Study on stability of Alprostadil Injection / 药物评价研究

Objective To study the stability of Alprostadil Injection,and provide theoretical basis for its production,packaging,storage,and transportation conditions.Methods The contents of PGE1 and A1 in Alprostadil Injection were determined by HPLC method through strengthen test,accelerated test,and longterm test.The stability of Alprostadil Injection was investigated.Results Linearity,precision,stability,and recovery rate of E1 and A1 met the requirements;Placed for 10 d under high light and high temperature conditions,the color was obviously deepened,the pH value was almost unchanged,the content decreased significantly and degradation of related substances increased significantly;At 25 ℃ and after 6 months of acceleration test,the PH value decreased slightly and the content changed obviously.Three batches of samples were stored at 4℃ and long-term tested after 12 months,its appearance traits,related substances,and content of the indicators were in line with the relevant requirements.Conclusion Alprostadil Injection is unstable to light and heat,easy degradation,this product should be stored in dark and cold conditions,with the validity for one year.

Determination of Chloride in Infant Formula and Adult/Pediatric Nutritional Formula by Potentiometric Titration: Single-Laboratory Validation, First Action 2015.07.

A potentiometric method for determination of chloride was validated against AOAC Standard Method Performance Requirement (SMPR(®)) 2014.015. Ten AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) matrixes, including National Institute of Standards and Technology (NIST) Standard Reference Material (SRM) 1849a, were tested in duplicate on 6 independent days. The repeatability (RSDr) ranged from 0.43 to 1.34%, and the intermediate reproducibility (RSDiR) ranged from 0.80 to 3.04%. All results for NIST SRM 1849a were within the range of the certified concentration (701 ± 17 mg/100 g). Recovery was demonstrated with two overspike levels, 50 and 100%, in the 10 SPIFAN matrixes. Samples were tested in duplicate on 3 different days, and all results were within the SMPR requirement of 95 to 105%. The LOQs of the method for powdered products and ready-to-feed or reconstituted products were 20 mg/100 g and 2.2 mg/100 mL, respectively. A wide analytical range from the LOQ to 99.5% chlorine content can be reached with an appropriate dilution factor, but in practice, the upper analytical value observed in routine matrix testing was approximately 1080 mg/100 g in skim milk powder. This is a rapid, simple, and reliable chlorine-testing method applicable to infant formula, adult nutritionals, and ingredients used in these dairy-based products, such as skim milk powder, desalted whey powder, whey protein powder, and whole milk powder.

Two novel mutations in fibrillin-1 gene of Marfan syndrome / 中华医学遗传学杂志

<p><b>OBJECTIVE</b>To detect novel mutations in the fibrillin-1(FBN1) gene by screening the gene from 9 patients with Marfan syndrome (MFS).</p><p><b>METHODS</b>Denaturing high-performance liquid chromatography (DHPLC) was used to screen for FBN1 mutation exon by exon. The DNA amplification fragments of which the DHPLC elution profiles showed difference in comparison with the corresponding normal elution profile were sequenced to identify the position and nature of mutation. The detected mutations were further proved by allele specific PCR or restriction fragment length polymorphism.</p><p><b>RESULTS</b>Two novel FBN1 gene mutations were found and identified in two Marfan patients respectively, one of which was a small insertion in exon 34 at nucleotide 4307-4308 (4307insTCGT) and the other a missense mutation in exon 43 at nucleotide 5309 (5309G>A).</p><p><b>CONCLUSION</b>The findings suggested that the frameshift mutation (4307insTCGT) and point mutation (5309G>A) caused the corresponding patients to have MFS.</p>

Rare constituents with anti-cancer activity from hydrolytic products in saponins of Panax quinquefolium stems and leaves / 中草药

Objective To study the chemical constituents of the acid hydrolytic products from the stems and leaves of Panax quinquefolium. Methods The stems and leaves of P. quinquefolium were hydrolyzed with acid;Isolation and purification were carried out by various chromatographic techniques,such as silica gel and so on. Compounds were identified and elucidated by spectral and chemical methods. Results Eight compounds were obtained from the acid hydrolytic products in the stems and leaves of P. quinquefolium and identified as 20 (S)-panaxadiol (Ⅰ),20 (S)-protopanaxadiol (Ⅱ),20 (R)-protopanaxadiol (Ⅲ),20 (S)-panaxatriol (Ⅳ),24 (R)-ocotillol (Ⅴ),20 (R)-protopanaxatriol (Ⅵ),20 (R)-dammarane-3?,12?,20,25-tetrol (Ⅶ),and 20 (R)-dammarane-3?,6?,12?,20,25-pentol (Ⅷ). Conclusion Compounds Ⅰ-Ⅷ are the derivates of the aglycones of ginsenosides,isolated from the acid hydrolytic products from the stems and leaves of P. quinquefolium for the first time. Among these compounds,Ⅳ,Ⅶ,and Ⅷ are discoverd from the roots,stems,leaves,fruits,and buds of P. quinquefolium for the first time. Compound Ⅶ is discovered and reported that it is the derivate of the aglycone of protopanoxadiol ginsenoside,with the conspicuous anticancer activity from the fruits of P. ginseng for the first time.