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Objective To study the effect of relatively closed environment dispensing mode on insoluble particles in pharmaceuticals.Methods The numbers of insoluble particles in conventional manual dispensing mode and relatively closed environment dispensing mode in lass Ⅰ and class Ⅲ environment were detected, effect of different dispensing modes on the number of insoluble particles in pharmaceuticals was compared.Results When adopting manual dispensing, the numbers of 1-10 μm insoluble particulates in different groups in class Ⅰ environment were less than those in class Ⅲ environment respectively, differences were all statistically significant (all P＜0.05). When adopting a new mode of dispensing in relatively closed environment, there was no significant difference in the numbers of 1-15 μm insoluble particulates in different groups between class Ⅰ and class Ⅲ environment respectively (all P＞0.05). The numbers of 1-20 μm and 1-15 μm insoluble particles in different groups were less than those in manual dispensing when the new mode of dispensing were adopted in class Ⅲ and class Ⅰenvironment respectively, differences were all statistically significant (all P＜0.05). The numbers of 1-15 μm insoluble particles in different groups in manual dispensing in class Ⅰ environment were more than those in class Ⅲ environment respectively, difference were all statistically significant (all P＜0.05).Conclusion The relatively closed environment dispensing mode can effectively reduce environmental particulates entering intravenous infusion system during dispensing process.
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OBJECTIVE: To study the compatibility of inner surface of anatomy bottle and Caffeine citrate injection.METHODS: After treated with high temperature (60 ℃, 10 days), light (5 000 Lx, 10 days), freezing and thawing (2 days for freezing at -18 ℃ and 2 days for thawing at 40 ℃ as a circulation, and repeat for 3 times), sterilizing (121 ℃, 2 h), Caffeine citrate injection packed in anatomy bottle was tested in respects of pH value, insoluble particle, glass stripping tendency before test and under the above conditions. The contents of arsenic, cadmium, lead, cobalt, manganese, vanadium, copper, lithium, barium, chromium, antimony, aluminum, boron, calcium, iron, potassium, magnesium, silicon and titanium that may dissolve by inner surface of anatomy bottle were tested by ICP method, and compared with analysis evaluation threshold (AET) of each element. RESULTS: Before the test, under high temperature, light, freezing and thawing, sterilization, and pH values of Caffeine citrate injection installed with ampoule were 4. 58, 4. 60, 4. 61, 4. 58, 4. 58. The insoluble particles were all in line with 0903 provisions stated in (four) general provisions of Chinese Pharmacopoeia (2015 edition). The inner surface of ampoule bottle glass had no stripping tendency. The arsenic, cadmium, lead, cobalt, manganese, vanadium, copper, lithium, barium, chromium, antimony, iron, magnesium and titanium were not detected in caffeine citrate injection, and the contents of aluminum, boron, calcium, potassium and silicon were far below its AET value. CONCLUSIONS: Caffeine citrate injection has no effect on inner surface of ampoule bottle.
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OBJECTIVE:To investigate the number of insoluble particle in total parenteral nutrition(TPN)solutions and to pro-vide reference for clinical application. METHODS:6 kinds of commonly used TPN prescriptions were selected. After prepared ac-cording to sterile operation procedure,TPN at 25℃was investigated at 0,1,4,8 and 24 h in terms of appearance,pH value,os-motic pressure and the numbers of insoluble particles. RESULTS:The appearance and pH value of TPN had no significant change within 24 h after preparation,and osmotic pressures were all lower than 900 mOsm/L. Study results showed that the numbers of in-soluble particles quickly increased,and ≥10 μm and ≥25 μm insoluble particles exceeded the limitation of Chinese Pharmacopoe-ia after Lipid-soluble vitamin for injection were injected into TPN. Medium/long chain fat emulsion injection,water-soluble vita-min,electrolytes and trace elements also increased the numbers of insoluble particles. CONCLUSIONS:Medium/long chain fat emulsion injection,lipid-soluble/water-soluble vitamin,vitamin C,electrolytes and trace elements have certain influence on the number of insoluble particle of TPN. To analyze the reason for the forming of insoluble particles has great meaning both for improv-ing the TPN quality and reducing the harm of particles for patients.
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OBJECTIVE: To evaluate the clinical safety differences between 2-chamber drug delivery system method and syringe method in preparation of intravenous fluids. METHODS: The light blockage method was used to record the count of insoluble particals in samples of before and after preparation through the 2-chamber drug delivery system method or syringe method. RESULTS: After preparation by the syringe method, the number of insoluble particles of each particle size increased significantly, P < 0.05; while the 2-chamber drug delivery system method does not increase the insoluble particle number after preparation; the solution contains significantly more ≥ 10 μm insoluble particles in the syringe method than in the 2-chamber drug delivery system method, P < 0.05. CONCLUSION: 2-Chamber drug delivery system method can significantly reduce the introduction of insoluble particles in the process of intravenous infusion preparation comparing with the syringe method, and despite of what the environment is, has a better clinical safety.
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OBJECTIVE:To investigate the effect of mixing herbal injections with transfusion fluid on production of insoluble particles.METHODS:To detect the amount of insoluble particles before and after mixing herbal injections with transfusion fluid with ZWF-4 particule counter.RESULTS:The insoluble particles increased obviously.CONCLUSION:It should be paid great attention to the increase of insoluble particles after mixing,as well as the relationship between the insoluble particles and adverse reactions.
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OBJECTIVE:To study the change of particles of Chinese medicinal injection added to different kinds of infu-sions fluid before and after filtration.METHODS:Particle analysator was adopted to measure the particles of Xueshuantong injection,Yinzhihuang injection,Yuxingcao injection before and after filtration and30minutes after being mixed with0.9%Sodium Chloride injection,5%glucose injection,and10%glucose injection respectively.RESULTS:The number of particles in all kinds of unfiltered mixture increased significantly while those of filtered ones remarkably decreased.CONCLUSION:It is recommended that when intravenous drip of Chinese medicinal injection in the clinic was used,particles addition should be considered.
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OBJECTIVE:To observe the changes of insoluble particles in traditional Chinese drugs injections(TCDI)mixed with infusion fluid and to study the way to solve METHODS:61 kinds of TCDI in therapeutic dosages were mixed in 0 9% sodium chloride solution,then the insoluble particles formed with diameters of 2 5?5 0?10 0 and 25 0?m were counted with Coulter counter,and determined with physical method and microscope The precise filter for liquid medicine were investigated in respect to its flow rate,quantity of flow,adsorbability and scavenging action RESULTS:(1)The number of insoluble particles in 26 kinds of TCDI exceeded the standard in ChP accounting for 42 6% of total samples observed (2)The insoluble particles included glass fragments,active carbon,rubber particles,soft flocks and residue of drugs (3)The flow rate and quantity of flow met the clinical requirement with a scavenging rate of 88 5%,and no adsorbability was found CONCLUSION:Precise infilter for liquid medicine can scavenge the particles in TCDI so as to ensure the safe use of drugs for patients