Intravenous infusion is a very common method in clinical treatment. In the evaluation and prediction of drug delivery, clinical efficacy and safety, the compatibility of drugs with intravenous infusion sets (containers, catheters, drug delivery systems) is very important. A study of the potential interaction between the two includes the sorption and penetration of the drug on the IV infusion, the infiltration of the infusion set into the drug solution and the modification of the drug to the infusion device material.
By studying the quality change behavior of the drug solution in the infusion set, the form and extent of the interaction between the two can be evaluated. The adsorption and absorption of the drug, when the drug is adsorbed on the inner surface of the infusion tube, is the drug that is initially given to the patient. When the concentration drops, when the inner surface tends to be saturated, the drug concentration rises rapidly; while the absorption is the migration of the drug into the tube wall, which shows that the initial drug concentration is low, and when the tube wall begins to saturate, the drug concentration slowly rises.
The penetration of the drug on the infusion set is a continuous drug loss. The drug migrates into the tube wall and penetrates the outer surface. The surface of the tube wall can never reach saturation. For many years, polyvinyl chloride (PVC) is the mainstream material for intravenous infusion sets. With the development of polymer materials technology, thermoplastic polyurethane (TPU) is increasingly used in intravenous infusion sets. However, there is no comprehensive study to evaluate the compatibility of intravenous infusion device materials with drugs.
Research
This study evaluated the compatibility between TPU intravenous infusion sets and a series of drugs of different natures by establishing an in vitro compatibility research platform, that is, the performance of the liquid before and after the drug solution was passed through the disposable intravenous infusion set. Change the situation and compare it with other IV devices. Combined with the pharmacopoeia's examination items and the purpose of this study, the compatibility of the study is based on: the main component of the drug, related substances, PH Value, visible foreign matter and insoluble particles. Among them, drug content and related substances as a key project.
In order to evaluate the safety of the infusion set in clinical use as much as possible, this study selected different types of liquid medicines commonly used in clinical practice, including moxifloxacin hydrochloride injection, docetaxel injection, furose. Rice injection, pantoprazole sodium for injection, metronidazole sodium chloride injection, levofloxacin hydrochloride and ranitidine hydrochloride injection. Under the conditions of simulated clinical use, the above different types of liquids are used for one-time use. Experimental study on drug compatibility of intravenous infusion products.
Refer to the clinical instruction manual of the selected drug solution, simulate the clinical usage and dosage, select the maximum drug use amount, the longest infusion time in the clinical use range, design the parameters of the study (drug dose, drug volume, drug concentration, drip Note the speed and drip time), to examine the quality changes of each liquid before and after flowing through the infusion set.
In the case of drug droplet injection, according to the Chinese medicine Pharmacopoeia ChP detection method '3', the drug content of the drug solution is determined at different time points, and the ratio of the concentration to the starting drug solution is calculated. Three intravenous infusion devices (TPU intravenous infusion) Device, TPE-S intravenous infusion set, PVC intravenous infusion set) for parallel comparison experiments.
Although the properties of the seven drugs are different, the TPU intravenous infusion sets have shown good drug recovery. Under the recommended clinical application parameters, the drug absorption is almost invisible, and more than 95% of the drug is recovered. In the long-term cycle time of the instillation time (up to 4 – 24 hours), no drug sorption occurred. In the study of pantoprazole sodium for injection, it was found that the TPE-S intravenous infusion set product existed in the initial stage of exposure to the drug solution. In the case of sorption, the recovery of the liquid is as low as 85%, and the concentration of the initial drug solution is 86.08%-94.52% in the whole cycle time; the venous infusion product of PVC material has sorption in the whole process of infusion, and the initial situation The concentration ratio of the drug solution is between 82.58% and 90.71%; and the TPU material intravenous infusion device has good drug compatibility for the drug solution. It can be seen from the drug recovery concentration curve that the drug concentration is in the PVC intravenous infusion set. The response is slower, and the sorption behavior is biased toward absorption; the rise in the TPE-S intravenous infusion set is faster, and the sorption behavior is biased toward adsorption. See Figure 4– Figure 7.
From the drug content of the whole infusion cycle of the experiment, the TPU intravenous infusion set showed similar or superior performance to TPE-S and PVC, and the sorption effect of drugs of different nature was very low. For pantoprazole sodium The performance of TPU intravenous infusion set is better than TPE-S and PVC, and the adsorption is less than TPE-S and PVC. The characteristics of TPU and its compatibility with drugs make it very suitable for intravascular infusion sets.