Perhexiline injection liquid and preparation method thereof

Abstract

The invention discloses a perhexiline injection liquid and a preparation method thereof, wherein the perhexiline injection liquid is prepared from radix salviae miltiorrhizae, ligusticum chuanxiong, sodium metabisulfite, sodium calcium edetate, HS-15 and water for injection. The preparation method of the perhexiline injection liquid comprises the steps: adding water to radix salviae miltiorrhizae and ligusticum chuanxiong, decocting, filtering the decoction, concentrating, carrying out precipitation treatment for 2 times with ethanol, filtering, concentrating the filtrate, diluting with water for injection, regulating the pH value with dilute hydrochloric acid, refrigerating, filtering, regulating the pH value with a sodium hydroxide solution, concentrating the filtrate, refrigerating, and filtering to obtain a solution 1; taking 100 ml of water for injection, adding sodium calcium edetate and sodium metabisulfite, stirring until being dissolved, and filtering with activated carbon to obtain a solution 2; adding the HS-15 into 100 ml of water for injection, evenly stirring to obtain a solution 3; and merging the three solutions, filtering, regulating the pH value, adding water for injection to the full amount, filling and sealing, and thus obtaining the product. With adopting of the new prescription and process, the perhexiline injection liquid has an outstanding advantage of greatly enhancing the medication security of the perhexiline injection liquid.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a Guanxinning injection and a preparation method thereof. Background technique [0002] Guanxinning injection is a traditional Chinese medicine preparation containing effective extracts of Danshen and Chuanxiong. It has been on the market in China for more than 30 years. It is often used in the treatment of cardiovascular and cerebrovascular diseases in clinical practice. [0003] Guanxinning Injection is one of the commonly used drugs in clinical practice. It is recorded in the instructions that there are occasional adverse reactions such as urticaria, wheal, angioedema, and allergic asthma. Among them, allergic reactions are the most prominent adverse reactions of Guanxinning. People with history of allergies are forbidden to use this medicine. After investigation, most of the co-solvents of Guanxinning injection currently available on the market are polyso...

AI Technical Summary

Problems solved by technology

After investigation, most of the co-solvents of the currently commercially available Guanxinning injections are polysorbate 80 (Tween-80). Relevant pharmacological studies have found that after intravenous injection of 2% Tween-80 into guinea pigs at 1ml / guinea pigs, the body is skewed, Drowsiness and other obvious symptoms, 5% Tween-80 guinea pigs all had very obvious symptoms such as purple ears, unsteady gait, body tilt, side lying, lethargy; Beagle dogs were slowly injected with Tween-80, and the dose was reduced to 0.02 When % Tween-80 is given at 4ml / volume, the animals will still have obvious allergic symptoms (Sun Li, Liu Xiaomeng, etc., J Toxicol August 2007 Vo1.21 No.4), and other literatures also prove that Tween -80 is the main cause of adverse reactions (anaphylaxis) during its clinical use

[0004] Guanxinning Injection is widely used clinically because of its definite curative effect in the treatment of coronary heart disease and ischemic cerebrovascular disease. It is a strong guarantee for the health of the disease population, but its increasingly prominent adverse reactions (allergic reactions) seriously restrict the large-scale clinical application of Guanxinning injection, so the development of high-safety Guanxinning injection preparations has become the era of the times. need