relatively large, stationary devices (tabletop devices). They are also sensitive to interference from radiofrequency radiation or to rapid, transient magnetic field changes, such as those caused by electrical switching processes. [Problem to be solved by the invention]

[0010] Test methods such as ISO 24444, FDA guidelines, or Australian Standards are used worldwide to determine the label SPF of topically applied protective measures in vivo. The basis of all these methods is the induction of a skin erythema response by irradiating the skin with UV light. This is necessary to determine the minimum erythema dose for untreated skin (MEDu) and formulation-treated skin (MEDp). Reliable in vitro methods that replace human skin with a synthetic substrate carrier are not available for determining SPF.

[0011] Monochromatic devices are known that use conventional xenon lamps and are therefore expensive to purchase and operate. The built-in monochromator measures different wavelengths one after the other, which is a disadvantage when the subject is moving. Polychromatic devices also use xenon lamps. In vivo measurements are weighted using filters to match the in vivo UVA PF. Laboratory multi-LED devices represent another variant, but due to the spectral detection, they are significantly larger and more expensive.

[0012] It is therefore an object of the present invention to provide a method for determining protection factors, which reduces radiation exposure on human skin, provides high quality analytical results, and is at the same time quick and easy to perform.

[0013] It is also an object of the present invention to provide an SPF rating system for the assessment of the protection factor of protective measures, which system provides high quality analytical results, reduces radiation exposure on human skin, and is cost-effective to manufacture and operate.

[0014] This object is achieved by the method according to the invention for determining the protection factor. Advantageous embodiments of the invention are set out in the following dependent claims.

[0015] The method for determining a protection factor including spectroscopic measurements according to the present invention comprises four method steps. In the first method step, radiation is emitted from a beam source. The emitted radiation comprises light with an irradiating wavelength between 280 nm and 2000 nm, preferably between 280 and 800 nm, and particularly preferably between 280 and 500 nm. In the context of this document, a beam source is a technical device for generating electromagnetic radiation. Therefore, the beam source is not an optical element for directing, deflecting, or changing the intensity and / or wavelength of the electromagnetic radiation. Therefore, the beam source is not, for example, a light guide, grating, prism, or filter. The beam source generates electromagnetic radiation with an irradiating wavelength between the blue spectral range (wavelengths of approximately 400 nm to 500 nm) and the UV range (280 nm to 400 nm).

[0016] The wavelength ranges are defined as follows: -<320nm (UVB), <0.1% of total UV intensity -320nm~340nm (UVA II), 8%~20% of total UVA intensity -340nm~400nm (UVA I), 80%~92% of total UVA intensity -400nm~500nm, blue light Preferably, the irradiation wavelength covers the wavelength range between 280 nm and 500 nm.

[0017] In a second method step, the measuring body is irradiated with the emitted radiation. In the case of in vivo measurements, the measuring body is human skin covered with the protective means to be tested, and in the case of in vitro measurements, the measuring body is a standardized test body covered with the protective means to be tested.

[0018] In a third method step, the diffusely reflected radiation of the irradiated measuring body is detected at a detection wavelength. The ratio of the intensity of the diffusely reflected radiation to the radiation coupled into the measuring body is a measure of the protective ability of the protective measure. The detection wavelength, like the irradiation wavelength, preferably includes a wavelength range, and the wavelength range of the detection wavelength preferably lies within the range of the irradiation wavelength or includes the entire range of the irradiation wavelength. Thus, the spectroscopic measurement particularly includes the recording of the diffuse reflectance spectrum I(λ) (diffuse backscattering).

[0019] In the fourth step of the method, the protection factor of the protective means is evaluated using the evaluation wavelength and the transmission spectrum from the diffusely reflected radiation, and the transmission spectrum data is used to evaluate the protection factor of the protective means. The transmission spectrum is determined based on the UV transmittance of the protective film in vitro. The substrate to which the protective film is applied only approximately replicates the uneven surface structure of human skin, for example, a polymethyl methacrylate (PMMA) sheet with a rough surface according to ISO 24443. The transmission spectrum data preferably includes intensity versus wavelength in digitized form.

[0020] The evaluation wavelength is the wavelength at which the protection factor is determined. The evaluation wavelength is different from the wavelength range of the irradiation wavelength and / or the detection wavelength. The evaluation wavelength is preferably a wavelength range similar to the irradiation wavelength and the detection wavelength, and the wavelength range of the evaluation wavelength includes at least the wavelength range of the irradiation wavelength and / or the detection wavelength.

[0021] Advantageously, the transmission spectral data are in silico data. Therefore, the transmission spectral data are not determined in vivo on a subject or in vitro according to ISO 24443, but are mathematically estimated or determined. If the properties of the filter material of the protection means are known, the transmission can be calculated and simulated. Based on the simulated transmission, the sun protection factor and all parameters characterizing the protection factor can be calculated.

[0022] The protection factor (SPF) is a scientific measure that indicates how low the risk of skin damage is when protective measures are used. This factor focuses on the time it takes for UVB rays to penetrate a protective measure and redden the skin (minimal erythema, MED) compared to the time it takes in the absence of protective measures. The dose of solar radiation required to cause skin reddening is divided by the dose required to cause reddening without protective measures. This calculation is based on applying 2 milligrams of protective measures per square centimeter of skin surface. Currently, the SPF of protective measures is determined by in vivo irradiation using a sun simulator (ISO 24444:2010 "Cosmetics - Sun protection test methods - In vivo determination of the sun protection factor (SPF)"), which represents the current state of the art. The basis for current testing of protective measures is to irradiate test subjects before and after applying the protective measures.

[0023] The advantage of the method according to the invention lies in the fact that in silico data do not represent a standard and can currently only be used for estimation, however the deviation of the estimates from the real data is significantly improved by the method according to the invention.

[0024] In a further development of the invention, the wavelength range of the transmission spectrum includes the evaluation wavelengths. The evaluation of the protection factor of the protective measure is based on the in vivo diffusely reflected radiation and the in silico transmission spectrum. Due to its high absorption characteristics, human skin does not emit enough UVB radiation to measure the absorption spectrum of the applied product in the UVB range. Therefore, it is necessary to separately record the absorption spectrum of the test material in the UVB part of the spectrum (280-320 nm) using a different technique. The approach applied herein uses the in vivo evaluation of the absolute UVA absorption spectrum measured by in vivo measurements using the calculated in silico transmission spectrum to determine the protection factor of the protective measure for the user. Evaluation and hybridization of the in vivo remission spectrum with the in silico transmission spectrum is performed to obtain the complete UV spectrum, and the protection factor is then calculated according to the formula of the applicable standard (ISO 24443). For this purpose, the wavelength range of the transmission spectrum preferably includes evaluation wavelengths covering the range from 280 nm to 500 nm.

[0025] In a further embodiment of the invention, the evaluation wavelengths comprise the wavelength range of 280 nm to 2000 nm, preferably the wavelength range of 280 nm to 800 nm, or particularly preferably the wavelength range of 280 nm to 500 nm. In a further development, the evaluation wavelengths cover the wavelength range of 400 nm to 500 nm, preferably 400 nm to 450 nm. Preferably, the wavelength range of blue light adjacent to the UVA range (up to 400 nm) is evaluated. Optionally, this wavelength range can also be evaluated in the UVB wavelength range (<320 nm) to determine the protective capacity of the protection measure.

[0026] In a further embodiment of the present invention, the evaluation of the protective ability of a protective device against light in the wavelength range of 400-500 nm is carried out in a separate process from the evaluation of the protective ability of a protective device against light in the wavelength range of 280-400 nm. Due to its high absorption characteristics, human skin does not emit enough UVB radiation to measure the absorption spectrum of an applied product in the UVB range. Therefore, it is necessary to separately record the absorption spectrum of the test material in the UVB part of the spectrum (280-320 nm) using a different technique. For this purpose, in vivo absorption spectra in the wavelength ranges of 320-400 nm, 280-320 nm, and 400-500 nm are recorded along with the in silico transmission spectrum.

[0027] In a further embodiment of the present invention, the evaluation of the protective ability of a protective device against light in the wavelength range of 400-500 nm is carried out in a different process from the evaluation of the protective ability of a protective device against light in the wavelength range of 280-400 nm. Due to its high absorption characteristics, human skin does not emit enough UVB radiation to measure the absorption spectrum of an applied product in the UVB range. Therefore, it is necessary to separately record the absorption spectrum of the test material in the UVB part of the spectrum (280-320 nm) using a different technique. For this purpose, in vivo absorption spectra in the wavelength ranges of 320-400 nm, 280-320 nm, and 400-500 nm are recorded along with the in silico transmission spectrum.

[0028] In a further embodiment of the present invention, the wavelength range of the irradiating wavelength or the wavelength range of the detecting wavelength is smaller than the wavelength range of the evaluating wavelength. The wavelength ranges of the irradiating wavelength and the detecting wavelength are preferably the same in the wavelength range of up to 320 nm to 400 nm. The wavelength range of the evaluating wavelength covers the range of up to 280 nm to 500 nm.

[0029] In a further embodiment of the present invention, the wavelength range of the irradiating wavelength or the wavelength range of the detecting wavelength in the wavelength range of the evaluation wavelength is smaller than the wavelength range of the evaluation wavelength. The wavelength range of the irradiating wavelength and the wavelength range of the detecting wavelength are preferably equal within the wavelength range of 320 nm to 400 nm, and here, the wavelength range of the irradiating wavelength and the wavelength range of the detecting wavelength are smaller than the aforementioned wavelength range of 320 nm to 400 nm. In the wavelength range of the evaluation wavelength (maximum 280 nm to 500 nm), the wavelength range of the irradiating wavelength or the wavelength range of the detecting wavelength within the wavelength range of the evaluation wavelength is smaller than the wavelength range of the evaluation wavelength.

[0030] In a further development of the invention, the wavelength range of the irradiating wavelength and / or the wavelength range of the detecting wavelength are less than 100 nm, preferably less than 50 nm, and particularly preferably less than 25 nm. Therefore, only one source is required to emit electromagnetic radiation having a narrow wavelength range of the irradiating wavelength. Similarly, a detector capable of detecting a narrow wavelength range of the detecting wavelength is required to record the remission spectrum. Therefore, the beam source and detector can be designed to be cost-effective in both manufacturing and operation.

[0031] In a further embodiment of the invention, the illumination and / or detection wavelengths include only light having wavelengths outside the wavelength range of 400 nm to 450 nm. For recording in vivo measurements, in particular the UVA wavelength range (320 nm to 400 nm) is coupled into the measuring body.

[0032] In a further embodiment of the invention, the irradiating and / or detecting wavelengths include only light having wavelengths outside the wavelength range of 400 nm to 500 nm. In particular, the UVA and UVB wavelength ranges are irradiated. This wavelength range poses the greatest risk to human skin, and therefore it is particularly important to determine the protective capacity of protective measures.

[0033] In a further embodiment of the invention, the evaluation wavelengths include wavelengths outside the wavelength range of 400 nm to 500 nm. In particular, the UVA and UVB wavelength ranges are irradiated. This wavelength range poses the greatest risk to human skin and is therefore particularly important for determining the protective capacity of protective measures.

[0034] In a further embodiment of the invention, the evaluation wavelengths include wavelengths λ<400 nm. For recording in vivo measurements, the UVA wavelength range (320 nm to 400 nm) is particularly evaluated.

[0035] In a further embodiment of the invention, the evaluation wavelengths include wavelengths λ in the range 320 nm < λ < 400 nm. To record in vivo measurements to determine the protective capacity of a protective measure, the UVA wavelength range (320 nm to 400 nm) is particularly evaluated. To determine the protective capacity of a protective measure in the UVB wavelength range (< 320 nm), this wavelength range can also be optionally evaluated.

[0036] In a further embodiment, the radiation is emitted from a single beam source, and the radiation emitted from the single beam source comprises light in the wavelength range between 280 nm and 500 nm. In the context of this document, a beam source is a technical device for generating electromagnetic radiation. Therefore, the beam source is not an optical element for guiding, deflecting, or changing the intensity and / or wavelength of the electromagnetic radiation. Therefore, the beam source is not, for example, a light guide, a grating, a prism, or a filter. The beam source generates electromagnetic radiation in the wavelength range of the blue spectral range (wavelengths of approximately 400 nm to 500 nm) and the UV range (280 nm to 400 nm). In a further development of the invention, the emitted radiation of the single beam source comprises only a partial range of the wavelength range between 280 nm and 500 nm. In a preferred embodiment, the wavelength range of the radiation emitted by the single beam source is less than 50 nm. In a particularly preferred embodiment, the single beam source is a single LED.

[0037] In a further development of the present invention, individual beam sources can be controlled, which allows targeted control of the beam sources and targeted adaptation of the entire spectrum to different applications. By appropriately selecting the intensity of the beam sources, the radiation dose can also be achieved either in the form of individual doses (e.g., 0.1 MED) or adjustable limits. This minimizes the radiation dose to the subject.

[0038] In a further aspect of the invention, the beam source is controlled by a beam source controller that, among other things, controls the beam source and allows targeted tailoring of the spectrum produced by the beam source, for example by controlling the wavelength range and intensity of the electromagnetic radiation produced by the beam source.

[0039] In a further embodiment of the present invention, the wavelength, exposure time, and / or intensity of each beam source is controlled by controlling the beam source. This allows for targeted control of the beam source for in vivo measurements on the one hand and in vitro measurements on the other hand. By appropriately selecting the intensity of the beam source and the exposure time of the measurement object, the radiation dose is also selected, either in the form of an individual dose (e.g., 0.1 MED) or an adjustable limit value. This minimizes the radiation dose to the subject.

[0040] In a further aspect of the invention, the transmission spectrum is adjusted using the detected diffusely reflected radiation. The adjustment is performed using a hybrid transmission spectrum T hyb is performed as determined according to the following formula:

[0041]

number

[0042] In a further embodiment of the invention, the radiation is emitted in vivo onto human skin according to ISO 24442, which defines an in vivo method in which the UVA protection factor is determined using the minimum UVA dose required to produce irreversible pigmentation (tanning) of the skin.

[0043] In a further advantageous embodiment of the invention, the protective capacity of the protective measure is assessed from two measurements: the time it takes for UVB rays to penetrate the protective measure and cause reddening of the skin (minimal erythema, MED) in the second measurement is compared with the time it takes for UVB rays to penetrate the protective measure and cause reddening of the skin in the absence of the protective measure in the first measurement, and the dose of solar radiation required to cause reddening of the skin is divided by the dose required to cause reddening without the protective measure.

[0044] In a further embodiment of the invention, a first measurement is taken before the protective means is applied to the measuring body, recording the time when minimal erythema (MED) appears on the subject's untreated skin.

[0045] In a further embodiment of the invention, a second measurement is carried out after the protective measure has been applied to the measurement body, which records the time when minimal erythema (MED) appears on the skin of the subject treated with the protective measure.

[0046] In a further embodiment of the invention, the beam source generates polychromatic radiation, which is then irradiated onto the measurement object without filtering. The beam source generates radiation with a maximum wavelength range of 280 nm to 500 nm (UVB to blue light). The generated polychromatic radiation is not altered by optical elements (filters, monochromators) within the generated wavelength range from the time the polychromatic radiation is generated until it impinges on the measurement object. This results in maximum intensity of the generated radiation, as well as maximum intensity of the diffusely reflected or transmitted radiation, and a resulting high signal-to-noise ratio.

[0047] In a further development of the invention, the measurements of the remission spectrum and / or remission value are carried out exclusively in vivo: in a first measurement, the remission spectrum and / or remission value of human skin without protective measures is recorded, and in a second measurement, the remission spectrum and / or remission value of human skin without protective measures is recorded.

[0048] This object is further achieved by means of an SPF rating system for the assessment of the protection factor of protective measures according to claim 25. Further advantageous embodiments of the invention are also described in the dependent claims.

[0049] The SPF rating system according to the present invention for assessing the protection factor of protective measures comprises a measuring device, which comprises a beam source device, which comprises a beam source, a detector unit, a control unit for controlling the measuring device, and an evaluation unit.

[0050] The measuring device is suitable for introducing electromagnetic radiation into the measuring body, preferably human skin, by means of a beam source. A beam source is a technical device for generating electromagnetic radiation.

[0051] Furthermore, the measurement device is suitable for detecting diffusely reflected electromagnetic radiation. The measurement device can be controlled by a control unit, and the radiation detected by the detector unit can also be processed by the control unit. The detection window and resolution of the spectrometer are determined by the control unit, and the detected signal is stored, processed (e.g., amplified), displayed, and evaluated by the evaluation unit.

[0052] In a further embodiment of the present invention, the SPF rating system is suitable for assessing the protective capacity of a protective measure for protection against light within an evaluation wavelength range. The evaluation wavelength range is a wavelength range for which a protection factor is determined. The evaluation wavelength range is different from the wavelength range of the irradiating wavelength and / or the detecting wavelength, and the wavelength range of the evaluation wavelength range includes at least the wavelength range of the irradiating wavelength and the detecting wavelength.

[0053] In an advantageous embodiment of the present invention, the SPF evaluation system has exactly one measurement device. In a further embodiment of the present invention, the exactly one measurement device has exactly one beam source device. In a further aspect of the present invention, the exactly one beam source device includes exactly one beam source. According to the present invention, the measurement and detection of electromagnetic radiation is not performed using the sum spectrum generated by different beam sources, but is performed using exactly one measurement device, exactly one beam source device, and exactly one beam source, which is preferably an LED. This makes the SPF evaluation system according to the present invention significantly more compact and cost-effective than known systems.

[0054] In a further embodiment of the invention, exactly one beam source device may be controlled by exactly one control unit for controlling the measurement device, the control unit being able to control the range of irradiation wavelengths and the intensity of the radiation emitted by the beam source device.

[0055] In a further embodiment of the present invention, exactly one measuring device has exactly one detector unit. In a further embodiment of the present invention, exactly one detector unit has exactly one detector. In a further embodiment of the present invention, exactly one detector unit can be controlled by exactly one control unit for controlling the measuring device. The detector unit includes, for example, a monochromator, a filter, a photomultiplier tube, a spectrometer, and / or a photodiode. All of these known devices are suitable for detecting electromagnetic radiation and measuring its intensity depending on wavelength. Detection of in vivo measurements is preferably performed using a photodiode. This makes the SPF evaluation system according to the present invention significantly more compact and cost-effective than known systems. The detection window and resolution of the spectrometer are set by the control unit, and the detected signal is stored, processed (e.g., amplified), and displayed by the control unit.

[0056] In a further embodiment of the present invention, exactly one beam source device is suitable for emitting light at an illumination wavelength, the wavelength range of the illumination wavelength being smaller than the wavelength range of the evaluation wavelength. The exactly one beam source device generates electromagnetic radiation at an illumination wavelength between the blue spectral range (wavelengths of approximately 400 nm to 500 nm) and the UV range (280 nm to 400 nm). The evaluation wavelength is the wavelength at which the protection factor is determined. The evaluation wavelength is different from the wavelength range of the illumination wavelength. The evaluation wavelength is similar to the illumination wavelength and preferably has a wavelength range, and the wavelength range of the evaluation wavelength includes at least the wavelength range of the illumination wavelength.

[0057] In a further embodiment of the invention, exactly one detector unit is suitable for detecting light at a detection wavelength, the wavelength range of the detection wavelength being smaller than the wavelength range of the evaluation wavelength, the detection wavelength preferably including a wavelength range similar to the illumination wavelength, and the wavelength range of the detection wavelength preferably being within or including the range of the illumination wavelength.

[0058] In a further embodiment of the present invention, the wavelength range of the evaluation wavelengths is smaller than the wavelength range of the irradiation wavelength or the detection wavelength. For recording in vivo measurements, the wavelength range of the irradiation wavelength particularly includes the UVA wavelength range (320 nm to 400 nm) irradiated into the measurement body. The wavelength range of the detection wavelength covers the maximum of the wavelength range of the irradiation wavelength (320 nm to 400 nm). The wavelength range of the evaluation wavelength covers a wider range, and in particular the wavelength range of 280 nm to 500 nm (UVB to blue light) is evaluated.

[0059] In a further development of the present invention, the wavelength range of the irradiating wavelength and / or the wavelength range of the detecting wavelength are less than 100 nm, preferably less than 50 nm, and particularly preferably less than 25 nm. Therefore, only one source is required to emit electromagnetic radiation having a narrow wavelength range of the irradiating wavelength. Similarly, a detector capable of detecting a narrow wavelength range of the detecting wavelength is required to record the remission spectrum. Therefore, the beam source and the detector can be implemented in a way that makes them cost-effective to manufacture and operate.

[0060] In a further embodiment of the present invention, the SPF evaluation system has exactly one control unit. The control unit is typically a PC or notebook computer equipped with an appropriate computer program. The control unit can control the SPF evaluation system and can also process the radiation detected by the detector unit. The wavelength range of the detection wavelength and the resolution of the detector unit are determined by the control device, and the detected signal is stored, processed (e.g., amplified), and displayed. This allows for targeted control of the beam source and targeted adaptation to different applications across the entire spectrum. By appropriately selecting the intensity of the beam source, the radiation dose can also be achieved, either in the form of an individual dose (e.g., 0.1 MED) or an adjustable limit value. This minimizes the radiation dose to the subject.

[0061] In an advantageous embodiment of the present invention, the SPF rating system is suitable for assessing the protective capacity of a protective measure against light and / or for evaluating the protection factor of a protective measure using only measurement data from a measurement data device. The evaluation is carried out by the inventive method for determining a protection factor as defined in claims 1 to 24. The SPF rating system makes it possible to detect diffusely reflected radiation of an irradiated measurement body (human skin without and with a protective measure). The evaluation of the protective measure is carried out using data from the remission spectrum and taking into account data from the transmission spectrum, which according to the present invention are in silico data.

[0062] An exemplary embodiment of the method according to the invention for determining a protection factor, including spectroscopic measurements and an SPF rating system according to the invention for assessing the protection factor of protective measures, is shown schematically in simplified form in the drawing and is explained in more detail in the following description. [Brief explanation of the drawings]

[0063] [Figure 1]1 shows an SPF rating system, where the rating unit is located outside the measuring device. [Figure 2] 1 shows an SPF rating system, in which the control unit and the rating unit are arranged in one device. [Figure 3] 1 shows an SPF evaluation system, in which a beam source control unit is controlled by a control unit. [Figure 4] 1 shows an SPF rating system, where the control unit and the rating unit are arranged separately in one device. [Figure 5] 1 shows an SPF evaluation system, in which a control unit, a beam source control unit and an evaluation unit are arranged in one device. [Figure 6] A method is presented for performing spectroscopic measurements (in vivo) and recording reflectance spectra. [Figure 7] A combined method for determining protection factors with measurements for recording in silico data in the form of reflectance and transmittance spectra is presented. DETAILED DESCRIPTION OF THE INVENTION

[0064] 1 shows a schematic representation of an embodiment of an SPF evaluation system 1 according to the invention for carrying out in vivo measurements. The SPF evaluation system 1 comprises a measurement device 6 with a beam source device 12. The beam source device 12 comprises a beam source 12.1 and optical elements, such as light guides, filters, monochromators, mirrors and / or other optical elements, intended and / or suitable for conditioning and / or redirecting the radiation generated by the beam source 12.1.

[0065] Light emitted by the beam source device 12 with an irradiation wavelength between 280 nm and 500 nm is introduced into the measurement body 3 via the probe head 5 via a light guide 4.1. Light reflected by the measurement body 3 reaches the detector unit 13 via a further light guide 4.2. The detector unit 13 includes, for example, a monochromator, a filter, a photomultiplier tube, a spectrometer, and / or a photodiode. In this and all subsequent embodiments, the detector unit 13 includes a photodiode. The detector unit 13 and the beam source device 12 are connected to a control unit 2 via data lines 23, 24, which in turn is connected to the evaluation unit 10 via a further data line 25. The control unit 2 is typically a PC or notebook computer equipped with an appropriate computer program. The control unit 2 and the detector unit 13 are also connected to each other via a data line 22.

[0066] A further embodiment of an SPF evaluation system 1 according to the invention is shown in Figure 2. The SPF evaluation system 1 also has a measuring device 6 with a beam source device 12. By means of a light guide 4.1, the light emitted by the beam source device 12 is introduced via the probe head 5 into the measuring body 3, and the light reflected by the measuring body 3 reaches a detector unit 13 via a further light guide 4.2. The detector unit 13 and the beam source device 12 are connected via data lines 23, 24 to a control unit 2, which in this embodiment forms a structural unit together with the evaluation unit 10.

[0067] A further embodiment of an SPF evaluation system 1 according to the invention, also for carrying out in vivo measurements, is shown in Fig. 3. The SPF evaluation system 1 has a measurement device 6 with a beam source device 12. By means of a light guide 4.1, light emitted by the beam source device 12 is introduced via the probe head 5 into the measurement body 3, and light reflected by the measurement body 3 reaches a detector unit 13 via a further light guide 4.2. The detector unit 13 and the beam source device 12 are connected to a beam source control device 11 via data lines 23, 24. The beam source control device 11 and the detector unit 13 are each connected to a control unit 2 via a data line 21, and the evaluation unit 10 is arranged separately and is also connected to the control unit 2 and the beam source control device 11 via the data line 21.

[0068] A further embodiment of an SPF evaluation system 1 according to the present invention is shown in FIG. 4. The SPF evaluation system 1 also includes a beam source device 12. A light guide 4.1 guides light emitted by the beam source device 12 through the probe head 5 into the measurement body 3, and light reflected by the measurement body 3 reaches the detector unit 13 via a further light guide 4.2. The detector unit 13 and the beam source device 12 are connected to the beam source control device 11 via data lines 23 and 24. In this embodiment, the control unit 2 is arranged in a structural unit together with the evaluation unit, separate from the SPF evaluation system 1, and is connected to the evaluation unit via an interface 16. The connection can be wired or wireless, for example via an IP connection, Bluetooth, etc. The interface 16 and the detector unit 13 on the one hand, and the interface 16 and the beam source control device 11 on the other hand, are connected to each other via data lines 21 and 22.

[0069] A preferred embodiment of an SPF evaluation system 1 according to the present invention for performing in vivo measurements is also shown in Figure 5. The SPF evaluation system 1 corresponds to the system shown in the first embodiment (see Figure 1), i.e., in the SPF evaluation system 1, only the control unit 2 is arranged in a structural unit together with the beam source control device 11 and the evaluation unit 10 in the measurement device 6. The SPF evaluation system 1 has exactly one measurement device 6 with exactly one beam source 12.1 and exactly one detector unit 13. The beam source 12.1 is an LED, and the detector unit 13 is a photodiode. The exactly one control unit 2 in the structural unit with exactly one evaluation unit 10 and exactly one beam source control device 11 controls the exactly one beam source 12.1 via data line 23 and receives data from the exactly one detector unit 13 via data line 24. The SPF evaluation system 1 presented here has a particularly compact design, requires only a small number of components, and is therefore cost-effective to manufacture and use.

[0070] Figure 6 shows an embodiment of an implementation of an in vivo measurement method 100 for detecting the remission spectrum by the SPF rating system 1 according to the invention from the previous embodiment (see Figures 1 to 5). The test is carried out in vivo according to ISO 24442 or 24444. The measurement method 100 requires the recording of the remission spectrum of the skin of a subject 3 not treated with a protective measure and of the remission spectrum of the skin treated with a protective measure.

[0071] For this purpose, the probe head 5 is applied to the untreated skin of the subject 3, i.e. the protective means to be tested is not applied to the skin of the subject 3. For this purpose, the inside of the forearm or the back of the subject 3 is usually selected. A first measurement 110 is then performed by the beam source control device 11, which controls the LED 12.1 (see Figure 4) in such a way that the light emitted by the LED 12.1 is guided onto the skin of the subject 3 through the light guide 4.1.

[0072] The generated electromagnetic radiation has an illumination wavelength range with a maximum FWHM of 20 nm, and the generated electromagnetic radiation is in the wavelength range of 330 nm to 350 nm. The wavelength range of the detection wavelength, in which the detector unit 13 detects the radiation diffusely reflected by the light guide 4.2, also has a range of 20 nm, for example in the range of 330 nm to 350 nm. Furthermore, the range of the illumination wavelength and / or the wavelength range of the detection wavelength is less than 100 nm, preferably less than 50 nm, and particularly preferably less than 25 nm.

[0073] In some applications, the FWHM can be up to 30 nm, with the generated electromagnetic radiation in the wavelength range of 400 nm to 800 nm, while other applications can use FWHMs of up to 100 nm or more, with the generated electromagnetic radiation in the wavelength range of 800 nm to 2000 nm, and / or can be reduced by filters as needed.

[0074] The light generated by the LED 12.1 is irradiated onto the subject 3 without filtering, ensuring a high signal-to-noise ratio. In particular, the light generated by the LED 12.1 is polychromatic, with a maximum intensity at a wavelength in the UVA range of 340 nm. Alternatively, an LED generating light with a maximum intensity in the UVA range of 365 nm can be used. The irradiation occurs at an intensity that does not cause acute damage to the skin, and this intensity is below the simple MED, or below the MPE [Maximum Permissible Exposure] value, or significantly below the value caused by sunlight irradiation. The light diffusely reflected by the subject 3's skin is guided through the light guide 4.2 to the photodiode of the detector unit 13, where it is detected and converted into a measurement value, which is transmitted to and stored in the control unit 2.

[0075] The control unit 2 then checks from 120 whether a second measurement of the skin of the subject 3 treated with the protective means has already been carried out. If not, the control unit 2 indicates this. In order to carry out the second measurement (110) with the protective means applied, the protective means must be applied to the skin surface to be tested, for example, in accordance with ISO 24442 or 24444, at a concentration of 2.0 mg / cm 2 . 2 is applied (130) to the skin of the subject 3 in an amount of 0.001 g. The application (130) of the protective means and the subsequent second measurement (110) are performed at the same location on the measurement sample 3, in particular at the same location on the subject's skin, in order to ensure reproducibility of the first and second measurements (110). Also to ensure reproducibility, the control unit 2 controls the beam source controller 11 in such a way that it controls the LED 12.1, whereby the light generated by the LED 12.1 is directed through the light guide 4.1 onto the skin of the subject 3, and the intensity and / or exposure time of the first and second measurements (110) are coordinated with one another.

[0076] Light diffusely reflected by the skin of the subject 3 is also detected by photodiodes in the detector unit 13 and converted into a measurement value, which is transmitted to and stored in the control unit 2.

[0077] If the query 120 indicates that the second measurement (110) has already been carried out, an evaluation of the protective measures (140) is carried out. For this purpose, the control unit 2 calculates the reflection spectrum T according to equation 1 in vivo Run the program to calculate

[0078]

number

[0079] As an alternative to the method shown in FIG. 6 using one LED, this method can also be carried out using a multi-LED radiation source.

[0080] 7 shows an embodiment of a method 400 according to the present invention for performing a composite in vivo reflectance measurement 100 (see FIG. 5) including data for a transmission spectrum 200. According to the present invention, the value of the transmission spectrum 200 is calculated (in silico).

[0081] If the amount and properties of the UV filter substances of the protection means are known, the UV transmittance can be calculated, taking into account the irregularities of the film and its photodegradation. Based on the simulated UV transmission, the SPF and all parameters characterizing the protection against UVA and / or UVB can be calculated in silico.

[0082] The in silico determination of the transmission spectrum 200 data is performed according to ISO 24443. 2 The emitted radiation is assumed to be in the wavelength range of 280 nm to 500 nm (UVB to blue light), and therefore this wavelength range includes the wavelength range of the evaluation wavelength up to 280 nm to 500 nm.

[0083] The results of the evaluation of the in vivo remission spectrum 140 and the in silico transmission spectrum 200 are evaluated together (300). For this purpose, a hybrid transmission spectrum T hyb is first calculated, where the in silico transmission spectrum T in silico is the in vivo reflectance spectrum T in vivo is scaled by

[0084] The results of the two separate evaluations 140, 230 are then evaluated in combination (300). For this purpose, the hybrid transmission spectrum T hyb is first calculated, where the in vitro transmission spectrum T in silico is the reflectance spectrum T in vivois scaled by

number

[0085] Next, the protection capacity of the protection means for the spectral range from UVA (320 nm) to the HEV spectral range (450 nm) SF is calculated according to equation 4 (where E = IPD(λ) is the IPD spectrum and S = I(λ) is the solar spectrum):

number

[0086] The protection capacity of a protection measure in the blue light spectral range (400 nm - 500 nm) of interest in this invention is determined according to Equation 5, where E = IPD(λ) is the IPD spectrum and S = I(λ) is the solar spectrum.

number

[0087] The protection capability of the protection means for SF (400nm-450nm) is determined according to Equation 6 (where E = IPD(λ) is the IPD spectrum and S = I(λ) is the solar spectrum):

number

[0088] Next, the protective capacity (UVA-SF) of the protective means against the spectral range of UVA (320-400 nm) is calculated according to Equation 4 (where E = PPD(λ) is the PPD spectrum and S = I(λ) is the solar spectrum or UVA source for PPD testing):

number

[0089] The protective capacity (280-400 nm) of a protective measure against the spectral range from UVB to UVA (280-400 nm) is given by Equation 4.

number

[0090]

number

[0091] In vivo values ​​are measured without photolysis, so photolysis must be taken into account appropriately. in silico_ir This can be done by calculating T in silico using (λ) without photolysis and then calculating the spectral index.

[0092]

number

[0093] Using this

number

[0094] The method can be calibrated using a suitable reference analytical method such as electron spin resonance spectroscopy. [Explanation of symbols]

[0095] 1. SPF rating system 2. Control Device 3. Sample / measurement body 4.1, 4.2 Light guides / fiber bundles 5 Probe head 6. Measuring Devices 10 Evaluation Devices 11 Beam source control device 12 Beam source device 12.1 Beam Source 13 Detection unit 21 Connection of beam source controller and control device 22 Connecting the detector / spectrometer to the control device 23 Connection of beam source controller and beam source device 24 Connection of beam source control device and detection unit 25 Connecting the control device and evaluation device 100 How to record spectroscopic measurements (in vivo) 110 Performing Reflectance Spectrum Measurements 120 Query Execution 130 Application of protective measures 140 Evaluation of Reflectance Spectra 200 Method for determining transmission spectrum data 300 Determination of protection factor 400 Method for determining protection factors

Claims

1. A method (400) for determining a protection factor, comprising: - emitting radiation from a beam source (12.1), the emitted radiation comprising light having an irradiation wavelength in the range of 280 nm to 2000 nm, preferably 280 to 800 nm, particularly preferably 280 to 500 nm; irradiating a measuring body (3) with said emitted radiation; detecting the radiation diffusely reflected by the illuminated measuring body (3) at a detection wavelength; evaluating the protection factor of a protection measure using an evaluation wavelength and a transmission spectrum from the diffusely reflected radiation; Including, the transmission spectral data is used to estimate the protection factor of the protection measure; The method (400) for determining the protection factor, wherein the evaluation wavelength is different from the wavelength range of the illumination wavelength and / or the detection wavelength, and the transmittance spectral data is in silico data.

2. 2. The method (400) for determining a protection factor according to claim 1, wherein the wavelength range of the transmission spectrum includes the evaluation wavelength.

3. 3. The method (400) for determining a protection factor according to claim 1 or 2, characterized in that the evaluation wavelengths cover the wavelength range from 280 nm to 2000 nm, preferably from 280 nm to 800 nm, or particularly preferably from 280 nm to 500 nm and / or from 400 nm to 500 nm and / or from 400 nm to 450 nm.

4. 4. The method (400) for determining a protection factor according to claim 3, characterized in that the evaluation of the protection capability of the protection means against light in the wavelength range of 400 nm to 500 nm is carried out in a process separate from the evaluation of the protection capability of the protection means against light in the wavelength range of 280 nm to 400 nm.

5. 5. The method (400) for determining a protection factor according to claim 4, characterized in that the evaluation of the protection capability of the protection means against light in the wavelength range of 400 nm to 500 nm is carried out in a separate process from the evaluation of the protection capability of the protection means against light in the wavelength range of 280 nm to 400 nm.

6. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the wavelength range of the illumination wavelengths or the wavelength range of the detection wavelengths is smaller than the wavelength range of the evaluation wavelengths.

7. 7. The method (400) for determining a protection factor according to claim 6, characterized in that the wavelength range of the illumination wavelength or the wavelength range of the detection wavelength that is in the wavelength range of the evaluation wavelength is smaller than the wavelength range of the evaluation wavelength.

8. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the range of irradiation wavelengths and / or the wavelength range of detection wavelengths is smaller than 100 nm, preferably smaller than 50 nm, particularly preferably smaller than 25 nm.

9. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the illumination wavelength and / or the detection wavelength includes only light having wavelengths outside the wavelength range of 400 nm to 450 nm.

10. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the illumination wavelength and / or the detection wavelength includes only light having wavelengths outside the wavelength range of 400 nm to 500 nm.

11. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the evaluation wavelengths include wavelengths lying outside the wavelength range of 400 nm to 500 nm.

12. 12. The method (400) for determining a protection factor according to claim 11, characterized in that the evaluation wavelengths include wavelengths λ<400 nm.

13. 13. The method (400) for determining a protection factor according to claim 12, characterized in that the evaluation wavelengths include wavelengths λ in the range of 320 nm<λ<400 nm.

14. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the radiation emission originates from a single beam source (12.1), and the irradiation wavelength of said single beam source (12.1) comprises light in the wavelength range from 280 nm to 500 nm.

15. 15. A method (400) for determining a protection factor according to claim 14, characterized in that the individual beam sources (12.1) can be controlled.

16. 16. A method (400) for determining a protection factor according to claim 14 or 15, characterized in that the control of the beam source (12.1) is controlled by a beam source control device (11).

17. 17. The method (400) for determining a protection factor according to claim 16, characterized in that by controlling the beam sources (12.1), the wavelength, exposure time and / or intensity of the individual beam sources (12.1) are controlled.

18. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the transmission spectrum is adjusted using the detected diffusely reflected radiation.

19. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that said radiation is emitted in vivo onto human skin.

20. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the assessment of the protection capacity of the protection means is carried out from two measurements.

21. 21. Method (400) for determining a protection factor according to claim 20, characterized in that a first measurement is performed before the protection means is applied to the measuring body (3).

22. 22. A method (400) for determining a protection factor according to claim 20 or 21, characterized in that a second measurement is carried out after the application (130) of the protection means to the measuring body (3).

23. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the beam source (12.1) generates polychromatic radiation, the generated polychromatic radiation being emitted unfiltered onto the measuring body (3).

24. 10. A method (400) for determining a protection factor according to one or more of the preceding claims, characterized in that the spectroscopic measurements (100) are carried out exclusively in vivo.

25. A measuring device (6), a beam source device (12) including a beam source (12.1), and said measuring device (6) comprising a detector unit (13); a control unit (2) for controlling said measuring device (6); an evaluation unit (10); Including, An SPF rating system (1) for assessing the protection factor of the protective product.

26. 26. The SPF rating system (1) for the assessment of the protection factor of the protective means according to claim 25, characterized in that the SPF rating system (1) is suitable for the assessment of the protective capacity of the protective means for protection against light in an evaluation wavelength range.

27. 27. An SPF rating system (1) for the assessment of the protection factor of the protective measures according to claim 25 or 26, characterized in that the SPF rating system (1) has exactly one measuring device (6).

28. 28. An SPF evaluation system (1) for the assessment of the protection factor of the protection measures according to claim 27, characterized in that the exactly one measuring device (6) has exactly one beam source device (12).

29. 29. The SPF evaluation system (1) for the assessment of the protection factor of the protection measures according to claim 28, characterized in that the exactly one beam source device (12) has exactly one beam source (12.1).

30. 30. An SPF evaluation system (1) for the assessment of the protection factor of the protection measures according to claim 28 or 29, characterized in that exactly one beam source device (12) can be controlled by exactly one control unit (2) for controlling the measuring device (6).

31. 31. An SPF rating system (1) for the assessment of the protection factor of the protective measures according to one or more of claims 27 to 30, characterized in that the exactly one measuring device (6) has exactly one detection unit (13).

32. 32. An SPF rating system (1) for the assessment of the protection factor of the protection measures according to claim 31, characterized in that the exactly one detector unit (13) comprises exactly one detector.

33. 33. An SPF evaluation system (1) for the assessment of the protection factor of the protection measures according to claim 31 or 32, characterized in that exactly one detector unit (13) can be controlled by exactly one control unit (2) for controlling the measuring device (6).

34. said exactly one beam source device (12) being suitable for emitting light at an illumination wavelength; An SPF rating system (1) for the assessment of the protection factor of the protective measures according to one or more of claims 26 to 33, characterized in that the wavelength range of the irradiation wavelengths is smaller than the wavelength range of the evaluation wavelengths.

35. said exactly one detector unit (13) being suitable for detecting light at a detection wavelength, An SPF rating system (1) for the assessment of the protection factor of the protective measures according to one or more of claims 26 to 34, characterized in that the wavelength range of the irradiation wavelengths is smaller than the wavelength range of the evaluation wavelengths.

36. 36. The SPF evaluation system (1) for the assessment of the protection factor of the protective measures according to claim 34 or 35, characterized in that the wavelength range of the irradiation wavelength or the wavelength range of the detection wavelength in the wavelength range of the evaluation wavelength is smaller than the wavelength range of the evaluation wavelength.

37. 37. An SPF rating system (1) for the assessment of the protection factor of protective measures according to one or more of claims 34 to 36, characterized in that the range of irradiation wavelengths and / or the wavelength range of detection wavelengths is smaller than 100 nm, preferably smaller than 50 nm, particularly preferably smaller than 25 nm.

38. An SPF rating system (1) for the assessment of the protection factor of the protective measures according to one or more of claims 25 to 37, characterized in that the SPF rating system (1) has exactly one control unit (2).

39. 39. The SPF rating system (1) for the assessment of the protection factor of a protective measure according to one or more of claims 25 to 38, characterized in that the SPF rating system (1) is suitable for the assessment of the protective capacity of the protective measure and / or the protection factor of the protective measure for protection against light using only measurement data from a measurement data device (6).

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