Zedoary injection preparation and its preparing method

Abstract

The present invention features that effective component of zedoary is clathrated with 2-hydroxypropyl beta-cyclodextrin in the clathrated rate over 90 % and then mixed with medicine supplementary material, and the mixture is then prepared into water injection, transfusion preparation, powder for injection or freeze dried powder for injection. Pharmacological experiment shows that the zedoary injection preparation of the present invention has high pharmacological effect.

Description

Technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a curcuma injection preparation and a preparation method thereof. Background technique [0002] 2-Hydroxypropyl-β-cyclodextrin (HP-β-CD for short) is a kind of hydroxyalkylated derivatives of β-cyclodextrin. In each glucose residue of β-cyclodextrin (β-CD), the hydrogen atoms of 3 hydroxyl groups in C-2, C-3 and C-6 can be replaced by hydroxypropyl (-CHCHOHCH) to generate 2-HP-β-CD, 3-HP-β-CD, 2,3-DHP-β-CD, 2,6-DHP-β-CD, 2,3,6-THP-β-CD and other homologs . If the conditions are controlled, the product mainly composed of 2-HP-β-CD can also be generated. 2-HP-β-CD is currently the CD derivative with the most research, the most sufficient work, the most comprehensive safety data collected, and the best effect on drug solubilization and stability improvement. Many properties of 2-HP-β-CD have changed, mainly in the following aspects: (1) ...

AI Technical Summary

Problems solved by technology

At present, the encapsulation rate of β-CD to fat-soluble drugs is only about 60%, because it is particularly difficult to extract fat-soluble drugs in traditional Chinese medicine. , which is a huge waste of traditional Chinese medicine resources and reduces the pharmacological efficacy of traditional Chinese medicine preparations; the inclusion rate has not been well resolved in the current preparation process, and the release rate of fat-soluble drugs included by β-CD is low, resulting in The concentration of fat-soluble drugs is low, and the pharmacological effects cannot be fully exerted

[0004] Curcuma aerugionosa Roxb is the rhizome of Curcuma aerugionosa Roxb., which has the functions of promoting qi, breaking blood, eliminating stagnation and relieving pain. Modern pharmacological research shows that the effective parts extracted from Curcuma have anti-cancer, anti-virus, pain relief, antipruritic, etc. Function, injections, suppositories, and ointments made from the effective parts of Zedoary have been widely used in clinics; the effective parts of Zedoary are fat-soluble components, which are difficult to dissolve in water. The marketed Zedoary injection preparations mainly use some surfactants to help dissolve Such as Tween, etc., but these co-solvents have hemolytic side effects, which have great limitations in clinical application and are potentially dangerous to patients; the patent application number is 02109680, which uses stirring method or grinding method or ultrasonic oscillation Method, use hydroxypropyl-β-cyclodextrin to carry out inclusion to the effective part of Curcuma, the patent mentions that the inclusion rate is under the same inclusion conditions, only the amount of hydroxypropyl-β-cyclodextrin is different, so that The inclusion rate of hydroxypropyl-β-cyclodextrin spans from 62% to 95%, its reliability is questionable, and the patent does not do any experiments and elaborations on the inclusion rate of hydroxypropyl-β-cyclodextrin