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Objective To establish the method of thin layer chromatography (TLC) for identification and quantitative determination of Shipi Xiaoshui gel plaster. Methods TLC was adopted to qualitatively identify astragalus radix, plantaginis semen, curcumae rhizome, cinnamomi ramulus, polyporus umbellatus and akebia quinata. UPLC-MS was used to determine the content of astragaloside Ⅳ. Results TLC spots were clear and well-separated; RSDs of precision, reproducibility and stability tests were all lower than 3%, the linear range of astragaloside Ⅳ was 2.75-33 μg/ml (r=0.999 9, n=6), and the average recovery was 100.49% (RSD=1.98%, n=6). Conclusion The established method in this study is accurate, reliable and specific, which could be used for the quality control of Shipi Xiaoshui gel plaster.
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Huoluo Xiaoling Dan is a classical prescription commonly used for blood circulation and pain relief in clinic with obvious effects. To make it directly treat lesion and improve the effect, this research optimized the preparation process of Huoluo Xiaoling gel paste and further evaluated its in vitro transdermal absorption performance, so as to provide a scientific basis for its development and utilization. Using primary viscosity, holding viscosity, and sensory score as evaluation indexes, the matrix amount of gel paste was determined by the single factor test and Box-Behnken response surface method. The ultra-performance liquid chromatography(UPLC) method was established to determine the content of eight active ingredients, including Danshensu, ferulic acid, salvianolic acid B, salvianolic acid A, ligustilide, tanshinone Ⅱ_A, 11-keto-β-boswellic(KBA), and 3-acetyl-11-keto-β-boswellic acid(AKBA). A mo-dified Franz diffusion cell method was used to evaluate and compare the absorption properties of the gel paste without volatile oil and with volatile oil microemulsion. The results showed that the optimal prescription for Huoluo Xiaoling gel paste matrix was NP700(1.35 g), glycerol(7.00 g), micropowder silica gel(1.25 g), sodium carboxymethyl cellulose(0.20 g), tartaric acid(0.06 g), and glyceryl aluminum(0.04 g). The mass fractions of eight active ingredients in the paste were successively 0.48, 0.014, 0.95, 0.39, 0.57, 0.055, 0.35, and 0.97 mg·g~(-1). The results of the in vitro transdermal absorption test showed that the addition of the volatile oil or the volatile oil microemulsion promoted the transdermal absorption of the active ingredients, and the law of drug penetration conformed to the zero equation or the Higuchi equation. The gel paste prepared by the optimal prescription has good appearance and adhesion, with no residue, and has the characteristics of skeletal slow-release preparation, which is easy to reduce the number of administration, la-ying a foundation for the development of new external dosage forms of Huoluo Xiaoling Dan.
Subject(s)
Administration, Cutaneous , Skin Absorption , Chromatography, Liquid , Oils, Volatile , ViscosityABSTRACT
OBJECTIVE@#To observe the effect of acupoint application of gel plaster on quality of sleep and life in patients with insomnia.@*METHODS@#A total of 63 patients with insomnia were randomized into a gel plaster group (32 cases, 1 case dropped off) and a placebo plaster group (31 cases). Acupoint application of gel plaster was applied at Yintang (GV 29) and Yongquan (KI 1) in the gel plaster group, placebo plaster was applied at the same acupoints in the placebo plaster group. The treatment was given from bedtime to early moming of the next day, 5 days were as one course, with 2-day interval, totally 4 courses were required in the both groups. Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS) and Flinders fatigue scale were used to evaluate the sleep quality and fatigue level of the patients in the both groups before and after treatment and at 2 weeks of follow-up. The variations of insomnia TCM syndrome score and the 36-item short-form health survey (SF-36) score before and after treatment were observed.@*RESULTS@#Compared before treatment, the scores of PSQI, ESS and FFS after treatment and at follow-up were decreased in the both groups (@*CONCLUSION@#Acupoint application of gel plaster can effectively improve the quality of sleep and life in patients with insomnia.
Subject(s)
Humans , Acupuncture Points , Acupuncture Therapy , Sleep , Sleep Initiation and Maintenance Disorders/therapy , Treatment OutcomeABSTRACT
Objective: To optimize the mixing technology of Daphnes Giraldii Cortex gel plaster (DGCGP) by using rheological parameters elastic modulus (G'), viscous modulus (G″), yield stress (τ0), creep compliance [J(t)] and loss coefficient (tanδ) as evaluation indexes. Methods: Using orthogonal design, L9(34) orthogonal design was used to screen out the best mixing technology of DGCGP and predict the suitable coating conditions by taking the temperature, rotating speed and mixing time of the mixed materials as influencing factors and the rheological parameters of the medicated compound as evaluating indexes. Results: The optimum DGCGP mixing process was as following: 70℃ at 10 r/min for 2 h. Under this condition, the viscoelasticity, temperature and shear resistance, deformation resistance and stability of the mixture were all good. Conclusion: DGCGP prepared by this optimized process had good appearance, soft texture, good adhesion with skin, good viscoelasticity and better quality.
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Objective: To optimize the formulation of Jieyu Anshen Gel Plaster (JAGP) and evaluate its quality. Methods: With the bonding strength and sensory evaluation scores as indicators, the formulation of JAGP was optimized by using orthogonal experiment design method. Then the content of methyl eugenol, elemicin, β-asarone and α-asarone in JAGP were determined by GC-MS and the in vitro transdermal properties were studied by modified Franz diffusion cells. Results: The optimized blank matrix formulation was as following: NP700 of 3%, glycerol of 36%, PVP K30 of 4% and aluminium glycinate of 0.08%. The containing ointment of prepared gel plaster was 217.4 mg/cm2 and the effective component of the total index in gel paste was 5.77 mg/paste. Then the accumulated transdermal permeation of methyl eugenol, elemicin, β-asarone and α-asarone was (81.798 6 ± 14.872 6), (72.110 2 ± 17.776 1), (146.390 6 ± 33.794 1), (5.522 6 ± 1.279 6) μg/cm2, respectively within 24 h, which were all consistent with the zero-order equation. Conclusion: The preparation of JAGP with good stability and drug-releasing properties conformed to the relevant quality requirement, And this study provides certain basis for the development of production.
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As an important part of transdermal drug delivery system, gel plaster of Chinese materia medica (CMM) has inherited the traditional theory of traditional Chinese medicine and developed rapidly in recent years in combination with the new technology and technology of modern preparations. Compared with the traditional black paste and rubber paste, the gel plaster of CMM, which uses water-soluble polymer as the matrix, has the advantages of good moisturizing performance, good compatibility with the skin, and repeated patching. It has been paid more and more attention by researchers. At the same time, the gel plaster of CMM also faces many problems, such as unreasonable matrix ratio, simple preparation process, and imperfect quality evaluation system. This article reviews the development status, matrix composition, and preparation technology of gel plaster of CMM in recent years, and provides reference for the further study of gel plaster of CMM.
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OBJECTIVE: To screen the preparation technology of Xiaoerjianpiwentong plaster using the technique for order preference by similarity to ideal solution (TOPSIS) comprehensive evaluation method. METHODS: Using color, uniformity, adhesive ability, and peeling strength as the quality control indexes with different weighting factors, plasters of different prescriptions were scored by the TOPSIS comprehensive evaluation method. Experiments were conducted to repeat eight representative literatures to select the matrix and preparation process for the gel plaster. Single factor experiment was performed in combination with TOPSIS comprehensive evaluation method to select the best composition of prescription, and verification tests were conducted. RESULTS: The best prescription of Xiaoerjianpiwentong plaster was as follows: gelatin-polyvinyl pyrrolidone K30(PVP K30)-sodium polyacrylate-glycerol-laurocapram-extract powder-volatile oil=2:1:2.5:12:1:1:0.234(m/m). CONCLUSION: The best composition of prescription of Xiaoerjianpiwentong plaster is determined. The plaster not only has good appearance and peeling strength, but also has stable quality and formability.