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1.
China Pharmacy ; (12): 2473-2478, 2021.
Article in Chinese | WPRIM | ID: wpr-887427

ABSTRACT

OBJECTIVE:To establish the fingerprint of Fritillariae thunbergii formula granules and determine the contents of 3 components. METHODS :HPLC method was used. Using peiminine as reference ,HPLC fingerprints of 13 batches of F. thunbergii formula granules were drawn with Similarity Evaluation System of TCM Chromatogram Fingerprint (2012 edition). Similarity evaluation and common peak identification were conducted. The contents of peimisine ,peimine and peiminine in F. thunbergii formula granules were determined by the same HPLC method. The quality difference of samples were compared among different manufacturers. RESULTS :There were 5 common peaks in 13 batches of F. thunbergii formula granules ,and the similarity was 0.669-0.971. Three common peaks of peimisine ,peimine and peiminine were identified. The linear ranges of peimisine ,peimine and peiminine were 30.00-180.00 μg/mL(r=0.999 9),79.58-477.50 μg/mL(r=0.999 6)and 97.33-584.00 μg/mL(r=0.999 4), respectively. RSDs of precision ,stability(24 h)and reproducibility tests were all lower than 3%. The average recoveries were 95.82%(RSD=1.17%,n=6),99.00%(RSD=1.96%,n=6)and 95.39%(RSD=2.00%,n=6),respectively. In the 13 batches of samples ,the content of peimisine ,peimine and peiminine were 0.17-1.02 mg/g,0.52-2.26 mg/g,and 0.70-3.50 mg/g, respectively. Their average total content was 3.62 mg/g. The average total content of manufacturer C and A was higher (5.02 mg/g and 4.61 mg/g),followed by manufacturer E and B (3.48 mg/g and 3.02 mg/g);the lowest was manufacturer D(only 1.87 mg/g). CONCLUSIONS:Established fingerpri nt and content determination method is simple ,feasible and reproducible ,which can be used for the quality evaluation of F. thunbergii formula granules. There are some differences in content among different manufacturers.

2.
Article in Chinese | WPRIM | ID: wpr-879014

ABSTRACT

To establish the method for determining non-volatile ingredients of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, isochlorogenic acid A, rosmarinic acid, ferulic acid, rutin, luteoloside, isoquercitrin, hesperidin, diosmin, diosmetin, luteolin, acacetin and linarin in Menthae Haplocalycis Herba formula granules and traditional herbal pieces by UPLC-MS/MS, and analyze the correlation of non-volatile ingredients in Menthae Haplocalycis Herba formula granules and traditional herbal pieces. Shim-pack GIST C_(18) column(2.1 mm×100 mm, 2 μm) was adopted with acetonitrile-0.1% formic acid aqueous solution as the mobile phase for gradient elution at the flow rate of 0.4 mL·min~(-1). The column temperature was set at 35 ℃. The quantitative analysis was performed using the electrospray ionization source and the multiple reaction monitoring. The linear relationship, resolution, repeatability and recovery of the 16 chemical components all met the requirements. The 16 non-volatile ingredients in traditional herbal pieces of Menthae Haplocalycis Herba could be tracked in formula granules. There were certain differences of the 16 chemical components among Menthae Haplocalycis Herba formula granules of different manufacturers and traditional herbal pieces of different producing areas. The UPLC-MS/MS method was simple, rapid and accurate, and could be used for the quality control of non-volatile ingredients in Menthae Haplocalycis Herba formula granules and traditional herbal pieces.


Subject(s)
Chromatography, High Pressure Liquid , Chromatography, Liquid , Correlation of Data , Drugs, Chinese Herbal , Tandem Mass Spectrometry
3.
China Pharmacy ; (12): 1051-1056, 2021.
Article in Chinese | WPRIM | ID: wpr-876576

ABSTRACT

OBJECTIVE:To study the improvement eff ects and its mech anism of Guiyuan decoction formula granules (GDFG) on model mice with decreased ovarian reserve (DOR). METHODS :Totally 42 female ICR mice whith with normal estrous cycle were randomly divided into control group ,model group ,estradiol valerate group (positive control ,0.15 mg/kg)and GDFG low-dose,medium-dose and high-dose groups (0.75,1.49,2.98 g/kg),with 7 mice in each group. Except for control group ,other groups were given cisplatin (3 mg/kg)intraperitoneally to establish DOR model. After modeling ,administration groups were given relevant medicine intragastrically;model group and control group were given normal saline intragastrically ,once a day ,for consecutive 4 weeks. After last administration ,ELISA assay was used to measure the serum levels of anti-Müllerian hormone (AMH)and follicle-stimulating hormone (FSH)in mice. Histopathological morphology of ovarian was observed by HE staining. Protein distribution of AMH receptor Ⅱ(AMHRⅡ)and Smad 4 in ovarian tissue were observed by immunohistochemistry. Protein expression of AMHR Ⅱ and Smad 4 were detected by Western blot assay. RESULTS :Compared with control group ,theserum level of AMH ,the expression of AMHR Ⅱ and Smad 4 protein in ovarian tissue in model group were significantly decreased (P<0.01),while the FSH level in serum was significantly increased (P<0.01);follicles were crumpled and lost nucleus ,ovarian interstitial were fibrosis ,luteum were loose ; AMHRⅡ and Smad 4 protein in ovarian tissue were mainly distributed in the follicle membrane and ovarian interstitial. Compared with model group ,the serum level of AMH ,the expression of AMHR Ⅱ and Smad 4 protein in ovarian tissue was increased significantly in GDFG groups (P<0.01),while the serum level of FSH was decreased significantly (P<0.05 or P<0.01);in ovarian tissue ,follicles at all levels could be found and follicle morphology was improved ,and no obvious nuclear loss and cumulus formation were found ;AMHRⅡ and Smad 4 protein were mainly distributed in the follicular nucleus (except for GDFG high-dose group) and the granular cell membrane (mainly distributed in the sinus follicles of GDFG medium-dose group );they were slightly distributed around the mature follicular nucleus or in corpus luteum. CONCLUSIONS :GDFG can improve ovarian function of DOR model mice. The mechanism may be related with promoting serum level of AMH ,protein expression of AMHR Ⅱ and Smad 4,improving the distribution of AMHR Ⅱ and Smad 4 protein in ovarian granulosa cell membrane and follicular nucleus , reducing FSH levels.

4.
Article in Chinese | WPRIM | ID: wpr-846131

ABSTRACT

By referring to Chinese Pharmacopoeia 2015 edition and relevant literatures, combining the Technical Requirements for Quality Control and Standard Formulation of Traditional Chinese Medicine Formula Granules (Draft for Comments) issued by China Pharmacopoeia Committee in 2016, and considering the actual production situation of formula granules, the specificity of quality standards, the selection of quantitative detection indexes, index component transfer rate and other aspects in the Publicity of Uniform Standards for Trial Use of Traditional Chinese Medicine Formula Granules were comprehensively discussed. According to the results of the discussion, relevant suggestions are put forward for the development and improvement of the quality standard of traditional Chinese medicine formula granules, which provides reference for promoting the healthy development of formula granule industry.

5.
Article in Chinese | WPRIM | ID: wpr-828434

ABSTRACT

To evaluate the quality of Moutan Cortex Formula Granules from different manufacturers based on the structural characteristics of the genuine components of Moutan Cortex. High performance liquid chromatography(HPLC) fingerprint analysis method of Moutan Cortex Formula Granules was established to characterize the elements of the structural characteristics for genuine Moutan Cortex. Nineteen common peaks were determined and the similarity between the Moutan Cortex Formula Granules of each batch and the control fingerprint was 0.856-0.981. The results showed that there were differences in the internal quality of Moutan Cortex Formula Granules from three manufacturers. The contents of components as well as inter-component and intra-component quantity ratio for Moutan Cortex Formula Granules from different manufacturers were analyzed. It was found that the inter-component quantity ratio of G1 and G2 produced by manufacturer A was close to that of G4 produced by manufacturer B; the inter-component quantity ratio of G3 from manufacturer B was close to that of G7 from manufacturer C; and the inter-component ratios of samples G5, G6, G8-G11 produced by manufacturer C were closer to each other. The results of the study guided by the theory of "component structure" provide a new analytical method and basis for the quality evaluation of Moutan Cortex Formula Granules.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Paeonia
6.
Article in Chinese | WPRIM | ID: wpr-773720

ABSTRACT

To evaluate the pesticide residue risk of Jinyinhua Formula Granules( made from Lonicerae Japonicae Flos) used in the market preliminarily,20 samples of Jinyinhua Formula Granules from 5 manufactures were collected randomly through the national evaluative sampling test program. Totally 262 pesticides( involving 270 chemical monomers) with monitoring significance to traditional Chinese medicinal materials were detected. Samples were extracted by high speed homogenate with acetonitrile as solvent. And their residues were analyzed by GC-MS/MS and LC-MS/MS in MRM mode. No less than 2 groups of characteristic ion pairs were adopted for qualitative detection,and the calibration curve method was used for quantitative detection. The results showed that 20 pesticides were detected in 20 batches of Jinyinhua Formula Granules,with an average of about 9 pesticides detected in every batch,but no restricted pesticide was detected. The detected pesticides were all at the trace level,which was far lower than the limit of the general food standard. Therefore,the safety risk was low in Jinyinhua Formula Granules. In this study,a screening method for pesticide residues in Jinyinhua Formula Granules was established for the first time. The method was accurate and rapid,and the detection indicators were highly targeted. The results could provide theoretical reference for the prevention and control of pesticide safety risks in Jinyinhua Formula Granules and even traditional Chinese medicine formula granules.


Subject(s)
Chromatography, Gas , Chromatography, Liquid , Drug Contamination , Drugs, Chinese Herbal , Pesticide Residues , Quality Control , Tandem Mass Spectrometry
7.
Article in Chinese | WPRIM | ID: wpr-773127

ABSTRACT

A scientific and perfect quality evaluation system for Moutan Cortex Formula Granules was established,including content determination method,characteristic chromatogram method and mass spectrometry method. The content of paeoniflorin and paeonol in Moutan Cortex Formula Granules was determined by high performance liquid chromatography( HPLC),and the average content was 1. 72% and 1. 42%,respectively. The characteristic chromatogram was used to characterize Moutan Cortex Formula Granules,which contained 7 characteristic peaks,namely gallic acid,p-hydroxybenzoic acid,oxypaeoniflorin,paeoniflorin,tetragalloyl glucose,1,2,3,4,6-penta-O-galloyl-β-D-glucose and paeonol. A total of 40 compounds in Moutan Cortex Formula Granules,including gallic acids,paeoniflorins,paeonols,flavonoids and benzoic acids,were identified by mass spectrometry. In this study,a variety of analytical methods were used to evaluate the quality system of Moutan Cortex Formula Granules,which could play a positive role in improving the level of quality evaluation and process quality control.


Subject(s)
Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Paeonia , Chemistry , Phytochemicals , Quality Control
8.
Article in Chinese | WPRIM | ID: wpr-851442

ABSTRACT

Objective To study the dry extract rate, determination and transfer rate of maker compounds, and fingerprint of standard decoction of ginger juice Magnoliae Officinalis Cortex (GJMOC) and provide a reference for the preparation and quality assessment of its dispensing granules by establishing 16 batches of standard decoction of GJMOC. Methods A total of 16 batches of GJMOC standard decoctions were prepared following literature requirements. The quantitative analysis method of magnolol and honokiol was according to Chinese Pharmacopoeia (2015 edition). The transfer rate of total magnolol and honokiol and extraction rate were calculated. the pH value was determined and HPLC fingerprint was established under a flow rate of 1 mL/min and eluted with a mobile phase of acetonitrile (A)-0.1% phosphoric acid solution (B) in a gradient mode (0-15 min, 12%-16% A; 15-30 min, 16%-28% A; 30-42 min, 28%-74% A; 42-55 min, 74%-80% A). The column temperature was set at 40℃ and the detection wavelength was 294 nm. Results By measuring the of 16 batches of standard decoction, the transfer rate of the sum of magnolol and honokiol ranged from 6.5% to 12.0%, the extraction rate was at a range of 3.41% to 7.14% and pH value was 4.63 to 5.43. The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprints, and seven common peaks were determined and four were identified including magnoloside B (peak 1), magnoloside A (peak 2), honokiol (peak 6), and magnolol (peak 7). The similarity among 16 batches of standard decoction of GJMOC was evaluated, and the similarity was all greater than 0.69. Moreover, this study established an HPLC fingerprint analysis method of GJMOC standard decoction. Conclusion The preparation method established in this study is stable and feasible, and the analysis method shows good precision, stability, and repeatability in fingerprint analysis and it is suitable for evaluating the quality of standard decoction of GJMOC.

9.
China Pharmacy ; (12): 1898-1901, 2019.
Article in Chinese | WPRIM | ID: wpr-817202

ABSTRACT

OBJECTIVE: To provide reference for the establishment of quality standard of Tussilago farfara formula granules. METHODS: TLC method was used for qualitative identification of tussilagone in T. farfara formula granules. The content of tussilagone in T. farfara formula granule was determined by HPLC. The determination was performed on a Thermo ODS Hypersil C18 column with the mobile phase consisted of methanol-water (85 ∶ 15, V/V) at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm, the column temperature was 25 ℃. Sample size was 20 μL.  RESULTS: TLC spots of tussilagone were clear and well-separated, without interference from negative control. The linear range of tussilagone was 1.39-27.75 μg/mL (r=0.999 9). The limits of quantification and detection were 0.153 87 and 0.051 42 μg/mL, respectively. RSDs of precision, stability and reproducibility tests were lower than 2%. The recoveries were 97.12%-103.96% (RSD=2.60%, n=6). CONCLUSIONS: The method is simple, accurate and reproducible, and suitable for quality control of T. farfara formula granules.

10.
China Pharmacy ; (12): 937-941, 2019.
Article in Chinese | WPRIM | ID: wpr-817018

ABSTRACT

OBJECTIVE: To optimize and improve the quality standard for Citrus reticulata formula granules. METHODS: Totally 13 batches of C. Reticulata formula granules from 4 different manufacturers were used as trial samples, and qualitative identification of hesperidin and nobiletin in the samples were carried out by TLC according to the method of 2015 edition of Chinese Pharmacopoeia (part Ⅳ). The quantitative analysis of naringin, hesperidin, hesperetin, nobiletin and tangeretin in C. reticulatae formula granules were conducted by UPLC[The determination was performed on Waters Acquity UPLC BEH C18 column with mobile phase consisted of acetonitrile-0.2% phosphoric acid aqueous solution (gradient elution). The detection wavelength was set at 283 nm, and sample size was 3 μL]. RESULTS: The results of TLC showed that in the chromatograms of samples, same color spots were shown in the corresponding positions of the chromatogram of reference substance. The results of UPLC showed, that the linear range of naringin, hesperidin, hesperetin, nobiletin and tangeretin were 0.64-6.44, 15.78-157.80, 0.17-1.66, 2.08-20.85 and 2.04-20.43 μg/mL, respectively (all r≥0.999 2); the limits of detection were 0.03, 0.33, 0.10, 0.20 and 0.06       μg/mL; the limits of quantitation were 0.07, 1.34, 0.20, 0.60 and 0.22 μg/mL. The average recoveries were 99.4%, 99.6%, 99.7%, 99.7% and 99.7% (n=9); RSDs of precision (n=6), stability (n=7) and reproducibility (n=6) tests were all≤2.03%; naringin was detected in only 3 batches of samples from one manufacturer (the content ranged from 0.067 3 to 0.069.6    mg/g), while the other 4 components were detected in 13 batches of samples (the contents of them ranged 0.646 5-1.728 0,   0.102 6-0.290 5, 0.023 1-0.689 8, 0.018 2-0.270 7 mg/g). CONCLUSIONS: In this study, the quality standard of C. reticulata formula granules was improved by qualitative and quantitative methods, and the contents of hesperidin, hesperetin, nobiletin and tangeretin were not less than 0.60, 0.10, 0.02 and 0.01 mg/g, respectively.

11.
Article in Chinese | WPRIM | ID: wpr-852209

ABSTRACT

Objective To optimize the prescription of dry granulation process of Anti-Hashimoto’s Thyroiditis Formula Granules. Methods Regarding primary formation rate, friability, and dissolubility and comprehensive in granulation process as indexes, the physical properties of water content, the angle of repose and the degree of compression were investigated to select dry granulation prescription. The technological parameters including horizontal speeds, rotate speed of roller and pressure rollers were screened by L9(34) orthogonal experiment were composed to be optimal technological prescription, and the optimum process was verified. Results The optimum lubricant and accessories ratio were 0.5% magnesium stearate and 20% dextrin respectively. The optimized dry granulation process parameters: horizontal speed 30 r/min, press roll speed 5 r/min and press roll pressure 7 MPa. Conclusion The optimized dry granulation preparation technology is feasible and reasonable, which shows good flakes continuous and granules with color uniformity, suitable rigidity and well formability in dry granulation preparation. After three batches of pilot-scale test, the dry granulation preparation technology is stable and feasible.

12.
Article in Chinese | WPRIM | ID: wpr-851805

ABSTRACT

Objective: To study the prescription and process of Fritillariae Thunbergii Bulbus (FTB) formula granules. Methods: FTB was extracted by decocting method. FTB extract powder was prepared by spray drying method. Wet-extruding granulating, extruded-rolling granulating, and one-step granulating were adopted for preparing the formula granules. A comprehensive evaluation method was based on the powder fluidity parameters such as the rest angle, the final volume reduction degree (a), the filling velocity constant (b, k), and the yield of the particles, to optimize the optimum preparation process, prescription excipients and their proportion. An HPLC method was used to determine the contents of peimine and peiminine. The chromatographic column was the Agilent Zorbax Eclipse XDB-C18 column (150 mm × 4.6 mm, 5 μm), and the flow phase was Acetonitrile-water-diethylamine (70:30:0.03); The volume flow was 1.0 mL/min; The column temperature was 30 ℃. Results: The synthesis score of the FTB formula granules prepared by one-step granulating method was the highest. The best prescription was the extract powder-dextrin- 95% ethanol solution (100:100:160). The particle yield was 91.3%, the rest angle was 30.73°, the value of a was 0.109 1, the value of b was 0.025 5 and the value of k was 0.030 1, the fluidity of the granules was good and the yield was high. The content of peimine was 0.305% and the content of peiminine was 0.098% in the particles by HPLC. Conclusion: In this experiment, the formulation and process of FTB formula granules were designed to met the design requirements, which could be used in the production of the technology.

13.
Article in Chinese | WPRIM | ID: wpr-851714

ABSTRACT

The characteristics of Chinese materia medica (CMM) decoction with its composition, usage, and dosage can be flexibly changed with the actual situation. It has been used for thousands of years and it is still the most commonly used form of Chinese medicine. However, there are few research on the quality of “decoction” of CMM. Some scholars put forward the concept of “standard decoction”. As a standard substance and standard system, the standard decoction of CMM not only ensures the efficacy of clinical medication, but also can be used to standardize other dosage forms of clinical medicine. In this article, the influencing factors of the “standard” decoction were analyzed and discussed to standardize the preparation of decoction process and ensure the accuracy of the clinical medication and the consistency of efficacy, and provide reference for the research of formula granules, classical prescription, and CMM compound.

14.
Article in Chinese | WPRIM | ID: wpr-690700

ABSTRACT

To establish HPLC-MS/MS method for simultaneous determination of 14 toxic or active components in Fuzi formula granules, and further analyze the quality consistency of 29 batches of formula granules by considering the cluster analysis (CA), principal component analysis (PCA), and partial least squares discriminant analysis (PLS-DA) and other chemometrics methods. Phenomenonex Gemini C18 column (4.6 mm×150 mm, 5 μm) was used with 0.1% formic acid solution (A) -acetonitrile (B) as the mobile phase. The mass spectrum was scanned by ESI⁺ multiple reaction monitoring (MRM) mode. The contents of aconitine, mesaconitine, hypaconitine, Indaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconitine, aconine, fuziline, neoline, talatisamine, songorine, higenamine and salsoline were determined. The results showed that 14 compounds had a good linear relationship within their respective concentration range (R²>0.990 0). The limit of quantification was 2.07-7.71 mg·L⁻¹, and the average recovery was 96.07%-102.2%. The content determination results demonstrated that all batches of Fuzi formula granules had very low hypertoxic ingredients and high safety, while the content of active ingredients was greatly different. CA and PCA results showed that there were significant differences in the formula granules between two manufacturers; even though the different batches of samples from the same manufacturer had certain differences, but the difference in manufacturer A was less than that of B. Further PLS-DA showed that the content of cardiotonic substance salsola in the formula granules from manufacturer A was generally higher, while the contents of analgesic and anti-inflammatory substances benzoylmesaconitine and fuziline were generally lower than those in the products from manufacturer B. In conclusion, the safety of Fuzi formula granules was assured well, but the consistency needed to be improved. We recommend that all manufacturers establish strict standard for decoctions in the production process, and form a unified standard method to produce better Fuzi formula granules.

15.
Article in Chinese | WPRIM | ID: wpr-690544

ABSTRACT

To build the quality standard of processed Cinnamomi Cortex standard decoction and provide quality reference for Cinnamomi Cortex formula granules. Fourteen batches of Cinnamomi Cortex standard decoction pieces were prepared according to the preparation requirements for standard decoction of Chinese herbal medicine containing volatile oil. With cinnamaldehyde as the quantitative index, the transfer rate and extraction rate were calculated; pH value was determined and HPLC fingerprint analysis method was established. By the measurement of 14 batches of standard decoction, the transfer rate ranged from 25.0% to 68.4%; the extraction rate was at a range of 3.7% to 10.1% and pH was 3.72 to 5.48. Then the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012A) was used to analyze and compare the fingerprints. Four common peaks were determined and three were identified including coumarin (peak 1), cinnamic acid (peak 2) and cinnamaldehyde (peak 3). Moreover, the similarity was 1.0. This study established an HPLC fingerprint analysis method of processed Cinnamomi Cortex standard decoction. The method showed good precision, stability and repeatability in fingerprint analysis, with significance in identification.

16.
Article in Chinese | WPRIM | ID: wpr-710166

ABSTRACT

AIM To establish an HPLC method for the simultaneous content determination of five constituents in Baishao Formula Granules (Paeoniae Radix Alba).METHODS The analysis of aqueous extract of this drug was performed on a 30 ℃ thermostatic Phenomenex C18 column (4.6 mm × 250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.05% phosphoric acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 230 nm.RESULTS Paeoniflorin,albiflorin,paeoniflorin sulfonate,gallic acid and benzoic acid showed good linear relationships within the ranges of 0.020-0.639 mg/mL (r =0.999 8),0.005-0.172 mg/mL (r =0.999 9),0.020-0.652 mg/mL (r =1.000 0),0.003-0.097 mg/mL (r =0.999 8),0.002-0.058 mg/mL (r =0.999 7),whose average recoveries were 99.1%,98.3%,98.6%,98.1% and 99.5% with the RSDs of 1.86%,1.37%,1.69%,1.46% and 2.26%,respectively.The contents of various constituents in twenty-seven batches of samples demonstrated obvious differences.CONCLUSION We should pay attention to Paeoniae Radix Alba in Baishao Formula Granules due to its unstable quality.

17.
Article in Chinese | WPRIM | ID: wpr-775411

ABSTRACT

The fingerprint technology could reflect the internal chemical characteristics of Chinese herbal medicine or preparation, which has the characteristics of "wholeness" and "fuzziness". It is suitable for evaluating the quality of intermediate and finished products in the production process of traditional Chinese medicine formula granules. In this paper, the applications of high performance liquid chromatography (HPLC), thin layer chromatography (TLC), gas chromatography (GC) and infrared spectrum (IR) fingerprint technology in the quality control of traditional Chinese medicine formula granules were reviewed, and their advantages and disadvantages were analyzed. The aim of this article is to enhance the combined application of various fingerprint technologies in traditional Chinese medicine formula granules. It could provide technical reference for realizing the stability of production process and improving the overall quality of formula granules.


Subject(s)
Chromatography, High Pressure Liquid , Chromatography, Thin Layer , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Quality Control
18.
China Pharmacy ; (12): 4182-4185, 2017.
Article in Chinese | WPRIM | ID: wpr-704402

ABSTRACT

OBJECTIVE:To provide reference for exploring the strategy of promoting TCM formula granules.METHODS:The questionnaire was designed to investigate the cognition and attitude of TCM practitioners from different grades to TCM formula granules in our university,and the investigation data were analyzed statistically.RESULTS:A total of 312 questionnaires were collected and 306 questionnaires were collected with recovery rate of 98.08%.Among them,305 questionnaires were effective with effective rate of 99.67%.46.89% of interviewed practitioners were found to know and understand about TCM formula granule,52.46% knew but did not understand;the higher the grade,the higher the proportion of the known and the better understanding (P<0.05);the cognitive channels included diagnosis and treatment course (69.64%),took by others (65.02%),took by oneself (51.49%).TCM formula granules were easy to take without decoction (95.71%) and easy to carry (87.13%),the advantage of which had high popularity,but there was not much knowledge about other advantages.7.54% of interviewed practitioners fully appreciated TCM formula granules and 69.18% recognized them;the higher the grade,the higher the degree of recognition (P< 0.05).89.51% were willing to learn more about TCM formula granules.60.98% said they would prescribed TCM formula granules in the furure.Among the influential factors for the attitude of the practitioners to TCM formula granules,the three factors with the highest influence were the influence of the teachers,the influence of the patients and their own practice.CONCLUSIONS:The practice of TCM practitioners in our university in Beijing is not ideal for the cognition of TCM formula granules.There is still a great room for improvement in the attitude to TCM formula granules.The teachers and patients are key influential factors for the attitude to TCM formula granules.

19.
Article in Chinese | WPRIM | ID: wpr-608137

ABSTRACT

Objective To study the correlation of fingerprint chromatograms of Cinnamomi Ramulus formula granules, decoction pieces and water decoction by HPLC; To investigate the difference of main chemical constituents among different forms. Methods The Diamonsil C18 column (4.6 mm × 250 mm, 5 μm) was used with mobile phase of acetonitrile and 0.1% phosphoric acid at the flow rate of 1.0 mL/min, with detection wave of 280 nm and temperature of 30 ℃. The detection of 10 batches of Cinnamomi Ramulus formula granules, 10 batches of decoction pieces and 10 batches of water decoction were established respectively. Results Totally 12 peaks in the HPLC fingerprint chromatogram from 10 batches of formula granules could be tracked in the water decoction; 10 peaks in the HPLC fingerprint chromatogram could be tracked in the decoction pieces. Three components, such as protocatechuic acid, coumarin and cinnamic acid were verified. Conclusion The main chemical components of Cinnamomi Ramulus formula granules and water decoction are basically the same, and the common component contents have similar proportion.

20.
China Pharmacy ; (12): 2978-2980, 2017.
Article in Chinese | WPRIM | ID: wpr-617680

ABSTRACT

OBJECTIVE:To establish UPLC fingerprint of Gehua formula granules. METHODS:UPLC method were adopted. The determination was performed on Zorbax Eclipse XDB-C18 column with mobile phase consisted of acetonitrile-water at the flow rate of 0.5 mL/min. The detection wavelength was set at 264 nm,column temperature was 25 ℃,and the sample size was 1 μL. Using tectorigenin as reference substance,UPLC chromatograms of 10 batches of Gehua formula granules were determined. The common peak identification and similarity evaluation were conducted by TCM Chromatogram Fingerprint Similarity Evaluation Sys-tem(2004 A edition). RESULTS:14 common peaks were identified in UPLC chromatograms of 10 batches of Gehua formula gran-ules and similarities were all higher than 0.90. UPLC chromatograms of 10 batches of samples were in good agreement with control fingerprint. CONCLUSIONS:Established UPLC fingerprint can provide reference for identification and quality evaluation of Gehua formula granules.

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