Alprostadil, also known as prostaglandin E1, is one of the natural prostaglandins. Alprostadil has the effect of inhibiting platelet aggregation, thromboxane formation, atheromatous plaque formation and immune complex, and can expand the peripheral and coronary arteries so far, alprostadil has undergone three generation of dosage forms. The first generation is sterile powder injection. Because the water solution of alprostadil is very unstable, it needs to be made of powder needle The dosage forms are easy to preserve and transport. The side effects of the dosage form are quite a few. There are many side effects reported. The side effects that have been reported are mainly intravenous drip with different degrees of burning like swelling and swell pain or spasmodic itching. Some patients appear "red line" along the skin of the veins. They are generally tolerated. The pain is aggravated when the infusion is too fast. The pain and "red line" disappear after the injection, but some appear. The second generation of non infectious phlebitis is a cyclodextrin inclusion complex, and the market product is a alprostadil one-to-one cyclodextrin inclusion compound, which is wrapped in a cyclodextrin cavity. However, there are still third generations of lipid emulsions with poor stability and toxic side effects. At present, there are also commercially available products, but the current process is not very mature. The process is complex and the degree of industrial production is low.
Cyclodextrin research has been constantly deepening the existing technology, usually using cyclodextrin or hydroxypropyl cyclodextrin for alprostadil inclusion. However, further studies have found that the stability and bioavailability of the alprostadil inclusion complex obtained by cyclodextrin and its analogues still exist for a period of time. There is an urgent need for clinical preparations of alprostadil, which still has good bioavailability after storage for a certain period of time.
The latest research shows that the stability and bioavailability of the alprostadil inclusion complexes prepared by hydroxypropyl cyclodextrin are far superior to those of other cyclodextrins that have been included in the existing technologies.
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