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1.
China Pharmacy ; (12): 458-464, 2022.
Article in Chinese | WPRIM | ID: wpr-920463

ABSTRACT

OBJECTIVE To prepare Neuritic acid oral emulsion ,to optimize its formulation and preparation technology ,and to investigate its stability. METHODS Neuritic acid oral emulsion was prepared by mechanical method. On the basis of single factor experiment ,the appearance ,centrifugal stability ,centrifugal stability constant (Ke)and particle size of the emulsion as indexes,the formulation was optimized by orthogonal design ,taking the dosage of oleic acid ,octylphenol polyoxyethylene ether-10 and propylene glycol as factors ,the preparation technology was optimized by taking emulsification temperature ,shear time,pressure of high-pressure homogenization and cycle times of high-pressure homogenization as factors. The content of neuritic acid was determined by high performance liquid chromatography. The stability of Neuritic acid oral emulsion was investigated by high temperature test ,accelerated test and long-term test. RESULTS The optimal formulation and preparation technology were as follows:neuritic acid of 1 g,oleic acid of 5% ,octylphenol polyoxyethylene ether- 10 of 4% ,propylene glycol of 2% , emulsification temperature of 60 ℃ ,shear time of 2 min,homogenization pressure of 40 MPa and cycle times of twice. After three experiments ,the average particle size of Neuritic acid oral emulsion was 158.05 nm(RSD=1.58%,n=3),the average Ke was 0.39(RSD=1.49%,n=3),and the appearance was uniform milky white ,there was no stratification. The results of high temperature test showed that Neuritic acid oral emulsion was prone to stratification in high temperature environment ,and the content of neuritic acid increased. The results of accelerated test and long-term test showed that there was no significant change in the appearance or the content of neuritic acid when Neuritic acid oral emulsion was placed at room temperature for 6 months. CONCLUSIONS The formulation and preparation technology are stable and feasible ,and can be used for the preparation of Neuritic acid oral emulsion. Neuritic acid oral emulsion should not be placed in high temperature environment. It has good stability at room temperature for 6 months.

2.
China Pharmacy ; (12): 413-418, 2022.
Article in Chinese | WPRIM | ID: wpr-920456

ABSTRACT

OBJECTIVE To prepare Leonurine hydrochloride tablets and evaluate the quality. METHODS The wet granulation technology was adopted ;leonurine hydrochloride was used as the crude drug ,and the types of fillers ,disintegrants,binders and lubricants were screened by single-factor experiments. Combined with orthogonal experiments ,using the cumulative dissolution rate within 15 minutes(using water as dissolution media )as index ,the proportion of disintegrants ,the mass fraction of binder solution,and the proportion of lubricants were screened and verified. The in vitro dissolution behavior of the prepared Leonurine hydrochloride tablets (dissolution media were hydrochloric acid solution of pH 1.2,acetic acid-sodium acetate solution of pH 4.5, phosphate buffer solution of pH 6.8,water),tablet appearance ,hardness,friability and content uniformity were tested according to the general principles in 2020 edition of Chinese Pharmacopoeia (part Ⅳ). RESULTS The optimal formulation of Leonurine hydrochloride tablets included leonurine hydrochloride crude drug of 500 mg,dextrin of 9 250 mg,crosslinking polyving y- pyrrolidone of 200 mg,magnesium stearate of 50 mg,1% hydroxypropyl methyl cellulose solution of 4 mL. The average 15-minute cumulative dissolution rate of the three batches of tablets was 81.25%(RSD=1.12%,n=3). In above 4 dissolution media,the dissolution equilibrium of prepared tablets could be reached within 30 minutes,and the cumulative dissolution rates exceeded 85%. The prepared tablets had uniform beige in color ,smooth surface ,complete edge ,no mottle ,spot,foreign matter , etc.,hardness of 57.3 N(n=6),weight loss rate of 0.15%. The content uniformity was in accordance with relevant provisions in 2020 edition of Chinese Pharmacopoeia (part Ⅳ). CONCLUSIONS Leonurine hydrochloride tablets are successfully prepared , and the quality comply with relevant regulations.

3.
Article in Chinese | WPRIM | ID: wpr-927942

ABSTRACT

Essential oils from Chinese medicine are popular in the fields such as medicine, food, and cosmetics because of their unique biological characteristics. However, since essential oils are lipophilic compounds with high volatility, poor stability, and strong irritation, various preparation technologies need to be employed to improve stability, reduce irritation, and increase bioavailability. At present, a variety of preparation technologies have been applied to the encapsulation of essential oils. Various encapsulation strategies are formed because of different delivery systems featured with multiple principles and characteristics and are widely used to improve the stability of essential oils. Essential oils of Chinese medicine are widely used in the medical field, and they are under continuous innovation and development in clinical research, the pharmaceutical industry, medical products, etc. The present study summarized various delivery systems that could improve the stability of essential oils and reviewed the applications of essential oils encapsulated in the delivery systems in the medical field to provide re-ferences for the improvement of stability of essential oils and their safety, efficiency, and wide use in the medical field.


Subject(s)
China , Oils, Volatile
4.
Article in Chinese | WPRIM | ID: wpr-927934

ABSTRACT

Due to the characteristics of confusing varieties of Chinese medicinal materials, different sources, complex chemical composition, non-standard preparation process, and non-standard pharmaceutical equipment, the quality of Chinese medicinal preparations is difficult to be controlled and evaluated effectively under the current quality control mode and method of Chinese medicinal preparation. The present study proposed an engineering quality view of Chinese medicine pharmacy and a strategy to control the quality of Chinese medicinal preparations based on the current situation. The "overall, dialectical, and dynamic" multi-factor engineering quality view, covering original medicinal materials, preparation technologies, pharmaceutical equipment, and Chinese medicinal preparations, ensures the traceable process, measurable procedures, and feedback quality. The quality control mode of Chinese medicinal preparation with controllable sources, standardized preparation technologies, green pharmaceutical equipment, and intelligent manufacturing is built up.


Subject(s)
Commerce , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Pharmacy , Quality Control
5.
China Pharmacy ; (12): 1189-1197, 2022.
Article in Chinese | WPRIM | ID: wpr-924071

ABSTRACT

OBJECTIVE To prepare hyperoside mixed nanomicelles (Hyp-F127/TPGS) and optimize its preparation technology,and to investigate its intestinal absorption characteristics. METHODS Hyp-F127/TPGS was prepared by thin film dispersion method. Based on single factor test and Plackett-Burman design ,combined with Box-Behnken response surface method , the preparation process was optimized and validated using entrapped efficiency (EE)and drug loading (DL)as evaluation indexes , F127-TPGS mass ratio ,hydration time and the amount of Hyp as factors. The appearance and microscopic morphology of Hyp-F127/TPGS obtained by the optimal technology were observed ,and the particle size ,polydispersity index (PDI)and Zeta potential were also determined. The critical micelle concentration (CMC)of blank micelle (F127/TPGS),in vitro release behavior and preliminary stability of Hyp-F 127/TPGS were investigated ,and absorption characteristics of Hyp-F 127/TPGS were investigated by in situ unidirectional intestinal perfusion model. RESULTS The optimal preparation technology of Hyp-F 127/TPGS included F127-TPGS mass ratio of 2∶1,hydration time of 2 h,and Hyp amount of 9 mg. Results of three validation tests showed that the EE of Hyp-F 127/TPGS was (87.20±0.99)%,and the DL was (5.02±1.20)%,deviations from predicted values were 0.92% and 2.39%. The micelles prepared by optimal technology were yellow ,clear and transparent solution ,with good Tyndall effect ;under transmission electron microscope ,they were spherical ,complete and evenly distributed ;the particle size was (15.02±0.16)nm, the PDI was 0.092±0.031,and the Zeta potential was (-6.67±1.47)mV. The CMC of F 127/TPGS was 21 μg/mL,Hyp-F127/ TPGS was stable after 4 weeks of storage at 4 ℃,and the cumulative release rates of Hyp-F 127/TPGS and Hyp control were (66.30±2.93)%(96 h)and(99.24±0.27)%(60 h),respectively. Hyp-F 127/TPGS and Hyp reference were absorbed in each intestinal segment ,and the main absorption sites were jejunum and duodenum respectively ;drug absorption rate constant andapparent absorption coefficient of the former were significantly higher than those of the latter (P<0.05 or P<0.01). E-mail:zhangyuhangxz@163.com CONCLUSIONS The optimized preparation technology of Hyp-F127/TPGS is stable and feasible ;prepared Hyp-F 127/ TPGS shows a sustained -release effect ,which promotes the intestinal absorption of H yp to a certain extent.

6.
China Pharmacy ; (12): 320-327, 2021.
Article in Chinese | WPRIM | ID: wpr-872684

ABSTRACT

OBJECTIVE:To prepare Liguatrazine opthalmic liposome therm osensitive gel ,and to investigate its in vivo and in vitro characteristics. METHODS :The ammonium sulfate gradient method was used to prepare Liguatrazine liposomes. The preparation technology was optimized by using orthogonal test. Using poloxamer P 407 as gel matrix ,Liguatrazine liposomes were prepared into thermosensitive gel. A membraneless model was used to study the dissolution and in vitro drug release of the gel. The modified Franz diffusion cell was used to investigate corneal permeability and further determine corneal hydration value. The effects of the gel on the proliferation of human corneal epithelial cell HCE-T. HE staining and Draize test were used to investigate the stimulatory effects of the gel on corneal cells of the rabbit ,and the histological changes of the eyes were observed. RESULTS :The optimal preparation technology of Liguatrazine liposome was drug-lipid ratio of 1 ∶ 10(m/m),the ammonium sulfate concentration of 0.2 mol/L,phospholipid-cholesterol ratio of 4∶1(m/m),incubation temperature of 45 ℃. Then ligustrazine opthalmic liposome thermosensitive gel was prepared with 23% poloxamer P 407 as gel matrix. The gel had good gelatinization temperature. The in vitro drug release and dissolution showed zero-order kinetic characteristics ,and in vitro drug release of the gel was mainly related to dissolution (R2=0.993 4). The cumulative transcorneal permeability of the gel was 43.3% within 6 hours and corneal hydration value was 72.98%. Low and medium concentrations (1,5 mg/L)of Ligustrazine opthalmic liposome thermosensitive gel had no obvious proliferation toxicity to HCE-T cells ,but it showed cytotoxicity at high concentration (10 mg/L). The mean Draize eyeirritation score of the gel on rabbit cornea was within non-stimulation,and there was no abnormal change in rabbit (No.2018001) corneal histology. CONCLUSIONS : Prepared Ligustrazine opthalmic liposome thermosensitive gel has a suitable phase transition temperature ,good corneal permeability ,and low corneal irrit ation.

7.
Article in Chinese | WPRIM | ID: wpr-905057

ABSTRACT

Objective:Powders and decocted powders account for about 1/3 in the Catalogue of Ancient Famous Classical Formulas (the First Batch), and have a very important position. Determination of preparation technology and particle size in the pulverization process is the key step in the research and development of powders and decocted powders following the original methods. However, there are many terms describing the preparation technology and particle size of powders and decocted powders in ancient Chinese medical books, and the parameters are not clear. Due to the lack of unified basis of particle size, the existing research results have not formed a uniform consensus. Based on ancient textual researches and experimental results, this article discusses the particle size of decocted powders and powders. Method:Through textual researches of the preparation technology and particle size of powders and decocted powders and powder classification in the 2020 edition of Chinese Pharmacopoeia, the specifications of pulverized particle size were suggested. In addition, Xiebaisan and Danggui Buxuetang were taken as examples to investigate the influence of different particle sizes (4, 10, 24 mesh) on the preparation process of decocted powders and the obtained decoction. Result:The particle size of 4 mesh was equivalent to that of ancient as big as hemp bean. The contents of index components in Xiebaisan and Danggui Buxuetang with particle size of 4 mesh were higher than that of 10 mesh and 24 mesh, but the particle size of 50 mesh was too fine to be filtered. Conclusion:The suggested particle sizes of powders and decocted powders are recommended as Cumo is the power through 10-mesh sieve, Mo is the power through 24-mesh sieve, Ximo is the power through 80-mesh sieve, as big as hemp bean is the power through 4-mesh sieve and not through 10-mesh sieve.

8.
Acta Pharmaceutica Sinica ; (12): 1902-1910, 2021.
Article in Chinese | WPRIM | ID: wpr-887017

ABSTRACT

Nanocrystal drugs have many advantages, such as no carrier materials, easy industrialization, diversified dosage forms, and can significantly improve the solubility and bioavailability of insoluble drugs, so many drugs have been on the market. The traditional nanocrystal preparation technology has the problems of low preparation efficiency and process limitation of the smallest achievable particle size. With the progress of pharmaceutical preparation technology, the preparation technology of nanocrystal drugs is constantly improving, and new preparation technologies are constantly emerging. The emergence of new technologies has greatly shortened the process time and makes it possible to prepare nanocrystal drugs with smaller particle diameters. In this paper, the preparation technologies of nanocrystal drugs, especially the new preparation technologies such as high gravity controlled precipitation, microfluidic reaction technology and various combination technologies, are reviewed from three aspects: "Top-down" technology, "Bottom-up" technology and combination technology. This article also prospects the development of new preparation technologies, hoping to provide reference for the related research of nano-preparations.

9.
China Pharmacy ; (12): 2112-2118, 2020.
Article in Chinese | WPRIM | ID: wpr-825191

ABSTRACT

OBJECTIVE:To prepare Brucine (shorted for “Bru”)bilayer polymer soluble microneedles ,and to investigate their in vitro transdermal permeation characteristics under different drug loading modes. METHODS :Taking the degree of difficulty of microneedle film uncovering ,array integrity ,bubble amount ,needle shape ,tip hardness and backing toughness as the indexes , tip and backing materials were screened. The swelling method and drying method of matrix were screened using the morphology of microneedles as index. The double-layer polymer soluble microneedle was prepared by two-step method ,then it was characterized and evaluated in the safety. The in vitro transdermal permeation characteristics of tip-loaded ,backing-loaded and full-loaded Bru bilayer polymer soluble microneedles were investigated by Franz diffusion cell. The in vitro skin penetration curve was drawn ,and the cumulative permeability amount (Q)and cumulative permeability rate were calculated. RESULTS :The optimal preparation technology of bilayer polymer soluble microneedles included chondroitin sulfate (CS)and polyvinylpyrrolidone K 30(PVP K 30) (1∶1,m/m)as tip materials ,15% polyvinyl alcohol (PVA)as backing material ,matrix swelling in the refrigerator at 4 ℃ for 1 h,and drying at room temperature for 24 h in dryer. Prepared microneedle array was complete and had good mechanical properties,and could successfully puncture aluminum foil and rat skin. After microneedle treatment ,the skin could return to its original state within 6 h. The results of in vitro transdermal test showed that microneedle drug delivery could greatly increase the cumulative transdermal permeability amount of GNYL Bru,and the tip material could dissolve and release the drug within 10 min; the tip-loaded microneedle was basically released within 8 h,Q8h was 102.185 μg/cm2 and the cumulative permeability rate reached 94.05% ; the drug cumulativepermeability rate of backing-loaded and full-loaded microneedlesexceeded 50% within 8 h and exceeded 90% within 48 h;Q48h were 840.77 and 1 156.73 μg/cm2,showing sustained-release characteristics. CONCLUSIONS :Bru bilayer polymer soluble microneedles with hard tip and tough backing material are successfully prepared to achieve effective transdermal delivery and sustained release through full-loaded mode.

10.
Chinese Pharmaceutical Journal ; (24): 445-450, 2020.
Article in Chinese | WPRIM | ID: wpr-857753

ABSTRACT

OBJECTIVE: To design and evaluate the formula of Weisu microemulsion-ion sensitive gel. METHODS The prescription of microemulsion-ion sensitive gel was conducted on the basis of single factor method and pseudotemary phase diagram method combining with central composite design-response surface methodology. The final formulation was evaluated by particle size, viscosity, potential, contents of naringin, hesperidin and neohesperidin. RESULTS: The optimum prescription ratio of Weisu microemulsion-ion sensitive gel was as following:volatile oil 3 g, RH-40 9 g, PEG-400 3 g, 0.3% deacetylated gellan gum made into 333 mL microemulsion gel. The results of physicochemical properties showed that microemulsion gel appearance was clear. The particle diameter was 20.14 nm. The Zeta potential was -4.04 mV. pH value was 5.43. The contents of naringin, hesperidin and neohesperidin are respectively 6.122 4, 2.094 1, 4.277 mg•mL-1. CONCLUSION: The preparation process of Weisu microemulsion gel is reasonable and feasible. The prepared microemulsion gel is system are stable.

11.
Chinese Pharmaceutical Journal ; (24): 1401-1408, 2020.
Article in Chinese | WPRIM | ID: wpr-857592

ABSTRACT

Solid dispersions provide an effective technical method for improving solubility and bioavailability of insoluble drugs. From its discovery to the present 60 years, 26 drug formulations have been approved by FDA. Moreover, the preparation technology of solid dispersion system has been continuously innovated and developed, such as electrospinning method, supercritical fluid method, spray freeze-drying technology and so on. In this paper, the development process of solid dispersion technology and carrier is reviewed, and the development of solid dispersion technology and carrier is summarized, and the existing problems are analyzed and prospected. It is expected to provide the reference for the research and development of drug solid dispersion.

12.
Article in Chinese | WPRIM | ID: wpr-845209

ABSTRACT

Objective: To optimize the formulation and preparation process of compound Shenzao chewable tablets, and establish a method for the determination of the active ingredient spinosin. Methods: Using the wet granulation process, the types, dosages and adding manners of diluents, wetting agents, sweeteners and lubricants were optimized, and three batches of the compound Shenzao chewable tablets were prepared. An HPLC method for the determination of spinosin in the tablets was established and the HPLC conditions were as follows: ZORBAX SB-C 18 column(4.6 mm×250 mm, 5 μm)was adopted. The mobile phase was the acetonitrile-water solution in a gradient elution. The flow rate was 1.0 ml/min, the column temperature was 25℃ and the detection wavelength was 335 nm. Results: In the wet granulation process, the dry Lepidium meyenii (Maca)powder and 20% mannitol were used as diluents, the 80% ethanol as wetting agent, and the 0.50% aspartame as sweetener. In the tabletting process, the 1.0% magnesium stearate was used as lubricant. The prepared tablets showed smooth surface, moderate sweetness, and a stable and controllable quality. The HPLC method for the determination of spinosin showed a good linearity within the concentration range of 5~100 μg/ml (r=0.9995)and the average recovery was 98.55%. Conclusion: The optimized formulation and preparation process are stable and feasible for the preparation of the compound Shenzao chewable tablets. The determination of spinosin by the HPLC method is accurate and reliable, which might be used for the quality control of the preparation.

13.
Article in Chinese | WPRIM | ID: wpr-850697

ABSTRACT

Objective: In order to solve the problem of ginkgolide B (GB) for preparing the intravenous injection dosage form, such as it’s low solubility, rapid elimination in vivo and poor stability in long-term storage, a novel biodegradable polysaccharide polymer was used as a carrier to encapsulate GB into nanoparticles with sustained-release profile, which then was freeze dried for keep its stability. Methods: GB nanoparticles (GB-NP) were prepared by coacervation method with hydrophilicity polymer. The Design-Expert 8.0 software was applied for experimental design. The formulation was finalized by investigating the concentration of GB, the mass ratio of GB to polymer, and the pH of the polymer solution with size and polydispersity indexas the evaluation parameters. The optimum formulation and technique were selected by response surface method. Then the nanoparticle suspension was further freeze dried and in vitro release behavior was tested in PBS containing 30% ethanol. Results: The optimum prescription conditions were as follows: the concentration of GB was 1.5 mg/mL, the ratio of GB mass to polymer mass was 0.1 and the polymer solution pH was set at 5.0. The entrapment efficiency was (99.64 ± 0.45)% with the drug loading ratio of (9.04 ± 0.04)%. Average particle size of GB-NP was (192.8 ± 2.8) nm with a preferable PDI of 0.18 ± 0.03. The freeze-drying conditions were described as follows: using 1% mannitol as freeze- drying supporting agent, the solution of GB-NP was pre-frozen for 12 h at −80 ℃ and dried for 24 h at −40 ℃. The release behavior of free GB was rapid with the cumulative release rate reaching (64.74 ± 3.95)% during the first hour, while the cumulative release rate of GB in nanoparticles was (36.90 ± 1.41)% during the first hour. Conclusion: The GB-NP using this special biodegradable polysaccharide polymer can improve GB’s dissolution behavior in water and make GB sustained release in vitro, which is beneficial for preparing GB’s intravenous injection dosage form.

14.
China Pharmacy ; (12): 2920-2925, 2019.
Article in Chinese | WPRIM | ID: wpr-817469

ABSTRACT

OBJECTIVE: To prepare Zingiber officinale oil microcapsules and to evaluate its quality. METHODS: Z. officinale oil microcapsules were prepared by spray drying method with sodium starch octenyl succinate as capsule material. The preparation technology was optimized by orthogonal test with mixing temperature of capsule material and capsule core, mass ratio of capsule material and capsule core, stirring speed as factors, using encapsulation efficiency as index. The drug loading, encapsulation efficiency, appearance, particle size distribution and stability of light, heat and humidity (using iodine value and peroxide value as indexes) were evaluated. RESULTS: The optimal preparation technology of Z. officinale oil microcapsules was that the mixing temperature of capsule material and core was 60 ℃; mass ratio of capsule material and capsule core was 10 ∶ 1; stirring speed was 12 000 r/min. Average drug-loading amount and encapsulation efficiency of Z. officinale oil microcapsules prepared by optimal technology were 17.97% and 73.57% (n=3). The morphology of Z. officinale oil microcapsules was round, smooth, non-sticky and uniform in size distribution. The average diameter of microcapsules was (6.30±0.27) μm. Under light, heat and humidity conditions, the iodine value and peroxide value of Z. officinale oil microcapsules changed slightly. CONCLUSIONS: The optimal preparation technology of Z. officinale oil microcapsules is simple and reproducible. The prepared microcapsules have good encapsulation efficiency, high drug loading amount and good stability.

15.
China Pharmacy ; (12): 2908-2912, 2019.
Article in Chinese | WPRIM | ID: wpr-817467

ABSTRACT

OBJECTIVE: To prepare Jinlei capsule and evaluate its quality. METHODS: Wet granulation was adopted. The molding technology of Jinlei capsule content granule was optimized with drug-excipient ratio, excipient ratio and ethanol volume fraction as factors, using comprehensive score of particle forming rate, moisture content and fluidity as the evaluation index. According to 2015 edition of Chinese Pharmacopoeia (part Ⅳ), the characters, moisture, volume difference, disintegration time limit were checked. Qualitative identification of Gentianopsis paludosa and Lysimachia christinale were analysed by TLC, and quantitative analysis of luteolin and kaempferol were analysed by HPLC. RESULTS: The optimal molding technology of Jinlei capsule content granule was that the maltodextrin and the micro-silica gel are mixed as a mixed auxiliary material according to 10 ∶ 1 and then mixed with the drug powder by 1 ∶ 0.5, using the wet granulation method with 90% ethanol as wetting agent. The characters, moisture, volume difference and disintegration time limit of Jinlei capsule were in line with Chinese Pharmacopoeia. TLC showed the same color spots on the corresponding positions of the reference chromatogram. The linear range of luteolin and kaempferol were 4.4-88.0 μg/mL and 9.6-96.0 μg/mL (all r=0.999 9). RSD of precision (n=6), reproducibility (n=6) and stability (18 h, n=7) tests were all lower than 2.5%. The average recoveries were 95.74% and 99.77% (RSD=1.50%, 2.72%, n=6); the content of them were 2.52, 0.34 mg/g. CONCLUSIONS: The optimal molding technology of Jinlei capsule is stable and feasible; prepared Jinlei capsule in controllable in quality.

16.
China Pharmacy ; (12): 3360-3363, 2019.
Article in Chinese | WPRIM | ID: wpr-817395

ABSTRACT

OBJECTIVE: To establish the method for content determination of eugenol in Syzygium aromaticum oil dropping pills, and to optimize the preparation technology. METHODS: The content of eugenol in S. aromaticum oil dropping pills was determined by UV spectrophotometry. Based on single factor test, using the percentage of drugs in total amount, liquid temperature, falling distance of condensate, liquid drop distance as factors, taking the roundness, weight and hardness difference and comprehensive score as factors, L9(34) orthogonal design test was adopted to optimize the preparation process. RESULTS: The linear range of eugenol was 15.15-45.45 μg/mL(r=0.999 6); RSDs of precision, stability and reproducibility tests were all lower than 1%; the recoveries were 97.41%-100.59%(RSD=1.35%, n=6). The optimal preparation technology included that the percentage of drugs in total amount was 5%; liquid temperature was 80 ℃; falling distance of condensate was 13 cm; liquid drop distance was 6 cm. The dropping pills had smooth appearance, good roundness and moderate hardness; the average content of engenol was 4.073%(RSD=0.35%,n=6). CONCLUSIONS: The established method is simple, and can be used for the content determination of eugenol in S. aromaticum oil dropping pills. The optimal preparation technology is stable and feasible.

17.
Article in Chinese | WPRIM | ID: wpr-707126

ABSTRACT

Objective To optimize prescription of gentiopicroside nanoemulsion; To evaluate its quality and security. Methods According to the basic properties of gentiopicroside, single-factor test and pseudo-ternary phase diagram were adopted to optimize prescription of gentiopicroside nanoemulsion. The physicochemical property was investigated, and the content was evaluated by HPLC. Results Optimal prescription was obtained as gentiopicroside/ethyl acetate/ EL-35/ absolute ethyl alcohol/ ultrapure water (1.77:7.66:5.94:11.91:72.71); the particle size of nanoemulsion was 23.08 nm; the content of gentiopicroside was determined by HPLC; the specificity of the method was good with a linear range of 0.004 28–0.214 mg/mL; stability of prepared gentiopicroside nanoemulsion was good in the state of different temperatures, illumination intensity and humidity conditions, without significant changes. Conclusion The optimized preparation technology of gentiopicroside nanoemulsion is simple, repeatable and stable, which can provide references for improving the bioavailability of gentiopicroside.

18.
China Pharmacy ; (12): 615-620, 2018.
Article in Chinese | WPRIM | ID: wpr-704639

ABSTRACT

OBJECTIVE: To prepare zedoary turmeric oil compound liposomes (ZTOC-LPS) and evaluate its quality.METHODS: The preparation method of liposome, the addition amount of soybean phosphatidylcholine (SPC), ratio of SPC to cholesterol (CH) in lipid, drug-lipid ratio of zedoary turmeric oil (ZTO), drug-lipid ratio of tretinoin in formulation, and water bath temperature were screened using encapsulation efficiency and drug-loading amount of ZTO (represented by germacrone) and tretinoin as investigation indexes. Quality evaluation and primary stability investigation were conducted for liposomes prepared by optimal preparation technology. RESULTS: The optimal preparation method was ethanol injection method; The optimal preparation technology were SPC 4 mg in 1 mL lipid, the mass ratio of SPC to CH 3:1, the ratio of ZTO to lipid 1:9, the ratio of tretinoin to lipid 1:70, water bath temperature of 55 ℃. Encapsulation efficiencies of ZTO and tretinoin were (64. 63 ± 1. 00)% and (90. 33 土 0. 72)% in 3 batches of ZTOC-LPS, respectively. Drug-loading amount of ZTO and tretinoin were (9. 09 ± 0. 14)% and (1. 43 ± 0. 02)%, respectively. Particle size was (257. 41 ± 7. 58) nm, Zeta potential was (-38. 77 ± 0. 81) mV,PDI was 0. 10 ± 0. 04; the results of centrifugal acceleration test showed that the liposomes had good physical stability. No obvious change was found in each investigation index of ZTOC-LPS that stored at (4 ± 2) ℃ for 1 month. CONCLUSIONS: Established preparation technology is simple and feasible, the quality of the prepared ZTOC-LPS conforms to the requirements, and it can provide reference for the following research of ZTOC-LPS.

19.
Article in Chinese | WPRIM | ID: wpr-687265

ABSTRACT

The compressibility of tablets is the essential operating unit during the preparation of traditional Chinese medicine tablets, as well as a complicated process. Therefore, it is of great significance to comprehensively study the influencing factors on the formation process. This paper aimed to review the evaluation methods for the tablet forming quality and highlight the effects of material powder properties, excipients and preparation technology on the quality of traditional Chinese medicine tablets on the basis of relevant literatures. Furthermore, the common problems in tablet forming process are also analyzed to provide useful references for the development of tablet forming quality of traditional Chinese medicines.

20.
Article in Chinese | WPRIM | ID: wpr-851892

ABSTRACT

In this review, the ability of borneol and menthol as the common penetration enhancers in traditional Chinese medicines was summarized, and the effect of borneol and menthol on the ability of nanopreparations across the main physiological barriers of the human body promoting drug absorption or increasing the distribution of drugs was also reviewed, which aims to provide reference for promoting the treatment effect of nanopreparations through the combination of traditional Chinese medicine and modern preparation technology.

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