A preparation method of sustained-release capsules containing large doses of niacin

Abstract

The invention discloses a preparation method of spansules containing large dosage of nicotinic acid, aiming to provide a preparation method of spansules which are high in nicotinic acid content, are ideal in slow-release effect, are simple in production process, and are good in reproducibility. The preparation method of the spansules sequentially comprises the following steps of (1) pretreating original auxiliary materials; (2) mixing the original auxiliary materials and premixed powder together, placing blank pill cores into a coating granulator, adding the premixed powder into a charging hopper, additionally spraying 5% hydroxypropyl methylcellulose solution, and preparing pill cores containing nicotinic acid by a lamination method; (3) preparing a coating liquid, taking 18-20-mesh pill cores containing nicotinic acid, placing into the coating granulator, spraying the coating liquid, meanwhile spraying talcum powder on the pill cores containing nicotinic acid at the speed of 0.6g-1.4g / min, and stopping spraying the talcum powder when spraying of the coating liquid is finished, thereby obtaining the coated medicine pills; (4) mixing the coated medicine pills together after thermal treatment; and (5) filling the capsules according to the percentage content of nicotinic acid in the coated pills. The preparation method of the spansules containing large dosage of nicotinic acid belongs to the technical field of medicine preparation.

Description

technical field [0001] The invention provides a method for preparing sustained-release capsules, in particular, a method for preparing sustained-release capsules containing large doses of niacin, which belongs to the technical field of pharmaceutical preparation. Background technique [0002] Niacin is currently one of the four most commonly used lipid-regulating drugs. It has been clinically used for more than half a century and can effectively improve the lipid metabolism in patients with dyslipidemia. Clinical observations have confirmed that niacin has an exact and comprehensive lipid-lowering effect. It can not only effectively reduce plasma triglyceride (TG), increase high-density lipoprotein-cholesterol (HDL-C), but also reduce total cholesterol (TC) and Low-density lipoprotein-cholesterol (LDL-C), but also has a unique effect of lowering lipoprotein (a) [Lp(a)]. [0003] Since the half-life of niacin is extremely short, only 25-45 minutes, and high doses of niacin o...

AI Technical Summary

Problems solved by technology

And containing the coating suspension of large dose of talcum powder, even if the particle size of talcum powder is fine, still unavoidably block the pipeline in the spraying process, cause production efficiency to be low; Easy to settle, resulting in a part of the amount of talcum powder can not be sprayed on the pellets, resulting in large fluctuations in the release of pellets between batches

[0010] In summary, sustained-release pellets are currently recognized as one of the more ideal sustained-release dosage forms, but it is found in the existing research data that the formation of the coating film during the coating process of the pellets is affected by the properties of the pellet core and the coating solution. Prescription, process parameters and other factors, while the slow-release coating film is directly related to the release characteristics of the pellets, the change of each factor will cause changes in the release of the pellets, and ultimately make the slow-release effect of the sustained-release pellets The reproducibility is poor, and the qualification rate of the product is unstable in the actual production process, which increases labor costs

Images