| With new drug approvals become more stringent,Good Clinical Practice(GCP)extensively applied and the rapid development of evidence-based medicine,clinical scientific researchers often use randomized,double-blindd,placebo-controlled trials for scientific research.This test method is a "gold standard" and "touchstone" for evaluating the effectiveness of medical interventions.Therefore,the requirements of Chinese herbal placebo is increasing with each passing day.However,due to the special color,odor and taste of traditional Chinese medicine,it is difficult to prepare placebo,which is completely consistent with the appearance of model drug.Color,which is one of the important factors affecting the placebo quality,plays a crucial role in placebo preparation.Computer color matching technology is a high-tech and modern technology that combine computer technology with colorimetry knowledge.It is widely used in textile,inkjet and leather field.This work intends to simulate the color of Chinese herbal placebo by computer color matching technology.Simultaneously,the comprehensive evaluation index ?E value is used to evaluate the color quality of Chinese herbal placebo in a objective and quantized way.This study provides a new idea and method for rapidly simulating color of Chinese herbal placebo.The detailed content of the study is as follows:Firstly,the research status of Chinese herbal placebo was summarized.The significance and wide application of Chinese herbal placebo in clinical research were demonstrated.At the same time,the research significance was reflected by the difficulty in Chinese herbal placebo preparation process.Then,a summary of computer color matching technology was reviewed including the development history,theoretical basis and application in various fields.It provided theoretical and technical support for computer color matching technology,which was applied to Chinese herbal placebo color simulation.Secondly,taking traditional Chinese medicine compound Ruyijinhuang power as an example,the applied feasibility of computer color matching technology was researched by mathematical modeling method in the field of Chinese herbal solid powder placebo color simulation.Using the texture of auxiliary material and powder properties as indicators,the basic matrix was choosed,which was similar to Ruyijinhuang power.The results showed that the basic matrix was a mixture of microcrystalline cellulose and starch,whose weight ratio was 2:1.A series of single pigment and multiple pigment's samples were prepared and measured to obtain samples's color parameters L,a*,b*values with basic matrix.Then,different color models and mathematical models were filtered to fit the function relationship of color parameters L,a*,b*and three pigment's concentrations.The final result was using logarithmic function fiting with Lab color model.Following,the experimental data were fitted by Newton iterative method and least squares method.The established function equation was as follows,which was between color parameters L,a*,b*values and three pigment's concentrations respectively:L(x,y,z)= 101.021-20.333 ln(x0.38 + 10.404y0.52 + 7.39 0z0.46 + 1.145)a*(x,y,z)=-10.48 + 7.10 ln(x1.5 + 260.2y + 9.98z1.5 + 1.058)-5.08 ln(y3 + 267.0z + 0.141)b*(x,y,z)= 105.95 + 10.09ln(x1.09 + 0.3576y1.29 + 0.0474zy1.31 + 0.0026)-22.45ln(x1.32 + 74.40y0.61 + 69.045z0.59 + 5.590)The fitting function equations were evaluated in both intuitive and precise numerical values.The results showed that the fitting was good and the error was little,so the precision was well.Finally,the application of the established functional model was validated by the preparation and color evaluation of Ruyijinhuang power placebo.The results showed that the comprehensive evaluation index ?E value of different color between validation sample and model drug was 2.750 0±0.353 6.It indicated that the difference between the sample color and the model drug color was little,which was consistented with obvious visual evaluation.They proved that there was no significant difference between the sample color and the model drug.The computer color matching technology can be used for the color simulation in the field of Chinese herbal solid powder placebo.Thirdly,using Pudilan oral liquid as a representative of liquid formulation drug,the applied feasibility of computer color matching technology was studied by mathematical modeling method in the field of Chinese herbal liquid formulation placebo color simulation.The first step was to prepare a series experimental samples with different color pigment and determine the samples obtaining color parameters L,a*,b*values.The second step was to combine the least squares method and the Newton iteration method establishing the functional formulas between color parameters L,a*,b*value and pigment concentration.The specific fitting function equation was as follows:L(x,y,z)=-2425.9+ 4011.2 ln(x1.1624 + 1522.83 y1.238 + 421.173 z0.125 + 2505.29)-4578.89 ln(x0.525 + 291.255 y1.187 + 86.417 z0.140 + 547.148)a*(x,y,z)=-10463.2-381.362 ln(x0.468 + 2.44824 y1.784 + 0.97787 z0.449 + 1.43307)+ 334.484 ln(x0.565 + 0.795843 y1.435 + 1.28004 z0.640 + 0.87358)-8.9026 ln(x2.363 + 0.000629523)+ 3801.52 ln(y0.850 + 15.6033)-16.2547 ln(z2.245 + 0.000256094)b*(x,y,z)=-1894.48+ 774.796 ln(x1.193 + 0.12689 y1.43 + 0.11342 Z0.145 + 0.50942)-731.64 ln(x1.283 + 0.0571316 y1.906 + 0.108762 z0.088+ 0.580944)+ 1292.57 ln(x0.946 + 605.174)-1947.65 ln(y0.732 + 25.9912)-10.798 ln(z2.01 + 0.000305985)The fitting function equations were evaluated in two aspects of intuitive and precise numerical value.The results showed that the fitting was good and the error was little.So the precision was well.In the third step,the color parameters L,a*,b*of model drug Pudilan oral liquid were measured,which was prepared for Pudilan oral liquid placebo verification samples.Then,evaluation of the placebo-proven samples was conducted from subjective and objective aspects.The experimental results showed that the ? E value was 1.590 0±0.485 9,which was the comprehensive evaluation index of color difference between validation sample and model drug.And there was no obvious visual difference between the medicine compound and its placebo.The color of Pudilan oral liquid placebo verification sample was similar to its model drug.In summary,this work studied the feasibility of computer color matching technology for rapid simulating color in Chinese herbal placebo by solid topical powders and liquid oral liquids.The experimental results showed that computer color matching technology had a good application prospect in simulation of placebo color in Chinese herbal placebo.This study provided a new idea and method for Chinese herbal placebo color simulation. |
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