Croscarmellose sodium pdf
The innovative point of this patent is the synthetic Sodium Croscarmellose that can be used as pharmaceutical excipient of single stage method chemically crosslinked, and the reaction times is short, easily-controlled reaction conditions. Its degree of crosslinking promptly through the performance of product swelling ratio is up to state standards, and has good flowability.
Explain: national standard is meant the 2g product in the 50mL beaker, adds 50mL water and leaves standstill 20min, and the sample swelling volume is not less than 23mL. The preparation method who the purpose of this invention is to provide a kind of Sodium Croscarmellose; This method is used the raw material of Xylo-Mucine and organic acid anhydride and these three kinds of stable performances of inorganic acid catalyst; Carry out the esterification building-up reactions, finally make Sodium Croscarmellose.
The concrete preparation process of the present invention is following:. The preparation method of Sodium Croscarmellose may further comprise the steps:.
Said organic solvent is 1,4-dioxane or THF or N. Described inorganic acid catalyst is sulfuric acid or hydrochloric acid. The alcohol solvent of said alkalization is in gram absolute ethyl alcohols, to add the resulting homogeneous solution of 0.
Why the present invention selects above-mentioned synthesis material or organic solvent or various aftertreatment solvent for use; All with its good stability; Aftertreatment is not more simply, produce any chemical or physical property spinoff to the disintegrating agent as pharmaceutical excipient; Can not produce the interaction with the chemistry or the physics of medicine, be a kind of qualified pharmaceutical excipient disintegrating agent.
The chemical principle of foundation of the present invention is following:. The structure of Xylo-Mucine: the former substitution value is high, and latter's substitution value is littler. The substitution value of the normal Xylo-Mucine that uses is at 0. The structure of linking agent: this dibasic acid anhydride belongs to heterocycle structure.
Such as maleic anhydride has the formula succinic anhydride has the formula adipic acid anhydride of formula and so on. The Sodium Croscarmellose structure that produces: cross-linking set is that hydroxyl or the methylol on the glucose anhydride unit of Xylo-Mucine produces through the esterification of linking agent to each other, as shown in the formula.
The former is hydroxyl and structure with the esterification of a part anhydride crosslinkers on the glucose anhydride unit in methylol and another molecule on the glucose anhydride unit in the molecule; The latter is two hydroxyls on the glucose anhydride unit in the molecule and esterification structure with a part anhydride crosslinkers.
According to the size of the substitution value of Xylo-Mucine, the cross-linking set of Sodium Croscarmellose more should be latter's structure.
Here be to utilize under the acidic conditions, the alcoholic extract hydroxyl group of Xylo-Mucine and the esterification of acid anhydrides. The degree of esterification depends on reaction conditions, controls suitable esterification condition, obtains well behaved Sodium Croscarmellose smoothly.
Innovative point of the present invention is the synthetic Sodium Croscarmellose that can be used as pharmaceutical excipient of single stage method chemically crosslinked, and the reaction times is short, easily-controlled reaction conditions, the dependable performance of synthetics, steady quality.
Below in conjunction with embodiment the present invention is done explanation further. Its swelling capacity is The substitution value of Xylo-Mucine is 0. Above-mentioned Xylo-Mucine structural formula is following:. Above-mentioned Sodium Croscarmellose structural formula is following:. CNB en. CNA en. Drug composition containing dienogest and estradiol valerate and preparation method thereof.
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Sidney Haas created the Specific Carbohydrate Diet to avoid harmful bacterial flora growth in the intestines. Under the guidelines of this diet, croscarmellose sodium should be specifically avoided because of its ability to promote overgrowth of flora, both good and bad.
If you have any symptoms of gastrointestinal trouble, you may want to avoid this additive when possible. Based outside Boston, Elizabeth Thatcher began writing health-related articles in Monitor the health of your community here.
More Articles. Croscarmellose Sodium Side Effects. Written by Elizabeth Thatcher. Faroongsarng and G. Gottschall Drugs.
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