Improvements On The Preparation Technology Of The Compound Amino Acid Injection(18AA-Ⅱ)(Non-PVC)

The Compound Amino Acid Injection(18AA-Ⅱ)(Non-PVC) is composed of Non-essential amino acids and essential amino acids, including eighteen amimo acids such as L-Threonine, L-Valine, L-Methionine,L-Tryptophan, L-Isoleucine, L-Leucine, L-Lysine monohydrochloride, L-Proline, L-Phenylalanine, L-Cystine, L-Tyrosine, L-Arginine, L-Alanine, Glycine, L-Histidine, L-Serine, L-Glutamic acid and L-aspartic acid. The Compound Amino Acid injection (18AA-Ⅱ) is mainly used for the patients who can not absorb the nutrition by oral administration or through intestinal tract as well as those people for whom the absorbed nutrition can’t meet the need of the body.In this article, we improved the preparation technology of Compound Amino Acid Injection(18AA-Ⅱ) based on the results of literatures’investigation, the specific proplems in the preparation process and the current research situation, The results indicated that, not only the quality of Compound Amino Acid Injection(18AA-Ⅱ) was improved but also the product profit was increased.For the improvement of preparation technology of Compound Amino Acid Injection (18AA-Ⅱ), we investigated every factors in the manufacture process, such as the impact of water, formulation process, filling operation, sterilization, workshop equipments and package process, to solve the problems existed in the preparation of the Compound Amino Acid Injection (18AA-Ⅱ)(Non-PVC).Firstly, liquid nitrogen was used to control the pressure of nitrogen fumes because the liquid nitrogen was more pure than the gaseous nitrogen and it could keep the pressure more stable in the filling process. Secondly, ethylene diamine tetraacetic acid (EDTA) was used to chelate the free metal ions on the surface of the dispensing tank to avoid the interaction between amino acids and free metal ions. Thirdly, the way of filling the nitrogen was changed. Before filling the nitrogen fumes, Air were pumped away from the dispensing tank, reaching vacuum condition every time. Then the tank were filled with nitrogen fumes and the pressure were kept at0.2Mpa. This operation were repeated three times to replace oxygen completely with nitrogen to aviod the interaction between amino acids and oxygen to the greatest extent. Fourthly, because the metal ions in the activated carbon can cause adverse influence the transmittancy of the injection, EDTA solution was used to wash the activated carbon. Fifthly, the adding sequence of the different amino acids were controlled, Anmio acids with low solubility(Leucine, Isoleucine, Valine) were dissolved firstly, then other amino acids were added. Novel technologies, such as magnetic stirring and efflux, were also employed to enhance the stirring strength. The recycle temperature was controlled at80-85℃, lasting for30minutes, to accelerate the dissolution process. When the temperature of the solution decreased to50-60℃, the L-Cysteine which was pre-dissolved in hydrochloric acid was added to the solution. Sixthly, in order to increase the stability and the active content of the Compound Amino Acid Injection (18AA-Ⅱ), pH of the amino acids solution was adjusted between5.8to6.2.Furthermore, the way of sterillization was also improved.4230bags instead of7560bags were sterilized every time. Before sterillization, air was pumped from the dispensing tank to reach the vacuum condition, then the tank was filled with nitrogen. This operation was repeated three times to replace the oxygen with nitrogen completely.After optimization of production process, the transmittance of the Compound Amino Acid Injection (18AA-Ⅱ) was increased, which meant the problem of visible foreign matter was solved. The influencing factors test, accelerated test and long-term stability test were carried out to evaluate the quality of the the Compound Amino Acid Injection (18AA-Ⅱ) produced by the original technology, by optimized technique and the18AA-Ⅱ product packaged by glass bottles. These results showed that the product’s indicators, such as transmittance, visible foreign matter and final yield etc, of the18AA-Ⅱ produced by improved technique was much better than that produced by original one.In a word, the quality of Compound Amino Acid Injection(18AA-Ⅱ)(Non-PVC) prepared by the improved preparation technique was controllable and stable, so the optimized preparation technology for the Compound Amino Acid Injection (18AA-Ⅱ) was applicable.