Study On Preparation Technology And Quality Standard Of Xinqibai Freckle Removing Gel

"Qizibai",a famous prescription for whitening,comes from the book "Taiping Shenghui Fang" in the Song Dynasty.After the improvement,it was included in the "Yu Yao Yuan Fang".It consists of Atractylodes macrocephala,Poria,Bletillae Rhizoma,Ampelopsis Radix,Paeoniae Radix Alba,Bombyx Batryticatus and Angelicae Dahuricae Radix.It has the effect of moisturizing and wrinkle removal,and is widely used in modern beauty and skin care.In this prescription,Atractylodes macrocephala is beneficial to the spleen and stomach.It is good at treating dull or dark spots caused by weak spleen and stomach and dehydration of the skin,which is the whitening medicine in ancient prescriptions."Pharmacological theory" said that it "makes the face shiny,keeps young,removes freckle".It is the main drug;Poria can enhance the effect of Atractylodes macrocephala which is beneficial to the spleen and stomach,"Buque Zouhou Fang" recorded it "removes freckle".It is an auxiliary drug;Bletillae Rhizoma has a benefit to the lungs and skin."Pharmacological theory" said that it "treats the blister on the face,makes skin slippery".It can be used together with Ampelopsis Radix to prevent and treat skin diseases such as sores.They form the complementary drugs with Angelicae Dahuricae Radix and Paeoniae Radix Alba.In this prescription,Atractylodes macrocephala,Poria and Bletillae Rhizoma all have the effect of removing spot.Atractylodes macrocephala and Poria can strengthen spleen and dehumidify,keep the face young and remove spots.The entire prescription acts directly on the face,eliminating facial dark spots,making it white and moist.The original prescription is a powder,which is inconvenient to carry and has a large dosage for single use.In addition,Angelicae Dahuricae Radix in the original prescription has photosensitivity and phototoxic,which is a banned drug for cosmetics.In addition to preserve the activeing redients of the original prescription,the gel has the advantages of convenient use,convenient storage and transportation.This thesis aimed at the secondary development of Qizibai.On the basis of consulting a large amount of literature,the banned drug of Angelicae Dahuricae Radix in the original prescription is replaced by Dioscoreae Rhizoma,which has the effect of health and anti-aging and beauty,to form Xinqibai Powder.At the same time,on the basis of the literature research on the extraction process,pharmacological action and clinical application of the main medicinal ingredients of the above-mentioned medicinal materials,combined with the modern related technology,the improved medicinal formula was extracted by the method of water extraction after alcohol extraction,and the two extracts were combined to form a certain amount of shape.The agent was prepared into a gelling agent,and the quality standard of Xinqibai Freckle Removing Gel was established.The stability of Xinqibai Freckle Removing Gel was preliminarily investigated.Preparation process research:This topic referred to the preparation method of gelling agent in the 2015 edition of Chinese Pharmacopoeia and related literatures,and combined the physicochemical properties,pharmacological effects and clinical application of the chemical constituents of various medicinal materials in Xinqibai Freckle Removing Gel.The orthogonal design test method was used to extract the active ingredients of each medicinal material in the formulation.The comprehensive evaluation of paeoniflorin content extraction and gallic acid content was used as the evaluation index in the ethanol extraction,and the total polysaccharide content was used as the evaluation index in the water extraction.The factors and levels affecting the content of the main active ingredients in the prescription were investigated to optimize the extraction process.Then the molding process of Xinqibai Freckle Removing Gel was studied.Taking the comprehensive evaluation of the coating performance and stability of the gel as the evaluation index,the factors such as the type and amount of the gel matrix,solvent,p H adjuster,etc.were investigated by orthogonal design test method to select the optimal molding process.Finally,the process of the optimal extraction process and the optimal molding process were verified.The experimental results showed that the optimal preparation process had good stability and controllability.Quality Standards Research:In this study,the three reference medicinal materials of Ampelopsis Radix,Bletillae Rhizoma and Paeoniae Radix Alba and Paeoniflorin were used as controls.qualitative identification method for Bletillae Rhizoma,Ampelopsis Radix,Paeoniae Radix Alba in Xinqibai Freckle Removing Gel was established by thin layer chromatography.Using paeoniflorin and gallic acid as reference materials,the content of the active constituents of paeoniflorin and gallic acid in Xinqibai Freckle Removing Gel was determined by reversed-phase high performance liquid chromatography(RP-HPLC).And the methodological investigation was carried out.The qualitative identification method and content determination method of Xinqibai Freckle Removing Gel were established,and the quality standard system of Xinqibai Freckle Removing Gel was completely established.Stability test:In this paper,the influencing factors test and accelerated stability test of Xinqibaibai spot gel were investigated.The properties,p H value,uniformity,qualitative identification of thin layer and determination of liquid phase of Xinqibai Freckle Removing Gel were checked in the specified time.The test results showed that paeoniflorin was sensitive to light and gallic acid was sensitive to humidity and light in the influencing factors test.In the accelerated stability test,each inspection item complied with the relevant requirements and related quality requirements in the 2015 edition of the Chinese Pharmacopoeia General Rules for Gels,and the stability was good.In summary,this topic had in-depth investigation of the preparation process of Xinqibai Freckle Removing Gel.The quality standard specification of Xinqibai Freckle Removing Gel was fully established.And the stability of Xinqibai Freckle Removing Gel was Preliminarily investigated.The scientific basis was provided for the development and application of Xinqibai Freckle Removing Gel in the future.