| Purpose:Calcium gluconate is a supplement to calcium in the human body.It can maintain the nerve and muscle excitability of the human body.When the body is deficient in calcium,symptoms such as convulsions and weakness may occur.Therefore,calcium gluconate injection is often used to treat calcium deficiency.In addition,it can also be used for anti-allergic effects,as well as the rescue of magnesium poisoning and fluorosis.However,the visible foreign matter and crystallization of calcium gluconate injection are more common.Under the influence of environmental factors,production equipment and personnel in the clean area,the qualified rate of calcium gluconate injection is slightly lower than other small-volume injections.And after the calcium gluconate injection is stored at room temperature for a period of time,the visible foreign matter item inspection will appear similar to white spots or relatively large block crystals,which will seriously affect the product quality of calcium gluconate injection.It will also affect the patient’s medication safety.Therefore,to solve the problem of visible foreign matter and crystallization of this variety,it is necessary to optimize the production process of calcium gluconate injection through experimental research.Method:This paper analyzes the process literature and production data of calcium gluconate injection,and analyzes the problem of visible foreign matter and crystallization in calcium gluconate injection,and analyzes it from the human-machine method ring.The actual production data is statistically combined,and the experimental research is carried out from the aspects of cooking time,the amount of activated carbon used,the temperature of the liquid in the potting,and the sterilization parameters.Result:Finally,determine the production process of calcium gluconate injection,that is:(1)take about 50%of the total volume of the drug,water for injection above 70℃,heat to boiling,add the prescribed amount of calcium gluconate,stir with stirring,stir To completely dissolve;(2)add the prescribed amount of calcium hydroxide;(3)add lactic acid,adjust the pH(4.5～5.0);(4)add the prescribed amount of activated carbon,heat to boil for 30 minutes,cool to 50℃～60℃,placed for 8 to 10 hours;(5)The liquid is filtered through a 3μm titanium rod,and 200ml is sampled.After confirming that the liquid is clear and there is no black spot,the liquid is filtered to a thin tank,diluted to a constant volume,and the temperature of the liquid is Controlled at 45℃～55℃;(6)semi-finished product inspection;(7)10 ml glass ampoules filled,sealed;(8)sterilization at 105℃ for 40 minutes;(9)defective product inspection;(10)sampling Inspection;(11)Qualified product packaging.In the production,three batches of verification production have been carried out to determine the production process of calcium gluconate injection,and the product quality is in line with the "standard and related substances China Pharmacopoeia" 2015 two edition.In this paper,according to the standard items in the second edition of the Chinese Pharmacopoeia in 2015,the content of the sample was analyzed by chemical titration method,and the heavy metal was inspected by colorimetry.Through the analysis and comparison of the test items of calcium gluconate injection,and the comparison with other company products purchased in the market,it is determined that the test items and methods have reached the expected level.Through comparative research,the quality of the products produced is in line with the "standard and related substances China Pharmacopoeia" 2015 two edition.Conclusion:Through the evaluation of product stability of three batches of products by calcium gluconate injection,the yield of the product is stable,mainly from high temperature,high humidity,light and freezing conditions,namely:temperature conditions of 60℃ and 40℃respectively.Under the condition of increasing the light intensity and increasing the ambient humidity,the product was stored for 10 days,and the product was inspected after freezing and melting three times.Under the condition of 10 days of light,the content of the product decreased correspondingly,pH value,traits and visible foreign matter.There are no obvious changes in other projects,and other product quality control projects are in compliance with the standards.After 6 months of accelerated testing,the products of calcium gluconate injection was no significant change,which was in compliance with the regulations.After 24 months of investigation,the properties of calcium gluconate injection,sucrose or reducing sugar,heavy metals,pH value,visible foreign matter,content determination,bacterial endotoxin traits were all in compliance with the regulations,and qualitative observation of stable products revealed calcium gluconate.The test results of the injection are relatively stable,and the changes are regular,and each test item meets the requirements during the product stability investigation period.By improving the production process of calcium gluconate injection,the inspection results of the product inspection project are investigated,and the product stability inspection of the process verification batch is carried out.The inspection results can effectively prove that the quality of the product produced by the optimized process is stable and the inspections are completed.The project is in full compliance with the "standard and related substances China Pharmacopoeia" 2015 two edition. |
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