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Objective: The alcohol extraction and water precipitation processes of Shenmai Injection were optimized based on quality by design (QbD) concept and satisfaction algorithm. Methods: Hazard and operational analysis method was applied to conduct risk assessment of various process parameters in alcohol extraction and water precipitation processes of Shenmai Injection. Ethanol concentration, extraction time and alcohol-material ratio were selected as the critical process parameters of alcohol extraction, and the material pH, temperature and time were selected as the critical process parameters of water precipitation. A multiple linear regression model of critical process parameters and critical quality attributes were established by using Box-Behnken design. A design space was delineated according to the level of each index. Finally, the optimum operating condition was determined by the multi-index optimization algorithm. Results: Within the scope of the design space, when the alcohol concentration was 89.0%, the extraction time was 110 min, the alcohol-material ratio was 2.99, the desirability function of alcohol extraction of 0.722 was the best. When the material pH was about 4, the time was 40 h, the temperature was 2.0 ℃, the desirability function of water precipitation of 0.995 was the best. When the material pH was about 5, the time was 35 h, the temperature was 2.0 ℃, the desirability function of water precipitation of 0.999 was the best. Conclusion: The optimal conditions were determined based on QbD and satisfaction algorithm were conducive to ensuring the product quality and reducing the cost of production. This study has reference value for the guidance of pharmaceutical process research and actual industrial production.
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Objective:To optimize the extraction process of the total lignans from Fructus chinensis. Methods:The comprehensive weighted score method for the extraction rate and the extraction content was regarded as the index by orthogonal experimental method, the effects of ethanol concentration, extraction duration, amount of ethanol and extraction times on the extraction of the total lignans from Fructus chinensis were studied. The chromatographic separation was performed on a Unitary C18 column (250 mm × 4. 6 mm,5μm). Methanol(A)-water(B) was used as the mobile phase (0-10 min:70% A;10-13 min:70% A-85% A;13-30 min:85% A). The detection wavelength was set at 217 nm, the column temperature was maintained at 30℃,the flow rate was 1. 0 ml·min-1 and the sample size was 10μl. Results:The extraction conditions of the total lignans were as follows:14-fold amount of 85% ethanol was used for 3 times extraction with 2. 5 h for each time. Under the above conditions, the extraction rate of Schisandra lignans was 1. 10%, and the extraction content was 22. 99%. Conclusion:The extraction and purification technology for Schisandra lignans and the total poly-saccharides is stable and reliable, which provides scientific basis for the reform of Shengmai new dosage forms.
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The near-infrared (NIR) spectroscopy for offline monitoring of alcohol extraction process of Salvia miltiorrhiza was investigated, with high performance liquid chromatography (HPLC) determination of value for reference. The partial least squares method was adopted to establish the tanshinone ⅡA quantitative calibration model, so as to detect extraction process of Salvia miltiorrhiza. Because the differences between batches of raw materials may endanger the robustness of the original model, the simple interval calculation (SIC) was applied in updating the near-infrared quantitative model for traditional Chinese medicine extraction process for the first time, and compared with Random Selection (RS) method. SIC's final updating results showed that root mean square with cross validation (RMSECV), root mean square error of prediction (RMSEP) and residual predictive deviation (RPD) of tanshinone ⅡA were 0.006 8 g•L⁻¹, 0.005 4 g•L⁻¹ and 3.14, respectively; but RS' final updating results showed that RMSECV, RMSEP and RPD were 0.006 4 g•L⁻¹, 0.006 8 g•L⁻¹ and 2.50, respectively. This study suggested that SIC is superior to RS, and provided a research foundation for quality control and monitoring of S. miltiorrhiza extraction process in the future.
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Objective:To optimize the alcohol extraction process of Yiqigutuo granules. Methods: Using the L9 (34 ) orthogonal design method, the active ingredients astragaloside and ferulic acid in the formula were quantitatively analyzed by HPLC. The concen-tration and amount of ethanol, extraction times and extraction duration and the other parameters affecting the extraction volume were ex-amined. Results:Analysis of variance showed that the ethanol concentration and extraction times had significant influence on the ex-tract content and the extraction of ferulic acid. The best alcohol extraction process was as follows:70% ethanol of 10-fold volume, ex-tracting 3 times with 1. 5h for each time. Conclusion:The process is stable, and suitable for the industrial production.
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Objective To study the hypoglycemic effect and mechanism of n￣butyl alcohol extraction from Anoectochilus roxburghii. Methods The total of 12 normal rats were used as normal control group, and 48 diabetic model rats were divided into model control group, and high dose, middle dose and low dose treatment groups with 12 rats in each group,three treatment groups received Anoectochilus roxburghii at dose 600,400,200 mg.kg-1 , respectively, normal control group and model control group were administered with equal volume of 0.9% sodium chlorade solution once a day.After 21 days of drug administration, the weights of rats, the levels of blood glucose and insulin were examined. Results Compared with normal control group, the body weight in model control group decreased significantly(P<0.01), while blood glucose significantly increased (P<0.01).Compared with model control group, the body weight in Anoectochilus roxburghii groups exhibited no obvious difference,while blood glucose decreased significantly (P<0.01 or P<0.05).The level of insulin in high dose group increased remarkably (P<0.05). Conclusion The n￣butyl alcohol extraction from Anoectochilus roxburghii shows markedly hypoglycemic effect,specifically for which at high dose increases the level of insulin significantly,its mechanism may involve with promoting β cells regeneration.
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Objective To provide effective reference for quality analysis of the chemical composition and extraction of astragalus separation process by comparing the extract of astragalus and it’s IR spectra. Methods The saponins and flavonoids in astragalus were firstly extracted by the method of circumfluence with ethanol as solvent and the residue of ethanol-extraction was then used to extract polysaccharides by distilled water. Fourier transform infrared spectroscopy (IR) combined with second derivative infrared spectroscopy was applied to quickly identify astragalus herbs powder, water extraction of astragalus, astragalus alcohol extraction and water extraction of the residue of ethanol-extraction. Results The powder and 70% ethanol extract, 80% ethanol extract were around at 1 735 cm-1 (carbonyl stretching vibration absorption peak) has a weak, broad absorption, while the absorption peak was less obvious in boiling water extraction. So the maln components of astragalus water extraction are polysaccharides and also contaln a small amount of water-insoluble flavonoids. Alcohol extraction malnly contalns saponins and flavonoids, and flavonoid extract volume increases with increasing alcohol concentration in a certaln range.Conclusion This method can be a quick and easy identification for astragalus and it’s extraction for its chemical composition class, and provide the basis for further research quality.
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Objective To extraction method optimization and the content of the different parts of Xinjiang Bergenia crassifolia (L.), provide the basis for efficient extraction of Bergenia crassifolia pigment. Method Using the orthogonal experiment, the alcohol extraction process of ethanol concentration, dosage of ethanol, extraction time, extraction times, as well as to Bergenia crassifolia pigment content of the different part. Results Of optimization, the best ethanol extract of xinjiang Bergenia crassifolia pigment process conditions is 8 times the amount of 50%ethanol, extracting 3 times, each time 0.5 h. In Bergenia crassifolia pigment content of different parts exists obvious difference. Bergenia crassifolia pigment content of Taproot and fibrous root is higher, at 8.65%to 9.58%, while Bergenia crassifolia pigment content of the leaves is relatively low, at just 0.15%. Bergenia crassifolia pigment content of leaves significantly higher than the old leaves. Conclusion This experimental study on efficient extraction of xinjiang Bergenia crassifolia pigment to provide strong technical support and theoretical basis.
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Objective To ascertain the optimum condition for extracting Rhizoma polygoni cuspidati and Radix angelicae sinensis with alcohol. Method With extract yield and the amount of polydatin as index,the primary factors of affecting the extraction were optimized. Result The optimum extraction condition was as follows:taking 60% alcohol as solvent,the meterials were refluxed and extracted two times with 10 and 8 times volume of alcohol for 1.5 h and 1.0 h,respectively. Conclusion The optimum extraction process provides an experimental basis for industrial production.
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Objective To Study the relation between analgesic action of alcohol extraction of Natrix tigrina Lateralis and central nervous system. Methods Manifold ache models of experimental nerve centre were established to observe the analgesic action and degree of alcohol extraction of Natrix tigrina Lateralis to the ache models. Results Alcohol extraction of Natrix tigrina Lateralis had analgesic action to all ache models of nerve centre, and the high-dose group was obviously. Conclusions Analgesic action of alcohol extraction of Natrix tigrina Lateralis is related to effecting on central nerves system, which effects antinociceptive in central nervous.
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extraction temperature. The optimum condition of the alcohol extraction was: 35mL solvent consumption, 15 min the extraction time, 3 times of extraction, 40℃temperature of extraction for extraction process(The Gentiana Mass was 0.5g). Conclusion: The extraction times had significant effects on the extraction of gentiopicroside.
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Objective: To optimize the alcohol-extraction process and condition of Radix Pulsatillae.Methods: Alcohol concentration,the extraction time and number of extraction on effect of extraction rate of pulchinenoside B4 were evaluated by orthogonal design L9(34).Results: The optimum condition of the alcohol extraction was: 75% ethanol,3 times of extraction,3h for extraction process.Conclusion: The extraction method can be used for reference for the extraction process of Radix Pulsatillae.
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Objective: To ascertain the condition for extracting tetramethylpyrazine from Rhizoma Chuanxiong with alcohol. Methods: With the transferring rate of tetramethylpyrazine as index, the optimum extraction condition for the first time was selected by uniform test, and the times of extraction was studied. Results: Taking 80% alcohol as solvent, Rhizoma Chuanxiong was extracted two times with 8 and 6 times volume of alcohol for 2hr and 1.5hr, respectively. In this condition, tetramethylpyrazine could be effectively extracted. Conclusion: The experimental results provided the basis for the ascertainment of extraction process of Rhizoma Chuanxiong preparation.
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The tanshinone ⅡA,an effective component of Radix Salviae Miltiorrhizae(RSM)can be extracted up to 90% in alcohol,but mostly decomposed in the later concentrating and drying procedures.Although reducing-pressure concentrating processes can reduce the decomposi- tion in experiment,but it can not preserve effectively the tanshinone during the large scale production because of the extended time of tanshinone in dampness and heat.Supercritical carbon dioxide extraction(SFE-CO_2)of RSM can give crystalline substance and dark red modifier when the alcohol is used as modifier at extraction pressure of 10 Mpa and the tem- perature at 40℃.The SFE-CO_2 technology can get higher concentration of tanshinone and be used during preparation production directly.The SFE-CO_2 technology is superior to the alco- hol-extraction technology.