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Objective To optimize the extraction process of total phenolic acids from Cibotii rhizoma using Box-Behnken design-response surface methodology and evaluate antioxidant activity of total phenolic acid in vitro.Methods Taking the liquid-solid ratio,ethanol concentration and extraction temperature as influencing factors,and the extraction rate of total phenolic acids as evaluation indicator,the extraction process of total phenolic acids from Cibotii rhizoma was optimized using a three-factor and three-level Box-Behnken design-response surface methodology on the basis of single factor tests.Meanwhile,the scavenging effects of total phenolic acid extract from Cibotii rhizoma on ABTS·+and DPPH· was determined.Results The optimized extraction process for total phenolic acids from Cibotii rhizoma was as follows:the ethanol concentration of 55％,the extraction temperature of 88℃ and the liquid-solid ratio of 60∶1 mL/g.Under these conditions,the extraction rate could reach 8.67％.When the mass concentration of total phenolic acids extract were 2 mg/mL and 1 mg/mL,the clearance rates of ABTS·+and DPPH·were 92.76％and 88.66％,respectively.Conclusion The theoretical values obtained from the response surface optimization method are consistent with the actual measured values,and the extraction process of total phenolic acids from Cibotii rhizoma was simple and feasible.The total phenolic acids extract from Cibotii rhizoma exhibit strong antioxidant activity in vitro.
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Objective To optimize the granularity and decocting process of Codonopsis Radix decoction.Methods Adding water,soaking time and decoction time were set as examine factors,and flavonoids,total polysaccharides,and extract yield were set as the indexes,AHP-entropy weight method combined with the Box-Behnken design-response surface method were used to determine the best particle size and the technological parameters of Codonopsis Radix decoction.Results The optimum size of precise Codonopsis Radix decoction was 4.00-4.75 mm(4-5 mesh);the optimum decocting process was 13 times the amount of water added;the soaking time was 15 min;the decocting time was 10 min.Conclusion The granularity of Codonopsis Radix decocting powder optimized in this study is scientific and reasonable,which is suitable for practical production.The established decocting process is convenient,reasonable and feasible,and provides a theoretical basis for the industrial production of decocting powder.
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AIM To optimize the processing technology of red Notoginseng Radix et Rhizoma and evaluate its blood tonifying activity.METHODS On the basis of a single factor experiment,with steaming temperature,steaming time,drying temperature,and drying time as influencing factors,the total contents of notoginsenoside R1,ginsenoside Rg1,Rb1,Rk3,Rh4,and 20(R)-ginsenoside Rg3 as evaluation indicators,Box-Behnken response surface method ology was used to optimize the processing technology.Upon the anemic mouse models jointly induced by 1-acetyl-2-phenylhydrazine(APH)and cyclophosphamide(CTX),the investigation of the blood tonifying activity of red Notoginseng Radix et Rhizoma was carried out in contrast to that of the steamed Notoginseng Radix et Rhizoma.RESULTS The optimal conditions,contributing saponin content of 8.326%and RSD of 0.087%,were determined as follows:steaming temperature of 130℃,steaming time of 4 hours,drying temperature of 60℃,and drying time of 48 h.The pharmacological activity revealed that the different processing techniques were responsible for the different blood enriching activity of notoginseng,with red Notoginseng Radix et Rhizoma displaying a better efficacy than that of steamed Notoginseng Radix et Rhizoma.CONCLUSION This stable and feasible method can be used to control the production of red Notoginseng Radix et Rhizoma.
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Objective To optimize the preparation process of hydroxysafflor yellow A(HSYA)nanoparticle and conduct in vitro release evaluation.Methods HSYA nanoparticles were prepared with PLGA as carrier by modified compound emulsion method.The optimal preparation process of the experiment was selected by Plackett-Burman and Box-Behnken response surface method.The nanoparticles were characterized by using particle size analyzer,TEM scanning electron microscope,Fourier transform infrared spectroscopy(FT-IR),X-ray diffraction(XRD).Frozen(4℃)storage stability,stability in physiological medium,lyophilized protective agent and in vitro release rate were investigated.Results The optimal process prescription of nanoparticle is as follow:pH value is 6.95,the dosage is 2.8 mg,and carrier dosage is 18.2 mg.The size of nanoparticles obtained at optimum condition is(176.4±1.29)nm,the polydiseperse index(PDI)is 0.152±0.014,the Zeta potential is(-17.6±0.46)mV,the encapsulation rate is(78.5±0.49)％,drug loading is(7.3±0.07)％.These nanoparticles showed round and good dispersion.Good stability in 4℃ storage environment and different physiological media of nanoparticles were observed.The best lyophilized protective agent was 1％glucose and the in vitro release rate of nanoparticles at 48 hours was 85％.Conclusion The optimization method is reasonable and reliable.The obtained nanoparticles have good stability and sustained-release effect.The in vitro release behavior conformed to first-order kinetic model.
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OBJECTIVE To study the extraction technology of Sophora flavescens-Phellodendron chinense drug pair and provide a reference for the development of new drugs for the treatment of anorectal diseases. METHODS Using the contents of total alkaloids of S. flavescens （matrine+oxymatrine）， berberine hydrochloride and total flavonoid， and extract yield as evaluation indicators， analytic hierarchy process-entropy weight method was used to calculate the weight coefficient of each indicator， and was combined with Box-Behnken design-response surface method to study the extraction technology of S. flavescens-P. chinense drug pair and verify it. RESULTS The optimal extraction technology of S. flavescens-P. chinense drug pair was immersed in 12-fold amount of 58% ethanol for 30 minutes and extracted twice， each time for 120 minutes. The relative error between the verification experimental results and the predicted value was 1.88%. CONCLUSIONS The obtained extraction technology is stable and feasible and can provide reference for the application of S. flavescens-P. chinense drug pair and development of new drugs.
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OBJECTIVE To optimize the extraction process and to primarily evaluate the anti-anxiety and anti-depression efficacy of polysaccharide from Baihe dihuang decoction. METHODS Based on Plackett-Burman experimental design， using the comprehensive score of yield and content of polysaccharide as indicators， with extraction time， water amount， alcohol precipitation concentration as factors， Box-Behnken response surface methodology was used to optimize the extraction process of polysaccharide from Baihe dihuang decoction； and the validation test was conducted. Forty ICR mice were divided into control group， venlafaxine group [positive control， 13.5 mg/（kg·d）]， Baihe dihuang polysaccharide high-dose and low-dose groups [5.28， 2.64 g/（kg·d），by raw material]， with 10 mice in each group （half male and half female）. Administration groups were given corresponding drug solution intragastrically， and control group was given water 10 mL/kg intragastrically， once a day， for 7 test， forced swimming test and tail suspension test were used to evaluate the effects of the extract prepared by the optimal process on the anxiety-like and depression-like behavior of mice； enzyme-linked immunosorbent assay was used to detect the effects of the extract on the levels of neurotransmitter in cerebral tissue of mice. RESULTS The optimal extraction process of Baihe dihuang decoction was： the water amount of 25 times， extract time of 1.5 hours， and alcohol precipitation concentration of 70%. In 3 times of validation test， the average yield and content of polysaccharide were 33.10% and 0.62 mg/mg， the relative deviations of which from the predicted values （36.14% and 0.65 mg/mg） were 8.40% and 4.62% respectively （RSD＜2%， n＝3）. The polysaccharide extract of Baihe dihuang decoction could effectively increase the percentages of open-arms entry， the percentages of open-arms time， the total distance of voluntary activities and the activity distance in central area， and significantly shortened the immobility time of forced swimming test and tail suspension test （P＜0.05 or P＜0.01）. The polysaccharide extract could significantly increase the levels of 5-hydroxytryptamine， norepinephrine （except for the Baihe dihuang polysaccharide low-dose group） and gamma-aminobutyric acid in cerebral tissue of mice， while significantly decrease the levels of glutamic acid （except for the Baihe dihuang polysaccharide low-dose group） （P＜0.05 or P＜ 0.01）. CONCLUSIONS The optimized extraction process of polysaccharide from Baihe dihuang decoction is stable and feasible， and the obtained polysaccharide extract has obvious anti-anxiety and anti-depression effect in vivo.
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OBJECTIVE To optimize the extraction process of Sarcandra glabra. METHODS The contents of rosmarinic acid and isofraxidin in S. glabra were determined by HPLC； ultrasonic time， ultrasonic temperature， solid-liquid ratio （mL/g） and methanol volume fraction were investigated by single factor test. Based on the results of single factor test， experimental scheme was designed by Box-Behnken response surface method， and the entropy weight method was used to assign the weight of each index and calculate the comprehensive score. Taking the comprehensive score as the evaluation index， the extraction process of S. glabra was optimized， and then optimized extraction process was verified. RESULTS The optimal extraction technology of S. glabra included ultrasonic time of 40 min， ultrasonic temperature of 45 ℃， liquid-solid ratio of 50∶1， methanol volume fraction of 70%. The results of 3 times of verification experiment showed that average comprehensive score was 0.988 6， and the RSD was 0.50%. The deviation between the actual value and the predicted value （0.985 1） of each comprehensive score was within ±1%. CONCLUSIONS The optimized extraction method is stable， feasible and repeatable， which can provide reference for extraction of S. glabra.
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Objective To optimize the culture and fermentation conditions of the Penicillium aurantiocandidum Z12 strain, a fungal strain with molluscicidal actions against Oncomelania hupensis, so as to provide the basis for the research and development of molluscicidal active substances from the P. aurantiocandidum Z12 strain and its fermentation broth and large-scale fermentation. Methods The carbon source, nitrogen source and mineral salts were identified in the optimal culture medium for the P. aurantiocandidum Z12 strain with a single-factor experiment to determine the best fermentation condition for the P. aurantiocandidum Z12 strain. Factors that significantly affected the growth of the P. aurantiocandidum Z12 strain were identified using the Plackett-Burman design, and the best range of each factor was determined using the steepest climb test. Response surface analyses of temperature, pH value, seeding amount and liquid-filling quantity were performed using the Box-Behnken design to create a regression model for fermentation of the P. aurantiocandidum Z12 strain to identify the optimal culture medium. Results Single-factor experiment preliminarily identified the best culture medium and conditions for the P. aurantiocandidum Z12 strain as follows: sucrose as the carbon source at approximately 20 g/L, tryptone as the nitrogen source at approximately 5 g/L, K2HPO4 as the mineral salt at approximately 5 g/L, initial pH at approximately 8, temperature at approximately 28 °C, seeding amount at approximately 6%, and liquid-filling quantity at approximately 50 mL/100 mL. Plackett-Burman design showed that factors that significantly affected the growth of the P. aurantiocandidum Z12 strain included temperature (t = −5.28, P < 0.05), seeding amount (t = 5.22, P < 0.05), pH (t = −4.30, P < 0.05) and liquid-filling quantity (t = −4.39, P < 0.05). Steepest climb test showed the highest mycelial growth at pH of 7.5, seeding amount of 8%, and liquid-filling quantity of 40 mL/100 mL, and this condition was selected as the central point of response surface analysis for the subsequent optimization of fermentation conditions. Response surface analyses using the Box-Behnken design showed that the optimal conditions for fermentation of the P. aurantiocandidum Z12 strain included sucrose at 15 g/L, tryptone at 5 g/L, K2HPO4 at 5 g/L, temperature at 28.2 °C, pH at 7.5, seeding amount at 10%, and liquid-filling quantity at 35.8 mL/100.0 mL, resulting in 0.132 g yield of the P. aurantiocandidum Z12 strain. Conclusion The optimal culture condition for the P. aurantiocandidum Z12 strain has been identified, and the optimized culture medium and fermentation condition may effectively improve the fermentation yield of the P. aurantiocandidum Z12 strain.
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OBJECTIVE To optimize the extraction process of Xuelian yishen formula. METHODS The contents of total flavone， echinacoside and acteoside， and extraction yield in Xuelian yishen formula were chosen as indexes， entropy weight method-analytic hierarchy process was adopted to determine the weight coefficient. Box-Behnken response surface methodology was used to optimize the extraction process of Xuelian yishen formula with extraction time， solid-liquid ratio and extraction times as factors， using comprehensive score of above indexes as index. RESULTS The optimal extraction process of Xuelian yishen formula was extraction time of 2 h， solid-liquid ratio of 1∶12， extracting for 3 times. Average comprehensive score of 3 validation tests was 96.40 points （RSD＝0.28%）， the deviation of which with predictive value was 0.98%. CONCLUSIONS The optimized extraction process is stable， feasible and reproducible， which can provide reference for the extraction process of Xuelian yishen formula.
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The weight coefficients of appearance traits, extract yield of standard decoction, and total content of honokiol and magnolol were determined by analytic hierarchy process(AHP), criteria importance though intercrieria correlation(CRITIC), and AHP-CRITIC weighting method, and the comprehensive scores were calculated. The effects of ginger juice dosage, moistening time, proces-sing temperature, and processing time on the quality of Magnoliae Officinalis Cortex(MOC) were investigated, and Box-Behnken design was employed to optimize the process parameters. To reveal the processing mechanism, MOC, ginger juice-processed Magnoliae Officinalis Cortex(GMOC), and water-processed Magnoliae Officinalis Cortex(WMOC) were compared. The results showed that the weight coefficients of the appearance traits, extract yield of standard decoction, and total content of honokiol and magnolol determined by AHP-CRITIC weighting method were 0.134, 0.287, and 0.579, respectively. The optimal processing parameters of GMOC were ginger juice dosage of 8%, moistening time of 120 min, and processing at 100 ℃ for 7 min. The content of syringoside and magnolflorine in MOC decreased after processing, and the content of honokiol and magnolol followed the trend of GMOC>MOC>WMOC, which suggested that the change in clinical efficacy of MOC after processing was associated with the changes of chemical composition. The optimized processing technology is stable and feasible and provides references for the modern production and processing of MOC.
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Zingiber officinale , Magnolia/chemistry , Drugs, Chinese Herbal/chemistry , Biphenyl Compounds/chemistry , Lignans/chemistryABSTRACT
The present study optimized the ethanol extraction process of Ziziphi Spinosae Semen-Schisandrae Sphenantherae Fructus drug pair by network pharmacology and Box-Behnken method. Network pharmacology and molecular docking were used to screen out and verify the potential active components of Ziziphi Spinosae Semen-Schisandrae Sphenantherae Fructus, and the process evaluation indexes were determined in light of the components of the content determination under Ziziphi Spinosae Semen and Schisandrae Sphenantherae Fructus in the Chinese Pharmacopoeia(2020 edition). The analytic hierarchy process(AHP) was used to determine the weight coefficient of each component, and the comprehensive score was calculated as the process evaluation index. The ethanol extraction process of Ziziphi Spinosae Semen-Schisandrae Sphenantherae Fructus was optimized by the Box-Behnken method. The core components of the Ziziphi Spinosae Semen-Schisandrae Sphenantherae Fructus drug pair were screened out as spinosin, jujuboside A, jujuboside B, schisandrin, schisandrol, schisandrin A, and schisandrin B. The optimal extraction conditions obtained by using the Box-Behnken method were listed below: extraction time of 90 min, ethanol volume fraction of 85%, and two times of extraction. Through network pharmacology and molecular docking, the process evaluation indexes were determined, and the optimized process was stable, which could provide an experimental basis for the production of preparations containing Ziziphi Spinosae Semen-Schisandrae Sphenantherae Fructus.
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Ethanol , Molecular Docking Simulation , Network Pharmacology , Seeds/chemistry , Ziziphus/chemistry , Plant Extracts/chemistry , Schisandra/chemistry , Fruit/chemistry , Technology, PharmaceuticalABSTRACT
Objective To optimize the extraction process of Puji disinfection oral liquid.Methods Based on Box-Behnken design,the extraction process of volatile oil was optimized with the extraction rate of volatile oil as index.Based on Box-Behnken design combined with G1-entropy weight method,the extraction rate and dry extract rate of(R,S)-epigoitrin,hesperidin,baicalin,berberine hydrochloride and arctiin were used as indices to optimize the water extraction process.Results The optimum extraction conditions of volatile oil from Puji disinfection oral liquid were as follows:adding 10 times of water,soaking time of 1.5 h and extraction time of 5 h.The optimal water extraction process was as follows:10 times of water,1.8 h of extraction time and 2 times of extraction.Under the optimal extraction conditions,there was no significant difference among the three batches of verification tests.Conclusion The optimized extraction process is stable and feasible,which can provide the basis for the subsequent experimental study and industrial production of Puji disinfection oral liquid.
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Objective To prepare Compound Nanxing Pain Relief Gel(CNPRG)and evaluate its quality and sensitization.Methods CNPRG uses Carbopol 980 NF as the matrix;Appearance,viscosity,coating,centrifugal stability,cold stability,thermal stability as comprehensive indicators,single test and Box-Behnken effector method to optimize the prescription;The quality evaluation methods of appearance,pH,viscosity,stability,vapor phase identification of volatile components,and determination of diaconitine and eugenol content of CNPRG were preliminarily established;CNPRG sensitization was assessed by Active Cutaneous Anaphylaxis.Results The best prescription for CNPRG was Carbopol 980 NF 0.35 g,drug 1.02 g,glycerol 5.00 g,and pH 6.20.CNPRG ′s appearance likes jelly,is smooth,uniform and delicate;pH=6.20±0.03;viscosity 68.43±1.14 Pa·s;Centrifugation,high,low temperature stability,no stratification and precipitation;Identify camphor,(±)-Borneol and(±)-Isoborneol,Cinnamaldehyde,eugenol,phenol;Hypaconitine content 0.2983±0.0073 μg·g-1;Eugenol content 155.66±0.97 μg·g-1;CNPRG confirmed no sensitization.Conclusion CNPRG has good appearance,stable quality and no sensitization,and it can provide a choice for the development of new dosage forms of compound Nanxing pain relief cream to alleviate sensitization.
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OBJECTIVE To optimize the formulation of a porcine fibrin patch （abbreviated as “DBT”）. METHODS Based on single-factor tests， with the contents of fibrinogen， thrombin and collagen before freeze-drying as the factors， with the overall desirability （OD） value of adhesion strength， holding viscosity and water absorption as response value， the formulation of DBT was optimized by Box-Behnken-response surface methodology， and the verification tests were conducted. RESULTS According to the results of the single factor tests and Box-Behnken-response surface methodology， combined with the actual production， the optimal formulation of DBT was 6.5 mg/cm2 of fibrinogen， 8.0 IU/cm2 of thrombin and 5.6 mg/mL of collagen. The average OD value of 3 validation tests was 0.726 6 （RSD＝0.58%， n＝3）， and the relative error of which with the predicted value （0.733 0） was －0.87%. CONCLUSIONS The optimal formulation of DBT is stable and feasible.
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OBJECTIVE To optimize the molding process of Shuangye pipa granules based on the concept of quality by design （QbD） and analyze its physical fingerprint. METHODS The dry extract of Shuangye pipa granules was used as the main drug. The retention rate of total flavonoid， moisture absorption rate， dissolution rate， angle of repose and molding rate of the granules were selected as evaluation indexes. The single-factor test combined with the entropy weight method and Box-Behnken response surface design was used to optimize the molding process， and validation test was conducted. The physical fingerprints of 10 batches of Shuangye pipa granules prepared by the optimal process were comprehensively analyzed by eight secondary physical indexes （relative homogeneity， moisture， moisture absorption rate， Hausner ratio， angle of repose， bulk density， tap density and porosity）. RESULTS The optimal molding process of Shuangye pipa granules was as follows： soluble starch-maltodextrin-mannitol was 1∶1∶1 （m/m/m）， 95% ethanol was as wetting agent and the amount of it was 37%， the drug-assisted ratio was 1∶0.8 （m/m）， the drying temperature was 59 ℃， drying time was 28 min. The results of 3 validation tests showed that the average comprehensive score was 0.879 6， the RSD of which with prediction value （0.881 9 score） was 1.97%. The similarity between the physical fingerprints of 10 batches of Shuangye pipa granules and the control physical fingerprint was higher than 0.99. CONCLUSIONS The optimized molding process of Shuangye pipa granules is stable and feasible， and the physical property of Shuangye pipa granules is stable and controllable.
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OBJECTIVE To optimize the extraction process of polysaccharides from Dendrobium officinale， and preliminarily study its effect on acute lung injury （ALI） in mice. METHODS Using D. officinale as raw material， the polysaccharides were extracted from D. officinale by ultrasonic-assisted hot water immersion. Using the extraction rate of D. officinale polysaccharides as response value， the single-factor experiments and Box-Behnken response surface method were used to optimize the ratio of material to liquid， extraction time and extraction temperature. ALI mice were induced by lipopolysaccharide. Using prednisone acetate （5 mg/kg） as the positive control， the effects on the mass ratio of wet and dry lung and pathological changes of lung tissue （HE staining and Masson staining） of low-dose， medium-dose and high-dose D. officinale polysaccharides （50，100，200 mg/kg） were investigated. RESULTS The optimal extraction technology of D. officinale polysaccharides was as follows： the ratio of material to liquid was 1∶25 （g/mL）， the extracting time was 1 h， and the extracting temperature was 58 ℃ . Under these conditions， the average extraction rate of D. officinale polysaccharides was 37.75% （RSD＝1.12%，n＝3）， the relative error of which with predicted value （38.63%） was 2.28%. Compared with the model group， the ratios of wet and dry lung in the positive control group and D. officinale polysaccharides groups were all decreased significantly （P＜0.05 or P＜0.01）， and the pathological changes in lung tissue （severe destruction of alveolar structure， significant widening of alveolar septa， extensive infiltration of inflammatory cells and proliferation of fibroblasts） were alleviated to varying degrees. CONCLUSIONS The optimal extraction process of D. officinale polysaccharides is feasible； the obtained polysaccharide extract has a certain improvement effect on ALI in mice.
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OBJECTIVE To optimize the water extraction process of Maxing kechuan granules. METHODS With the contents of ephedrine hydrochloride， bergenin， prim-O-glucosylcimifugin， 5-O-methylvisamin， naringin and hesperidin and the rate of extraction as the evaluation indexes， the weight was determined by the analytic hierarchy process（APH）-entropy weight method， and the comprehensive score was calculated as the response value. Based on the single-factor test， the Box-Behnken response surface method was used to investigate the factors， and the best water extraction process of Maxing kechuan granules was optimized； process validation was also carried out. RESULTS The best water extraction process of Maxing kechuan granules optimized was as follows： soaking for 40 minutes， adding 8 times water， and extracting for 180 minutes. After three validation tests， the comprehensive score was 94.82 （RSD＝0.96%， n＝3）， which had a small difference from the predicted value of 94.64. CONCLUSIONS The water extraction process of Maxing kechuan granules is stable and reliable， which can provide a reference for the development of the preparation.
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Based on the concept of quality by design(QbD), the Box-Behnken design-response surface methodology combined with standard relation(SR) and analytic hierarchy process(AHP)-entropy weight method(EWM) was applied to optimize the extraction process of the classic prescription Yihuang Decoction. The content of geniposidic acid, phellodendrine hydrochloride, and berberine hydrochloride in Yihuang Decoction, the extract yield, and fingerprint similarity were used as the critical quality attributes(CQAs) of the extraction process. The extraction time, water addition, and extraction times were used as the critical process parameters(CPPs). After determining the levels of each factor and level through single-factor experiments, response surface experiments were designed according to the Box-Behnken principle, and the experimental results were analyzed. The SR between each sample and the reference sample under various evaluation indicators of different extraction parameters was calculated. The weights of the five evaluation indicators were determined using AHP-EWM, followed by comprehensive evaluation. A function model between CPPs and CQAs characterized by comprehensive scores was established to predict the optimal extraction process parameters. In the final comprehensive weight coefficients, the yield rate accounted for 43.1%, and the content of berberine hydrochloride, phellodendrine hydrochloride, and geniposidic acid accounted for 35.1%, 6.3%, and 15.5%, respectively. After comprehensive score analysis with SR, the established second-order polynomial model was statistically significant(P<0.01, and the lack of fit was not significant). The predicted optimal extraction conditions for Yihuang Decoction were determined as follows: 8-fold volume of water, extraction time of 1.5 h, and extraction once. The mean comprehensive score of the validation experiment was 85.77, with an RSD of 0.99%, and it met the quality control stan-dards for the reference sample of Yihuang Decoction. The results indicate that the optimized extraction process for Yihuang Decoction is stable and reliable, and the water extract is close in quality attributes to the reference sample. This can serve as a foundation for the research and development of granules in the future. Box-Behnken design-response surface methodology combined with SR and AHP-EWM can provide references for the modern extraction process research of other classic prescriptions.
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Drugs, Chinese Herbal , Analytic Hierarchy Process , Berberine , Entropy , WaterABSTRACT
The ethanol precipitation process of Nauclea officinalis extract was optimized based on the concept of quality by design(QbD). Single factor tests were carried out to determine the levels of test factors. The ethanol volume fraction, pre-ethanol precipitation drug concentration, and ethanol precipitation time were taken as critical process parameters(CPPs). With the comprehensive scores of strictosamide transfer rate and solid removal rate as the critical quality attributes(CQAs), Box-Behnken design was employed to establish the mathematical models and space design between CPPs and CQAs, and the obtained optimal operating space was validated. The optimal operating space included ethanol volume fraction of 65%-70%, pre-ethanol precipitation drug concentration of 22-27 mg·mL~(-1), and ethanol precipitation time of 12 h. Based on the concept of QbD, this study adopted the design space to optimize the ethanol precipitation process of N. officinalis extract, which provided a reliable theoretical basis for the quality control in the production process of N. officinalis preparations. Moroever, this study provided a reference value for guiding the research and industrial production of traditional Chinese medicines.
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Drugs, Chinese Herbal , Ethanol , Medicine, Chinese Traditional , Quality Control , Models, TheoreticalABSTRACT
Biofuel is one of the best ways to reduce our dependence on fossil fuels. Ever since commercial biodiesel production began, waste glycerol, the biodiesel byproduct, has gained researchers’ interest, especially its recycling. Here, we explored using glycerol residue (carbon source) as a substrate in the fermentation process for ethanol production by Escherichia coli K12 in anaerobic conditions. The factors affecting the ethanol production was optimised by response surface methodology (RSM). Significant variables that impact the ethanol concentration were pH, temperature and the substrate, with a statistically significant effect (P <0.05) on ethanol formation. The significant factor was analyzed by the Box-Behnken design. The optimum conditions for bioethanol formation using glycerol as substrate was obtained at pH 7 and temperature 37°C. The ethanol productivity was 0.77 g/L/h. The ethanol concentration of 9.2 g/L achieved from glycerol residue was close to the theoretical value with the fermentation achieved at optimised terms.