Kallidinogenase enteric coated tablet and preparation method thereof

Abstract

The invention discloses a kallidinogenase enteric coated tablet which contains kallidinogenase which is used as an active ingredient, and a tablet core contains sodium alga acid or inorganic salt which is taken as a stabilizer. The invention further discloses a preparation method of the kallidinogenase enteric coated tablet, wherein adjuvants are taken as blank particles at first, kallidinogenaseserving as the main active ingredient is then added and is uniformly mixed, the tablet is produced according to a conventional method, and finally, enteric coating is used to coat a premixing agent into enteric film coating. The added stabilizer has the activity of being combined with the kallidinogenase into activating enzyme, so the kallidinogenase is prevented from titer loss during the production process, and the active ingredient input is in accordance with finished product yield. An adhesive has strong adhesive force, large particle adhesive power, and is easily mixed with the kallidinogenase uniformly. The formula has the characteristics of little unit titer loss during the production process and high finished product titer recovery rate; all adjuvants have no interference with thefinished product inspection, the finished product is high in quality, safe and effective.

Description

technical field [0001] The invention relates to a pancreatic kininogenase enteric-coated tablet and a preparation method thereof. Background technique [0002] Pancreatic kininogenase is a peripheral vasodilator with the effect of dilating blood vessels and improving microcirculation. Pancreatic kininogenase acts on kininogen in the body to release kinin, which directly acts on small blood vessels and capillaries, thereby producing a A series of pharmacological effects, such as dilating capillaries, dilating small arteries, etc., can improve the permeability and blood flow of blood vessels while dilating blood vessels; it can regulate blood pressure and reduce myocardial oxygen consumption; it can also promote the secretion of prostate and improve various Organ blood flow. As an internationally recognized microcirculation improving agent, pancreatic kininogenase is an enzyme drug with definite curative effect and mild side effects, suitable for long-term administration, and...

AI Technical Summary

Problems solved by technology

Relevant literature and published patents show that the existing pancreatic kininogenase preparations, especially tablets, tend to lose a lot of potency due to wet granulation in the production process, and the use of blank granulation method tends to make the content uniformity of the finished product If it does not meet the regulations, the potency is easy to decrease, and the water-soluble film coating premix is ​​used in the encapsulation process, and the potency is more likely to be lost at high temperature, resulting in unstable quality of the drug

[0004] The Chinese invention patent with the publication number CN101069742 discloses a pancreatic kininogenase tablet and its preparation method. The release rate of the prepared tablet can reach more than 85%, and the purity can reach 77%, but its process design is unreasonable. During the preparation process and storage process, it is easy to cause the potency to decrease, and the content uniformity does not meet the requirements.

Images