Method for testing untoward effects of cosmetics

Abstract

The invention belongs to the technical field of cosmetic testing, and discloses a method for testing untoward effects of cosmetics, which comprises the following specific steps: step 1, sample analysis: selecting a target cosmetic to be tested, performing component analysis on the target cosmetic, screening out suspicious components, recording and separating, and determining a sample to be detected; and preparing the separated target cosmetic suspicious components into paste with the same concentration as a test sample, and numbering the test sample. According to the method, four test groups are arranged, suspicious components of a to-be-measured target cosmetic are analyzed and extracted and then made into patches, and then different patches are divided into the four test groups to be subjected to a spot patch test and a light spot patch test at the same time; and finally, evaluating according to the analysis result to determine the adverse reaction caused by the suspicious components of the target cosmetic, so that the test efficiency of the to-be-tested target cosmetic can be improved, and the adverse reaction caused by the suspicious components of the to-be-tested target cosmetic can be analyzed more accurately.

Description

Technical Field

[0001] The invention belongs to the technical field of cosmetics testing, and in particular relates to a testing method for adverse reactions of cosmetics. Background Art

[0002] Cosmetics refer to daily chemical industrial products that are applied to the human body surface such as skin, hair, nails, lips, etc. by rubbing, spraying or other similar methods for the purpose of cleansing, protection, beautification and modification. According to the use part, they can be divided into skin cosmetics, hair cosmetics, lip and eye cosmetics, oral cosmetics, nail cosmetics, etc.; according to the dosage form, they can be divided into aqueous products, oil products, emulsion products, powder products, gel products, block products, etc.

[0003] With the increasing demand for cosmetics and the increase in the variety of cosmetics, the problem of adverse reactions to cosmetics has attracted more and more attention. Studies have shown that cosmetics may cause allergic reactions, such as local itching and erythema, and in severe cases, even physical symptoms such as headache and nausea. Currently, the most commonly used diagnostic method for adverse reactions to cosmetics is patch testing, but patch testing can only diagnose contact adverse reactions, and adverse reactions after ultraviolet radiation require a separate light patch test. The two tests are conducted separately, which is not only time-consuming, but also the accuracy is easily affected by external factors. Therefore, this needs to be improved. Summary of the Invention

[0004] The object of the present invention is to provide a testing method for adverse reactions of cosmetics to solve the problems raised in the above background technology.

[0005] In order to achieve the above object, the present invention provides the following technical solution: a method for testing adverse reactions of cosmetics, comprising the following specific steps:

[0006] Step 1: Sample analysis

[0007] Select the target cosmetics to be tested, perform component analysis on the target cosmetics, screen out suspicious components and record and separate them, make pastes of the same concentration of the separated suspicious components of the target cosmetics as test samples and number them;

[0008] Step 2: Test Preparation

[0009] Select subjects with the same skin condition, similar age, and gender. The subjects clean their skin and wipe it after cleaning to ensure that the skin is dry and undamaged.

[0010] Step 3: Patch production

[0011] Cut the spot tester into a corresponding number of spot tester samples according to the number of the test sample, while ensuring that the spot tester samples are of the same size and can maintain a close fit with the skin. Then, mark the spot tester samples. After marking, select the test sample of the same mass as the filler and fill it into the spot tester samples. Then, according to the same preparation method, set up a test group with the same filler and two test groups with a blank matrix as the filler. The four test groups are numbered as No. 1, No. 2, No. 3 and No. 4, among which the No. 1 and No. 2 test groups are the spot tester samples filled with the test sample, and the No. 3 and No. 4 test groups are the spot tester samples filled with the blank matrix;

[0012] Step 4: Test

[0013] Four test groups of patch tester samples were attached and fixed to designated areas of the skin of the same subject, ensuring that there was no gap between the patch tester samples and the skin. Then, patch tester samples 1 and 3 were covered with a dressing to protect them from light. Patches 2 and 4 were irradiated with ultraviolet light of the same wavelength. Next, another test subject was irradiated with ultraviolet light of a different wavelength under the same conditions. These two test subjects formed a group, and the remaining test subjects underwent the same procedure. Patches 1 and 3 were used for the patch test, while patches 2 and 3 were used for the light patch test.

[0014] Step 5: Record the results

[0015] After 72 hours, remove the four test groups from the subjects, and then observe and record the allergic reactions on the corresponding skin locations of the subjects.

[0016] Step 6: Result Analysis

[0017] Based on the recorded results, analyze and evaluate the adverse reactions of the suspicious ingredients in the target cosmetics to be tested to determine whether the target cosmetics to be tested are safe.

[0018] As a preferred technical solution of the present invention, high performance liquid chromatography is used in the component analysis of the target cosmetics in step one to determine and separate the suspicious ingredients in the cosmetics by high performance liquid chromatography. The suspicious cosmetic ingredients in step one are identified based on standard allergens, and those that are consistent with or similar to the allergens recorded in the standard allergens are recorded as suspicious ingredients.

[0019] As a preferred technical solution of the present invention, the subjects described in step 2 choose physiological saline or a mild detergent to clean their skin to remove grease and dirt from the skin. After cleaning, they choose sterile gauze to wipe the skin. When selecting the subjects described in step 2, it is necessary to exclude those with skin diseases, recent skin damage or excessive ultraviolet exposure, those taking medications that may affect skin reactions, and special populations.

[0020] As a preferred technical solution of the present invention, when selecting the spot tester described in step three, it is necessary to use a non-toxic, non-irritating material with good skin compatibility. The size and shape of the spot tester sample described in step three need to be suitable for application on the skin of the subject. When the filler described in step three is filled into the spot tester sample, it is necessary to replace the filling device according to different fillers to avoid cross infection caused by repeated use.

[0021] As a preferred technical solution of the present invention, when the second and fourth rays described in step four are irradiated with ultraviolet rays of the same wavelength, long-wave ultraviolet rays of 320-400 nm are selected for irradiation on one subject, and medium-wave ultraviolet rays of 280-320 nm are selected for irradiation on the other subject. The irradiation dose of the long-wave ultraviolet rays is 20 to 30 times the MED, and the irradiation dose of the medium-wave ultraviolet rays is below the MED.

[0022] As a preferred technical solution of the present invention, the MED refers to the minimum erythema dose. Before the subject is irradiated with ultraviolet rays, the subject is first irradiated with medium-wave ultraviolet rays and long-wave ultraviolet rays to measure the subject's MED. The MED serves as a reference standard for ultraviolet irradiation dose.

[0023] As a preferred technical solution of the present invention, when recording the results in step 5, the results are recorded once every 24 hours, 48 hours, and 72 hours.

[0024] As a preferred technical solution of the present invention, the evaluation criteria described in step six are negative reaction: no reaction; suspicious reaction: light erythema; positive reaction: mild erythema and papules; strong positive reaction: edematous erythema and papules; very strong positive reaction: significant erythema, blisters or maculopapules. The negative reaction represents that the suspicious ingredient of the target cosmetic to be measured is safe and has no adverse reactions; the suspicious reaction and positive reaction represent that the suspicious ingredient of the target cosmetic to be measured is safe and has no adverse reactions but has a mild adverse reaction risk; the strong positive reaction and very strong positive reaction represent that the suspicious ingredient of the target cosmetic to be measured has low safety.

[0025] As a preferred technical solution of the present invention, when removing the four test groups from the subject in step five, tweezers are used to peel off the small sample of the spot tester. At the same time, after removing the test groups, the subject needs to continue to regularly observe the skin reaction within the next 72 hours.

[0026] The beneficial effects of the present invention are as follows:

[0027] The present invention sets four test groups. After analyzing and extracting the suspicious ingredients of the target cosmetics to be measured, the suspicious ingredients are made into patches. Then, the different patches are divided into four test groups to simultaneously perform patch tests and photopatch tests. Finally, based on the analysis results, an evaluation is performed to determine the adverse reactions caused by the suspicious ingredients of the target cosmetics. In this way, the testing efficiency of the target cosmetics to be measured can be improved, so that the adverse reactions caused by the suspicious ingredients of the target cosmetics to be measured can be analyzed more accurately, thereby providing a strong data reference for the safety issues of the cosmetics. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a flow chart of the present invention. DETAILED DESCRIPTION

[0029] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0030] like Figure 1 As shown, the embodiment of the present invention provides a method for testing adverse reactions of cosmetics, and the specific steps are as follows:

[0031] Step 1: Sample analysis

[0032] Select the target cosmetics to be tested, perform component analysis on the target cosmetics, screen out suspicious components and record and separate them, make pastes of the same concentration of the separated suspicious components of the target cosmetics as test samples and number them;

[0033] Step 2: Test Preparation

[0034] Select subjects with the same skin condition, similar age, and gender. The subjects clean their skin and wipe it after cleaning to ensure that the skin is dry and undamaged.

[0035] Step 3: Patch production

[0036] Cut the spot tester into a corresponding number of spot tester samples according to the number of the test sample, while ensuring that the spot tester samples are of the same size and can maintain a close fit with the skin. Then, mark the spot tester samples. After marking, select the test sample of the same mass as the filler and fill it into the spot tester samples. Then, according to the same preparation method, set up a test group with the same filler and two test groups with a blank matrix as the filler. The four test groups are numbered as No. 1, No. 2, No. 3 and No. 4, among which the No. 1 and No. 2 test groups are the spot tester samples filled with the test sample, and the No. 3 and No. 4 test groups are the spot tester samples filled with the blank matrix;

[0037] Step 4: Test

[0038] Four test groups of patch tester samples were attached and fixed to designated areas of the skin of the same subject, ensuring that there was no gap between the patch tester samples and the skin. Then, patch tester samples 1 and 3 were covered with a dressing to protect them from light. Patches 2 and 4 were irradiated with ultraviolet light of the same wavelength. Next, another test subject was irradiated with ultraviolet light of a different wavelength under the same conditions. These two test subjects formed a group, and the remaining test subjects underwent the same procedure. Patches 1 and 3 were used for the patch test, while patches 2 and 3 were used for the light patch test.

[0039] Step 5: Record the results

[0040] After 72 hours, remove the four test groups from the subjects, and then observe and record the allergic reactions on the corresponding skin locations of the subjects.

[0041] Step 6: Result Analysis

[0042] Based on the recorded results, analyze and evaluate the adverse reactions of the suspicious ingredients in the target cosmetics to be tested to determine whether the target cosmetics to be tested are safe.

[0043] By extracting and separating the suspicious ingredients in the target cosmetics to be tested and making a patch through this method, it is possible to determine the dangerous ingredients in the target cosmetics to be tested, and the setting of four test groups can test the adverse reactions and phototoxicity caused by the suspicious ingredients. The patch test and the light patch test are carried out at the same time, which can improve the test efficiency and the accuracy of the test of suspicious ingredients in the target cosmetics to be tested.

[0044] Among them, high performance liquid chromatography is used to analyze the ingredients of the target cosmetics in step one, and high performance liquid chromatography is used to determine and separate the suspicious ingredients in the cosmetics. The suspicious ingredients in the cosmetics in step one are identified based on standard allergens, and those that are consistent with or similar to the allergens recorded in the standard allergens are recorded as suspicious ingredients.

[0045] High-performance liquid chromatography uses a fine-particle stationary phase and a high-pressure infusion pump to greatly improve the separation efficiency of samples in the chromatographic column. At the same time, high-performance liquid chromatography is equipped with a variety of highly sensitive detectors, such as ultraviolet detectors, fluorescence detectors, electrochemical detectors, etc., which can detect trace or even trace amounts of compounds. By optimizing detection conditions and chromatographic conditions, its detection limit can reach the nanogram or even picogram level, meeting the analysis needs of low-content components.

[0046] Among them, when cleaning the skin in step 2, the subjects choose normal saline or mild detergent to clean and remove oil and dirt from the skin. After cleaning, they choose sterile gauze to wipe it. When making the selection in step 2, the subjects need to exclude those with skin diseases, recent skin damage or excessive ultraviolet exposure, those taking medications that may affect skin reactions, and special populations.

[0047] By having the subjects clean their skin, the influence of bacteria and other factors on the test can be eliminated. Selecting subjects with healthy skin, no damage, no inflammation, no infection, and no history of allergies can ensure the accuracy of the test. In addition, when conducting tests for adverse reactions to cosmetics, attention must also be paid to protecting the privacy and safety of the subjects.

[0048] Among them, when selecting the spot tester in step three, it is necessary to use non-toxic, non-irritating materials with good skin compatibility. The size and shape of the spot tester sample in step three need to be suitable for application on the skin of the subject. When the filler in step three is filled into the spot tester sample, the filling device needs to be replaced according to different fillers to avoid cross infection caused by repeated use.

[0049] During the entire patch production process, it is necessary to strictly adhere to the principles of aseptic operation to avoid external infection. At the same time, when filling the filler into the patch tester sample, it is also necessary to avoid overflow or bubble formation and the filler must be free of granular impurities.

[0050] Among them, when No. 2 and No. 4 in step 4 are irradiated with ultraviolet rays of the same wavelength, long-wave ultraviolet rays of 320-400nm are used for irradiation on one subject, and medium-wave ultraviolet rays of 280-320nm are used for irradiation on the other subject. The irradiation dose of long-wave ultraviolet rays is 20 to 30 times the MED, and the irradiation dose of medium-wave ultraviolet rays is below the MED.

[0051] Ultraviolet rays (UVR) and long-wave UVB rays are two different wavelengths in the UV spectrum. UVR rays have shorter wavelengths and higher energy, so they have stronger biological activity. Ultraviolet rays (UVR) have longer wavelengths and lower energy, but they have stronger penetrating ability and can penetrate deep into the dermis of the skin.

[0052] Among them, MED refers to the minimum erythema dose. Before the subjects are exposed to ultraviolet rays, they are first exposed to medium-wave ultraviolet rays and long-wave ultraviolet rays to measure the subjects' MED. MED serves as a reference standard for ultraviolet radiation dose.

[0053] The exposure time of medium-wave ultraviolet and long-wave ultraviolet rays needs to be greater than 30 minutes to ensure that the test substances have sufficient time to remain in the skin and penetrate the skin.

[0054] Among them, when recording the results in step 5, record them once every 24 hours, 48 hours and 72 hours respectively.

[0055] By setting the test subject's status to be recorded once every 24 hours, 48 hours and 72 hours respectively, the test subject's adverse reaction to the test sample can be determined in time, so that the test can be stopped in time when the subject has a severe reaction to ensure the safety of the subject.

[0056] Among them, the evaluation criteria in step six are negative reaction: no reaction; suspicious reaction: light erythema; positive reaction: mild erythema and papules; strong positive reaction: edematous erythema and papules; very strong positive reaction: significant erythema, blisters or maculopapular rash. Negative reaction means that the suspicious ingredient of the target cosmetic to be tested is safe and has no adverse reactions. Suspicious reaction and positive reaction mean that the suspicious ingredient of the target cosmetic to be tested is safe and has no adverse reactions but has a mild adverse reaction risk. Strong positive reaction and very strong positive reaction mean that the suspicious ingredient of the target cosmetic to be tested is of low safety.

[0057] The evaluation standards of the four test groups are consistent. By evaluating the test results of the four test groups, the adverse reactions of the suspicious ingredients of the target cosmetics to be tested can be determined, thereby providing a reference for the safety issues of the target cosmetics.

[0058] In step five, when removing the four test groups from the subject, use tweezers to peel off the small sample of the spot tester. At the same time, after removing the test groups, the subject needs to continue to observe the skin reaction regularly within the next 72 hours.

[0059] When removing the spot tester sample, you need to be gentle to avoid causing skin damage to the subject. Subsequent observation can ensure that the test does not pose a safety hazard to the subject.

[0060] It should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such process, method, article, or apparatus.

[0061] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A test method for adverse reactions to cosmetics, characterized in that: The specific steps are as follows: Step 1: Sample analysis Select the target cosmetics to be tested, perform component analysis on the target cosmetics, screen out suspicious components and record and separate them, make pastes of the same concentration of the separated suspicious components of the target cosmetics as test samples and number them; Step 2: Test Preparation Select subjects with the same skin condition, similar age, and gender. The subjects clean their skin and wipe it after cleaning to ensure that the skin is dry and undamaged. Step 3: Patch production Cut the spot tester into a corresponding number of spot tester samples according to the number of the test sample, while ensuring that the spot tester samples are of the same size and can maintain a close fit with the skin. Then, mark the spot tester samples. After marking, select the test sample of the same mass as the filler and fill it into the spot tester samples. Then, according to the same preparation method, set up a test group with the same filler and two test groups with a blank matrix as the filler. The four test groups are numbered as No. 1, No. 2, No. 3 and No. 4, among which the No. 1 and No. 2 test groups are the spot tester samples filled with the test sample, and the No. 3 and No. 4 test groups are the spot tester samples filled with the blank matrix; Step 4: Test Four test groups of patch tester samples were attached and fixed to designated areas of the skin of the same subject, ensuring that there was no gap between the patch tester samples and the skin. Then, patch tester samples 1 and 3 were covered with a dressing to protect them from light. Patches 2 and 4 were irradiated with ultraviolet light of the same wavelength. Next, another test subject was irradiated with ultraviolet light of a different wavelength under the same conditions. These two test subjects formed a group, and the remaining test subjects underwent the same procedure. Patches 1 and 3 were used for the patch test, while patches 2 and 3 were used for the light patch test. Step 5: Record the results After 72 hours, remove the four test groups from the subjects, and then observe and record the allergic reactions on the corresponding skin locations of the subjects. Step 6: Result Analysis Based on the recorded results, analyze and evaluate the adverse reactions of the suspicious ingredients in the target cosmetics to be tested to determine whether the target cosmetics to be tested are safe.

2. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: High performance liquid chromatography is used in the component analysis of the target cosmetics described in step 1 to determine and separate the suspicious ingredients in the cosmetics. The suspicious ingredients in the cosmetics described in step 1 are identified based on standard allergens, and those that are consistent with or similar to the allergens recorded in the standard allergens are recorded as suspicious ingredients.

3. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: When cleaning the skin, the subjects described in step 2 should use normal saline or a mild detergent to remove grease and dirt from the skin. After cleaning, sterile gauze should be used to wipe the skin. When selecting the subjects described in step 2, it is necessary to exclude those with skin diseases, recent skin damage or excessive ultraviolet exposure, those taking medications that may affect skin reactions, and those in special groups.

4. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: When selecting the spot tester described in step three, it is necessary to use non-toxic, non-irritating materials with good skin compatibility. The size and shape of the spot tester sample described in step three need to be suitable for application to the skin of the subject. When filling the filler described in step three into the spot tester sample, it is necessary to replace the filling device according to different fillers to avoid cross infection caused by repeated use.

5. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: When No. 2 and No. 4 described in step 4 are irradiated with ultraviolet rays of the same wavelength, long-wave ultraviolet rays of 320-400 nm are used for irradiation on one subject, and medium-wave ultraviolet rays of 280-320 nm are used for irradiation on the other subject. The irradiation dose of the long-wave ultraviolet rays is 20 to 30 times the MED, and the irradiation dose of the medium-wave ultraviolet rays is below the MED.

6. A method for testing adverse reactions to cosmetics according to claim 5, characterized in that: The MED refers to the minimum erythema dose. Before the subjects are exposed to ultraviolet rays, they are first exposed to medium-wave ultraviolet rays and long-wave ultraviolet rays to measure the subjects' MED. The MED serves as a reference standard for ultraviolet radiation dose.

7. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: When recording the results as described in step 5, record once every 24 hours, 48 hours, and 72 hours.

8. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: The evaluation criteria described in step six are negative reaction: no reaction; suspicious reaction: light erythema; positive reaction: mild erythema and papules; strong positive reaction: edematous erythema and papules; very strong positive reaction: significant erythema, blisters or maculopapules. The negative reaction represents that the suspicious ingredient of the target cosmetic to be tested is safe and has no adverse reactions; the suspicious reaction and positive reaction represent that the suspicious ingredient of the target cosmetic to be tested is safe and has no adverse reactions but has a mild adverse reaction risk; the strong positive reaction and very strong positive reaction represent that the suspicious ingredient of the target cosmetic to be tested is low in safety.

9. A method for testing adverse reactions to cosmetics according to claim 1, characterized in that: When removing the four test groups from the subject as described in step 5, use tweezers to peel off the spot tester sample. At the same time, the subject needs to continue to observe the skin reaction regularly within the next 72 hours after removing the test groups.

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