| Sinomenine hydrochloride is a alkaloids hydrochloride,extracted from Chinese traditional medicine orientvine menispermaceae plants(Sinomenium Scutum Rehd et Wils).Now it was used to treat rheumatoid arthritis for long-term medication in clinical.Administrated by oral has big adverse reactions,and the biological half-life is short,ordinary preparation needs frequent dosing to reduce the patient’s compliance.Therefore,from the perspective of pharmacy,we prepared sinomenine hydrochloride cataplasm with tourmaline(THSM Cataplasm),avoid the liver first effect,increase the drug concentration of local surface area,reduce the side effects.Tourmaline can release infrared ray and anion,reduce the water molecule clusters,promoting skin penetration drugs.Established the sinomenine hydrochloride in vitro analytical method,repeatability and stability of this method is good,accessories for determination without interference,using the method of determination of THSM Cataplasm dose of drug content in the accurate and reliable,conform to the requirements of the methodology.Examines the different pH value on the effects of sinomenine hydrochloride ultraviolet absorption.Sinomenine hydrochloride were measured under different pH value of solubility and oil/water partition coefficient(P).Characterization of the particle size of Tourmaline and chemical composition,the effect of the solution pH was investigated.The safety of a preliminary determination of the Tourmaline.According to the results of single factor experiment,confirmed the factors and levels of orthogonal experiment,adhesion and sensory index as the index,orthogonal design,determine the optimal prescription,investigate the order of material joined and preparation process on the quality of the product.The results showed that the sodium polyacrylate(NP-700)as skeleton material,Dihydroxy aluminium Aminoacetate and citric acid as the crosslinking agent and crosslinking regulator,glycerin for moisturizing factor,tourmaline as the transdermal absorption promoting agent,sodium carboxymethyl cellulose as tackifier,oil-water two phase separation to join method is used,in rolling coating method for preparation,according to the optimal prescription preparation THSM Cataplasm,measured the THSM cataplasm made by the most superior adhesion and sensory indexes.For the preparation of THSM Cataplasm properties was investigated.Adhesion experiment resultsshow that the system of THSM cataplasm adhesion and relatively stable;paste content results show that the three batch samples paste content stability;Contain the dosage experiment results show that the main medicine in cataplasm dispersed uniformly in matrix;In vitro transdermal experiments show that the accumulation of THSM cataplasm through quantity is greater than the HSM cataplasm.Release of results show that the system of three batch samples of in vitro release curve,by 97.6% in 480 min to release;vehicle test show that the samples made by vehicle is good,no flow phenomenon;Hot/cold test results show that the fracture on the back of three groups of samples are no oil leakage phenomenon,paste surface luster,finger touch test has no obvious change.The guinea pigs skin irritation experiments show that the THSM cataplasm no skin irritation and sensitization sexual contact,preliminary showed that the skin for external use safety.On the body torsion reaction caused by acetic acid and formaldehyde induced pain reaction in mice has obvious inhibitory effect,analgesic effect of pain reaction.Mouse ear swelling induced by xylene and egg white in rats foot swelling experiment results show anti-inflammatory effect.Positive effects were better than HSM cataplasm control group and the negative cataplasm blank control group. |
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