| 1 Objective Pinellia is the dry tuber of Pinellia ternata(Thunb.)Breit.,a plant of the Araceae family.It has the effects of removing dampness,reducing phlegm,reducing adverse effects,relieving vomiting,eliminating ruffian,and dispersing knots.Pinelliae Rhizoma Praeparatum cum Zingibere et Alumine(PRPZA)is a commonly used processed product,but the traditional production process of PRPZA is cumbersome,the process is overlapping and repeated,and the production cycle is long,which increases the production cost and affects the quality of decoction pieces.Based on the above problems,this study takes the peeled fresh Pinelliae Rhizoma(PR)as the raw material,studies the integrated production process and processing of PRPZA,determines the key technical parameters of integrated production of PRPZA,investigates and screens the storage methods and processes of peeled fresh PR,and determines the best preservation conditions;then compare the quality and efficacy between the Integrated Decoction Pieces(IDP)and Traditional Decoction Pieces(TDP)of PRPZA,and analyze the rationality and feasibility of the integrated production of PRPZA,to provide an important basis for the production and quality evaluation of the IDP of PRPZA.2 Method 2.1 Study on integrated processing technology of PRPZA The Box-Behnken response surface method was used to design and analyze.Taking the comprehensive score of appearance character score,water-soluble extract content,alum content,and calcium oxalate needle crystal content as the evaluation index,the three factors of fresh PR drying water loss rate,water addition amount,and decoction time were investigated to optimize the processing and processing integrated process in the producing area of PRPZA.2.2 Study on preservation technology of peeled fresh PR Peeled fresh PR is the raw material for IDP production of PRPZA.Its preservation methods and conditions directly affect the quality of processed products.Firstly,the peeled fresh PR was treated by "mixing alum".The effects of alum dosage(5%,6%,7%,8%),alum particle size(10,50,80,100 mesh)and temperature(10,15,20,25 ℃)on storage time,water-soluble extract and alum residue were investigated.Secondly,the peeled fresh PR was treated with the method of "mixing 5% alum",and samples were taken at 0,2,4,6,8,and 10 days for PRPZA processing.Taking the appearance properties,water-soluble extract,alum residue,calcium oxalate needle crystal content,total alkaloids,polysaccharides,and nucleosides as the indexes,the quality of PRPZA prepared by alum was compared with that of the traditional method,to determine the effect of fresh PR mixed with alum on the quality of the IDP of PRPZA.2.3 Comparative study on the quality of IDP and TDP of PRPZA According to the quality requirements of "PRPZA" in the 2020 edition of Chinese Pharmacopoeia,the quality of IDP and TDP of PRPZA were tested;a method for the determination of calcium oxalate needle crystal,protein,total alkaloids,polysaccharides,and three nucleosides(inosine,guanosine,and adenosine)in PRPZA was established.The two decoction pieces were determined and analyzed,and a statistical comparative study was made.HPLC method was used to establish the characteristic maps of PRPZA,and the characteristic peaks and similarities between IDP and TDP were compared and analyzed.2.4 Comparative study on efficacy and irritation between IDP and TDP of PRPZA The anti-inflammatory,expectorant,and irritant effects of IDP and TDP of PRPZA were compared by using the acute inflammation model of mice auricle swelling induced by xylene,phenol red method of the tracheal segment,and conjunctival irritation test of rabbit eyes.3 Result 3.1 Study on integrated processing technology of PRPZA The best process for the integration of PRPZA was as follows: take the peeled fresh PR,put it in twice the amount of fresh PR with ginger and alum,boil it together for 4 hours,take it out,and dry it at 50 ℃ until dry.Or dry at 50 ℃ for 50% and cut into thin slices,and continue to dry.3.2 Study on preservation technology of peeled fresh PR The results of single factor showed that mixing with alum could significantly prolong the storage time of peeled fresh PR.Alum dosage and alum particle size have little effect on the three indexes,and temperature is the main influencing factor.The results of quality comparison showed that the appearance of peeled fresh PR changed on the 5th day after mixing with alum,and the content of measured index components showed a downward trend except for alum;The OD value decreased continuously and was lower than the traditional method on the 6th day.3.3 Comparative study on the quality of IDP and TDP of PRPZA The results showed that:(1)The characters are in line with the provisions of the Pharmacopoeia,and the cross-section color of the IDP of PRPZA is light yellow-brown,while the cross-section color of the TDP is dark yellow-brown;(2)The inspection items and identification items meet the Pharmacopoeia standards: the residue of alum in the IDP is significantly reduced by 16.95%,and the content of an extract is significantly increased by 7.62%;(3)Other contents: The contents of calcium oxalate needle crystal,protein,polysaccharide,inosine,guanosine and total nucleosides in the IDP of PRPZA decreased by 21.27%,23.78%,4.74%,52.12%,0.24% and 26.04% respectively compared with the TDP of PRPZA;the contents of water-soluble extract,total alkaloids and adenosine increased by 7.62%,114.83% and 125.42% respectively compared with the TDP of PRPZA.The characteristic maps showed that the similarity between the maps of PRPZA prepared by the two processes was more than 0.81.3.4 Comparative study on efficacy and irritation between IDP and TDP of PRPZA The results showed that the IDP and TDP of PRPZA had obvious inhibitory effects of ear edema in mice(P < 0.01),but there was no significant difference between them,and their anti-inflammatory effects were consistent;Both IDP and TDP of PRPZA could significantly enhance the excretion of phenol red in mouse trachea(P < 0.01).There was no significant difference in expectorant effect between the two decoction pieces at the same dose,and the effect was similar;The two kinds of PRPZA had no irritation to rabbit conjunctiva,and there was no significant statistical difference between them,and the safety was similar.4 Conclusion The integrated production process and processing of PRPZA optimized by response surface method is simple,stable,and feasible,and is suitable for large-scale production.The single factor test was used to screen the short-term storage methods and conditions of fresh PR after peeling.The treatment with an alum can significantly prolong the storage time of peeled fresh PR,and ensure the quality of PRPZA,which provides a scientific and reasonable method for short-term storage of fresh PR in the process of integrated production.Through the comparison of quality and pharmacological effects,the content of components between the IDP and TDP of PRPZA was different,the anti-inflammatory,expectorant,and irritant effects were similar,and the quality of the IDP was slightly better than the TDP.PR’s integrated production process mode was reasonable and feasible,with a short production cycle,high production efficiency,labor-saving,and time-saving.The quality of decoction pieces was stable and excellent,which provides a reference basis for the scientific production and application of PRPZA. |