ABSTRACT
Recombinant humanized anti-ricin monoclonal antibody (MIL50) is a recombinant humanized monoclonal antibody targeting ricin. In this study, an ELISA method was used to establish a method for the determination of MIL50 in macaque serum, and a cross design method was used. Twelve rhesus monkeys were intravenously injected 1 mg·kg-1 test preparation (MIL50 freeze-died powder injection) and reference preparation (MIL50 liquid preparation) to determine the plasma concentration of MIL50 at different time points, and the pharmacokinetic parameters were analyzed to compare the pharmacokinetic characteristics of MIL50 liquid preparation and freeze-died powder injection in rhesus monkeys. Animal welfare and experimental procedures follow the regulations of the Animal Ethics Committee of the Chinese Academy of Medical Sciences and Use of Laboratory Animals and the regulations derived by the Animal Care and Welfare Committee of the Institute of Radiation Medicine, Academy of Military Medical Sciences (IACUC-DWZX-2020-503). The results showed that there was no significant difference between Cmax and AUC0-5d in the two groups. The liquid preparation was the reference preparation, with Cmax ratio of 101.6% and AUC0-5d ratio of 101.9%, the 90% confidence interval of Cmax was 79.42%-129.92%, and the 90% confidence interval of AUC0-5d was 85.72%-121.18%. These results suggested that different dosage forms of MIL50 had certain differences in the changes of blood drug concentration in rhesus monkeys.
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Tizanidine hydrochloride is a centrally acting skeletal muscle relaxant, used in the management of spasticity. This drug is commercially available only as tablets, which highlights the need to develop oral liquid formulations. In the hospital environment, this aspect is circumvented by the preparation of suspensions, to allow administration to children and adults with impaired swallowing, but there are no data regarding their stability. The purpose of this study was to evaluate the physicochemical andmicrobiological stability of liquid dosage forms prepared in the hospital environment from tizanidine hydrochloride tablets, applying high performance liquid chromatography (HPLC) and microbiological analysis. A simple and stability-indicating HPLC method was developed and validated for specificity, linearity, limits of detection and quantification, precision, accuracy and robustness. The liquid formulations were placed in amber PET and glass bottles, which were stored under three different conditions: at room temperature, under refrigeration and at 40 ºC. The liquid formulations were analyzed and demonstrated chemical stability for 56 days, allowing their use for long periods. However, the determination of microbiological stability showed that these formulations are prone to microbial contamination, which has dramatically reduced its stability to 7 days, in both bottles and at all evaluated temperatures
Subject(s)
Tablets/pharmacology , Pharmaceutical Preparations/analysis , Microbiological Techniques/instrumentation , Chromatography, High Pressure Liquid/methods , Sensitivity and Specificity , Amber , Dosage Forms , Drug Stability , MethodsABSTRACT
Plant polyphenols have a wide range of pharmacological activities and application prospects. Liquid polyphenol preparations have special physical phases and complex chemical compositions, with problems such as poor stability and easy precipitation during production and marketing. Taking the multi-precipitation mechanism of plant polyphenol liquid preparations as an example,we discuss the chemistry and composition of the precipitation, how it forms, whether precipitationcan be controlled, and the interaction law of three precipitation approaches. An unstable mechanism model is proposed where hydrolyzed tannin hydrolysis and catechin non-enzymatic oxidative polymerization repeatedly induces associative colloid aggregation and precipitation. This study explains the complex physicochemical changes in polyphenol solutions and the microcosmic mechanism of instability in the induced system and proposes a steady state reconstruction of liquid polyphenol preparation consistent with the common law of precipitation and control. It has scientific significance for promoting the development and manufacture of high quality liquid polyphenol preparations.
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Objective: To analyze the common dosage of oral liquid preparations used in a children's hospital in order to provide reference for the best drug specifications for children's medicines. Methods: The prescription data of patients containing oral liquid preparations were collected from January 2014 to December 2016 and used for the analysis in the sample hospital. The most commonly used doses were compared with the existing specifications to provide suggestions on the best specifications for children. Results: There were 11 kinds of oral liquid preparations commonly used in the children's hospital. Only 4 kinds of drugs met with the best drug speci-fications for children, and the others were not able to meet the clinical needs in the children's hospital. Conclusion: The best specifi-cations of children's medicines need to be readjusted.
ABSTRACT
Heterogeneous liquid preparations are widely used in clinic, and played an important role in pharmaceutical preparations. But at the same time, since the instability of the physical and chemical properties of the heterogeneous liquid preparation, the dispersed particles have a large specific surface energy and form a thermodynamic unstable system. Especially when in the traditional Chinese medicine liquid preparation, which has a large number of unknown non quantitative components, can easily appear the phenomenon of subsidence, coalescence, stratification and phase inversion during the storage process. Therefore, it is of great significance to study the stability observation and prediction of heterogeneous liquid preparation for its prescription design, production process screening, quality evaluation, storage and transportation. However, only in the fields of food, beverage, cosmetics and other related fields have some research at home and abroad for the moment, and we fond there are few reports on heterogeneous liquid formulations. This paper attempts to study the methods of stability prediction in the fields mentioned above, and then we expect to provide a reference for the establishment of rapid, accurate, economic, scientific and objective prediction methods of the heterogeneous liquid preparation.
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To recognize the key influential factors during the liquid preparation process of Tanreqing injection, the near infrared(NIR) spectra of the raw materials and the operating parameters of 24 batches of physical manufacturing were recorded as independent variables, and the total soluble solids contents and the light inspection acceptance rate of the final products were collected as dependent variables. The calibration models were developed using the partial least-square regression (PLSR) method, and the correlation coefficients between the independent variables and the dependent variables were calculated. For the quantitative models, the correlation coefficients for the calibration and inner cross validation of total soluble solids contents and the light inspection acceptance rate reached 0.911 9, 0.724 2 and 0.873 8, 0.795 9, respectively. Using the correlation coefficients diagrams, several key influence factors were preliminarily determined, and the physical significance were analyzed combined with production experience. This work demonstrated that NIR spectroscopy with PLSR algorithm could be used for the key influential factors recognization during the liquid preparation process of Tanreqing injection and can be popularized to solve similar problems..
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Objective To obtain a clear and qualified oral liquid preparation of Huoxiangzhengqi by improving the addition methods of patchouli oil and perilla leaf oil. Methods Palvis Talci was used to improve the solubility of patchouli oil and perilla leaf oil. Firstly, the two kinds of oil were mixed with Palvis Talci and triturated sufficiently. Then, the mixture was mixed with the physic liquor and agitated sufficiently. At last, the clear preparation was obtained after filtration. Results The preparation was clear, well-tasted and qualified. Conclusion The improved method is feasible, simple, stabilized and economical.
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Objective To obtain a clear and qualified oral liquid preparation of Huoxiangzhengqi by improving the addition methods of patchouli oil and perilla leaf oil. Methods Pulvis Talci was used to improve the solubility of patchouli oil and perilla leaf oil. Firstly, the two kinds of oil were mixed with Pulvis Talci and triturated sufficiently. Then, the mixture was mixed with the physic liquor and agitated sufficiently. At last, the clear preparation was obtained after filtration. Results The preparation was clear, well-tasted and qualified. Conclusion The improved method is feasible, simple, stabilized and economical.
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The studies on the preparation technology,quality control and pharmacodyrnamics of Xi- aoyaosan Oral Liquid have been carried out. The experiment results suggested that,using the color reaction, TLC Identification and TLC-scanner could effectively control the intrinsic quality of oral liquid. Both possessed practical availability and their operations were simple Meanwhile,pharmacodynamic study also indicated that oral liquid could increase the peristalsis of stomach and bowel,the amount of consumed food and the body weight of mice,which was in conformity with the indication and efficacy of the original prescription.