Preparation method of compound glycyrrhizin tablets and quality control detection method

Abstract

The invention provides a preparation method of compound glycyrrhizin tablets. The preparationraw materials includes, by weight,10-15parts of monoammonium glycyrrhizanate (calculated byglycyrrhizin), 10-15parts ofglycine, 10-15parts ofDL-methionine, 5-20parts ofdisintegrating agent, 0.2-5 parts ofadhesive, 0.2-5 parts of lubricant, 0.2-5 parts of flow aid, 5-40 parts ofthinner,and 0.5-5parts ofcoating powder.The preparation method includes the steps of powder sieving, premixing, dry-process granulation, whole mixing, intermediate content detection, tableting and coating.The inventionfurther provides a quality control detection method.Ahigh performance liquid chromatography method based on a non-derivative method is adopted to directly determine the glycine and DL-Methionine content, related substances and dissolution. The process steps are simple, the production cost is low, the detection method is rapid, accurate and reliable, facilitates improvement of the stability of the tablets and improves product quality.

Description

technical field [0001] The invention belongs to the technical field of traditional Chinese medicine pharmacy, and in particular relates to a preparation process of compound glycyrrhizin tablets and a quality control detection method thereof. Background technique [0002] The functions of licorice have been summarized as early as in "Treatise on Febrile Diseases" as follows: nourishing the heart and rejuvenating the pulse, strengthening the body and venting the swelling, nourishing the middle and warming the yang, harmonizing yin and yang, softening the liver and regulating the spleen, harmonizing the stomach, replenishing qi and strengthening the middle, invigorating the spleen and diuresis, and purging There are more than a dozen kinds of fire and detoxification, throat-clearing and heat-clearing, harmonizing camp and health, unobstructing expression, eliminating phlegm and relieving cough. Glycyrrhizin (GL) is a triterpenoid active ingredient extracted from the root and st...

AI Technical Summary

Problems solved by technology

[0005] At present, the glycyrrhizic acid products that have been marketed in China are mainly injections. The problem is that it is inconvenient to use drugs, and it is difficult for patients with chronic liver diseases to insist on long-term injections, which affects the therapeutic effect.

Existing glycyrrhizic acid tablets all adopt wet granulation process, such as patent CN103845350 A "a kind of compound glycyrrhizin tablet and its preparation method" and patent CN101288651A "a kind of compound glycyrrhizin dispersible tablet and its preparation method". Soft materials, wet granulation, drying and granulation are several steps, the process is more cumbersome, more equipment is used, the energy consumption is higher, and the stability of the finished product is not good; on the other hand, the determination of related substances, dissolution rate and content is It is a key link in the quality control and testing of intermediates and finished products in the production process of traditional Chinese medicine preparations. For the single and compound preparations of glycyrrhizic acid (the main components include glycyrrhizin, glycine, and methionine), due to the limitations of chromatographic columns and detection conditions, At present, the detection of glycine and methionine adopts high-performance liquid chromatography with pre-column or post-column derivatization, and the derivatives of glycine and methionine are used as detection targets. The disadvantage is that the derivatization reaction needs to be performed in advance. It is cumbersome, has many interference factors, and the derivative products are unstable, and the measurement precision, accuracy and reliability need to be further improved

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