| Since 1957 Isaacs and Lindenman had discovered the interferon, man has been having the thick interest to the research of the interferon. The research discovered the interferon in addition to having the broad-spectrum antiviru and antiknub function, still having a series of immune function for cell. Through researching, the therapist has proved that interferon took on obvious creature activity in human body, having a practical value for prevention and cure to virus disease and tumor. It is a regulator like the function of polypeptide hormone too. Interferon is a valid biological agent at the treatment of various viruses diseases in current domestic and international clinical application. The clinical interferon types in domestic and international are injection,eyedropper,vagina suppository,ointment. These types all acquired good curative effect .But all types to pediatrics, especially baby's infant, are limited. For clinical demand, we empolder a rectal suppository of recombinant alpha-2a-interferon, which kept direct function to target cell. It produced antivirus albumen in the sensitive cells not infected and kept impressionable cell from infection. Interferon albumen restrain the virus reproduce of infective cell, procuring remedial purpose. The part giving could make interferon attain a higher level. The interferon suppository given to rectum directly not only can alleviate the medicine damage to the liver, but also can keep digested enzyme from impacting on medicine It is a suitable type for the child . The designing of this prescription is accorded with《Pharmacy》 .Carbowax of matrical suppository can dissolve in water and various organic solvents, having superior lubricity and thermostability, having no toxicity and stimulation. The electrolysis has no influence on it dissolved in water. As a excipient , it has a protection to the interferon albumen. The raw material is easy to get and cheap. The substrate has no physiology activity. It is stable, having no stimulation to the mucosa of rectum, as well as not interfering with the medical efficacy of main medicine, intenerated and liquated when meeting the body temperature. The releasing to interferon is better, and interferon amid it is stable too. Based on above reasons, the formulation is draft. The suppository is prepared by melting .For active valence stable ,the craft of strict controlling temperature is confirmed by tests time after time. The temperature is at 50- 55℃, it can't over 55℃ ,it will affect the active valence otherwise. The article should accord with the regulation of the suppository in《Chinese codex》 (2000 version)and the quantity standard of《Chinese biologic regulation version》.It's quantity standard should be assessed from appearance, active valence, weight mensurate ,microorganism limit check, melt time etc. Recombinant interferon rectal suppository is a solid preparation made of original liquid of Recombinant interferon and carbowax. For giving medicine to rectal, it is made into the torpedo shape.The article is a ivory lubricous torpedo form suppository . The weight different limit is ±10% including( the article is 1g).Melting time is 15-17 minutes.The microorganism limit also meets to the provision. Various index signs all meets to suppository provision. For investigating the stability of interferon suppository under different environment,we saw about appearrance and active valence under 3 kinds of different states, such as at 4℃,relative humidity 75±5%,25℃,relative humidity 60±10%, 40℃,relative humidity 75±5%. For Observing the stability of accelerated trial , three batches of samples are observed at 40℃ and 25℃ for three and six months . The physical and chemic index has no obvious change. The article is jarless .The result at 4℃ is better too. Because article is conserved at 4℃ , so we study continually to certain the storage life. The interferon rectal suppository is used for the treatment of virus disease in clinic . We proceeded medicine research as follows . I... |
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