A propranolol hydrochloride tablet having a low content of N-nitroso propranolol impurities and a method for preparing the same

By using excipients such as mannitol, glyceryl behenate, and magnesium stearate, along with a combination of crospovidone, alanine, and glycine, the problems of poor tableting effect and impurity formation in propranolol hydrochloride tablets were solved, resulting in better tableting effect and prolonged efficacy.

CN117205168BActive Publication Date: 2026-02-03JIANGSU YABANG AIPUSEN PHARMA
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Patent Information

Application Number
CN202311232275.3
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2023-09-22
Publication Date
2026-02-03
Estimated Expiration
2043-09-22

AI Technical Summary

Technical Problem

The existing propranolol hydrochloride tablets have poor flowability during the tableting process, resulting in poor tableting effect. In addition, the secondary amine in propranolol hydrochloride is prone to react with nitrosating agents to produce impurities such as N-nitrosoprene propranolol, which affects the efficacy.

Method used

Mannitol, glyceryl behenate, and magnesium stearate were used as excipients, and a mixture of crospovidone, alanine, and glycine was added as an inhibitor. By controlling the flowability and uniform dispersion of the excipients, the formation of N-nitrosoprene propranolol was reduced.

Benefits of technology

It improves the tableting effect and stability of propranolol hydrochloride tablets, reduces the generation of impurity N-nitrosopranolol, prolongs the efficacy, and improves patient compliance.

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Abstract

The application relates to the technical field of pharmaceutical preparations, and particularly discloses a propranolol hydrochloride tablet with low N-nitrosopropylol impurity content and a preparation method thereof. The propranolol hydrochloride tablet with low N-nitrosopropylol impurity content comprises the following components in parts by weight: 0.2-0.3 parts of propranolol hydrochloride, 2.0-2.3 parts of mannitol, 0.2-0.3 parts of glycerin behenate and 0.05-0.1 parts of magnesium stearate. In the application, mannitol, glycerin behenate and magnesium stearate are used as excipients, the mannitol, the glycerin behenate and the magnesium stearate all have high fluidity, and the glycerin behenate has lubricating and excipient effects, so that the compression of the tablets is facilitated.
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