Application of pharmaceutical grade mixed fatty acid glycerides in gynecological suppositories

Application of pharmaceutical grade mixed fatty acid glycerides in gynecological suppositories 1.
1 appearance: sensory examination
.

1.
2 This product is easily soluble in chloroform or benzene, soluble in petroleum ether, and almost insoluble
in water or ethanol.

1.
3 melting point: the melting point of this product according to the melting point determination method inspection is: 34 type 33 ~ 35 °C; Type 36 35~37°C; Type 38 37~39°C; Type 40 39~41°C
.

1.
4 acid number: The acid value of this product is checked according to the acid value inspection method, which is not more than 1.
0
.

1.
5 Iodine value: The iodine value of this product is checked according to the iodine value inspection method, not more than 2.
0.
1.
6 saponification value: the saponification value of this product is checked according to the saponification value inspection method, which is: 34 type 225 ~ 235; 36 type 220 ~ 230; 38 and 40 type 215 ~ 230
.

1.
7 hydroxyl value: take about 1g of this product, precision weighing, placed in a 250ml dry Erlenmeyer flask with a condenser, precision addition of acetic anhydride pyridine solution (1→4) 5ml, put in a water bath after reflux for 1 hour, add 10ml of water from the condenser mouth; Shake well, continue to heat for 10 minutes, cool, rinse the inner wall and neck of the condenser with neutral ethanol (p-phenolphthalein indicator liquid is neutral) 25ml, add 1ml of phenolphthalein indicator solution, titrate with ethanol to potassium hydroxide solution (0.
5mol/L), and do blank test at the same time, The volume (ml) of the ethanol to potassium hydroxide liquid (0.
5molL) consumed for the test product is A, the volume (ml) consumed by the blank test is B, the weight (g) of the test product is G, and the acid number is D.
According to the following formula, the hydroxyl value is not more than 6.
0
.

(B-A)× 28.
05 The hydroxyl value of the test product = ————————— + D3, thermal decomposition: fatty acids will decompose thermally at high temperatures to generate carboxylic acids and olefins
.

Synthesis principle: fatty acids (RCOOH) and glycerol (C3H8O3) are prepared by esterification reaction under the action of catalysts
.

Different fatty acids can be used to make different glycerides
.

Its reaction formula is: RCOOH catalyst -0.
1MPa C12H24O2 + C18H36O2 + C3H8O3 C3H5O3 (COR) 3 + H2O 218 °C catalyst The main role: is to increase the hydrogen ion and hydrogen-oxygen ions conducive to the hydrolysis reaction, promote the emulsification of water in the oil ester, increase the contact area between water and oil, in order to facilitate the hydrolysis reaction
.

It does not change the limit of the reaction equilibrium and has nothing to do with the amount added, it only acts to accelerate the reaction, under the same conditions, the amount of catalyst added is inversely proportional to the time to reach equilibrium
.

The reaction equilibrium rate K is used to determine the amount of production prescription dosing and the length of reaction time
.

Thus, the main quality indicators
such as acid number and hydroxyl value can be better controlled.

In the production process, the temperature and vacuum of the materials participating in the reaction are effectively controlled so that the materials are completely reactive
.

In the process of dehydration transesterification, it is necessary to pay attention to the degree of
material reaction.