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According to the method of predicting the physical properties of oily powder based on the additive physical properties of Chinese medicinal powder, Dioscoreae Rhizoma and calcined Ostreae Concha with high sieve rate and good fluidity were mixed and crushed with Persicae Semen, Platycladi Semen, Raphani Semen, Ziziphi Spinosae Semen, and other typical oily materials with high fatty oil content in proportion to obtain 23 mixed powders. Fifteen physical properties such as bulk density, water absorption, and maximum torque force were measured, and the physical properties of typical oily powders were predicted. When the mixing and grinding ratio was in the range of 5∶1-1∶1, the r value in the correlation equation between the weighted average score of the mixed powder and the powder proportion ranged from 0.801 to 0.986, and the linearity was good, indicating that the method of predicting the physical properties of oily powder based on the additive physical properties of traditional Chinese medicine(TCM)powder was feasible. The results of cluster analysis showed that the classification boundaries of the five kinds of TCM materials were clear, and the similarity of the physical fingerprints of powdery and oily materials decreased from 80.6% to 37.2%, which solved the problem of fuzzy classification boundaries of powdery and oily materials due to the lack of representativeness of oily material model drugs. The classification of TCM materials was optimized, laying a foundation for optimizing the prediction model of the prescription of personalized water-paste pills.
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Medicine, Chinese Traditional , Drugs, Chinese Herbal , Powders , PrescriptionsABSTRACT
In this paper, the low-field nuclear magnetic resonance technology CPMG (Carr-Purcell-Meiboom-Gill) echo method was used to determine the cross-linking degree and cross-linking density of crospovidone (PVPP) from different manufacturers. Based on the seven physical properties of PVPP, a fingerprint spectrum (radar chart) of twenty secondary quality indicators were obtained, and three compressibility evaluation indicators, index of the parameter (IP), index of parametric profile (IPP), index of good compression (IGC) were calculated by the fingerprint spectrum. It was found that the cross-linking degree and compressibility index IP of PVPP showed a strong correlation (r = 0.816) by the correlation analysis, indicating that the cross-linking degree is one of the key quality attributes for evaluating the compressibility of PVPP.
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Chinese medicinals feature different medicinal parts and enriched components, which makes their powders show obvious microscopic identification characteristics and specific physical properties. On this basis, the commonly used Chinese medicinals can be divided into several categories, such as powdery, fibrous, sugar, oil, and brittle materials, which is of great importance to the research and development of personalized Chinese medicinal preparation technology. However, the existing classification methods are highly subjective and thus difficult to meet the requirements for the development of personalized Chinese medicinal preparations with high quality. In this study, 55 representative Chinese medicinals, such as Dioscoreae Rhizoma and Leonuri Herba, were selected, and the physical properties of their powders were systematically characterized by comprehensive powder tester, torque rheometer, texture analyzer, etc., based on which a data set encompassing physical properties of these powders was built. The typical physical fingerprints of powders from the above 5 categories were established by multivariate statistical analysis. Then, the Chinese medicinals were classified according to the Euclidean distance between each of them and the typical value in the PCA score plot. For those with multiple material properties, whose classification boundary was fuzzy, the proportions of different types of materials were calculated with the combination of Euclidean distance, powder properties, microscopic identification characteristics, and chemical composition, so as to achieve the multivariate quantitative classification of Chinese medicinals. This lays the foundation for the further creation of intelligent personalized Chinese medicinal preparation technology.
Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Powders , RhizomeABSTRACT
Objective:Taking ultrafine granular powder of Salviae Miltiorrhizae Radix et Rhizoma （UGPSMR） as the research object， to establish a method for evaluating its physical properties. Method:A method was established for measuring the particle size distribution and specific surface area of UGPSMR， and the methodological investigation was carried out. A total of 15 physical indicators ［D90 （particle size value when the cumulative particle distribution reaches 90%）， particle size distribution range， particle size distribution width， bulk density， tap density， intergranular porosity， Carr index， specific surface area， pore volume， angle of repose， tablet angle， Hausner ratio， black to white degree L*， red to green degree a*， yellow to blue degree b*］ were used to characterize the quality attributes of UGPSMR and to construct the physical fingerprint. Multivariate statistical analysis methods such as similarity analysis， cluster analysis （CA）， principal component analysis （PCA） and orthogonal partial least squares discriminant analysis （OPLS-DA） were used to evaluate the quality of 11 batches of UGPSMR （S1-S11） produced in different years， and to find out the difference index between samples from different batches. Result:The method for measuring the particle size distribution and specific surface area of UGPSMR was feasible and repeatable. The similarities between the physical fingerprint of 10 batches of samples （S1-S3， S5-S11） from production and control fingerprint of UGPSMR were above 0.85， but the similarity between sample S4 and the control fingerprint was only 0.488. There were some differences in physical property indicators between different batches of UGPSMR， and the characteristic difference indicators were intergranular porosity， specific surface area， pore volume， b*， L*， Carr index， particle size distribution width， respectively. Conclusion:This method can comprehensively evaluate the physical quality attributes of UGPSMR， and can reflect the effect of differences in material basis of the medicinal materials or production process on the physical properties of finished products， and can evaluate quality consistency between batches from the physical state level， which provides new ideas for the quality control of ultrafine granular powder of herbal medicine.
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Objective: To study the prescription and preparation technology of Carthami Flos Granules and evaluate its physical quality based on quality by design. Methods: Carthami Flos was used as a model drug. The evaluation indicators were retention rate of hydroxysafflor yellow A (HSYA) and total flavonoid, primary formation rate, bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. The single factor experiments and the Box-Behnken design response surface method were used to investigate the particle forming process parameters. The physical fingerprint of granules was constructed by seven indexes including bulk density, tap density, relative homogeneity index, Hausner ratio, angle of repose, loss on drying, and hygroscopicity. Results: The optimum conditions were as follows: the dosage ratio of drug to adjuvant was 10.8, the amount of wetting agent (95% ethanol) was 32%, and dried at 70 ℃ for 120 min. The similarity of the physical fingerprint of 10 batches of Carthami Flos Granules was higher than 0.99. Conclusion: The prescription and preparation technology of Carthami Flos Granules and the physical quality were scientific and reasonable, which can provide ideas and methods for the research and development of Chinese materia medica.
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Objective: To investigate the influence of different drying methods on physical fingerprint and total flavonoids content of Mori Ramulus extract.Method: The Mori Ramulus extract was dried by freeze drying,vacuum drying,ambient pressure drying,respectively.The content of total flavonoids in samples with different drying methods were determined and compared with each other.Physical fingerprint of Mori Ramulus extract was established by radar map and the physical fingerprint of samples with different drying methods were compared with each other.In the meantime,compressible parameters were employed to analyze the compressibility characteristics of Mori Ramulus extract treated by different drying methods.Result: Similarity of control physical fingerprint of Mori Ramulus extract treated by different drying methods was 77.8%-87.3%,relative standard deviation(RSD) of average value of the first level indexes and the compressible parameters was 0-16.6%.Except for homogeneity and stability,the remaining RSDs were less than 10%.Effects of different drying methods on homogeneity and stability of Mori Ramulus extract were greater than that of other factors.Conclusion: Different drying methods have certain effects on physical fingerprint of Mori Ramulus extract,but they have little influence on total flavonoids content in Mori Ramulus extract.
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Objective To establish the physical fingerprint of Shengmai Injection and evaluate its quality. Methods The physical fingerprint was visually showed by the radar map consisting of eight indexes (conductivity, pH, turbidity, refractive index, solid content, relative density, kinematic viscosity, and osmolality). Correlation coefficient method was used to calculate the similarity between the fingerprints and the control fingerprints. Results The products physical fingerprints and parameters of the same species from different manufacturers were quite different. In some companies, the quality of the same product was also unstable among different batches and specifications, mainly reflected in the three indicators of osmolality, conductivity, and turbidity. Conclusion Physical fingerprints can be used to evaluate the quality of Shengmai Injection and provide some ideas for the quality re-evaluation of Chinese medicine injection.
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Objective To optimize the vacuum drying process of extract paste of Huangqi Baihe Granules (HBG) and evaluate the physical quality of powder. Methods With drying temperature, vacuum degree, and material thickness as independent variables, the comprehensive evaluating indexes of content of calycosin 7-O-β-D-glucopyranoside, hesperidin, crude polysaccharide, ethanol extraction amount, and drying rate as response values, Box-Behnken design-response surface methodology and G1-entropy method were used to optimize the vacuum drying process. The similarity of fingerprints between extract powder dried by the optimized technology and extract paste was compared. Additionally, the properties of powder were evaluated comprehensively with nine physical indicators, including relative homogeneity index, bulk density, tap density, interparticle porosity, compressibility, Hausner ratio, angle of repose, moisture content, and hygroscopicity. The physical fingerprint of powder were established to evaluate the quality consistency of different batches of extract powder. Results The optimal drying parameter was as follows: the drying temperature was 68 ℃, the vacuum degree was 0.07 MPa, the material thickness was 6 mm. Three verification experiments were carried out under these conditions and the average comprehensive evaluating indexes of vacuum drying was 91.05, which was close to the model prediction 91.87, and the relative error was 0.89%. Compared with the extract paste, the similarity of fingerprint of extract powder were more than 0.91. The similarity of chemical and physical fingerprint of three batches of extract powder were higher than 0.99. Conclusion The optimized vacuum drying technology of extract paste of HBG is stable and feasible.
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The method of physical fingerprint spectrum for Reduning injection (RI) was proposed in this paper to improve its quality standards based on the strong correlation between physicochemical properties of drugs, their safety, effectiveness and stability. The quality of RI was studied by the thought and method of physical chemistry. The physical fingerprint spectrum was visually showed by the radar map, and consisted of eight indexes (pH, conductivity, turbidity, refractive index, osmolarity, surface tension, relative density, and kinematic viscosity). Then 12 batch of samples were verified. It was found that the physical fingerprint spectra of 3 batches of RI were in line with the standards within their validity time, with similarity above 0.999; in addition for the expired 9 batches of RI, their physical fingerprint spectra did not meet the standards. The results showed that physical fingerprint spectrum can be used for the quality control of RI, with a certain exemplary role in the quality evaluation of traditional Chinese medicine injection.
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In this paper, the granules intermediate prepared from the wet granulation process of ginkgo leaf tablet were taken as the research object, and then the stackability, homogeneity, flowability, compressibility and stability of granules were characterized by using micromeritics evaluation method. The physical fingerprint of granules were constructed by 16 indexes including bulk density, tapped density, span, width, relative homogeneity index, aspect ratio, Hausner ratio, angle of repose, granule flow time, inter-particle porosity, Carr index, specific surface area, pore volume, pore size distribution, loss on drying and hygroscopicity. Furthermore, compressibility parameters (i.e. index of parameter, index of parametric profile and index of good compression) were employed to analyze the compressibility characteristics of the granules. Two principal components (first principal component representing dimension parameter and second principal component representing morphology parameter), could be extracted from the physical fingerprint by the principal component analysis (PCA). The granules' physical fingerprint is of great importance to evaluate the batch-to-batch quality consistency of Ginkgo biloba granules and analyze the potential impacts of granules' quality attributes on product quality, which can provide guidance for the granules' quality control and process development..
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The physical properties of both raw materials and excipients are closely correlated with the quality of traditional Chinese medicine preparations in oral solid dosage forms. In this paper, based on the concept of the chemical fingerprint for quality control of traditional Chinese medicine products, the method of physical fingerprint for quality evaluation of traditional Chinese medicine extract powders was proposed. This novel physical fingerprint was built by the radar map, and consisted of five primary indexes (i.e. stackablity, homogeneity, flowability, compressibility and stability) and 12 secondary indexes (i.e. bulk density, tap density, particle size<50 μm percentage, relative homogeneity index, hausner ratio, angle of repose, powder flow time, inter-particle porosity, Carr index, cohesion index, loss on drying, hygroscopicity). Panax notoginseng saponins (PNS) extract was taken for an example. This paper introduced the application of physical fingerprint in the evaluation of source-to-source and batch-to-batch quality consistence of PNS extract powders. Moreover, the physical fingerprint of PNS was built by calculating the index of parameters, the index of parametric profile and the index of good compressibility, in order to successfully predict the compressibility of the PNS extract powder and relevant formulations containing PNS extract powder and conventional pharmaceutical excipients. The results demonstrated that the proposed method could not only provide new insights into the development and process control of traditional Chinese medicine solid dosage forms.