Summary of CDE Registration Number of Hubei Gedian Renfu Medicine Auxiliary Oil Accessories

Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd.medium chain triglyceridesIt has been publicized on the CDE raw and auxiliary package registration platform. At present, our company has completed the variety line of oil and fat pharmaceutical excipients.natural oil and fat,fatty acid glycerides,Polysorbate Series,Phospholipids and synthetic fatsFive categories of a total of more than a dozen products registered for the record.

Brief Introduction of Oil and Fat Medicinal Excipients

Grease is the general term for oil and fat. The liquid at room temperature is called oil, and the solid is called fat. Its main components are esters and derivatives formed by fatty acids and glycerol. Lipase in the human body under the action of hydrolysis into higher fatty acids and glycerol, and part of the fatty acid is necessary to maintain the normal life activities of the human body, but the body itself can not be synthesized. Oils and fats pharmaceutical excipients means that the pharmaceutical preparation matrix and excipients are fats and fats and their corresponding processing products, including fatty acids, fatty acid salts, fatty alcohols, oils and waxes, phospholipids, etc.

The fourth part of the 2020 edition of the Chinese Pharmacopoeia contains a number of oil and fat medicinal excipients, which can be divided into three categories according to chemical composition: simple oil, compound oil and derived oil.

Oils have been used as pharmaceutical excipients in the pharmaceutical industry for a long time, mostly used in the production of injections, emulsions, lubricants and other pharmaceutical excipients. Commonly used vegetable oils include soybean oil, almond oil, peanut oil, corn oil, coconut oil, sunflower oil, olive oil, etc.

The oil-in-water fat emulsion, which is made from vegetable oil as raw material, supplemented by phospholipid emulsifier, isotonic agent and water for injection, is used in clinic as a concentrated high-energy parenteral nutrition solution to provide energy and essential fatty acids for patients who cannot eat and are seriously deficient in nutrition. It can be injected intravenously and can be completely metabolized and utilized by the body. At present, the raw vegetable oil used in fat emulsion mainly includes soybean oil, olive oil, coconut oil and so on.

Key points of quality control of oil and fat pharmaceutical excipients

1. Physical property index

Solubility, relative density, refractive index, melting point/freezing point, viscosity, etc;

2. Chemical characteristic constant

Saponification value, iodine value, hydroxyl value, etc;

3. Natural Ingredient Analysis

Fatty acid composition, trans fatty acids, sterols, etc;

4. Rancid oxidation analysis

Acid value (free fatty acid), peroxide value, methoxy aniline value, etc;

5. General impurity analysis

Alkaline impurities, unsaponifiable matter, moisture and volatile matter, heating test, impurities, etc;

6. Trace metal elements

Nickel, lead, chromium, copper, iron, etc;

Hubei Gedian Renfu Pharmaceutical Auxiliary has independently developed a set of mature oil production technology and analysis and detection technology, which can efficiently and conveniently remove various impurities in the oil production process, strictly control the key quality attributes of various oils, and ensure that the final products conform to the current mainstream pharmacopoeia standards (ChP, USP, EP, JP). In order to help the consistency evaluation of domestic injections and meet the R & D and production needs of domestic and foreign preparation enterprises, our company is committed to the research and development of high-end pharmaceutical excipients. More high-quality oil pharmaceutical excipients CDE registration is in progress, so stay tuned!

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