Dew point method for determination of sodium hyaluronate gel osmotic pressure
Reprinted from: Li Naicheng 1, He Yanli 2, Su Huai 2, Zhang Tianmin 1
( 1. School of Pharmacy, Shandong University, Jinan 250012, China; 2. Shandong Dr. Lun Furida Pharmaceutical Co., Ltd., Jinan 250014, China)
Abstract: Objective To investigate the determination method of osmotic pressure of sodium hyaluronate gel. Methods 0.5%, 1.0% and 2.3% sodium hyaluronate gel osmotic pressure were measured by VAPRO5520 osmometer. The results of 0.5% sodium hyaluronate gel weighing and sampler loading were compared. Results The 0.5%, 1.0% and 2.3% sodium hyaluronate gel osmotic pressures were 295, 312 and 330 mOsmol/kg, respectively, and the RSD were 0.40%, 0.18% and 0.37%, respectively. The weighing sample was the same as the sampler. Conclusion The VAPRO5520 osmometer can accurately determine the osmotic pressure of 0.5%, 1. 0% and 2.3% sodium hyaluronate gel.
Key words: VAPRO5520 osmometer; sodium hyaluronate gel; osmotic pressure CLC number: TQ460.7 Document code: A Article ID: 1005 1678(2008)01 0056 02
1%~3% of sodium hyaluronate solution has good viscoelasticity and gel properties. It is mainly used for the treatment of ophthalmic surgery and osteoarthritis. It is approved for application in the form of medicines or surgical instruments in different countries. clinical. According to the requirements of the Chinese Pharmacopoeia for such preparations, the osmotic pressure should be isotonic with tears or human blood. However, due to the high viscosity of the sodium hyaluronate solution, the data is unstable when the osmotic pressure is determined according to the freezing point method commonly used in the Chinese Pharmacopoeia [1]. The result is difficult to judge. The United States Pharmacopoeia [2] also used the dew point method to measure, so we used the VAPRO5520 osmometer to determine the osmotic pressure of sodium hyaluronate gel according to the principle of vapor pressure drop dew point change.
1 material Â
VAPRO5520 osmometer, Wescor, USA;
CP225D electronic balance, Sartorius, Germany.
Sodium hyaluronate, Shandong Furida Biochemical Co., Ltd., batch number 20060102.
2 methods
2. 1 Preparation of sodium hyaluronate gel Â
9.0 g of sodium chloride was dissolved in 1000 mL of distilled water to obtain a 0.9% sodium chloride solution, and 3 parts were prepared in the same manner, and the osmotic pressure was measured by a VAPRO 5520 osmometer.
The sodium hyaluronate 5.0, 10.0 and 23.0 g were accurately weighed and added to 3 parts of 0.9% sodium chloride solution, and dissolved to obtain 0.5%, 1.0% and 2.3% gel samples.
2. 2 osmotic pressure measurement and precision test Â
Three samples prepared under 2.1 were measured by VAPRO5520 osmometer, and 10% of 0.5% sodium hyaluronate gel was sampled. The gel viscosity of 1.0% and 2.3% was large, and 10 mg was measured for each measurement. 6 times.
2. 3 Weighing and measuring 0.5% sodium hyaluronate gel osmotic pressure Â
10 mg of a 0.5% sodium hyaluronate gel was weighed and added to a filter paper in a sample cell, and then the osmotic pressure was measured for 3 times, and the average value was compared with the corresponding value in 2.2.
3 results
3. 1 osmotic pressure measurement results and precision test Â
The osmotic pressure of the three parts of the 0.9% sodium chloride solution was 273 mOsmol/kg, and the osmotic pressure of the three concentrations of the gel was shown in Table 1.
Table 1 Results of osmotic pressure measurement of sodium hyaluronate gel
Tab1 Results of osmolality andprecisionfor different concentrationgels
It can be seen from Table 1 that the osmotic pressure of the VAPRO5520 osmometer is stable; the osmotic pressure is increased compared with the 0.9% sodium chloride solution after the addition of sodium hyaluronate, and the concentration of sodium hyaluronate increases. Large, osmotic pressure also increases.
3. 2 Weighing and measuring 0.5% sodium hyaluronate gel osmotic pressure Â
The results of the 0.5% sodium hyaluronate gel weighing test were 295, 296 and 295 mOsmol/kg, respectively, with an average of 295 mOsmol/kg and an RSD of 0.20%, which was the same as that of the sampler.
4 Discussion Â
The osmotic pressure of the solution is dependent on the number, and the osmotic pressure can be obtained indirectly by measuring the vapor pressure of the solution and the decrease in the freezing point. Sodium hyaluronate gel has a large viscosity. It is difficult to determine the osmotic pressure by the freezing point method. The vapor pressure does not need to change the shape of the solution, and the dew point formation is not affected by the viscosity. Therefore, the dew point method can stably determine the osmotic pressure. We used the VAPRO5520 osmometer to determine the stability of the gel osmotic pressure based on the decrease in vapor pressure. This provides a viable method for the osmotic pressure measurement of this type of product.
The concentration of medical sodium hyaluronate gel is 1.0%, and the gel concentration of a kind of Healon5 is as high as 2.3% [3], so we use these two concentrations of the test to carry out the experiment; 0.5% hyaluronic acid The sodium solution has a relatively small viscosity and can be sampled by a sampler. Therefore, the solution is prepared to investigate the effect of the weighing on the measurement results.
The VAPRO5520 osmometer is widely used in the detection of osmotic pressure in blood and urine, and has good performance [4]. The method of adding the sample is to measure 10 or 15 L of the solution with a sampler, and add it to the filter paper for immediate determination. . Due to the high viscosity of the sodium hyaluronate gel, it is difficult to sample the sampler. Therefore, we weighed 10 mg of the test sample onto the filter paper and allowed it to fully unfold, and the measurement result was stable.
(Note: Wescor Vapro5520 osmometer has been upgraded to Vapro5600/5600XR)
For more information on osmometer, please refer to: http://
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