Study On The Preparation Technology And Quality Standard Of Menispermi Rhizoma Freeze-dried Quick-release Tablets

Menispermi Rhizoma is the dried rhizome of Menispermum dauricum DC.The Chinese Pharmacopoeia(2020 Edition)records that Menispermi Rhizoma has the effects of clearing heat and detoxification,dispelling wind and relieving pain.Its main active ingredient is alkaloid such as dauricine.Modern pharmacological studies have proved that it has good anti-inflammatory,antibacterial,cardiovascular protective effects and anti-tumor effects.For more than 20 years,the clinical treatment of chronic bronchitis,acute and chronic tonsillitis,sore throat has definite curative effect and few side effects.Based on the theory of traditional Chinese medicine,this study intends to use Chinese medicinal material extraction and separation technology and high-efficiency freeze-drying technology to make freeze-dried quick-release tablets with high bioavailability,fast onset,and strong compliance.Thereby improving curative effect and reducing adverse reactions.This topic is based on the chemical properties and pharmacological effects of the medicinal ingredients of Menispermi Rhizoma,combined with its functions,adopts the method of orthogonal experiment to retain the active ingredients to the greatest extent,and obtained the best extraction process through many experiments:the sulfuric acid concentration is 1%.Extract twice.The amount of sulfuric acid added for the first time is 10 times,and the amount of sulfuric acid added for the second time is 8 times.The extraction time was 40 min for each time,and the extraction temperature is 60℃.Then the acid water obtained by two extractions.The liquid was combined by centrifugation and filtered.The pH of the filtrate was adjusted to 9 with 40%NaOH solution,and after standing at room temperature for 24 hours,the supernatant was discarded to obtain the precipitate,and distilled water was added to wash to pH 7-8.The precipitate is decompressed and drained and then dried to obtain a finished product.According to the appearance,hardness,and disintegration time limit of freeze-dried quick-release tablets,single factor experiment design was used to screen out the main auxiliary materials of freeze-dried quick-release tablets of Menispermi Rhizoma.On this basis,orthogonal experimental design was used to optimize the preparation process.The preparation process of lyophilized quick-release tablets of Menispermi Rhizoma:add mannitol,Menispermi Rhizoma extract,aspartame,and peppermint flavor to the gelatin solution and ultrasonically dissolve to 100ml,stir well with ultrasonic,and dispense into 0.5ml aluminum In the bubble making cap,after pre-freezing at-80℃ for 6h,transfer it to the vacuum freeze dryer,start vacuuming and increase the temperature of the partition.The vacuum pressure reaches 20Pa,the heating rate is about 0.2℃/min.After sublimation for 18 h,the water was sublimated completely,and the temperature was raised to reach room temperature for 6 h.Each tablet contains 60mg of total alkaloids.The quality evaluation of the freeze-dried quick-release tablets of Menispermi Rhizoma was carried out.First,the corresponding thin-layer identification research experiment was carried out on the Menispermi Rhizoma,and the systematic methodological test study was carried out on the active ingredient dauricine in the Menispermi Rhizoma,and strict quality research has been conducted on the medicinal materials,extracts,and finished products used,and the quality control standards in the entire preparation process have been improved.It was finally determined that the freeze-dried quick-release tablets of Menispermi Rhizoma contained 60 mg of total alkaloids per tablet,and they were yellow-brown flakes with a sweet smell and flavor.The disintegration time should not exceed 6s,and the limit of dauricine content should be no less than 24.00 mg/tablet.The research results of this subject show that the preparation process of the freeze-dried quick-release tablets of Menispermi Rhizoma is reasonable and meets the requirements of the pharmacopoeia.On this basis,the preparation quality standard research and preliminary investigation of the stability of the preparation have been carried out.The root provides a preparation support,and also provides a reference for the preparation of freeze-dried quick-release tablets of other traditional Chinese medicines.