Source: Usually made from the caryopsis of corn (a gramineous plant) or the tuberous roots of cassava (a euphorbiaceous plant), and can also be extracted from potato tubers.
Chemical Formula: (C6H10O5)n
CAS Number: 9005 - 25 - 8
Appearance: White powder, odorless and tasteless.
Solubility: Insoluble in cold water or ethanol. When added with water and boiled, it can form a white - like translucent gel after cooling.
Quality Standards
Acidity: Take 20.0g of this product, add 100ml of water, shake for 5 minutes to mix evenly, and immediately determine according to the law. The pH value of corn starch should be 4.5 - 7.0, and that of potato starch should be 5.0 - 8.0.
Loss on Drying: Dry at 105℃ for 5 hours. The weight loss of corn starch shall not exceed 14.0%, and that of cassava starch shall not exceed 15.0%.
Ash Content: Take about 1.0g of this product, incinerate it until it is completely ashed and weigh it constantly. The ash left by corn starch shall not exceed 0.2%, and that of cassava starch shall not exceed 0.3%.
Microbiological Limit: The number of bacteria in each 1g of the test product shall not exceed 1000, the number of molds shall not exceed 100, and Escherichia coli shall not be detected.
Performance Characteristics
Good Disintegration Property: It has good water - absorbing and swelling properties, which can promote the rapid disintegration of tablets or capsules in the gastrointestinal tract, help the drug release more quickly, and improve bioavailability.
High Stability: It has relatively stable chemical properties, good compatibility with most drug components, and is not easy to have chemical reactions, which can ensure the stability of drug quality.
High Safety: As a natural polymer material, it is non - toxic and non - irritating, meeting the safety requirements of pharmaceutical excipients.
Production Method: Generally, medicinal starch is extracted and refined from plant raw materials through processes such as cleaning, crushing, filtering, precipitating, and drying.
Application Fields
Disintegrant: Commonly used in tablets, granules, capsules, etc., to help the preparation disintegrate quickly in the body. For example, it can accelerate the drug release in aspirin tablets.
Filler: It can increase the volume of the drug, make the preparation reach the required specification, and ensure the accuracy of the drug dose. It is commonly used in a variety of oral solid - state preparations.
Thickening Agent: It can increase the viscosity of liquid preparations in liquid preparations. For example, in some oral liquids, it can improve the use feeling of the drug.
Stabilizer: It is used to stabilize the physical properties of liquid preparations, prevent the decomposition or precipitation of active ingredients, such as playing a role in some suspensions.
Packaging and Storage
Packaging: Commonly 25KG/bag.
Storage: It should be sealed and stored in a dry place to prevent moisture and deterioration.