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Study on the Preparation and Quality Standard of Xiong-Bing Nasal Spray

Author: GuoLiRong
Tutor: WangLiSheng；ZhouLiLing
School: Guangzhou University of Traditional Chinese Medicine
Course: Of Pharmacy
Keywords: Chuanxiong Borneol Preparation Process Quality standards
CLC: R286
Type: Master's thesis
Year: 2011
Downloads: 116
Quote: 0
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Abstract

1 purpose Xiong ice prescription from Guangzhou University of Traditional Chinese Medicine, cardio-cerebral vascular medicine expert Professor Chen Hong Gui many years of experience in the treatment of stroke, the developed into Naoxing sprays, to obtain the exact effect after intranasal administration of the treatment of AIS. Fang Chuanxiong Sim, temperature, gas Hong channeling. Temperature channeling incense and blood circulation of qi, expelling wind and analgesic effect. Can uplink leader, downlink sea of ??blood \Borneol acrid, bitter, slightly cold, energy spread can go. \Resuscitation refreshing borneol is commonly used drugs used for stroke, phlegm, Shenhun orifices closed embolism, because of its \TCM theory holds, the Sim can sweating relieving, qi pain; yang and cold temperature may Tongluo; bitter dampness detoxification, heat Xiehuo. Chuanxiong, borneol combination, blood Tongzhi, Zuo makes law, scrape together a total of qi and blood circulation, fails to grasp the power, smoother sputum self-cleaning \treatment of force, in order to attain the power of AIS. The purpose of this project is to the information submitted in accordance with the medical institutions preparations approval number project requirements, the development of hospital preparations. 2 Methods 2.1 Chuanxiong Chuanxiong ferulic acid (FA) composition, extraction and purification of HPLC determination. Chuanxiong two kinds of extraction, purification process: 1. Factors and three levels orthogonal experiment investigated Chuanxiong water extraction process, the single factor experiment investigated Chuanxiong water extract and alcohol precipitation process. 2 four factors and three levels orthogonal experiment investigated Chuanxiong alcohol extraction process, the alcohol extract by macroporous resin purification. Ferulic acid content in the liquid and the mice were decapitated experimental results for the indicators, preferably Chuanxiong water extraction and alcohol precipitation purification and alcohol extract macroporous resin purification optimum parameters. 2.2 the borneol dissolution method research solubilizer solubilization, cyclodextrin inclusion and other methods to improve the for borneol dissolution conditions, and compare different cyclodextrin, timely package of different preparation methods, borneol dissolved and stability. 2.3 pH of the preparation and preservatives screening ferulic acid content in the preparations and preparations appearance as an indicator, filter formulation pH and preservatives. 2.4 quality standard in accordance with the 2010 version of \By TLC on Chuanxiong, borneol were identified according establish Xiong ice nasal sprays main ingredient ferulic acid by high performance liquid Determination the borneol Gas Determination. 2.5 fingerprint formulation to establish Chuanxiong Chuanxiong Extraction and Purification, Xiong ice fingerprints of the nasal spray, and correlation study, research among its specificity and accuracy. The 2.6 safety study visits preparations rabbit eye mucosa local irritation and toad palate mucosal toxicity. 2.7 Stability of light, high temperature, high humidity, exposed in the trial of the air four conditions influencing factors, and accelerated stability study. 3 Results 3.1 Chuanxiong extraction and purification of ferulic acid content and mice were decapitated mouth time indicators, get the best extraction and purification process: Chuanxiong extracted twice with 80% ethanol (12 times), (per times 1.5h), the extracts were combined, filtered, the ethanol was recovered under reduced pressure, and concentrated to per mL of crude drug 0.5g centrifuged 10min (3000r · min-1), the supernatant to 1BV · h-1 on sample velocity over HPD-100 macroporous resin column adsorption 1h, washed with distilled water and concentrated sulfuric acid to alpha-naphthol were negative and eluted with 50% ethanol the 9BV, vacuum recovery of ethanol that was collecting alcohol eluent. 3.2 borneol dissolution method solubilizing amount of borneol and appearance clarity as an index, the results show that the borneol with hydroxypropyl-β-cyclodextrin inclusion better ratio by feeding borneol: hydroxypropyl-beta-ring dextrin (0.3:4), grinding inclusion 1.5h, that is, too. 3.3 pH of the preparation and the preservative screening appearance of clarity to the ferulic acid and preparation as an indicator, to determine the pH of the present preparation for 6.0 0.01% benzalkonium bromide as the preservative in the present prescription. 3.4 Shenxiong ice nasal spray preparation process Chuanxiong herbs with 12 times the amount of 80% ethanol reflux extracted twice, each time 1.5h, the extracts were combined, concentrated, 3000r · min-1 after 15min centrifugation ferulic acid, concentrated to quality concentration of 0.5mg · mL-1, to 1BV · h-1 on the kind of speed too HPD-100 macroporous resin column, washed with distilled water to colorless, and then eluted with 50% ethanol 1BV · h-1 speed collect alcohol eluate was concentrated to the alcohol-free taste. Which borneol HP-B-cyclodextrin inclusion, and 0.01% benzalkonium bromide, and the pH was adjusted to the appropriate concentration with distilled water at constant volume. 3.5 quality standard to 3 batches Xiong ice nasal sprays were measured, the average pH of 6.38, RSD = 1.72%; the average installed amount, Meipingzhuang, the amount shall not be less than 95%; relative density between 1.2642-1.2664; each total sprayed times shall not be less than 100 spray bottle; spray volume per press 145 to 166mg; were TLC, the provisions the Gung ice nasal sprays can be identified ferulic acid, borneol the Gung ice nasal sprays. HPLC determination of ferulic acid content, that ferulic acid per mL of the Gung ice nasal sprays containing not less than 5.12mg; The GC method borneol content, require per mL of the Gung ice nasal sprays containing borneol (borneol and iso The borneol meter) shall not be less than 0.024mg. 3.6 fingerprint formulation were prepared ten lots Chuanxiong Chuanxiong Extraction and Purification, Xiong ice the nasal sprays fingerprint found similarity better three significant correlation. 3.7 security to the rabbit mucosal irritation test, the toad palate mucosal toxicity experiments examine preparations mucous membrane irritation, mild mucous membrane irritation and smaller ciliotoxicity The results showed that the preparation. 3.8 Stability of stability test results show that the nasal spray Chiungchiao ice good appearance, but the content of the ferulic acid component is within three months, decreased.

Study on the Preparation and Quality Standard of Xiong-Bing Nasal Spray

Abstract

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