The Dissolution Rate Of Shuanghuangbu Sustained-release Preparation In Vitro

Objective: Periodontitis is local infective disease caused by microganisms and dental plaque . Many studies have showed that periodontopathogens and their outcomes are vital causes and initial factors during the forming of periodontitis. So the key to periodontal therapy is controlling plaque. Systemacally and locally administered antibiotics had significant effects on in habiting periodontopathogens besides subgingival instrumentation. But systematical use of drugs for a long time would lead to unpleasant effects such as big dose required, low concentration and risk of increasing bacterial resistance to antibiotics. It is more and more emphasized to emploit safe, quickly effective bacteriocidal drugs locally administered in periodontal therapy. Chinese herbal medicine is the important part of traditional literature and has been used for a long time. It has been testified in some experimentals that many herbal medicine have obviously strong inhibition on periodontopathogens. Shuanghuangbu sustained-release preparation is a Chinese herbal sustained-release device locally administered in periodontal pockets. The preparation combined the elimination inflammation and induction bone formation. In vitro test, the preparation had exhibited obviously strong bacteriostatic activity against Porphyromonas gingivalis,Provotella intermedins and Fusobacterium nucleartum. In test of animal studied, Shuanghuangbu sustained-release preparation not only can effectively control periodontal inflammation of Beagle dogs but also obviously promote the new bone and cementum formation and restore supporting tissue of the teeth. In this test, High Performance Liquid Chromatography (HPLC) method and blasket stirring method were used to determine the contents and the dissolution rates of Baicalin and Beberine Hydrochloride of Shuanghuangbu sustained-release preparation in vitro. We established the standard of quality control which ensured the safety and effectiveness of the preparation. Releasing regularity and mechanism of it were explored initially. The experimental results will provide further reasonable basis for its clinical application.Methods: Shuanghuangbu sustained-release preparation and Shuanghuangbu preparation were made. They both contained Rhizoma coptidis, Radix scutellariae and Rhizona drynariae. Sets of standard solution of Baicalin and Beberine Hydrochloride were compounded and their areas of peak chromatogram at 280nm and 270nm separately, then their Huigui formulas could be figured out. The tests of precision and recovery were taken to the standard solution of Baicalin and Beberine Hydrochloride. HPLC method blasket stirring method were used to determin the contents and the dissolution rates of them. Shuanghuangbu sustained-release preparation was weighted accuratelly and laid in the circled bottom flask thatcontained distilled water. The revolving speed was 30r/min(37±0.5)°C. Samples were taked out respectively at lOmin, 20min, 30min, 40min, lh, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 7h, 9h, lOh, 14h, 22h, 24h, 38h, 40h, 49h, 52h, 59h, 58h. The dissolution rates of Baicalin and Beberine Hydrochloride were determined and the curves were designed about relation of dissolution rate and time.Results: Baicalin had a good linearity(r=0.9997) in the range of 4.59 u g/ml~ 114.80 u g/ml, the mean recovery was 99.63%(RSD 0.84%). Beberine Hydrochloride had a good linearity(r=0.9999) in the range of 2.52 u g/ml~ 50.40 u g/ml, the mean recovery was 99.80%(RSD 1.14%). Addition to 5 batches and 3 batches which were determined, the content of Baicalin can not less than 1.63% and the content of Beberine Hydrochloride can not less than 0.564%. Baicalin of Shuanghuangbu sustained-release preparation released early, quickly and its releasing continuous time was short, the wholly releasing time was fewer 3 hours than that of Shuanghuangbu preparation. Beberine Hydrochloride of Shuanghuangbu sustained-release preparation released lately, slowly and its releasing continuous time was long, the wholly releasing time more 35 hours than that of Shuanghuangbu preparation.Conclusions1 Baicalin and Beberine Hydrochloride respectively are the vital effective components of Radix scutellariae and rhizoma coptidis, their cntents and determined methods are stable...