Traditional Chinese medicine composition liniment for treating vitiligo and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition liniment for treating vitiligo and a preparation method of the traditional Chinese medicine composition liniment. The concentrated liquid medicine, 3-OH phlorizin and vegetable oil are mixed, and the liniment is obtained; and bottling and storing. Various Chinese herbal medicine components are prepared into the liniment, the liniment aims at improving skin conditions and promoting pigment recovery in an external application mode, the extracted Chinese herbal medicine components and 3-OH phlorizin are added into the vegetable oil, the adding amount and proportion are controlled, the dispersion uniformity and effect of the final liniment are ensured, parameters are determined according to actual working procedure conditions, and the liniment has the advantages of being simple in structure, convenient to use and high in practicability. According to the liniment preparation device, production requirements of different batches are flexibly met, so that stability and intelligence of batch production are achieved, intelligence of the production process is achieved by automatically monitoring and adjusting opening and closing of the feeding valve, the liniment preparation process is optimized, product quality and stability are improved, and production intelligence and adaptability are enhanced.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition liniment for treating vitiligo and a preparation method thereof. Background Art

[0002] Vitiligo is a common clinical pigmentary disorder. Its clinical manifestations include decreased melanin in the skin, localized depigmentation of the skin, and obvious white lesions (irregular or symmetrical white spots) on the skin epidermis. Due to the destruction of skin melanocytes, it has a harmful effect on the pigmentation of human skin and seriously affects the appearance of people. It is a disgusting and annoying skin disease that affects 1%-2% of the world's population. The exact etiology of vitiligo has not yet been determined, but based on indirect evidence and some hypotheses, factors such as autoimmunity, genetics, oxidative stress, melatonin receptor dysfunction, and damaged nerves and viral skin pathology are closely related to the pathogenesis of vitiligo. Among them, oxidative stress is a hot topic in recent research. Oxidative stress is also one of the main pathogenic factors leading to many chronic and degenerative diseases including atherosclerosis, ischemic heart disease, aging, diabetes, cancer, immunosuppression, and neurodegenerative diseases. At present, the in vitro research on vitiligo is mainly focused on the screening of antioxidants with protective mechanisms for melanocytes under oxidative stress and the study of their mechanisms. The most effective way to eliminate and reduce the free radical effects that cause oxidative stress is the antioxidant defense mechanism.

[0003] A Chinese patent document with authorization announcement number CN105902722B discloses a Chinese medicine composition for treating vitiligo, and a preparation method and application thereof. The Chinese medicine composition, wherein the Chinese medicine raw materials used to make the active ingredients are composed of the following weight percentages: 25% to 45% of golden snake, 25% to 45% of lake frog, 2.5% to 4.5% of anacardia root, 1% to 3% of gecko, 5% to 7% of calamus, 2.5% to 4.5% of scorpion, 4% to 7% of frankincense, 2.5% to 3.5% of processed strychnine, 0.5% to 1.5% of scabra, 0.5% to 1.5% of aloe, and 0.1% to 0.4% of saffron; it can be seen that in the existing preparation process of the liniment, the dispersion of the herbal ingredients and 3-OH phlorizin in the vegetable oil is often uneven, resulting in low production efficiency and low stability of the final product. Summary of the invention

[0004] To this end, the present invention provides a Chinese medicine composition liniment for treating vitiligo and a preparation method thereof, so as to overcome the problem in the prior art that the addition ratio of the Chinese herbal medicine concentrate and 3-OH phlorizin cannot be adjusted in time due to the lack of real-time monitoring of the liniment preparation process, resulting in low quality of the final liniment.

[0005] To achieve the above object, the present invention provides a method for preparing a Chinese medicine composition liniment for treating vitiligo, comprising:

[0006] Step S1, crushing, washing and drying each raw material of the Chinese medicine composition, and then putting it into a crusher for crushing to obtain coarse medicinal material particles;

[0007] Step S2, extracting, extracting the active ingredients in the coarse particles of the medicinal material to obtain a concentrated medicinal solution;

[0008] Step S3, preparing a liniment, mixing the concentrated medicinal solution, 3-OH phlorizin and vegetable oil to uniformly disperse them to obtain a liniment; wherein,

[0009] Step S3001, extracting 3-OH phlorizin from tender leaves of Malus hupehensis;

[0010] Step S3002, dispersing and mixing, adding the Chinese herbal medicine concentrate and the 3-OH phlorizin into the vegetable oil according to a preset ratio to form a mixed solution, and monitoring the adding process in real time, analyzing the dispersion rate of the mixed solution in real time to adjust the opening and closing of the feed valve, or determining that the dispersing and mixing process is completed, and obtaining the liniment;

[0011] Step S3003, cooling, cooling the liniment to room temperature;

[0012] Step S4, bottling and storage, put the prepared ointment into a clean glass bottle and seal it for storage.

[0013] Furthermore, real-time monitoring of the joining process includes,

[0014] Step S3012, taking pictures of the mixed liquid with a camera at a preset collection period to obtain a continuous dispersion process image;

[0015] Step S3022, determining an image grayscale change rate based on the continuous dispersion process image;

[0016] Step S3032, drawing a dispersion rate change curve based on the image grayscale change rate, determining whether to perform a fluidity test based on the dispersion rate change curve, or determining whether the dispersion and mixing process is completed, and obtaining the liniment;

[0017] Step S3042, determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a revised ratio based on the fluidity test result;

[0018] Step S3052, continue to add the Chinese herbal medicine concentrate and 3-OH phlorizin to the mixed solution according to the preset ratio or the corrected ratio, and repeat the above-mentioned camera taking pictures, drawing the dispersion rate change curve, and judging the change trend of the dispersion rate change curve to determine whether the dispersion and mixing process is completed and the ointment is obtained.

[0019] Further, drawing a dispersion rate change curve based on the image grayscale change rate includes:

[0020] The image grayscale change rate of each preset acquisition cycle is obtained, and a curve of the grayscale change rate of each image over time is plotted as a dispersion rate change curve.

[0021] Further, determining whether to perform a fluidity test based on the dispersion rate change curve includes:

[0022] Determine the change trend of the dispersion rate change curve,

[0023] If a peak appears in the dispersion rate variation curve, it is determined that the dispersion and mixing process is completed;

[0024] If no peak appears in the dispersion rate variation curve, a fluidity test is performed to determine whether the preset ratio should be adjusted.

[0025] Furthermore, the process of liquidity testing includes,

[0026] Sampling is performed in the mixed solution at a preset sampling period to form a mixed solution to be detected, and the mixed solution to be detected is placed in a test container for oscillation.

[0027] Further, determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a modified ratio based on the fluidity test result includes:

[0028] Determine the real-time flow rate based on the standard flow rate.

[0029] If the real-time flow rate is less than the standard flow rate, the preset ratio is adjusted to a correction ratio;

[0030] If the real-time flow rate is greater than or equal to the standard flow rate, the preset ratio is not adjusted and vegetable oil is added.

[0031] Further, the actual flow time and the actual outflow mass of the mixed liquid to be detected through the test container are obtained, and the real-time flow rate is calculated according to the actual flow time, the actual outflow mass and the cross-sectional area of ​​the container;

[0032] The real-time flow rate is the quotient of the product of the container cross-sectional area and the actual outflow mass and the actual flow time.

[0033] Further, determining the image grayscale change rate based on the continuous dispersion process image includes:

[0034] The grayscale value of the mixed liquid corresponding to each continuous dispersion image is calculated, and a curve of the grayscale value change of the mixed liquid over time is drawn with a preset acquisition time, and a linear fit is performed to obtain an average grayscale value fitting curve, and the maximum slope of the average grayscale value fitting curve is used as the image grayscale change rate.

[0035] Further, the active ingredients in the crude particles of the medicinal material are extracted to obtain a concentrated medicinal solution, including:

[0036] Step S201, soaking, putting the coarse medicinal material particles into a container, adding ethanol and soaking for 20 minutes to obtain a medicinal material soaking liquid;

[0037] Step S202, heating extraction, heating the medicinal material soaking liquid to boiling, maintaining it for 30 minutes, to obtain a medicinal material extract;

[0038] Step S203, filtering, filtering the medicinal material extract with gauze or a filter to remove the medicinal residues to obtain a medicinal material extract clear liquid;

[0039] Step S204, concentration, concentrating the medicinal material extract clear liquid at low temperature until the liquid volume is reduced to about 1 / 3 of the original volume, thereby obtaining the concentrated medicinal liquid.

[0040] On the other hand, a Chinese medicine composition liniment prepared by the above-mentioned Chinese medicine composition liniment preparation method for treating vitiligo comprises:

[0041] 5 g of Chinese medicine concentrate, 5 g of 3-OH phlorizin, 50 ml of vegetable oil, and 30-35 ml of ethanol;

[0042] Among them, the components of the Chinese medicine composition include:

[0043] 10-13 parts by weight of Psoralea corylifolia, 10-13 parts by weight of Tribulus terrestris, 10-13 parts by weight of Angelica sinensis, 15-20 parts by weight of Polygonum multiflorum, 10-13 parts by weight of Angelica dahurica, 5-6 parts by weight of Carthamus tinctorius, 10-14 parts by weight of Saposhnikovia divaricata, and 15-18 parts by weight of Astragalus membranaceus.

[0044] Compared with the prior art, the beneficial effect of the present invention lies in that a variety of Chinese herbal ingredients are prepared into an ointment, the purpose is to improve skin condition and promote pigment recovery by external use, by adding the extracted Chinese herbal ingredients and 3-OH phlorizin to vegetable oil, and controlling the addition ratio of the Chinese herbal concentrate and 3-OH phlorizin to ensure the dispersion uniformity and effect of the final ointment, so as to determine the parameters according to the actual process conditions and flexibly respond to the production requirements of different batches, thereby achieving the stability and intelligence of mass production, and realizing the intelligence of the production process through automatic monitoring and adjustment of the opening and closing of the feed valve, optimizing the preparation process of the ointment, not only improving the quality and stability of the product, but also enhancing the intelligence and adaptability of production.

[0045] Furthermore, due to the collision between the herbal ingredients and the vegetable oil molecules, the herbal ingredients will gradually aggregate and form a tiny dispersed phase, that is, as the Chinese herbal concentrate and 3-OH phlorizin are fully in contact with the vegetable oil, the dispersion speed of the Chinese herbal concentrate and 3-OH phlorizin in the vegetable oil is accelerated, that is, the number of dissolved and dispersed particles continues to increase; when the concentration of the Chinese herbal concentrate and 3-OH phlorizin in the mixed solution reaches a certain critical value, the dispersion speed no longer increases, and a downward trend appears. If it is determined that a peak appears in the dispersion rate change curve, it means that the concentration of the added Chinese herbal concentrate and 3-OH phlorizin has reached a certain critical value. The particles are completely dispersed, that is, the dispersion process is completed. If it is determined that no peak appears in the dispersion rate change curve, it means that the particles in the Chinese herbal concentrate and 3-OH phlorizin concentration have not been completely dispersed evenly. It may be that the preset matching is not suitable, or the mixed liquid is saturated. In this case, vegetable oil needs to be added to ensure complete dispersion. Therefore, by analyzing the dispersion effect, the peak value in the dispersion rate change curve is used as a feedback signal to determine whether to adjust the feed valve to open, realize automatic feeding control, increase the real-time detection, and ensure that the Chinese herbal concentrate, vegetable oil and 3-OH phlorizin are made into an ointment and are evenly dispersed.

[0046] Furthermore, when it is determined that the real-time flow rate is less than the standard flow rate, it indicates that the viscosity of the prepared ointment is relatively large. In this case, due to the excessive amount of Chinese herbal concentrate added, the viscosity of the entire ointment increases, affecting the fluidity and spreadability of the ointment. At the same time, it is explained that the reason affecting the uniformity of the dispersion of the ointment is that as the amount of Chinese herbal concentrate added increases, the excess Chinese herbal ingredients cannot be completely dissolved or dispersed, resulting in particle precipitation. Therefore, it is necessary to adjust the preset ratio to reduce the proportion of herbal concentrate to avoid the granular feeling of the ointment during use. At the same time, the addition ratio of the Chinese herbal concentrate and 3-OH phlorizin should be adjusted in real time according to actual needs to adapt to different production needs. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 The figure is a schematic flow chart of a method for preparing a Chinese medicine composition liniment for treating vitiligo according to an embodiment of the present invention;

[0048] Figure 2 It is a schematic diagram of the process of extraction process of an embodiment of the present invention;

[0049] Figure 3 The figure is a schematic diagram of a process for preparing a liniment according to an embodiment of the present invention;

[0050] Figure 4 The figure is a flow chart of real-time monitoring of the process of adding Chinese herbal medicine concentrate and 3-OH phlorizin to vegetable oil according to an embodiment of the present invention. DETAILED DESCRIPTION

[0051] In order to make the objects and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with embodiments; it should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0052] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the protection scope of the present invention.

[0053] It should be noted that, in the description of the present invention, terms such as "up", "down", "left", "right", "inside" and "outside" indicating directions or positional relationships are based on the directions or positional relationships shown in the drawings. This is merely for the convenience of description and does not indicate or imply that the device or element must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present invention.

[0054] In addition, it should be noted that in the description of the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0055] See also Figure 1 , Figure 2 as well as Figure 3 As shown, Figure 1 The figure is a schematic flow chart of a method for preparing a Chinese medicine composition liniment for treating vitiligo according to an embodiment of the present invention; Figure 2 It is a schematic diagram of the process of extraction process of an embodiment of the present invention;

[0056] Figure 3The present invention provides a method for preparing a liniment of a traditional Chinese medicine composition for treating vitiligo, comprising:

[0057] Step S1, crushing, washing and drying each raw material of the Chinese medicine composition, respectively putting it into a crusher for crushing, passing through a No. 2 sieve and a 40-mesh coarse sieve to obtain coarse medicinal material particles;

[0058] Step S2, extracting, extracting the active ingredients in the coarse particles of the medicinal material to obtain a concentrated medicinal solution; wherein,

[0059] Step S201, soaking, putting the coarse medicinal material particles into a container, adding ethanol and soaking for 20 minutes to obtain a medicinal material soaking liquid;

[0060] Step S202, heating extraction, heating the medicinal material soaking liquid to boiling, maintaining for 30 minutes, to obtain a medicinal material extract;

[0061] Step S203, filtering, filtering the medicinal material extract with gauze or a filter to remove the medicinal residues to obtain a medicinal material extract clear liquid;

[0062] Step S204, concentrating, concentrating the medicinal material extract at low temperature until the liquid volume is reduced to about 1 / 3 of the original volume, thereby obtaining the concentrated medicinal solution;

[0063] Step S3, preparing a liniment, mixing the concentrated medicinal solution, 3-OH phlorizin and vegetable oil to uniformly disperse them to obtain a liniment; wherein,

[0064] Step S3001, extracting 3-OH phlorizin from tender leaves of Malus hupehensis;

[0065] Step S3002, dispersing and mixing, adding the Chinese herbal medicine concentrate and the 3-OH phlorizin into the vegetable oil according to a preset ratio to form a mixed solution, and monitoring the adding process in real time, analyzing the dispersion rate of the mixed solution in real time to adjust the opening and closing of the feed valve, or determining that the dispersing and mixing process is completed, and obtaining the liniment;

[0066] Step S3003, cooling, cooling the liniment to room temperature;

[0067] Step S4, bottling and storage, put the prepared ointment into a clean glass bottle and seal it for storage.

[0068] In this embodiment, a variety of Chinese herbal ingredients are prepared into an ointment, aiming to improve skin condition and promote pigmentation recovery by external use. The extracted Chinese herbal ingredients and 3-OH phlorizin are added to vegetable oil, and the addition ratio of the Chinese herbal concentrate and 3-OH phlorizin is controlled to ensure the dispersion uniformity and effect of the final ointment. The parameters are determined according to the actual process conditions, and the production requirements of different batches can be flexibly responded to, thereby achieving stability and intelligence in mass production. The intelligent production process is achieved through automatic monitoring and adjustment of the opening and closing of the feed valve, and the preparation process of the ointment is optimized, which not only improves the quality and stability of the product, but also enhances the intelligence and adaptability of production.

[0069] In this embodiment, the process of extracting 3-OH phlorizin from the young leaves of Malus melongena is as follows: 100 grams of the young leaves of Malus melongena are taken, and reflux extraction is performed using water at 98° C. During the first extraction, 12 times the volume of water (i.e., 1200 ml) is added, and the mixture is filtered after extraction. During the second extraction, 8 times the volume of water (i.e., 800 ml) is added, and the mixture is filtered in the same manner. The filtrates from the two extractions are combined to obtain 2 liters of water extract of the young leaves of Malus melongena, ensuring that the crude drug mass concentration of the water extract is 50 mg·mL-1, and the content of phlorizin in the water extract is determined using high performance liquid chromatography (HPLC). Accurately weigh 100 g of fresh Agaricus bisporus, wash and chop, add the chopped Agaricus bisporus to 200 ml of pre-cooled phosphate buffer (pH 7.0, 0.1 mol·L-1), grind at low temperature, filter with gauze to obtain PPO crude enzyme solution, divide the PPO crude enzyme solution into 20 ml centrifuge tubes, store in -20 ℃ freezer to avoid repeated freezing and thawing, take 1 ml of 0.1 mol·L-1 catechol, add it to a 10 ml test tube, add 4 ml of pH 7.0 phosphate buffer, mix well and add 1 ml of PPO crude enzyme solution, use phosphate buffer as blank control, measure the absorbance of the reaction system at 420 nm, record once every 30 seconds, and define an increase of 0.001 in absorbance per minute as 1 enzyme activity unit (U); take 24 ml of Hubei Malus tender leaf water extract, add 20 mmol·L-1 ascorbic acid, use 1.0 mol·L-1 The pH value was adjusted to 7.0 with 1 L-1 NaOH aqueous solution, and 1 ml of PPO crude enzyme solution was added to start the reaction. The reaction was carried out at 25°C for 6 hours. 0.5 ml of the enzymatic reaction solution was taken and placed in an 80°C water bath for inactivation for 5 minutes. After cooling to room temperature with running water, 0.5 ml of methanol solution was added and 3-OH phlorizin was obtained by filtration.

[0070] See also Figure 4 As shown, it is a schematic flow chart of real-time monitoring of the process of adding Chinese herbal medicine concentrate and 3-OH phlorizin to vegetable oil according to an embodiment of the present invention;

[0071] Specifically, real-time monitoring of the joining process includes:

[0072] Step S3012, taking pictures of the mixed liquid with a camera at a preset collection period to obtain a continuous dispersion process image;

[0073] Step S3022, determining an image grayscale change rate based on the continuous dispersion process image;

[0074] Wherein, determining the image grayscale change rate based on the continuous dispersion process image includes:

[0075] Calculate the gray value of the mixed liquid corresponding to each continuous dispersion image, draw a curve of the gray value change of the mixed liquid over time with a preset acquisition time, and perform linear fitting to obtain an average gray value fitting curve, and use the maximum slope of the average gray value fitting curve as the image gray value change rate;

[0076] The preset collection period is 1 second, and the preset collection duration is 5 seconds;

[0077] Step S3032, drawing a dispersion rate change curve based on the image grayscale change rate, determining whether to perform a fluidity test based on the dispersion rate change curve, or determining whether the dispersion and mixing process is completed, and obtaining the liniment;

[0078] Step S3042, determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a revised ratio based on the fluidity test result;

[0079] Step S3052, continue to add the Chinese herbal medicine concentrate and 3-OH phlorizin to the mixed solution according to the preset ratio or the corrected ratio, and repeat the above-mentioned camera taking pictures, drawing the dispersion rate change curve, and judging the change trend of the dispersion rate change curve to determine whether the dispersion and mixing process is completed and the ointment is obtained.

[0080] Specifically, drawing a dispersion rate change curve based on the image grayscale change rate includes:

[0081] The image grayscale change rate of each preset acquisition cycle is obtained, and a curve of the grayscale change rate of each image over time is plotted as a dispersion rate change curve.

[0082] In this embodiment, the mean filtering method is used to filter the continuous dispersion process image. The grayscale values ​​of all pixels on any image are added and then divided by the total number of pixels to obtain the grayscale value of the mixed liquid of the corresponding continuous dispersion process image. A linear fitting of "mixed liquid grayscale value-time" is performed once every five frames of images. The fitting curve with a correlation coefficient greater than 0.9 is taken, and the maximum slope is taken as the image grayscale change rate;

[0083] The dispersion and mixing process was monitored by joint image recognition technology. Chinese herbal concentrate and 3-OH phlorizin were slowly added to the vegetable oil. The solid particles in the Chinese herbal concentrate and 3-OH phlorizin were gradually dispersed. Stirring helped to accelerate the dispersion process. When stirring stopped and the mixture was left standing, images of the continuous dispersion process were obtained. As the transmittance increased with the increase of sedimentation time, the image gradually changed from black to bright. Therefore, the grayscale change rate of the image represented the dispersion rate.

[0084] Specifically, determining whether to perform a fluidity test based on the dispersion rate change curve includes:

[0085] Determine the change trend of the dispersion rate change curve,

[0086] If a peak value appears in the dispersion rate change curve, it is determined that the dispersion and mixing process is completed, indicating that the solution is saturated, and the feed valve is not controlled to be opened to avoid excessive addition;

[0087] If no peak appears in the dispersion rate variation curve, a fluidity test is performed to determine whether the preset ratio should be adjusted.

[0088] Due to the collision between the herbal ingredients and the vegetable oil molecules, the herbal ingredients will gradually aggregate and form a tiny dispersed phase. That is, as the Chinese herbal concentrate and 3-OH phlorizin are fully in contact with the vegetable oil, the dispersion speed of the Chinese herbal concentrate and 3-OH phlorizin in the vegetable oil is accelerated, that is, the number of dissolved and dispersed particles increases continuously. When the concentration of the Chinese herbal concentrate and 3-OH phlorizin in the mixed solution reaches a certain critical value, the dispersion speed no longer increases and a downward trend appears. If it is determined that a peak appears in the dispersion rate change curve, it means that the concentration of the added Chinese herbal concentrate and 3-OH phlorizin has made the particles The particles are completely dispersed, that is, the dispersion process is completed. If it is determined that no peak appears in the dispersion rate change curve, it means that the particles in the Chinese herbal concentrate and 3-OH phlorizin concentration have not been completely dispersed evenly. It may be that the preset matching is not suitable, or the mixed liquid is saturated. In this case, vegetable oil needs to be added to ensure complete dispersion. Therefore, by analyzing the dispersion effect, the peak value in the dispersion rate change curve is used as a feedback signal to determine whether to adjust the feed valve to open, realize automatic feeding control, increase the real-time nature of the detection, and ensure that the Chinese herbal concentrate, vegetable oil and 3-OH phlorizin are made into an ointment and are evenly dispersed.

[0089] Specifically, the process of liquidity testing includes:

[0090] Sampling is performed in the mixed solution at a preset sampling period to form a mixed solution to be detected, and the mixed solution to be detected is placed in a test container for oscillation.

[0091] Specifically, determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a revised ratio based on the fluidity test result includes:

[0092] Determine the real-time flow rate based on the standard flow rate.

[0093] If the real-time flow rate is less than the standard flow rate, the preset ratio is adjusted to a correction ratio;

[0094] If the real-time flow rate is greater than or equal to the standard flow rate, the preset ratio is not adjusted and vegetable oil is added;

[0095] Among them, the correction ratio is the product of the preset ratio and the correction coefficient, the correction coefficient is 1 minus the correction step length, the correction step length is the product of the part of the standard flow rate that exceeds the real-time flow rate and the standard flow rate; the volume of supplemented vegetable oil is 5% of the initial volume, and the initial volume of vegetable oil is 50mL.

[0096] The preset ratio in this embodiment is the ratio of the Chinese medicine composition concentrate and 3-OH phlorizin, which is set to 1:1. The components of the Chinese medicine composition ointment are 5g of the Chinese medicine composition concentrate, 5g of 3-OH phlorizin, 50ml of vegetable oil, and 30-35ml of ethanol.

[0097] When the real-time flow rate is judged to be less than the standard flow rate, it means that the viscosity of the prepared ointment is relatively large. In this case, due to the excessive addition of the Chinese herbal concentrate, the viscosity of the entire ointment increases, affecting the fluidity and spreadability of the ointment. At the same time, it explains that the reason affecting the uniformity of the dispersion of the ointment is that as the amount of Chinese herbal concentrate added increases, the excess Chinese herbal ingredients cannot be completely dissolved or dispersed, resulting in particle precipitation. Therefore, it is necessary to adjust the preset ratio to reduce the proportion of herbal concentrate to avoid the granular feeling of the ointment during use. At the same time, the addition ratio of the Chinese herbal concentrate and 3-OH phlorizin should be adjusted in real time according to actual needs to adapt to different production needs.

[0098] Specifically, the actual flow time and actual outflow mass of the mixed liquid to be tested passing through the test container are obtained, and the real-time flow rate is calculated according to the actual flow time, the actual outflow mass and the cross-sectional area of ​​the container;

[0099] The real-time flow rate is the quotient of the product of the container cross-sectional area and the actual outflow mass and the actual flow time.

[0100] Specifically, the monitoring agency obtains the image grayscale change rate of each preset acquisition cycle, draws a curve of the change rate of each image grayscale change over time as a sedimentation rate change curve, and determines the change trend of the sedimentation rate change curve.

[0101] If a peak value appears in the sedimentation rate change curve, the monitoring mechanism determines that the dispersion and mixing process is completed, indicating that the solution is saturated, and the feed valve is not controlled to be opened to avoid excessive addition;

[0102] If no peak appears in the sedimentation rate change curve, the monitoring mechanism controls the feed valve to open, continues to add Chinese herbal medicine concentrate and 3-OH phlorizin to the stirring mechanism, and repeats the above-mentioned camera mechanism to take pictures. The monitoring mechanism draws the sedimentation rate change curve and determines the change trend of the sedimentation rate change curve.

[0103] As the Chinese herbal medicine concentrate and 3-OH phlorizin are in full contact with the vegetable oil, the precipitation rate is accelerated and the number of dissolved and dispersed particles increases continuously; when the concentration of the Chinese herbal medicine concentrate and 3-OH phlorizin in the feed liquid reaches a certain critical value, the precipitation rate no longer increases and shows a downward trend. If it is determined that a peak value appears in the sedimentation rate change curve, it means that the added Chinese herbal medicine concentrate and 3-OH phlorizin concentration have completely dispersed the particles, that is, the dispersion process is completed. If it is determined that no peak value appears in the sedimentation rate change curve, it means that the particles in the Chinese herbal medicine concentrate and 3-OH phlorizin concentration have not been completely dispersed evenly, and vegetable oil needs to be continuously added to ensure that the particles are completely dissolved and precipitated. Therefore, by analyzing the sedimentation effect, the peak value in the sedimentation rate change curve is used as a feedback signal, and the monitoring mechanism is used to determine whether to adjust the feed valve to open, so as to realize automatic feeding control, increase the real-time nature of the detection, and ensure that the Chinese herbal medicine concentrate, vegetable oil and 3-OH phlorizin are made into an ointment and are evenly dispersed.

[0104] Specifically, the present invention also provides a Chinese medicine composition prepared by the above-mentioned preparation method of the Chinese medicine composition liniment for treating vitiligo, and the components of the Chinese medicine composition include:

[0105] 10-13 parts by weight of Psoralea corylifolia, 10-13 parts by weight of Tribulus terrestris, 10-13 parts by weight of Angelica sinensis, 15-20 parts by weight of Polygonum multiflorum, 10-13 parts by weight of Angelica dahurica, 5-6 parts by weight of Carthamus tinctorius, 10-14 parts by weight of Saposhnikovia divaricata, and 15-18 parts by weight of Astragalus membranaceus.

[0106] The vegetable oil is olive oil or almond oil;

[0107] Example 1, the components of the Chinese herbal medicine composition are:

[0108] 10 parts by weight of Psoralea corylifolia, 10 parts by weight of Tribulus terrestris, 10 parts by weight of Angelica sinensis, 15 parts by weight of Polygonum multiflorum, 10 parts by weight of Angelica dahurica, 5 parts by weight of Carthamus tinctorius, 10 parts by weight of Saposhnikovia divaricata, and 15 parts by weight of Astragalus membranaceus;

[0109] The components of the Chinese medicine composition ointment are 5g of the Chinese medicine composition concentrated solution, 5g of 3-OH phlorizin, 50ml of vegetable oil and 30-35ml of ethanol.

[0110] Example 2, the components of the Chinese herbal medicine composition are:

[0111] 12 parts by weight of Psoralea corylifolia, 12 parts by weight of Tribulus terrestris, 12 parts by weight of Angelica sinensis, 18 parts by weight of Polygonum multiflorum, 12 parts by weight of Angelica dahurica, 6 parts by weight of Carthamus tinctorius, 13 parts by weight of Saposhnikovia divaricata, and 18 parts by weight of Astragalus membranaceus;

[0112] The components of the Chinese medicine composition ointment are 5g of the Chinese medicine composition concentrated solution, 5g of 3-OH phlorizin, 50ml of vegetable oil and 30-35ml of ethanol.

[0113] Psoralea corylifolia (Leguminosae) is an annual herb widely distributed in Southeast Asia. Modern pharmacological and clinical studies have shown that compounds related to clinical pharmacodynamics in Psoralea corylifolia have been isolated, and the main chemical components contained in Psoralea corylifolia are roughly coumarins, terpenoids, flavonoids, etc. Among them, coumarin compounds can be divided into furanocoumarins and pseudoestrolactone compounds. Representative drugs of furanocoumarins are psoralen, isopsoralen and 8-methoxypsoralen, and the latter's representative drugs are psoralen and isopsoralen; the representative drug of terpenoid compounds is bakuchiol, which is an isoprenyl terpene phenol chemical; flavonoid compounds include a variety of coumarins classified as flavonols, dihydroflavones, chalcones, etc. The active ingredients in Psoralea corylifolia have photosensitizing effects, which not only enhance the skin's absorption of ultraviolet rays, but also dilate blood vessels, improve local circulation, and promote the increase of skin pigmentation.

[0114] The main active ingredients in Tribulus terrestris, kaempferol and isorhamnetin, can inhibit the expression of inflammatory mediator nitric oxide, significantly increase the mRNA and TYR activity of melanin biosynthesis genes, reduce the content of TNF, reactive oxygen and hydrogen peroxide to reduce the production of free radicals, stabilize the mitochondrial membrane and inhibit the apoptosis of melanocytes, thereby achieving the effect of treating vitiligo.

[0115] Angelica sinensis is sweet, moist and heavy to nourish blood, and pungent, dispersing, warming and unblocking to remove blood stasis, so it is a blood-qi medicine. Angelica sinensis polysaccharide, the active ingredient of Angelica sinensis, can reduce the cell oxidation damage caused by hydrogen peroxide, promote the proliferation of T cells, IL-2 and interferon-γ, and reduce cell apoptosis and the production of IL-4 and ROS to exert its immunomodulatory activity.

[0116] Polygonum multiflorum belongs to the liver, heart, and kidney meridians. It is good at nourishing the liver and kidney, improving the essence and blood, and blackening the hair. It is good at treating the deficiency of essence and blood. Raw use is good at treating sores, scrofula, urticaria, itching, and constipation caused by dry intestines. Polygonum multiflorum can significantly promote the gene expression and protein synthesis of tyrosinase and microphthalmia-associated transcription factor in vitro, and can also activate the activity of tyrosinase to stimulate B16 cell melanogenesis. Polygonum multiflorum is rich in kaempferol, which can enhance the activity of nuclear factor E2-related factor 2, TYR, and MITF, and reduce the antioxidant activity of superoxide anions in oxidative stress to enhance the melanogenesis reaction in vivo and in vitro.

[0117] Angelica dahurica is pungent, warming and dry, aromatic and invigorating, and enters the lung, stomach and large intestine meridians. It has the effects of dispelling wind and dampness, moisturizing the face, removing spots and whitening. The main active ingredients of Angelica dahurica, such as angelica dahurica, imperatorin, and 8-oxymethylisoimperatorin, may play an anti-inflammatory and immune-regulating role by regulating target proteins such as MAPK1, MAPK8, MAPK14, and ESR1. Angelica dahurica is rich in photosensitive coumarins and is a specific drug for the treatment of vitiligo. It can significantly protect melanocytes damaged by hydrogen peroxide, and can induce mitochondrial and endoplasmic reticulum dysfunction to affect abnormal cell apoptosis to achieve anti-inflammatory, antioxidant, and anti-allergic functions.

[0118] Safflower is pungent, dispersing, warming and unblocking. It enters the heart and liver meridians, and is good at promoting blood circulation, removing blood stasis, promoting menstruation, reducing swelling and relieving pain, and treating various symptoms of blood stasis. Safflower contains quercetin, which can increase the density and number of melanin bodies in the skin of brown guinea pigs, inhibit hydrogen peroxide-induced immortalized normal human PIG1 melanocytes and vitiligo PIG3V melanocytes, apoptosis and reduce UVB-induced intracellular ROS production, regulate PI3K-AKT, p38 signals and partially reverse the phosphorylation of AKT and p38. Quercetin has shown biological activities such as scavenging oxygen free radicals, reducing mitochondrial damage, regulating pigments, and protecting keratinocytes from exogenous oxidative damage and endogenous consumption in animal and human experiments. Luteolin in safflower dose-dependently inhibits the expression of key inflammatory chemokines IL-8, cyclic adenosine monophosphate response element binding protein and TYR in vitiligo to inhibit the synthesis of melanin.

[0119] 3-OH phlorizin has significant antioxidant properties, which can scavenge free radicals in the body and reduce the damage of oxidative stress to melanocytes; 3-OH phlorizin has anti-inflammatory properties and can reduce the inflammatory response of the skin; 3-OH phlorizin has an activating effect on tyrosinase, and it plays a positive role in treating vitiligo by activating tyrosinase activity and improving oxidative stress damage.

[0120] Hubei crabapple is a commonly used medicine of the Tujia ethnic group. Its main ingredient, phlorizin, has multiple pharmacological effects such as anti-oxidation, hypoglycemic, anti-tumor, and antibacterial. 3-OH phlorizin is also an effective ingredient of Hubei crabapple. Its catechol structure makes its antioxidant capacity stronger than phlorizin. It also has the effects of lowering blood sugar, lowering uric acid, and acting as an estrogen. Phlorizin has a significant inhibitory effect on tyrosinase. Through the reverse selection method, it was found that 3-OH phlorizin has a significant activating effect on tyrosinase and has the potential for the treatment of vitiligo.

[0121] Saposhnikovia divaricata has a good effect of dispelling wind. Traditional Chinese medicine believes that vitiligo is related to wind evil in the body. Wind evil causes poor blood circulation on the skin surface, affecting the normal pigmentation of the skin. By dispelling wind, Saposhnikovia divaricata helps to improve the microcirculation of the skin, thereby helping to restore pigmentation. Saposhnikovia divaricata contains a variety of anti-inflammatory ingredients, such as saposhnikovia glycosides, which can reduce the inflammatory response of the skin. The skin of vitiligo patients is often accompanied by mild inflammatory reactions, which may further affect the function of melanocytes. The anti-inflammatory effect of Saposhnikovia divaricata may help protect these cells. Vitiligo is related to autoimmunity. Saposhnikovia divaricata has a certain immunoregulatory effect, which can help adjust the immune system and reduce autoimmune attacks on melanocytes, thereby helping to slow the progression of the disease.

[0122] Astragalus is rich in antioxidant ingredients, such as flavonoids and polysaccharides. These antioxidants can help reduce cell damage caused by free radicals and protect melanocytes from oxidative stress. Oxidative stress is considered a key factor in the pathogenesis of vitiligo. Astragalus also has the effect of promoting blood circulation and improving microcirculation. By improving the blood supply to the skin, it can increase the supply of nutrients and oxygen, which helps the growth and function of melanocytes, thereby having a positive effect on the treatment of vitiligo. Astragalus also has certain anti-inflammatory effects and can help reduce the inflammatory state of the skin. In the development of vitiligo, inflammatory reactions may exacerbate the depigmentation of the skin, so the anti-inflammatory effects of astragalus may help slow this process. Astragalus is believed to have an immune-enhancing effect. Vitiligo is associated with immune system dysfunction, especially autoimmune reactions that may attack and destroy melanocytes in the skin. By regulating the immune system, astragalus can help reduce the autoimmune attack on melanocytes, thereby helping to control and relieve the symptoms of vitiligo.

[0123] Specifically, the Chinese medicine composition liniment of the present invention was used on a test group for testing, and the use method, experimental data, and experimental results are as follows:

[0124] The test population selected patients with vitiligo. When using the product, the age range of patients with vitiligo was 18 to 65 years old, and gender was not limited. The test was randomly divided into two groups, the experimental group and the control group, with 50 people in each group.

[0125] Experimental group: Before use, volunteers with vitiligo should first clean the affected skin with warm water and mild detergent to ensure that the skin is clean and free of grease and dirt. After cleaning, pat dry with a clean towel; take an appropriate amount of Chinese medicine composition ointment (about 1-2 ml), adjust it according to the area of ​​the white spots and the part to be applied, apply the ointment evenly on the white spot area, gently massage to promote absorption, and avoid contact of the ointment with healthy skin to reduce unnecessary irritation. After application, keep the application area dry and avoid contact with water or sweat immediately after application to ensure that the effective ingredients of the ointment can fully exert their effects. The frequency of use is twice a day, once in the morning and once in the evening. Make sure to use it within a fixed time period and use it continuously for 12 weeks.

[0126] Control Group: The control group did not use any product.

[0127] Before the start of the trial, each patient's itching score (0-10 points, 0 points for no itching, 10 points for severe itching) and white spot area (measured using a skin measuring instrument, unit: square centimeters) were recorded. After the trial period, each subject's feelings were evaluated, including the above characteristics. Finally, a survey of patients' improved feelings was conducted. If any adverse events related to product use, such as allergic reactions or skin irritation, occur during the trial, use of the product should be stopped immediately and a doctor should be consulted.

[0128] The experimental results are shown in Tables 1 and 2, wherein Table 1 shows the test indexes and results of the liniment prepared from the Chinese medicine composition liniment formula of Example 1 of the present invention; Table 1 shows the test indexes and results of the liniment prepared from the Chinese medicine composition liniment formula of Example 2 of the present invention;

[0129] Table 1

[0130] Group Experimental Group Control group Baseline pruritus score 7.5 7.4 Pruritus score after 12 weeks 3.0 6.5 Itch score improvement rate 60％ 12.16％ <![CDATA[Baseline white spot area (cm 2 )]]> 25.0 24.5 <![CDATA[White spot area after 12 weeks (cm 2 )]]> 10.0 23.0 White spot area reduction rate 60％ 6.12％

[0131] Table 2

[0132] Group Experimental Group Control group Baseline pruritus score 8.0 7.9 Pruritus score after 12 weeks 2.5 7.0 Itch score improvement rate 68.75％ 11.39％ <![CDATA[Baseline white spot area (cm 2 )]]> 30.0 29.5 <![CDATA[White spot area (cm 2 )]]> 12.0 28.0 White spot area reduction rate 60％ 5.08％

[0133] Itch score improvement rate: There was a significant difference in the itch score improvement rate between the experimental group and the control group (p < 0.01).

[0134] White spot area reduction rate: There was a significant difference in the white spot area reduction rate between the experimental group and the control group (p < 0.01).

[0135] The Chinese medicine composition ointment prepared in this embodiment can effectively relieve the itching of vitiligo patients and reduce the area of ​​local white spots. It also provides efficacy experimental data that can confirm that the above-mentioned Chinese medicine composition ointment can be effectively used in clinical practice, and also provides a medicinal material control screening experiment.

[0136] So far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it is easy for those skilled in the art to understand that the protection scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will fall within the protection scope of the present invention.

[0137] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A method for preparing a Chinese medicine composition liniment for treating vitiligo, characterized in that: include, Step S1, crushing, washing and drying each raw material of the Chinese medicine composition, and then putting it into a crusher for crushing to obtain coarse medicinal material particles; Step S2, extracting, extracting the active ingredients in the coarse particles of the medicinal material to obtain a concentrated medicinal solution; Step S3, preparing a liniment, mixing the concentrated medicinal solution, 3-OH phlorizin and vegetable oil to uniformly disperse them to obtain a liniment; wherein, Step S3001, extracting 3-OH phlorizin from tender leaves of Malus hupehensis; Step S3002, dispersing and mixing, adding the Chinese herbal medicine concentrate and the 3-OH phlorizin into the vegetable oil according to a preset ratio to form a mixed solution, and monitoring the adding process in real time, analyzing the dispersion rate of the mixed solution in real time to adjust the opening and closing of the feed valve, or determining that the dispersing and mixing process is completed, and obtaining the liniment; Step S3003, cooling, cooling the liniment to room temperature; Step S4, bottling and storage, put the prepared ointment into a clean glass bottle and seal it for storage.

2. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 1, characterized in that: Real-time monitoring of the joining process includes, Step S3012, taking pictures of the mixed liquid with a camera at a preset collection period to obtain a continuous dispersion process image; Step S3022, determining an image grayscale change rate based on the continuous dispersion process image; Step S3032, drawing a dispersion rate change curve based on the image grayscale change rate, determining whether to perform a fluidity test based on the dispersion rate change curve, or determining whether the dispersion and mixing process is completed, and obtaining the liniment; Step S3042, determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a revised ratio based on the fluidity test result; Step S3052, continue to add the Chinese herbal medicine concentrate and 3-OH phlorizin to the mixed solution according to the preset ratio or the corrected ratio, and repeat the above-mentioned camera taking pictures, drawing the dispersion rate change curve, and judging the change trend of the dispersion rate change curve to determine whether the dispersion and mixing process is completed and the ointment is obtained.

3. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 2, characterized in that: Drawing the dispersion rate change curve based on the image grayscale change rate includes: The image grayscale change rate of each preset acquisition cycle is obtained, and a curve of the grayscale change rate of each image over time is plotted as a dispersion rate change curve.

4. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 2, characterized in that: Determining whether to perform a fluidity test based on the dispersion rate change curve includes: Determine the change trend of the dispersion rate change curve, If a peak appears in the dispersion rate variation curve, it is determined that the dispersion and mixing process is completed; If no peak appears in the dispersion rate variation curve, a fluidity test is performed to determine whether the preset ratio should be adjusted.

5. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 4, characterized in that: The process of liquidity testing includes: Sampling is performed in the mixed solution at a preset sampling period to form a mixed solution to be detected, and the mixed solution to be detected is placed in a test container for oscillation.

6. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 5, characterized in that: Determining whether to adjust the preset ratio of the Chinese herbal medicine concentrate and the 3-OH phlorizin to a revised ratio based on the fluidity test result includes: Determine the real-time flow rate based on the standard flow rate. If the real-time flow rate is less than the standard flow rate, the preset ratio is adjusted to a correction ratio; If the real-time flow rate is greater than or equal to the standard flow rate, the preset ratio is not adjusted and vegetable oil is added.

7. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 6, characterized in that: Obtaining the actual flow time and actual outflow mass of the mixed liquid to be tested through the test container, and calculating the real-time flow rate according to the actual flow time, the actual outflow mass and the cross-sectional area of ​​the container; The real-time flow rate is the quotient of the product of the container cross-sectional area and the actual outflow mass and the actual flow time.

8. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 2, characterized in that: Determining the image grayscale change rate based on the continuous dispersion process image includes: The grayscale value of the mixed liquid corresponding to each continuous dispersion image is calculated, and a curve of the grayscale value change of the mixed liquid over time is drawn with a preset acquisition time, and a linear fit is performed to obtain an average grayscale value fitting curve, and the maximum slope of the average grayscale value fitting curve is used as the image grayscale change rate.

9. The method for preparing the Chinese medicine composition liniment for treating vitiligo according to claim 1, characterized in that: Extracting active ingredients from crude medicinal material particles to obtain concentrated medicinal liquid includes: Step S201, soaking, putting the coarse medicinal material particles into a container, adding ethanol and soaking for 20 minutes to obtain a medicinal material soaking liquid; Step S202, heating extraction, heating the medicinal material soaking liquid to boiling, maintaining it for 30 minutes, to obtain a medicinal material extract; Step S203, filtering, filtering the medicinal material extract with gauze or a filter to remove the medicinal residues to obtain a medicinal material extract clear liquid; Step S204, concentration, concentrating the medicinal material extract clear liquid at low temperature until the liquid volume is reduced to about 1 / 3 of the original volume, thereby obtaining the concentrated medicinal liquid.

10. A Chinese medicine composition liniment for treating vitiligo prepared by the method for preparing the Chinese medicine composition liniment for treating vitiligo according to any one of claims 1 to 9, characterized in that: The Chinese medicine composition liniment component includes: 5 g of Chinese medicine concentrate, 5 g of 3-OH phlorizin, 50 ml of vegetable oil, and 30-35 ml of ethanol; Among them, the components of the Chinese medicine composition include: 10-13 parts by weight of Psoralea corylifolia, 10-13 parts by weight of Tribulus terrestris, 10-13 parts by weight of Angelica sinensis, 15-20 parts by weight of Polygonum multiflorum, 10-13 parts by weight of Angelica dahurica, 5-6 parts by weight of Carthamus tinctorius, 10-14 parts by weight of Saposhnikovia divaricata, and 15-18 parts by weight of Astragalus membranaceus.

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