Study On Preparation Technology And Quality Standard Of Zhihuang Tongxie Granules

The Zhihuang Tongxie Granules are consisted of Rhubarb,Ginger Magnolia,Bran-fried Citrus aurantium,Tangerine peel,Bran-fried Atractylodes,Codonopsis,Poria,Pinellia,and licorice.It has the effects of replenishing qi and stomach,clearing and purging turbidity.It is usually used for patients with acute and severe gastrointestinal dysfunction(pancreatitis)and intractable constipation.This subject is based on long-term clinical application experience,and for the convenience of patients and high compliance,the granule formulation is developed.In addition,the preparation process and quality standards of Zhihuang Tongxie Granules have been studied,and the draft quality standard has been compiled to ensure that the preparation is stable,safe and controllable.1.Extraction processThe index components should be specific,controllable and stable,and can fully reflect the efficacy and activity of the prescription.It was proposed to use ethanol to extract Rhubarb,Ginger Magnolia,Bran-fried Citrus Aurantium,Tangerine Peel and Bran-fried Atractylodes Macrocephala,and the remaining 4 herbs in the prescription and the alcohol extract part of the dregs were extracted with water.The content of Aloe-emodin,Rhein,Chrysophanol,Emodin,Emodin methyl ether,Magnolol,Honokiol and Hesperidin,and dry extract yield were used as the evaluation index in the alcohol-extracted part.By using orthogonal test to optimize the alcohol extraction process,add 10 times the amount of 60% ethanol,extract 3 times,each for 45 min.In the water extraction part,the content of Glycyrrhizin and Ammonium Glycyrrhizinate,and the dry extract yield were the evaluation indicators.By adopting orthogonal test to optimize the water extraction process: add 10 times the amount of water,extract 3times,60 min each time.2.Concentration and purification processRecovering ethanol from the alcohol extract and concentrate to a thick paste;concentrating the water extract under reduced pressure.The orthogonal design was used to optimize the alcohol precipitation process of the water extract: the relative density of the liquid medicine is 1.11(25 ℃),and the alcohol precipitation was carried out in 60% ethanol for 36 hours.3.Forming and SubpackageWe investigated the types and amounts of excipients.The determined they were water-soluble starch: mannitol=2:1,spray granulation(Inlet air temperature:90-100 ℃,sample flow rate: 10%,spray pressure: 0.20 Mpa),and divided into 12 g per bag.4.Quality standard researchThe name of this preparation is "Zhihuang Tongxie Granules".According to the requirements of the granule inspection item,the particle size,moisture,loading difference,etc.have been checked,and the results were in compliance with the regulations.The TLC of Rhubarb,Ginger Magnolia,Hesperidin,Bran-fried Atractylodes,and Licorice was established.The chromatogram obtained was negative without interference,clear spots,appropriate Rf value,and strong repeatability.HPLC content determination method was established.Each bag of this product contains rhubarb based on the total amount of emodin and chrysophanol not less than 9.8 mg;ginger magnolia is based on the total amount of honokiol and magnolol not less than19.8 mg;a qualitative analysis method for characteristic maps was established,and 23 common peaks were calibrated in 15 batches of samples.The draft quality standard for Zhihuang Tongxie Granules was established for quality control and evaluation.