Study on the Quality and Stability of Bromhexine Hydrochloride Dry Powder Inhalations / 中国药师

Objective: To study the quality and stability of bromhexine hydrochloride dry powder inhalations (BH DPIs). Meth-ods: BH DPIs were prepared by freeze-drying with an air jetting method. The humidity and critical relative moisture of the inhalations were investigated. The aerodynamic particle size ( Dae) and water content were also analyzed. The powder morphology was observed under a scanning electronic microscope. The fine particle fraction (FPF) and delivered dose uniformity (DDU) of BH DPIs were de-termined. The stability of the inhalations was determined by accelerated testing and long-term testing. Results: The prepared BH DPIs exhibited the following properties: the critical relative humidity was 65% ; Dae was <5 μm; the water content was less than 2% ; FPF was >30% ,and DDU was good according to the requirement of Chinese Pharmacopoeia. The accelerated testing and long-term testing both indicated promising stability of BH DPIs. Conclusion: Bromhexine hydrochloride dry powder inhalations are stable, and suitable for the use in pulmonary delivery system.

Study on the Preparation of Lansoprazole Enteric-coated Pellets Orally Disintegrating Tablets / 中国药师

Objective:To prepare lansoprazole enteric-coated pellets and compress them into orally disintegrating tablets , and e-valuate the acid resistance in the acid stage and the in vitro dissolution in the buffer stage .Methods:Lansoprazole enteric-coated pel-lets were prepared by fluid bed coating technology , and the effects of the ratio of methacrylic acid copolymer dispersion to ethyl acrylate–methyl methacrylate copolymer dispersion , the concentration of triethyl citrate and the main pressure on the acid resistance in the acid stage and the in vitro dissolution in the buffer stage were evaluated .The similarity of the self-prepared orally disintegrating tablets and the reference preparation was evaluated by using f 2 similarity factor method .Results:The average particle size of microcrystalline cellulose core was 150-180 μm, the ratio of methacrylic acid copolymer dispersion to ethyl acrylate –methyl methacrylate copolymer dispersion was adjusted to 8:2, the enteric-coated weight was 30％, 20％triethyl citrate was used and the main pressure was controlled within the range of 10-16 kN.Lansoprazole enteric-coated pellets had sufficiently flexibility and stability against the compression force . The enteric coating did not break , showing good acid resistance .The dissolution similarity factor of the self-prepared orally disintegra-ting tablets and the reference preparation was greater than 50.Conclusion: Lansoprazole enteric-coated pellets orally disintegrating tablets have good acid resistance and high similarity for the in vitro dissolution, which can be further amplified .

Preparation and Evaluation of Aripiprazole Oral Disintegrating Tablets / 中国药师

Objective:To prepare aripiprazole oral disintegrating tablets , investigate the formula and evaluate the quality .Meth-ods:The formula of aripiprazole oral disintegrating tablets was investigated by a factorial experiment design .The aripiprazole particle size distribution ( X1 , D90/μm) , the ratio of mannitol to microcrystalline cellulose ( X2 ,％) and the amount of disintegration ( X3 ,％) were selected as the independent variables , and the tablet hardness ( Y1 , N) , the disintegration time ( Y2 , s) and the dissolution in 30 min ( Y3 ,％) were used as the dependent variables to ultimately determine the optimal formula .The dissolution profile of aripiprazole oral disintegrating tablets and the reference preparation in four dissolution media were compared by f2 similarity factor, and the stability of aripiprazole oral disintegrating tablets was investigated by accelerated stability testing .Results: The results of factorial experiment design of variance analysis showed that the filler ratio had significant effect on the tablet hardness (P<0.05), the amount of disinte-grant and the filler ratio had significant effect on the disintegration time (P<0.05), and the aripiprazole particle size had significant effect on the drug dissolution ( P<0.05 ) .The optimal formula of aripiprazole oral disintegrating tablets was as follows: the particle size D90 of aripiprazole was 20-40μm, the amount ratio of mannitol to microcrystalline cellulose was 2.5:1, and the amount of disinte-gration was 5.0％.Aripiprazole oral disintegrating tablets prepared with the optimal formula had higher hardness , shorter disintegration time and faster drug dissolution , and the dissolution profiles were similar with those of the reference preparation .The relevant sub-stances showed no significant increase during the accelerated stability testing , and the quality was satisfactory .Conclusion:The formu-la of aripiprazole oral disintegrating tablets is reasonable , the preparation process is feasible and the quality is controllable .

The Active Mechanism of Dural Border Layer Cells in the Process of Subdural Fluid Collection Developing into Hematoma / 医学研究杂志

Objective Discuss the active mechanism of dural border layer cells in the process of subdural fluid collection developing into chronic subdural hematoma.Methods Review and analyse literature combined with one special return case whom with subdural fluid collection.Results At the same case,subdural fluid collection at left side did no change during 49 months,and that at right side developed into chronic subdural hematoma in 23rd week,and the latter was absorbed at 62rd week.Conclusion In the process of subdural fluid collection developing into chronic subdural hematoma,dural border layer cells roll on important functions.

Origin of Chronic Subdural Haematoma / 医学研究杂志

Objective To explore the origin of chronic subdural heamatoma.Methods Follow-up 92 patients of acute subdural haematoma(ASDH)and 207 patients of traumatic subdural effusion(TSE)S by CT or MRI.Results None of ASDHs developed into CSDHs directly,but ASDHs could become to CSDHs via TSEs;67 cases of TSE was proved becoming to CSDHs by CT scanning or operation.Conclusions Origin of CSDH is TSE.