Congenital Ptosis: Results of Treatment Using Lyophilized Fascia Lata for Frontalis Suspensions

In a prospective collaborative study, congenital ptosis was repaired using lyophilized allogeneic fascia lata as the suspension material for frontalis sling procedures. Over 50 cases of unilateral and bilateral ptosis procedures were performed by pediatric ophthalmologists during the initial study period. No infections or evidence of tissue rejection were reported during a follow-up period of up to 24 months. Four failures, ascribed to slippage, were noted within the first several months and required regrafting. In an additional case, minimal slippage occurred, but resulted in satisfactory lid levels. All remaining cases achieved satisfactory cosmetic and functional results. Most collaborators found this form of preserved fascia lata to be superior to nylon polyfilament, cable-type suture. Clinical features of the patient population included a high incidence of strabismus (28%) and amblyopia (24%).     

The interaction of factor VIIa with rehydrated,lyophilized platelets

The experiments presented here were undertaken to determine if factor VIIa (rFVIIa, the Novo Nordisk product NovoSeven?) will directly bind to rehydrated, lyophilized (RL) platelets for the formation of a catalytic surface with an enhanced ability to generate thrombin. The interaction between rFVIIa and the RL platelet surface was examined by measuring equilibrium and non-equilibrium binding of the coagulation factor to the cells and by following the effects of the surface modification on the kinetics of thrombin generation. The association of rFVIIa with RL platelets was rapid with saturation occurring within minutes. Disassociation was slow, with over half of the coagulation factor remaining bound after two hours. Densities of over one million molecules of rFVIIa per RL platelet were obtained when high concentrations of rFVIIa were incubated with RL platelets. Thrombin generation measurements showed that RL platelet-bound rFVIIa was catalytically active. Thus we can expect that RL platelets, which have been shown to effectively bind to sites of vascular injury, will localize rFVIIa to wounds for an increase in therapeutic index. These studies indicate that rFVIIa-RL platelets are worthy of preclinical and clinical development as an infusion agent for severe bleeding.     

The Nordic Trueness Project 2002: use of reference measurement procedure values in a general clinical chemistry survey

Up to 136 laboratories participated in a joint effort to assess the trueness of routine measurements for 14 serum components. An unmodified, fresh‐frozen human serum (“IMEP‐17 Material 1”), produced for an international inter‐laboratory comparison, served as the “master material”. The serum had assigned values of the highest available metrological quality, and is assumed to involve no or negligible commutability problems. The material was used in the assignment of traceable values to two other reference sera, “CAL” and “X”, through parallel measurements on the three materials according to a common protocol. In this transfer process, uncertainty estimates were provided for all values. The material CAL had been supplied with reference measurement procedure values in 1997, and the two sets of assigned values agreed well. A lyophilized control serum “HK02” was also included in the routine analysis series. It, too, had assigned values based on reference measurement procedures. Significant matrix effects were found. The project has provided:

• Assigned traceable values for 14 components in a fresh‐frozen serum, available to Nordic laboratories for the coming years as “NFKK reference serum X”.

• Confirmation of earlier assigned reference measurement procedure values for a number of components in CAL, the main calibrator in the Nordic Reference Interval Project (NORIP). The transferred values will now serve as the primary reference.

• Evidence of long‐term stability (≥5 years) of the fresh‐frozen serum CAL when stored at ?80°C.

• Evidence of substantial matrix effects in the processed serum HK02. The findings should be used to discuss to what extent reference measurement procedure values are useful and cost‐efficient for this type of material.

     

Preparation,characterization, and antibacterial activity of plaunotol and plaunoi extracts complexed with hydroxypropyl-β-cyclodextrin

Croton stellatopilosus (Plaunoi) leaves accumulate several diterpenes and possess various pharmacological activities. The present study aimed to prepare, characterize and assess the antibacterial activity of inclusion complexes prepared by mixing plaunotol (PL) or plaunoi extract (PE) with cyclodextrins (CD), including α-CD, β-CD, γ-CD, and hydroxypropyl-β-cyclodextrin (HP-β-CD). The inclusion complexes were characterized using SEM, XRD, DSC, and FT-IR and evaluated for aqueous solubility and thermal stability. The PL and PE lyophilized complexes with HP-β-CD were further evaluated for their antibacterial activity against acne-causing bacteria. The minimum inhibitory concentration (MIC) and the minimum bactericidal concentration (MBC) of PL, PE, and the inclusion complexes evaluated using the agar dilution method revealed that the MIC and MBC values of the inclusion complexes were lower than those of PL or PE alone. Interestingly, the complexes had a synergistic activity with clindamycin after testing with checkerboard assay. The hydrogel containing the inclusion complex and clindamycin were assessed for antibacterial activity using the agar well diffusion method. The results indicated that the hydrogels showed significant inhibition of bacterial growth. In conclusion, the prepared solid dispersion of PL or PE with HP-β-CD could enhance antibacterial activity by increasing the drug solubility. The hydrogels containing PL or PE complex and clindamycin could be considered as a candidate for the treatment of acne vulgaris.     

四逆散冻干粉化学成分变化的研究

目的采用RP-HPLC法分析四逆散冻干粉的化学成分变化,为其工艺控制和配伍规律提供可靠依据。方法采用高效液相色谱法,色谱条件:Kromasil C18柱(250 mm×4.6 mm,5μm),体积流量1.0 mL/min,柱温28℃,流动相A为乙腈;B为磷酸水(pH=3),在检测波长为210 nm和240 nm条件下,构建四逆散冻干粉、缺味四逆散及单味药冻干粉的HPLC色谱图,分析其化学成分的变化。结果四逆散冻干粉240 nm波长下高效液相色谱图21个成分峰中,确认了有2个组分来自柴胡,有3个组分来自白芍,有10个组分来自枳实,有5个组分来自甘草,1个组分为新物质。210 nm波长下高效液相色谱图24个成分峰中,确认了有1个组分来自柴胡,有4个组分来自白芍,有14个组分来自枳实,有5个组分来自甘草。结论本方法稳定可控,可用于四逆散冻干粉指纹图谱测定,可全面地反映其化学成分变化。     

蛞蝓冻干粉对支气管哮喘的治疗作用

目的:研究蛞蝓冻干粉对支气管哮喘的治疗作用。方法:运用氢氧化铝加卵白蛋白建立豚鼠支气管哮喘模型,观察蛞蝓冻干粉对支气管哮喘的治疗作用及对卵蛋白致敏豚鼠肺支气管灌流量、肺泡灌流液和血清中炎症因子的影响。结果:蛞蝓冻干粉能减少诱发豚鼠哮喘的死亡数,延长诱喘潜伏期(P<0.05),其抗哮喘作用与对照药氨茶碱相当;能显著降低哮喘豚鼠的外周血和肺泡灌洗液的白细胞计数以及肺组织嗜酸性粒细胞浸润(P<0.05),且在中剂量63 mg/kg时,药物达到最佳效应;氨茶碱和蛞蝓冻干粉中、高剂量治疗组豚鼠肺支气管灌流量显著增加,血清和肺泡灌洗液(BALF)中IL-2和IL-4显著降低(P<0.05)。结论:蛞蝓冻干粉能显著抑制支气管哮喘的发生。     

注射用血栓通(冻干粉)联合西药治疗强直性脊柱炎随机对照临床研究

[目的]观察注射用血栓通(冻干粉)联合西药治疗强直性脊柱炎的临床疗效。[方法]采用随机、平行对照的方法,将120例患者随机分为两组,对照组60例采用扶他林,沙利度胺,帕夫林治疗,治疗组60例在对照组的治疗基础上加用注射用血栓通(冻干粉)治疗。治疗前后两组分别检测两组ESR、CRP。均以2周为1个疗程,治疗1个疗程后进行疗效判定。[结果]治疗组在降低ESR、CRP等指标方面明显优于对照组(P<0.05),临床总有效率亦明显优于对照组(P<0.01)。[结论]注射用血栓通(冻干粉)联合西药治疗强直性脊柱炎疗效满意,且不增加副作用,值得借鉴。     

三七总皂苷脂质体微丸的制备

目的:制备三七总皂苷脂质体微丸.方法:以包封率为考察指标,大豆磷脂-胆固醇、水相-有机相,药物质量浓度,脂类用量为考察因素,通过正交设计优选三七总皂苷脂质体冻干粉的处方工艺,采用塑制法制备三七总皂苷脂质体微丸.结果:三七总皂苷脂质体冻干粉的最佳处方工艺为大豆磷脂-胆固醇(6∶1),水相-有机相(1∶4),药物质量浓度20 g·L-1,磷脂用量150 mg.制备的脂质体微丸溶解后脂质体的平均粒径220.5 nm,Zeta电位-71.21 mV,1h内溶出度达81.41％.结论:制备的三七总皂苷脂质体微丸体外溶出度较高,脂质体的粒径分布较好、质量稳定.     

注射用益气复脉(冻干)碱醇洗脱部分甲酯化方法的研究

目的: 研究注射用益气复脉(冻干)碱醇洗脱部分的最佳甲酯化方法。 方法: 分别采用1%硫酸-甲醇加热回流酯化法,10%硫酸-甲醇加热回流酯化法,25%硫酸-甲醇加热回流酯化法和2%氢氧化钾-甲醇加热回流酯化法对该部分物质进行甲酯化,并用合适的溶剂进行萃取,之后将所得萃取物进行GC-MS分析。 结果: 当采用10%硫酸-甲醇加热回流酯化法对该部分物质进行甲酯化并选用氯仿做萃取剂时,酯化效率最高。 结论: 10%硫酸-甲醇加热回流酯化法是注射用益气复脉(冻干)碱醇洗脱部分的最佳甲酯化方法,为该部分主要成分的研究提供依据。     

色差计法测定注射用丹参多酚酸溶液的颜色

目的:利用色差计建立注射用丹参多酚酸溶液颜色测定的方法。方法:采用《中华人民共和国药典》2010版附录XIA"溶液颜色检查法"第三法(色差计法)测定溶液的颜色。结果:该方法精密度和重复性良好,3 h内色差值△E*的RSD值为1.28%。测定的6批样品均小于黄色3号标准比色液(Y3)。结论:相比目视法,该方法将溶液颜色进行了量化检测、数据直观准确,可作为注射用丹参多酚酸溶液颜色测定的方法。通过色差法对中药注射剂质量进行控制将成为一种趋势,对提高中药注射剂安全性具有重要意义。