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The first chapter
second chapter powder and granule
third chapter tablet
fourth chapter capsules and pills.
fifth chapter suppository
sixth chapter ointment, eye ointment or gel
seventh chapter aerosol, film-forming agent and coating agent
eighth chapter injection and eye drops
ninth chapter tenth chapter liquid preparation of
drug stability of
eleventh chapter micro capsule, inclusion complexes and solid dispersions of
twelfth chapter sustained and controlled release preparation of
thirteenth chapter transdermal drug delivery formulations of
fourteenth chapter targeting preparation
fifteenth chapter biopharmaceutical
sixteenth chapter drug kinetics of
the seventeenth chapter drug compatibility and interaction of
eighteenth chapter biotechnology drugs
The copyright page: illustration: [test 10] sterile powder for injection and freeze-dried products 1 overview sterile powder for injection or powder. All is not stable in aqueous solution of the drug, they cannot produce water-soluble injection, but not in the solution heating sterilization, such as penicillin G, cephalosporins and some medical enzyme (trypsin, coenzyme A), biological agents, shall be made of sterile powder for injection. Freeze dried injection with 2 (1) principle of frozen frozen drying is the water contains a lot of material (solution or suspension) first freezes into a solid, and then heated in high vacuum conditions, the water vapor directly sublimation and drying method. The drying process is carried out in low temperature and airtight conditions, especially suitable for heat sensitive materials and the preparation of sterile products. (2) the freeze dryer according to the principle of freeze drying design, divided into the cooling system, vacuum system, heating system and control system four parts. (3) the process of freeze-drying products - Determination of low melting point pre freeze - drying and drying (4) has the advantages of freeze drying of thermolabile drugs can be avoided because of the heat decomposition of metamorphism; the loose texture, the water after the recovery of the original characteristics of rapidly dissolving liquid; low water content, generally in the 1% ~ 3% range, and drying in vacuum, it is not easy oxidation, long-term storage for products; products of particulate matter less than other methods because producers, pollution is relatively reduced; product accurate dosage, good appearance. Freeze drying product defects, such as solvent can not be chosen at random, need special equipment, high cost. 3 aseptic injection products will meet the requirements of the drug powder for injection in aseptic conditions directly packed in clean sterile vials or ampoules, sealing and. The key to the preparation is refined raw drug, by refining to obtain sterile powder, under sterile conditions to obtain the packing. Drugs in the water are particularly unstable suitable for preparing such injection. The sterile solvent crystallization, spray drying process raw material medicine refined into a sterile powder, packing to cleanliness and to control relative humidity of the environment, to ensure that products are sterile and good fluidity. Some drugs treatment of high temperature tolerance time in dry condition, supplementary sterilized product after certain conditions.  the main work center trial injection 1 of new products new product (1) based on the work of prescription and process design of; (2) determine the injection type, injection and dose; (3) experimental research on prescription and process design. Penetration of the 2 osmotic pressure regulating human body can withstand pressure, intramuscular injection of 0.45% ~ 2.7% NaCl solution of osmotic pressure, equivalent to 0.5 ~ 3 isotonic solution. If a lot of hypotonic intravenous solution, can cause hemolysis, and even lead to death. But as long as the injection speed is slow, can input a great number of hypertonic solution. Design of injection prescription, to hypotonic solution must be adjusted method commonly used osmotic adjustment: the cryoscopic method and sodium chloride isotonic equivalent method.
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