关于开发抗菌制剂 Sekstafag® (多价嗜血杆菌)胶囊最佳成分的制药技术研究

N. A. Kovyazina, A. M. Nikolaeva, E. V. Orlova
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The object of research for the development of encapsulated antibacterial drug is liquid combined polyvalent bacteriophage Sekstafag® (Piobacteriophage polyvalent), which is a mixture of sterile filtrates of six phagolysates of bacteria Staphylococcus spp., Streptococcus spp., Proteus spp., Pseudomonas aeruginosa, Klebsiella pneumoniae, enteropathogenic Escherichia coli. Pharmaceutical-technological tests were carried out according to GF. Granulate was investigated according to the following parameters: description, bulk density, friability. Solid capsules Sekstafag® were tested by the following parameters: mass uniformity, disintegration, acid resistance of bacteriophages in capsules, dissolution. The lytic activity of bacteriophages was evaluated by Appelman’s method. Optimization of Sekstafag® drug formulation in the form of capsules was carried out using generalized Harrington’s desirability function.Results and discussion. In order to optimize the composition of biomass for encapsulation, pharmaceutical compositions consisting of combined bacteriophage Sekstafag® and auxiliary substances were prepared. The influence of excipients on the technological quality parameters of mixtures and capsules of model compositions was studied. According to the empirical system of preferences (desirability) it was revealed that the optimal pharmaceutical-technological characteristics (granulate description, bulk density, bulkiness, capsule mass uniformity, disintegrability, lytic activity, acid resistance of bacteriophage, dissolution) are possessed by the model composition containing combined polyvalent Sekstafag®, methylcellulose, sorbitol, lactose, pectin, sodium alginate, calcium carbonate, magnesium stearate. 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引用次数: 0

摘要

简介目前,由不同厂家生产的液态治疗和预防性噬菌体被广泛使用。为了扩大俄罗斯高效抗菌噬菌体制剂市场,迫切需要开发固体胶囊形式的噬菌体固体分散剂。优化抗菌药物 Sekstafag® (多价噬菌体)胶囊的生物质成分。开发胶囊抗菌药的研究对象是液体复合多价噬菌体 Sekstafag®(Piobacteriophage polyvalent),它是葡萄球菌属、链球菌属、变形杆菌属、铜绿假单胞菌属、肺炎克雷伯菌属、肠致病性大肠杆菌六种细菌的无菌滤液的混合物。按照 GF 标准进行制药技术试验。根据以下参数对颗粒进行了研究:描述、体积密度、易碎性。固体胶囊 Sekstafag® 的测试参数如下:质量均匀性、崩解度、胶囊中噬菌体的耐酸性、溶解度。噬菌体的溶菌活性采用阿佩尔曼法进行评估。使用广义哈灵顿可取函数对胶囊形式的 Sekstafag® 药物制剂进行了优化。为了优化用于包囊的生物质成分,制备了由 Sekstafag® 复合噬菌体和辅料组成的药物组合物。研究了辅料对模型组合物的混合物和胶囊的技术质量参数的影响。根据经验偏好系统(可取性),发现含有多价 Sekstafag®、甲基纤维素、山梨糖醇、乳糖、果胶、海藻酸钠、碳酸钙、硬脂酸镁的模型组合物具有最佳制药技术特性(颗粒描述、体积密度、松软度、胶囊质量均匀性、解粘性、溶菌活性、噬菌体耐酸性、溶解性)。所开发的胶囊形式的组合物 Sekstafag® (多价噬菌体)的独创性得到了俄罗斯联邦专利 2660355 号 "含噬菌体的口服抗菌药物组合物 "的确认。药物 Sekstafag® (噬菌体多价)胶囊在 2 至 8 °C的温度下可稳定保存 18 个月。通过使用哈林顿可取函数进行复杂的制药技术研究,开发出了 2 号硬胶囊形式的抗菌制剂 Sekstafag® (噬菌体多价)的最佳成分。
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Pharmaceutical-technological Studies on the Development of Optimal Composition of Antibacterial Preparation Sekstafag® (Piobacteriophage Polyvalent) Capsules
Introduction. Nowadays liquid combined therapeutic and prophylactic bacteriophages produced by various manufacturers are widely used. In order to expand the Russian market with highly effective antibacterial phagopreparations it is urgent to develop solid dispersed dosage forms of bacteriophages in the form of solid capsules.Aim. Optimization of biomass composition for encapsulation of antibacterial drug Sekstafag® (Piobacteriophage polyvalent) capsules.Materials and methods. The object of research for the development of encapsulated antibacterial drug is liquid combined polyvalent bacteriophage Sekstafag® (Piobacteriophage polyvalent), which is a mixture of sterile filtrates of six phagolysates of bacteria Staphylococcus spp., Streptococcus spp., Proteus spp., Pseudomonas aeruginosa, Klebsiella pneumoniae, enteropathogenic Escherichia coli. Pharmaceutical-technological tests were carried out according to GF. Granulate was investigated according to the following parameters: description, bulk density, friability. Solid capsules Sekstafag® were tested by the following parameters: mass uniformity, disintegration, acid resistance of bacteriophages in capsules, dissolution. The lytic activity of bacteriophages was evaluated by Appelman’s method. Optimization of Sekstafag® drug formulation in the form of capsules was carried out using generalized Harrington’s desirability function.Results and discussion. In order to optimize the composition of biomass for encapsulation, pharmaceutical compositions consisting of combined bacteriophage Sekstafag® and auxiliary substances were prepared. The influence of excipients on the technological quality parameters of mixtures and capsules of model compositions was studied. According to the empirical system of preferences (desirability) it was revealed that the optimal pharmaceutical-technological characteristics (granulate description, bulk density, bulkiness, capsule mass uniformity, disintegrability, lytic activity, acid resistance of bacteriophage, dissolution) are possessed by the model composition containing combined polyvalent Sekstafag®, methylcellulose, sorbitol, lactose, pectin, sodium alginate, calcium carbonate, magnesium stearate. Originality of the developed composition Sekstafag® (Piobacteriophage polyvalent) in the form of capsules is confirmed by the patent of the Russian Federation № 2660355 "Antibacterial pharmaceutical composition for oral use containing bacteriophages". The drug Sekstafag® (Piobacteriophage polyvalent) capsules, is stable when stored for 18 months at temperatures from 2 to 8 °C.Conclusion. As a result of the conducted complex pharmaceutical-technological research using Harrington’s desirability function the optimal composition of antibacterial preparation Sekstafag® (Piobacteriophage polyvalent) in the form of hard capsules No. 2 was developed.
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