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Increasingly tincture is independently developed our hospital for the treatment of alopecia areata topical Chinese herbal compound preparation, approval number: Guangdong pharmacists word Z07022775, formerly known as: Shengfaling tincture. Increasingly tincture is impregnated with ethanol extraction process made tinctures, the party by a red peony, Chinese angelica, safflower, Oriental Arborvitae and other components of Chinese medicine, attending deficiency, blood stasis caused by alopecia areata. Clinical observations indicate that the preparations for treatment of 280 cases of alopecia areata patients, the treatment group, the total effective rate was 93.9%, significantly better than the control group. On this basis, we observed acute blood, hair removal, increasingly topical tincture deficiency rats after hemorrheological indicators and hair growth, the results show that increasingly tincture has good blood circulation and promote hair growth effect. To this end, we use double long TLC on preparations for the quantitative analysis of ferulic acid to formulate a preliminary quality standards. With increasingly tincture in clinical applications, its therapeutic effect so that patients and clinical experts satisfied. But we also recognize that this preparation since been developed, there is rough preparation process, such as lack of quality control standards behind a serious impediment to the clinical efficacy of the play, there is an urgent need for its preparation process and quality standards to improve, to better serve clinical services. Objective: This paper intends to increasingly tincture preparation process and quality standards for system studies, screening reasonable and economical optimum preparation process, the establishment of simple, accurate, reproducible, specific quality standards, so that increasingly tincture safe and effective, quality control, and better for clinical services, and also to carry out increasingly tincture of new drugs to provide experimental basis for further research. Method: 1 Preparation increasingly tincture (extract) Process 1.1 by steam distillation, extraction of volatile oil volume and time for the study of factors, respectively, of all the herbs and some herbs containing volatile oils extracted by steam distillation of volatile oil. 1.2 orthogonal design method to extract ferulic acid as index to high performance liquid chromatography (HPLC) analysis of the detection methods, the factors that affect the concentration of ethanol extraction process (A), the amount of ethanol (multiple) (B), extraction time (C) to inspect, choose three levels of each factor. 2 Create increasingly tincture of qualitative and quantitative methods of quality standards 2.1 Qualitative research methods: a reference, the reference drug as a reference, using thin-layer chromatography increasingly the main medicinal tincture prescriptions were identified. 2.2 Quantitative Research Methods: HPLC increasingly tincture ferulic acid, paeoniflorin approach and methodology of investigation conducted, including the measurement conditions, the linear relationship, precision, repeatability, stability and The recovery test. Results: 1. Preparation (extraction) Process: 1.1 Volatile Oil Extraction results show that: All ingredients were fried method to extract volatile oil, and containing volatile oils of the herbs before were fried essential oil was extracted two methods resulting volatile oil no significant difference extraction After 4.5 hours, the oil were not increased. So make sure 4.5 hours for the volatile oil extraction time. Angelica and other three kinds of herbs containing volatile oils extracted essential oil was extracted fry curve and total volatile oil extracted height of the curve fitting, indicating that the three herbs volatile oil is essentially equal to the total volatile oil. Herbs containing volatile oil extracted by steam distillation, the dregs and then combined with other herbs extracts other active ingredients, the final preparation of formulated by increasingly tincture, not only to ensure the complete proposed volatile oil, while saving energy, be more reasonable. and economical extraction process. 1.2 Extraction Technology Research results showed that ferulic acid for the detection of targets, increasingly tincture optimum extraction of A 2 C 3 B 2 < / sub>, the ethanol concentration was 75%, dipping time is 120h, eight times the amount of ethanol is increasingly tincture medicinal amount of ferulic acid on the extraction of the most complete. Analysis of variance showed that, A, C factor P <0.01 significant difference, indicating that the two factors on the extraction process is more important preparation, B factor in the amount of solvent relatively small impact on the content. (2) Quality Standard of 2.1 Qualitative research results show that: The increasingly tincture of 6 TLC flavor ingredients for qualitative identification, increasingly tincture in the corresponding position in the test sample can be detected peony, Chinese angelica, Oriental Arborvitae, fleece-flower root, safflower and chromatographic characteristics to yellow, clear spot, good separation, negative non-interference, was highly specific. 2.2 Quantitative results showed that: methodological studies that established by high performance liquid chromatography ferulic acid, paeoniflorin method, linear relationship, precision, repeatability, stability and recoveries are in line with requirements. Sample measurement, through the optimization of the mobile phase, the sample of ferulic acid, Paeoniflorin good peak shape, and impurity peak separation is high, and effectively remove impurities after the peak, making peaks with good reproducibility. Increasingly Paeoniflorin Tincture average 0.0348mg/ml, ferulic acid content was 0.0375mg/ml. Conclusion: The optimal preparation increasingly tincture as follows: The three herbs containing volatile oil first by steam distillation for 4.5 hours dregs and then combined with other herbs, with eight times the amount of 75% ethanol and immersed 120h, immersion fluid filtration, The filtrate was added to the extracted essential oil, adjusted to the required concentration of ethanol, add purified water to the mark, mix immediately after. This process allows the preparation of ferulic acid in the highest screening process is reasonable, economical and effective ingredient ferulic acid content is high, it is possible to improve the clinical efficacy of formulations. TLC developed increasingly the main medicinal tincture qualitative identification method that negative non-interference, reproducible method has special properties. HPLC was used to establish the increasingly tincture herbs angelica, red peony active ingredient ferulic acid, paeoniflorin measurement method is simple, accurate, reproducible, and can be used as increasingly tincture preparation of quality control standards.
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