Prescription optimization and stability investigation of urea ointment / 军事医学

Objective To adjust the prescription of urea ointment and investigate its stability .Methods In accordance with the original prescription , four groups of urea ointment were prepared .Group A and group B were made with yellow vaseline from different manufacturers , while groups C and D were prepared in summer and winter respectively with the same source materials.The viscosity and moldability of the four groups were evaluated through the senses .The prescription was slightly adjusted through the single-factor effect experiment .Three batches of urea ointment were prepared according to the new prescription and their stability was investigated .Results Using the original prescription , the urea ointment made with yellow vaseline provided by Manufacturer One had better viscosity and moldability than that from Manufacturer Two .The urea ointment made in summer had lower viscosity and poorer moldability than the one made in winter .The amount of beeswax increased in the adjusted prescription .Three batches of urea ointment were prepared with the new prescription and their stability was maintained .There were no changes in appearance , and the content and microbial limit remained in the standard range for 11 months.Conclusion The source of materials and change of the external environment could affect the characteristics of urea ointment .The adjusted prescription is feasible and stable .

Prescription optimization and stability investigation of urea ointment / 军事医学

Objective To adjust the prescription of urea ointment and investigate its stability .Methods In accordance with the original prescription , four groups of urea ointment were prepared .Group A and group B were made with yellow vaseline from different manufacturers , while groups C and D were prepared in summer and winter respectively with the same source materials.The viscosity and moldability of the four groups were evaluated through the senses .The prescription was slightly adjusted through the single-factor effect experiment .Three batches of urea ointment were prepared according to the new prescription and their stability was investigated .Results Using the original prescription , the urea ointment made with yellow vaseline provided by Manufacturer One had better viscosity and moldability than that from Manufacturer Two .The urea ointment made in summer had lower viscosity and poorer moldability than the one made in winter .The amount of beeswax increased in the adjusted prescription .Three batches of urea ointment were prepared with the new prescription and their stability was maintained .There were no changes in appearance , and the content and microbial limit remained in the standard range for 11 months.Conclusion The source of materials and change of the external environment could affect the characteristics of urea ointment .The adjusted prescription is feasible and stable .

Beeswax: A minireview of its antimicrobial activity and its application in medicine

Beeswax is the substance that forms the structure of a honeycomb; the bees secrete wax to build the honeycombs where to store honey. Thanks to its rich hydrophobic protective properties, the beeswax is in fact present within cosmetics and body products. Also, beeswax is used in the food industry: as a film to wrap cheese for maturing or as a food additive (E901) to give shine to the products. Exactly as the honey which it contains, beeswax is also characterized by several therapeutic properties of great interest to us; it is thought to be particularly effective in healing bruises, inflammation and burns. Recently, the interest of researchers has moved even on antimicrobial properties of beeswax although there are still few studies in the literature focused only on the action of beeswax. The few studies showed an antimicrobic effectiveness of beeswax against overall Staphylococcus aureus, Salmonella enterica, Candida albicans and Aspergillus niger; these inhibitory effects are enhanced synergistically with other natural products such as honey or olive oil. This minireview aims to be a collection of major scientific works that have considered the antimicrobial activity of beeswax alone or in combination with other natural products in recent years.

Beeswax: A minireview of its antimicrobial activity and its application in medicine

Beeswax is the substance that forms the structure of a honeycomb; the bees secrete wax to build the honeycombs where to store honey. Thanks to its rich hydrophobic protective properties, the beeswax is in fact present within cosmetics and body products. Also, beeswax is used in the food industry: as a film to wrap cheese for maturing or as a food additive (E901) to give shine to the products. Exactly as the honey which it contains, beeswax is also characterized by several therapeutic properties of great interest to us; it is thought to be particularly effective in healing bruises, inflammation and burns. Recently, the interest of researchers has moved even on antimicrobial properties of beeswax although there are still few studies in the literature focused only on the action of beeswax. The few studies showed an antimicrobic effectiveness of beeswax against overall Staphylococcus aureus, Salmonella enterica, Candida albicans and Aspergillus niger; these inhibitory effects are enhanced synergistically with other natural products such as honey or olive oil. This minireview aims to be a collection of major scientific works that have considered the antimicrobial activity of beeswax alone or in combination with other natural products in recent years.

Stability of 50mg-Beeswax alcohols tablets (Abexol®) packed in high-density polyethylene flasks

Introduction: beeswax alcohols, consisting in a reproducible mixture of six primary fatty alcohols from 24 to 34 carbon atoms purified from Apis mellifera beeswax, has been shown to produce antioxidant and gastroprotective effects. This substance is used to manufacture Abexol® 50 mg tablets, the finished form used in clinical studies and in routine practice. Objective: to determine the stability of 50 mg‒Beeswax alcohols tablets (Abexol®) packed in high‒density polyethylene flasks. Methods: samples from three batches of Abexol® 50 mg tablets packed in white high density polyethylene flasks (Rainbow & Nature, Sydney, Australia) were put into cardboard boxes and kept under climatic conditions of the zone IV (30±2 ºC, 70±5 percent of relative humidity) for five years. Results: all parameters tested were within specifications throughout the whole study: appearance (white round tablets with intact surfaces), average weight (initial average weight±7,5 percent), total content of the six fatty alcohols (50±3.75 mg), disintegration time (<15 min), hardness (˃3 kg/cm2) and microbiological content (≤1 000 bacteria/g and ≤100 fungi/g, absence of E. coli,S. aureus, Pseudomonas, Salmonella and C. albicans). This result is consistent with the data of a previous stability study of Abexol® 50 mg tablets manufactured in Cuba and packed in blisters of polyvinyl chloride and aluminum. Conclusions: the results of the present study support that Abexol®50mg tablets packed in white high density polyethylene flasks and stored at the conditions of the climatic zone IV have a shelf life of 5 years(AU)

Introducción: los alcoholes de la cera de abejas constituyen una mezcla reproducible de seis alcoholes grasos primarios de 24 a 34 átomos de carbono purificados de la cera de Apis mellifera. Esta sustancia, con efectos antioxidantes y gastroprotectores, es empleada para la elaboración de las tabletas de Abexol® con dosis de 50 mg de alcoholes, forma farmacéutica terminada utilizada en los ensayos clínicos y en la práctica de rutina. Objetivo: determinar la estabilidad de las tabletas con 50 mg de alcoholes de cera de abejas (Abexol®) en frascos de polietileno de alta densidad. Métodos: muestras de tres lotes de tabletas de Abexol® con dosis de 50 mg envasadas en frascos de polietileno de alta densidad ( Rainbow & Nature, Sydney, Australia) se pusieron en cajas de cartón y se mantuvieron en las condiciones de la zona climática IV (30±2 ºC, 70±5 por ciento de humedad relativa) durante cinco años. Resultados: los parámetros evaluados se mantuvieron dentro de sus especificaciones de calidad durante todo el estudio: apariencia (tabletas blancas redondas con superficies enteras), peso promedio (inicial±7,5 por ciento), contenido total de los seis alcoholes grasos (50±3,75 mg), tiempo de desintegración (<15 min), dureza (˃3 kg/cm2) y contenido microbiológico (≤1 000 bacterias/g y ≤100 hongos/g, ausencia de E. coli, S. aureus, Pseudomonas, Salmonella y C. albicans). Este resultado es consistente con los datos de un estudio previo de estabilidad de tabletas de Abexol® con dosis de 50 mg, fabricadas en Cuba y envasadas en blísteres de cloruro de polivinilo y aluminio. Conclusiones: los resultados del presente estudio sustentan que las tabletas de Abexol® con dosis de 50 mg, envasadas en frascos de polietileno de alta densidad y almacenadas en las condiciones de la zona climática IV, presentan un tiempo de vida útil de cinco años(AU)

Nanoparticles containing curcuminoids (Curcuma longa): development of topical delivery formulation

Solid lipid nanoparticles incorporating Curcuma longa L., Zingiberaceae, curcuminoids were produced by the hot melt emulsion method. A Box–Behnken factorial design was adopted to study the nanoparticles production at different levels of factors such as the percentage of curcuminoids, time of homogenization and surfactant ratio. The optimized nanoparticles were incorporated into hydrogels for stability, drug release and skin permeation tests. The average nanoparticle sizes were 210.4 nm; the zeta potential of −30.40 ± 4.16; the polydispersivity was 0.222 ± 0.125. The average encapsulation efficiency of curcumin and curcuminoids was 52.92 ± 5.41% and 48.39 ± 6.62%, respectively. Solid lipid nanocapsules were obtained with curcumin load varying from 14.2 to 33.6% and total curcuminoids load as high as 47.7%. The topical formulation containing SLN-Curcuminoids showed good spreadability and stability when subjected to mechanical stress test remained with characteristic color, showed no phase separation and no significant change in pH. As a result of slow release, the nanoparticles were able to avoid permeation or penetration in the pig ear epidermis/dermis during 18 h. The topical formulation is stable and can be used in further in vivo studies for the treatment of inflammatory reactions, in special for radiodermitis.

Evaluation of the effect of D-002, a mixture of beeswax alcohols, on osteoarthritis symptoms

BACKGROUND/AIMS: Nonsteroidal anti-inflammatory drugs relieve osteoarthritis (OA) symptoms but cause adverse effects. D-002, a mixture of beeswax alcohols, is effective against experimental OA. A pilot study found that D-002 (50 mg/day) for 8 weeks improves OA symptoms. The aim of this study was to investigate the effects of D-002 (50 to 100 mg/day) administered for 6 weeks on OA symptoms. METHODS: Patients with OA symptoms were double-blindly randomized to D-002 (50 mg) or placebo for 6 weeks. Symptoms were assessed by the Western Ontario and McMaster Individual Osteoarthritis Index (WOMAC) and the visual analog scale (VAS) scores. Patients without symptom improvement at week 3 were titrated to two daily tablets. The primary outcome was the total WOMAC score. WOMAC pain, joint stiffness and physical function scores, VAS score, and use of rescue medications were secondary outcomes. RESULTS: All randomized patients (n = 60) completed the study, and 23 experienced dose titration (two in the D-002 and 21 in the placebo groups). At study completion, D-002 reduced total WOMAC (65.4%), pain (54.9%), joint stiffness (76.8%), and physical function (66.9%) WOMAC scores, and the VAS score (46.8%) versus placebo. These reductions were significant beginning in the second week, and became enhanced during the trial. The use of rescue medication by the D-002 (6/30) group was lower than that in the placebo (17/30) group. The treatment was well tolerated. Seven patients (two in the D-002 and five in the placebo group) reported adverse events. CONCLUSIONS: These results indicate that D-002 (50 to 100 mg/day) for 6 weeks ameliorated arthritic symptoms and was well tolerated.

Effects of D-002, a mixture of high molecular weight beeswax alcohols, on patients with nonalcoholic fatty liver disease

BACKGROUND/AIMS: Nonalcoholic fatty liver disease (NAFLD) is intimately related to insulin resistance and ranges from a benign course to liver fibrosis and cirrhosis. NAFLD management mainly involves dietary modification and weight loss. Although no fully successful pharmacological intervention is available, alternative therapies to treat NAFLD have shown promising results. Experimental studies have shown that D-002, a mixture of beeswax alcohols with antioxidant effects, is hepatoprotective. The aim of this study was to investigate the efficacy and safety of D-002 in patients with NALFD. METHODS: Fifty patients with NAFLD were randomized to receive a placebo or D-002 (100 mg/day) for 24 weeks. The primary endpoint was a significant ultrasonography-detected reduction of liver fat infiltration versus a placebo. Secondary endpoints were decreases in the homeostatic model assessment (HOMA) index, insulin levels, serum liver enzymes, increases in plasma total antioxidant status (TAS) and improved clinical symptoms versus the placebo recipients. RESULTS: At randomization, all indicators were comparable in both groups. At study completion, seven (28.0%) D-002-patients, but none of the placebo recipients, exhibited a normal liver echo pattern on ultrasonography (p < 0.01). Also, D-002 significantly reduced (p < 0.01 vs. baseline and placebo) the HOMA index and insulin levels and increased the TAS, but did not affect other parameters. The proportion of D-002-patients (12/25, 48.0%) showing symptom improvement was higher (p < 0.001) than that of the placebo group (1/25, 4.0%). The treatment was safe and well tolerated. Three patients in each group withdrew from the study. CONCLUSIONS: D-002 (100 mg/day) improved ultrasonographic findings, indicators of insulin resistance, plasma TAS and clinical evolution on NAFLD patients. Further studies, however, are needed to confirm these results.

Design and evaluation of rectal drug delivery systems of non-steroidal anti-inflammatory drug.

The aim of the present study was to design and evaluate the suppositories of aceclofenac a non-steroidal anti inflammatory drug (NSAID). Aceclofenac, rectal suppositories were developed by employing various hydrophilic and hydrophobic polymeric bases like gelatin, PEG-400 and hydrogenated vegetable oil using propylene glycol as plasticizer and beeswax as hardening agent. The in-vitro release rate data was evaluated statistically and was found that from all the formulations the drug release is by diffusion mechanism (r = 0.9547 to 0.9967) according to Higuchi’s equation. All the prepared formulations have shown zero-order release kinetics except those prepared by utilizing 15% and 20 % of PEG-400. The formulation prepared using 7.5% beeswax in hydrogenated vegetable oil has dis-played zero-order drug release (r = 0.9927) and has released 99.18% of the aceclofenac within 4h, hence, this formulation is considered as a promising formulation. The stability study on the promising formulation was con-ducted over a period of 6 months and found that there are no significant changes in the drug content and in-vitro drug release rate (p<0.05). The result suggests that the suppositories can be prepared by employing hydrophilic and hydrophobic polymers.

Design and evaluation of rectal drug delivery systems of non-steroidal anti-inflammatory drug.

The aim of the present study was to design and evaluate the suppositories of aceclofenac a non-steroidal anti inflammatory drug (NSAID). Aceclofenac, rectal suppositories were developed by employing various hydrophilic and hydrophobic polymeric bases like gelatin, PEG-400 and hydrogenated vegetable oil using propylene glycol as plasticizer and beeswax as hardening agent. The in-vitro release rate data was evaluated statistically and was found that from all the formulations the drug release is by diffusion mechanism (r = 0.9547 to 0.9967) according to Higuchi’s equation. All the prepared formulations have shown zero-order release kinetics except those prepared by utilizing 15% and 20 % of PEG-400. The formulation prepared using 7.5% beeswax in hydrogenated vegetable oil has dis-played zero-order drug release (r = 0.9927) and has released 99.18% of the aceclofenac within 4h, hence, this formulation is considered as a promising formulation. The stability study on the promising formulation was con-ducted over a period of 6 months and found that there are no significant changes in the drug content and in-vitro drug release rate (p<0.05). The result suggests that the suppositories can be prepared by employing hydrophilic and hydrophobic polymers.

Study the Impact of Beeswax Removal on the Content of Total Flavonoids from Propolis / 医学研究杂志

Objective To study the impact of beeswax removal on the content of total flavonoids separated from propolis. Methods Rutin was used as contrast calibre, and content of total flavonoids was determined by using UV spectrophotometric method. Results 8.5% of the total flavonoids lost after beeswax were removed from propolis,but the amount of total flavonoids in the process propolis and water containing was stiu much higher than that mentioned in the natural unprocessed condition. Conclusion There was little impact of beeswax removal on content of total flavonoids. Beeswax as impurity would be removed when propoli as medicine was used in complex Chinese patent medicine for treatment of cardio-cerebral vascular diseases.

A Case of Contact Dermatitis due to Shiun-ko and Taitsu-ko / 日本東洋医学雑誌

A 50-year-old female developed severe dermatitis on her face during topical therapy with Shiun-ko and Taitsu-ko. The skin lesions almost disappeared in two weeks with oral steroid therapy and did not recur. Patch testing showed positive reactions to Shiun-ko, Taitsu-ko and Lithospermi radix, and beeswax, which were constituents of Shiun-ko and Taitsu-ko. The result suggests that the patient was sensitized with these topical medicaments and developed allergic contact dermatitis.