Effect of Packaging Materials and the Leached Iron on the Stability of Butorphanol Tartrate Injection.

The aim of this study was to investigate the effect of various parameters on the stability of butorphanol tartrate injection and to screen the optimal packaging material. The effect of the headspace oxygen levels, ampoule color, manufacturer, and size on the stability of butorphanol tartrate formulation were evaluated. The headspace oxygen levels controlled by nitrogen purging were found to be particularly effective in improving stability of the butorphanol formulation, especially below 2%. Although it is a photolabile drug, butorphanol tartrate was getting degraded at much higher extent in amber color ampoules in comparison to clear ampoules. The degradation by oxidation was found to be a free radical-mediated process catalyzed by the presence of iron ions leached from the amber ampoules. The ampoule manufacturers also had a significant effect on the stability of butorphanol. Two-milliliter ampoules provided a better stability of the butorphanol tartrate injection than 1mL ampoules as 2-mL ampoules had the lower headspace oxygen level at the same level of oxygen content. The oxidation mechanism of the butorphanol tartrate injection was investigated under various conditions, which include iron powder spiking, removal of excipients, exposure to oxygen/nitrogen, exposure to stainless steel and at different pH. Iron powder spiking, presence of citric acid, exposure to oxygen, exposure to stainless steel, and high pH accelerated the oxidative degradation. The effect of oxygen, iron ion and citric acid is in agreement with a metal-catalyzed oxidation mechanism called Udenfriend reaction. Based on the formulation test results, limiting headspace oxygen level, ampoule color, manufacturer, size, controlling iron ion contamination, and pH are recommended for formulation development. In conclusion, it can be suggested that this study can lead to a better understanding of the degradation mechanism of butorphanol tartrate; hence, it would contribute to the development of butorphanol tartrate injection with improved stability. Virous packaging materials have different effects on the stability of butorphanol tartrate injection, and the leached iron of packaging ampoules and stainless steel can trigger Udenfriend reaction with butorphanol tartrate and citric acid (CA), which lead to the oxydative degradation of butorphanol tartrate injection.

Small magnet aspiration as a pediatric emergency: a case report.

Tracheobronchial airway foreign body aspiration (FBA) in children is a common and serious pediatric medical emergency. With the increasing use of small magnets in home offices, in toys and the kitchen, inhalation of small magnets has become an increasing risk to children. We present a case of a 9-year-old boy who presented with cough and dyspnea three days following inhalation of an 3 cm-sized oval magnet. The history and the chest radiograph were important in planning for the removal of the aspirated foreign body. In this case, we removed the inhaled magnet using rigid bronchoscopy under general anesthetic. We herein reviewed the recent reports on the incidence and management of small foreign body aspiration as a pediatric emergency.

[Clinical study of post-operative pain following coblation tonsillectomy and/or adenoidectomy in children with sleep-disordered breathing].

OBJECTIVE: To explore the characteristics of post-operative pain following coblation tonsillectomy and/or adenoidectomy in children with sleep-disordered breathing (SDB) and explore the correlation between the first day post-operative pain scores and age and operating time. METHOD: 1) A total of 113 SDB children scheduled to undergo coblation tonsillectomy and/or adenoidectomy were recruited. 113 children were divided into two groups according to the method of operation, children who underwent coblation tonsillectomy and adenoidectomy were enrolled in study group one and children who underwent coblation adenoidectomy only were in study group two. Be sides, children of study group one with a history of chronic tonsillitis were in chronic tonsillitis group, children without a history of chronic tonsillitis were in non-chronic tonsillitis group. 2) The parents scored pain in their children on a VAS (anchored by "no pain" at 0 and "worst pain" at 10) in the morning, before using any analgesics and having breakfast, over the first 3 and the seventh post-operative days. 3) Post-operative pain scores were compared between both the study group one and two and chronic tonsillitis group and non-chronic tonsillitis group. Futhermore, the correlation between the first day post-operative pain scores and age and operating time were also analysed. RESULT: 1) The difference of post-operative pain scores over the first 3 and the seventh post-operative days were significant between the study group one and group two (P<0.05). 2) Non-chronic tonsillitis group were significantly less painful than chronic tonsillitis group on day 1, day 2 and day 7 (z=-2.004, -2.059, -2.334, P<0.05). But there was no significant difference in pain levels on day 3 (P>0.05). 3) The first day post-operative pain scores was correlated with age (r=0.273, P<0.01) and operating time (r=0.423, P<0.01). CONCLUSION: The first day post-operative pain scores was correlated with age and operating time. Children with a history of chronic tonsillitis were more painful than children without the history.

[Study of arousal index in children with sleep-disordered breathing].

OBJECTIVE: To explore which index is more suitable to show the degree of sleep fragment in children with sleep-disordered breathing (SDB). METHODS: Between October 2009 and August 2011, Forty-five children (4 - 8 years) who were diagnosed as obstructive sleep apnea hypopnea syndrome (OSAHS) were enrolled in OSAHS group[obstructive apnea index (OAI) > 1 times/h or apnea hypopnea index (AHI) > 5 times/h, lowest oxygen saturation (LSaO2) < 0.92] and 54 children were enrolled in SDB group (1 ≤ AHI ≤ 5 times/h and OAI ≤ 1 times/h), 18 children with chorditis nodules made up control group (AHI < 1 times/h and LSaO2 ≥ 0.92, without SDB-related history). The difference of respiratory arousal index (RAI), spontaneous arousal index (SAI), total arousal index (ARtotI) and sleep pressure score (SPS) were compared among three groups. The correlation between RAI, SAI, ARtotI, SPS and AHI were also analyzed. Furthermore, RAI, SAI, ARtotI and SPS were compared before and after operation in 14 OSAHS children with detailed pre- and after polysomnography data. RESULTS: The difference of SAI and ARtotI between SDB group and OSAHS group and ARtotI between OSAHS group and control group were not significant (P > 0.017), except this, the difference of other index between any two groups or SAI and ARtotI between otherwise two groups were significant (P < 0.017). RAI and SPS was correlated with AHI (coefficient correlation: 0.751, 0.829, P was 0.000). RAI and SPS decreased after operation and the difference was significant (Z were -3.045 and -2.982, P were 0.002 and 0.003). The difference of sleep structure was not significant. CONCLUSIONS: RAI and SPS were more suitable to show the degree of sleep fragment than other arousal index.

[Reasons of multiple operations in children with airway foreign body].

OBJECTIVE: To explore the reasons of multiple operations in children with airway foreign body through analyzing the clinical data of children who received two or more operations. METHODS: From 2003 to 2009, all children with airway foreign body who received two or more operations in hospital were enrolled. The clinical manifestations, image before and after operation and intraoperative conditions were retrospectively analyzed, in order to find the reasons of multiple operations. RESULTS: All children fully recovered, no serious complications or death. The reasons of two or more operations were multiple: 21 cases (42.8%) were related to the factor of apparatus, 20 (40.8%) cases were related to the quality, surrounding conditions and location of the foreign body and experience and surgical skills of operator, 4 (8.2%) cases were due to incarceration of foreign body, another 4 (8.2%) cases were due to unstable intraoperative oxygen saturation. CONCLUSIONS: Both subjective and objective factors (quality, surrounding conditions or location of foreign body, et al) were related to multiple operations. To reduce the chance of multiple operations, careful preoperative assessment and preparation are necessary.

[Correlation between serum uric acid levels and obstructive sleep apnea/hypopnea syndrome in children].

OBJECTIVE: To explore the level of serum uric acid (UA) in children with obstructive sleep apnea/hypopnea syndrome (OSAHS). METHOD: Between Sep. 2008 and Mar. 2010, 138 children with OSAHS were enrolled in study group. Sixty-five children with accessory auricle or ptosis of upper lid were enrolled into the control group. Furthermore, according to apnea/hypopnea index (AHI) or obstructive apnea index (OAI) the study group was further divided into three subgroups (mild, moderate and severe group). At last, the study group and control group were divided into two groups according to the body mass index (BMI), separately. The fasting serum UA level was compared among the different groups. Then the correlation between the serum UA level and AHI, BMI, oxygen desaturation index, least arterial oxygen saturation (LSaO(2)) and the percentage of total sleep time with arterial oxygen saturation < 0.92 was also analyzed in OSAHS children with or without overweight and obesity respectively. RESULT: The difference of serum UA level between the study group and control group (z = -0.443), and the difference among the three groups (χ(2) = 1.241) was not significant(P > 0.05). The serum UA level in overweight and obese children [study group, 273.0 (238.3 - 357.3); control group, 298.0 (253.0 - 336.0)] was significantly higher than that in children with normal BMI [study group, 246.5(215.8 - 300.0); control group, 266.0 (224.0 - 303.3)] (z = -2.084, -2.214, P < 0.05). That serum UA level did not correlate with the above index of OSAHS was observed in children with or without overweight and obesity in study group (P > 0.05). CONCLUSION: Findings of higher serum UA level were not observed in children with OSAHS. There was no correlation between serum UA level and the above indices of OSAHS. The serum UA level in overweight and obese children was significantly higher than that in children with normal BMI.

[The observation of the ciliotoxicity of nasal mucosa with nasal decongestant].

OBJECTIVE: To study the ciliotoxicity of nasalmucosal with nasal decongestant, in order to choose the appropriate nasal decongestant. METHOD: (1) Selected 100 healthy volunteers, by using 0.05% hydrochloride oxymetazoline, 0.025% hydrochloride oxymetazoline, 1.0% ephedrine and 0.5% ephedrine for 7 days with sacchariu technique to test nasal mucociliary transport, and compared with the normal saline. (2) To observe the mucosa of inferior turbinate with Electron Microscopy. RESULT: After using nasal decongestant for 7 days, Mean nasal mucociliary transport rate (MTR) in 0.0500 hydrochloride oxymetazoline groups was (7.64+/-1.56) mm/min and (7.46+/-1.65) mm/min in 0.25% hydrochloride oxymetazoline groups, Mean nasal mucociliary transport rate (MTR) in 1.0% ephedrine groups was (4.73+/-2.03) mm/min and (4.38+/-2.04) mm/min in 0.5% ephedrine groups,The normal saline groups was (7.14+/-1.76) mm/min. MTR was obviously different (F = 16.50, P <0.01). (2)With electron microscopy, it was found that the cilia of epithelial cells were in good order, uniformed in hydrochloride oxymetazoline groups and exfoliated in ephedrine groups. CONCLUSION: Ephedrine has ill effects on nasal mucosa; Hydrochloride oxymetazoline has neither effect on nasal mucosa, nor destroying the physical function of nose, it is an ideal nasal decongestant.