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Objective:To investigate the change of insoluble particles in 4 traditional Chinese medicine injections at different con-centrations in 0. 9% NaCl injection. Methods:Fufang Kushen injection, Shuxuetong injection, Lugua Duotai injection and Honghua Huangsesu injection were diluted by 0. 9% sodium chloride injection to obtain low concentration and high concentration solutions. The insoluble particles number of initial injections and dilutions at different time points(0,2,4,and 5 h) was detected according to the in-soluble particles test described in the fourth principle 0903 of China Pharmacopoeia (2015 edition). Results:The number of insoluble particles in 4 traditional Chinese medicine injections and 0. 9% sodium chloride injection met the requirements. The insoluble particles (≥25 μm) in 4 traditional Chinese medicine injections at different concentrations were few and almost stable with time, the insoluble particles(≥10 μm) showed an increasing trend in a concentration-dependent manner and varied with time. Conclusion:The insoluble particles(≥10 μm) in traditional Chinese medicine injections at high concentration are more than those at low concentration, which suggests that the concentration of traditional Chinese medicine injections should be restricted strictly according to the prescriptions and used up as soon as possible.
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Objective:To research the stability of Dazhu Hongjingtian injection combined with four different infusion solutions (0. 9% sodium chloride injection, 5% glucose injection, fructose injection, xylitol and sodium chloride injection) . Methods:The insolu-ble particles and pH value of Dazhu Hongjingtian injection in 0, 0. 5,1,2,4 and 8h after the combination were detected by the methods described in China Pharmacopeia ( 2010 edition ) . Results: Dazhu Hongjingtian injection combined with the four infusion solutions showed no significant changes in appearance and pH value in 8h. The number of insoluble particles in Dazhu Hongjingtian injection combined with 0. 9% sodium chloride injection and 5% glucose injection met the requirement in the pharmacopeia, and that in 0. 9%sodium chloride injection was lower than that in 5% glucose injection. The quantity of insoluble particles in Dazhu Hongjingtian injec-tion combined with fructose injection exceeded the standard level, and showed remarkable change in the fourth hour. The quantity of insoluble particles in xylitol and sodium chloride injection slightly exceeded the standard. Conclusion: Dazhu Hongjingtian injection can be mixed with 0. 9% sodium chloride injection and 5% glucose injection, and fructose injection and xylitol and sodium chloride in-jection are not suitable for the solvent of Dazhu Hongjingtian injection. Although there is no instruction indicating that 0. 9% sodium chloride injection can be used as the suitable solvent for Dazhu Hongjingtian injection, the results of the experiment can be reasonable reference for diabetes patients treated with Dazhu Hongjingtian injection.
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OBJECTIVE:To study the effects of electrolyte on the stability of the neonatal parenteral nutrition. METHODS:Under room temperature(25 ℃),the neonatal parenteral nutrition containing only monovalent or bivalent ion electrolyte(10% So-dium chloride injection,10% Potassium chloride injection,25% Magnesium sulfate injection,and Calcium gluconate injection) and containing both monovalent and bivalent ion electrolyte were investigated by the change of appearance to determine the pH val-ue,insoluble particles and the size and distribution (polydispersity index,PDI) within 24 h. RESULTS:The pH of the nutrition with electrolyte was over 5 and also met the quality requirements;there were no precipitate,flocculation and discoloration in the appearance;the neonatal parenteral nutrition containing only monovalent ion electrolyte appeared a small amount of hanging wall phenomenon for 24 h,but did not appear demulsification phenomenon;the neonatal parenteral nutrition containing only bivalent ion electrolyte appeared a small amount of hanging wall phenomenon and demulsification phenomenon for 24 h;the neonatal paren-teral nutrition containing both monovalent and bivalent ion electrolyte appeared a small amount of hanging wall phenomenon and de-mulsification phenomenon for 12 h and the hanging wall phenomenon was more obvious for 24 h. Meanwhile,a size bigger than 5μm microns and particle size bigger than 25 μm microns of insoluble particles appeared,and both the average particle size and PDI value were higher than those in the previous two situations(P<0.05). CONCLUSIONS:As more and more monovalent and biva-lent ion electrolyte being added into the neonatal parenteral nutrition,especially divalent ion electrolyte,the stability of the neona-tal parenteral nutrition decreases,which behaves as a phenomenon that the size of grains and the number of insoluble particles in-crease.
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Objective To analyze the influence of usual processing steps on insoluble particles in Chinese medicine injection,with Shuanghuanglian injection as an example.Methods Light block method was adopted to analyze the influence of the different conditions of sterilization,ultra filtration and PH value on insoluble particles in Chinese medicine injection.Results Sterilization,ultra filtration and PH value caused the change of insoluble particles in Chinese medicine injection.Conclusion The comprehensive use of sterilization,ultra filtration,PH value can reduce the quantity of insoluble particles and clinical risk.
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OBJECTIVE: To determine the insoluble particles in human immunoglobulin (pH 4) for intravenous injection and human hepatitis B immunoglobulin(pH 4) for intravenous injection in both liquid and freeze-dried forms from 14 domestic manufacturers. METHODS: Thirty-two batches of human immunoglobulin products including 19 batches of human immunoglobulin (pH 4) for intravenous injection, 5 batches of human immunoglobulin (pH 4) for intravenous injection (freeze-dried), 5 batches of human hepatitis B immunoglobulin (pH 4) for intravenous injection, and 3 batches of human hepatitis B immunoglobulin(pH 4) for intravenous injection (freeze-dried) were tested by light obscuration particle count test method recommend by appendix of 2010 CHP by GWF-8JA laser particle size analyzers. Insoluble particles greater than 10 and 25 μm were counted, respectively. Microscopy counting was carried out if the test results from light blockage method did not meet the qualification criteria in 2010 ChP. Trend analysis and comparison of the results from NIFDC and enterprises were done. RESULTS: The test results of insoluble particles in 32 batches of human immunoglobulin products indicate that 90.6%(29/32) of the products complied with the requirement of 2010 ChP and the results were in agreement between NIFDC and enterprises. Unfortunately, 3 batches of human immunoglobulin(pH 4) for intravenous injection(freeze-dried) failed in light obscuration particle count test, however, they met the requirement of 2010 ChP when microscopy counting method was used. CONCLUSION: The quality control of human immunoglobulin products in China market is generally fine, and the test results from different laboratories are basically consistent. Test result of insoluble particles in freeze-dried IVIG by microscopy counting method and light obscuration particle count test method show significant difference.
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Objective To study the stability of Qingkailing injection, Qingkailing and dexamethasone sodium phosphate injection in compatibility of 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection. Methods Such changes as appearance, pH, and insoluble particulate were observed at the room temperature after mixing together of the Qing Kai Ling Injection, Qingkailing and dexamethasone sodium phosphate injection with 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection. Results Dexamethasone sodium phosphate did not affect the stability of the Qingkailing. The PH value of Qingkailing stayed at 6.4～7.0 after being mixed with four kinds of solutions. The compatibility solutions had no significant change in appearance, met to the requirements of the Chinese Pharmacopoeia insoluble particle detection specification Conclusion Qing Kai Ling Injection, Qing Kai Ling and dexamethasone sodium phosphate injection can be used together with solvent compatibility of 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, glucose and sodium chloride injection within 8 h.
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OBJECTIVE:To investigate the infusion solutions which are compatible with Compound kushen injection. METHODS:The insoluble particles of kushen injection in four kinds of infusion solutions were detected respectively by light blockage method.RESULTS:Insoluble particles of different size and number were noted for Compound kushen injection when mixed respectively with four kinds of infusion solutions,but the insoluble particles in all kinds of infusion solutions except 10% glucose injection were all within the range specified in China Pharmacopeia(2005 edition).CONCLUSION: 0.9% sodium ch-loride injection is the optimal compatible infusion solution for Compound kushen injection.
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OBJECTIVE:To detect the insoluble particles in six kinds of traditional Chinese medicine injections. METHODS: The insoluble particles in six kinds of traditional Chinese medicine injections were detected by light blockage method specified in China Pharmacopeia (2005 edition). RESULTS: Insoluble particles of different size and number were noted in all the 6 kinds of traditional Chinese medicine injections. CONCLUSION:It is necessary to tighten control on the quality of traditional Chinese medicine injections and attach great importance to the monitoring of insoluble particles in drug use.