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1.
Acta Pharmaceutica Sinica ; (12): 1347-1353, 2023.
Article in Chinese | WPRIM | ID: wpr-978703

ABSTRACT

A dry suspension of Indigo Naturalis (IN) based on lactose-IN composite particles was designed by powder modification technology to meet the clinical needs of IN. The contact angle was used as an evaluation index to investigate the effects of the type of modifier lactose, the amount of lactose, and the co-grinding time of lactose and IN on the hydrophilicity of IN. The difference between IN before and after modification was compared through physical properties such as particle size and scanning electron microscope, as well as hydrophilic properties such as surface free energy and multiple light scattering. The optimal process of lactose-IN composite particles is as follows: after lactose is ground alone for 2 minutes, it is co-ground with IN at a ratio of 1∶1 for 6 minutes. The results of the investigation of powder properties show that the particle size d0.9 of IN is reduced from 112.75 μm to 87.30 μm after modification. The BET and Langmuir specific surface areas decreased by 8.661 m2·g-1 and 12.512 m2·g-1, respectively. SEM shows that lactose is attached to the surface of modified IN (MIN); surface element analysis shows that Si, Ca, and Mg elements of MIN are smaller than IN, and O elements are larger. The infrared spectrum shows that the MIN possesses the characteristic peaks of both IN and lactose. Compared MIN with IN, the contact angle and the non-polar surface free energy decreased by 35.1° and 9.975 mJ·m-2, respectively; the polar surface free energy and the surface free energy increased by 36.956 and 26.950 mJ·m-2, respectively. The results of multiple light scattering showed that the light transmittance of MIN was 35% lower than that of IN, and the backscattered light intensity was increased by about 25%. Only one excipient was used to successfully prepare IN dry suspension with good wettability and suspending property, which provided a basis for the development of new preparations of IN.

2.
Article in Chinese | WPRIM | ID: wpr-970590

ABSTRACT

Ionic liquids(ILs) are salts composed entirely of anions and cations in a liquid state at or near room temperature, which have a variety of good physicochemical properties such as low volatility and high stability. This paper mainly reviewed the research overview of ILs in the application of traditional Chinese medicine(TCM) volatile oil preparation technology. Firstly, it briefly introduced the application of TCM volatile oil preparation technology and composition classification and physicochemical properties of ILs, and then summarized the application of ILs in the extraction, separation, analysis, and preparation of TCM volatile oil. Finally, the problems and challenges of ILs in the application of TCM volatile oil were explained, and the application of ILs in TCM volatile oil in the future was prospected.


Subject(s)
Ionic Liquids/chemistry , Oils, Volatile/analysis , Medicine, Chinese Traditional , Cations , Biological Products , Technology
3.
Article in Chinese | WPRIM | ID: wpr-981397

ABSTRACT

In recent years, the use of active substances as excipients or as substitutes for other excipients in the design of modern drug delivery systems has received widespread attention, which has promoted the development of the theory of unification of medicines and excipients in the design of traditional Chinese medicine(TCM) preparations. Adopting the theory of unification of medicines and excipients to design drug delivery systems can reduce the use of excipients and thus the cost of preparations, reduce drug toxicity, increase drug solubility and biocompatibility, enhance synergistic effect, and realize targeted delivery and simultaneous delivery of multiple components. However, the research on the application of this theory in the modern drug delivery system of TCM preparations is still insufficient, with few relevant articles. In addition, the TCM active substances that can be used as the excipients remain to be catalogued. In this paper, we review the types and applications of the drug delivery systems with TCM active substances as excipients and describe their common construction methods and mechanisms, aiming to provide references for the in-depth research on the modern drug delivery systems for TCM preparations.


Subject(s)
Medicine, Chinese Traditional , Excipients , Drugs, Chinese Herbal , Nanomedicine , Pharmaceutical Preparations
4.
Article in Chinese | WPRIM | ID: wpr-981479

ABSTRACT

With the rapid development of computer technology, numerical simulation has gradually become an important method to study drying process and improve drying equipment. Using computer to simulate the drying process of traditional Chinese medicine(TCM) is characterized by intuitiveness, scientificity, and low cost, which serves as an auxiliary means for technical innovation in TCM drying. This paper summarizes the theories of different drying methods and the research status of numerical simulation in drying, introduces the modeling methods and software of numerical simulation, and expounds the significance of numerical simulation modeling in shortening the research and development cycle, improving drying equipment, and optimizing drying parameters. However, the current numerical simulation method for drying process has problems, such as low accuracy, lack of quantitative indicators for the control of simulation results on the process, and insufficient in-depth research on the mechanism of drug quality changes. Furthermore, this paper put forward the application prospect of numerical simulation in TCM drying, providing reference for the further study of numerical simulation in this field.


Subject(s)
Medicine, Chinese Traditional , Drugs, Chinese Herbal , Desiccation
5.
Article in Chinese | WPRIM | ID: wpr-1008708

ABSTRACT

In recent years, continuous manufacturing technology has attracted considerable attention in the pharmaceutical industry. This technology is highly sought after for its significant advantages in cost reduction, increased efficiency, and improved productivity, making it a growing trend in the future of the pharmaceutical industry. Compared to traditional batch production methods, continuous manufacturing technology features real-time control and environmentally friendly intelligence, enabling pharmaceutical companies to produce drugs more efficiently. However, the adoption of continuous manufacturing technology has been slow in the field of traditional Chinese medicine(TCM) pharmaceuticals. On the one hand, there is insufficient research on continuous manufacturing equipment and technology that align with the characteristics of TCM preparations. On the other hand, the scarcity of talent with diverse expertise hampers its development. Therefore, in order to promote the modernization and upgrading of the TCM pharmaceutical industry, this article combined the current development status of the TCM industry to outline the development status and regulatory requirements of continuous manufacturing technology. At the same time, it analyzed the problems with existing TCM manufacturing models and explored the prospects and challenges of applying continuous manufacturing technology in the field of TCM pharmaceuticals. The analysis focused on continuous manufacturing control strategies, technical tools, and pharmaceutical equipment, aiming to provide targeted recommendations to drive the development of the TCM pharmaceutical industry.


Subject(s)
Medicine, Chinese Traditional , Quality Control , Drug Industry , Technology, Pharmaceutical/methods , Drugs, Chinese Herbal , Pharmaceutical Preparations
6.
Article in Chinese | WPRIM | ID: wpr-1008799

ABSTRACT

Spray drying technology is one of the most commonly used unit operations in the production of traditional Chinese medicine(TCM) preparations, offering advantages such as short drying time and uniform product quality. However, due to the properties of TCM extracts, such as high viscosity, strong hygroscopicity, and poor flowability, there is limited scope to solve the problems of wall adhesion and clumping in spray drying from the macroscopic perspective of pharmaceutical production. Therefore, it has become a trend to study and optimize the spray drying process from the microscopic point of view by investigating single droplet evaporation behavior. Based on the reaction engineering approach(REA), the single droplet drying system, as a novel method for studying droplets, collects parameter data on individual TCM droplets during the drying process and uses the REA to process the data and establish predictive models. This approach is crucial for understanding the mechanism of TCM spray drying. This paper summarized and analyzed the cha-racteristics of various single droplet systems, the application of REA in single droplet drying systems, and its significance in optimizing the process, predicting drying states, and shortening the development cycle in the field of TCM spray drying, and looked ahead to the prospects of this method, including the introduction of new parameters and imaging techniques, aiming to provide a reference for further research in the field of TCM spray drying.


Subject(s)
Medicine, Chinese Traditional , Spray Drying , Desiccation/methods , Temperature , Technology
7.
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
8.
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
9.
Article in Chinese | WPRIM | ID: wpr-928010

ABSTRACT

The present study explored the kinetics and variation of volatile components of Atractylodis Macrocephalae Rhizoma during the hot-air drying process to obtain the optimal process parameters under multiple goals such as drying efficiency and drying quality. The dry basis moisture content and drying rate curves along with the change of drying time of Atractylodis Macrocephalae Rhizoma were investigated at five levels of drying air temperatures(30, 40, 50, 60, and 70 ℃). The relationship between moisture ratio and time in the drying process of Atractylodis Macrocephalae Rhizoma was fitted and verified by Midilli model, Page model, Overhults model, Modified Page model, Logaritmic model, Two terms Exponential model, and Newton model. Meanwhile, the effective diffusion coefficient of moisture(D_(eff)) and activation energy(E_a) in Atractylodis Macrocephalae Rhizoma were calculated under different drying air temperatures. GC-MS was used to determine the volatile components and content changes of the fresh Atractylodis Macrocephalae Rhizoma and dried products at different temperatures. The dry basis moisture content and drying rate of Atractylodis Macrocephalae Rhizoma were closely related to the temperature of the drying medium, and the moisture of the Atractylodis Macrocephalae Rhizoma decreased with the prolonged drying time. As revealed by the drying rate curve, the drying rate increased with the increase in hot air temperature, and the migration of moisture was accelerated. The comparison of the correlation coefficient(R~2), chi-square(χ~2), and root mean standard error(RMSE) of each model indicated that the parameter average of the Midilli model had the highest degree of fit, with R~2=0.999 2, χ~2=8.78×10~(-5), and RMSE=8.20×10~(-3). Besides, the D_(eff) at 30-70 ℃ was in the range of 1.04×10~(-9)-6.28×10~(-9) m~2·s~(-1), and E_a was 37.47 kJ·mol~(-1). The volatile components of fresh Atractylodis Macrocephalae Rhizoma and dried products at different temperatures were determined by GC-MS, and 18, 18, 18, 17, 17, and 18 compounds were identified respectively, which accounted for more than 84.76% of the volatile components. In conclusion, the hot-air drying of Atractylodis Macrocephalae Rhizoma can be model-fitted and verified and the variation law of the moisture and volatile components of Atractylodis Macrocephalae Rhizoma with temperature is obtained. This study is expected to provide new ideas for exploring the drying characteristics and quality of aromatic Chinese medicine.


Subject(s)
Atractylodes , Drugs, Chinese Herbal , Hot Temperature , Kinetics , Rhizome
10.
Article in Chinese | WPRIM | ID: wpr-928048

ABSTRACT

The present study explored the drying effect of new spiral vibration drying technology on Chinese medicinal pills with Liuwei Dihuang Pills, Zhuanggu Guanjie Pills, and Muxiang Shunqi Pills as model drugs. With the drying uniformity, drying time, energy consumption, pill split, dissolution time, and change of index components as evaluation indicators, the drying effect of spiral vibration drying technology on model drugs was evaluated and compared with traditional drying methods, such as hot air drying and vacuum drying in the oven. The dynamic changes of moisture in Liuwei Dihuang Pills with different drying time were investigated. Compared with the traditional drying methods in the oven(hot air drying and vacuum drying) at 80 ℃, the spiral vibration drying only took 80 min, shortened by 80%, with 10%-13% energy consumed. The results showed that the moisture of Liuwei Dihuang Pills was negatively related to the drying time. By virtue of multi-layer countercurrent drying and super resonant fluidization techniques, the new spiral vibration drying technology can significantly improve the drying quality of Chinese medicinal pills, improve the drying efficiency, and enhance the manufacturing capacity of Chinese medicinal pills. This study is expected to provide references for the innovation and development of new drying technology of Chinese medicinal pills.


Subject(s)
China , Desiccation , Physical Therapy Modalities , Technology , Vibration
11.
Article in Chinese | WPRIM | ID: wpr-905850

ABSTRACT

Succus Bambusae, regarded as the holy medicine for the treatment of phlegm by traditional Chinese medicine experts, has the functions of clearing heat and resolving phlegm, resuscitating and relieving convulsions. In clinical practice, it is mainly used to treat phlegm-heat cough, phlegm yellow and shortness of breath, stroke with exuberant phlegm and other syndromes. The research of its processing procedure and quality standard is the key issue to realize the process modernization and quality standardization of this traditional medicine resource. On the basis of literature research, this paper conducted the herbal textual research on Succus Bambusae, sorted out its medicinal history, and compared the advantages and disadvantages of its traditional and modern preparation procedure. Based on the historical records, it is pointed out that there are still many problems in the traditional and modern processing procedure of Succus Bambusae, such as low-yield processing procedure and extensive production technology that cannot meet the requirements of large-scale green manufacturing. At present, there are a lot of literature on the comparative study of the origin, variety and processing procedure of Succus Bambusae, but most of them are limited to the chemical components, and lack of in-depth study on its pharmacodynamic substance basis and mechanism. Meanwhile, the pharmacological effects of Succus Bambusae are mostly limited to antitussive and expectorant, and few other pharmacological effects have been reported. Based on the above analysis, it is suggested that the follow-up research work can be carried out from these five aspects:①Clarifying the original source, enriching and perfecting the medicinal resources. ②Standardizing the processing procedure, establishing relevant quality standards. ③Clarifying the pharmacological mechanism, strengthening the basic research on the pharmacological effect and clinical application. ④Inheriting ancient processing, researching and developing special preparation equipment and standardizing production operation rules. ⑤Comprehensive utilization of the by-products in preparation process.

12.
Article in Chinese | WPRIM | ID: wpr-878908

ABSTRACT

Drying is one of the most common unit operations in the production of traditional Chinese medicine. The drying process of traditional Chinese medicine materials is accompanied by the dynamic reduction of water content. As a key index to determine the end of the drying process, the moisture content of materials plays an important role in improving drying efficiency and saving energy. Recently, the drying process of traditional Chinese medicine is mostly monitored by offline detection, and there are few reports of online moisture detection applications. In this paper, the principle and current application of online inspection technology for the material drying process in different fields were introduced. The significance of online detection technology in drying of traditional Chinese medicine was also analyzed. Meanwhile, the application prospect of online detection technology in the field of drying of traditional Chinese medicine was predicted. In response to urgent transformation and upgrading of the traditional Chinese medicine manufacturing industry, the application of online moisture detection technology is expected to be a key breakthrough in the intelligent upgrading of traditional Chinese medicine drying technology and equipment.


Subject(s)
Desiccation , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Technology, Pharmaceutical
13.
Article in Chinese | WPRIM | ID: wpr-879067

ABSTRACT

Texture sensory attributes are the key items in quality control of Chinese medicinal honeyed pills. The purpose of this study is to develop a quality control method for assessing the texture sensory attributes of Chinese medicinal honeyed pills based on real-world Tongren Niuhuang Qingxin pilular masses and finished products. First, parameters of texture profile analysis(TPA) were optimized through single factor and central composite design(CCD) experiments to establish a detection method for texture sensory attri-butes of Tongren Niuhuang Qingxin Pills. The results showed that the established detection method was stable and reliable, with the optimal parameters set up as follows: deformation percentage of 70%, detection speed at 30 mm·min~(-1), and interval time of 15 s. Furthermore, 540 data points yielded form six texture sensory attributes of pills from 30 batches were subjected to multivariate statistical process control(MSPC) with Hotelling T~2 and squared prediction error(SPE) control charts to establish the quality control method of Tongren Niuhuang Qingxin Pills. This study is expected to provide a reference for improving the quality control system of Chinese medicinal honeyed pills.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control
14.
Article in Chinese | WPRIM | ID: wpr-1008534

ABSTRACT

Essential oils are easy to cause oxidative damage, chemical transformation or polymerization, and have some intrinsic problems, such as instability, low water solubility and low bioavailability, which restrict their application in the fields of product development. Nanostructured lipid carriers(NLCs) can overcome some of the restrictions of other colloidal carriers, such as emulsions, liposomes, polymer nanoparticles and solid lipid nanoparticles. NLC is an efficient and stable delivery system for bioactive substances. With unique lipid properties(mixture of solid and liquid lipid), it can overcome the disadvantages of essential oils and protect them from adverse environments, thus improving the stability, bioavailability and safety of essential oils, and achieve sustained release and controlled release. In EOs-NLCs system, essential oils, as special liquid lipid with biological activities and medicinal properties, can fully play the role of medicine-adjuvant integration by changing the structural characteristics of mixed lipid. Based on the development of nanocarriers system, this paper introduces the composition and structural characteristics of EOs-NLCs, and clarifies how to improve the stability of essential oils based on the effects of NLCs on physical and chemical properties, physical stability and release of active components of essential oils. In addition, it also introduces the application of the system in the fields of pharmaceutical, food, cosmetics and skin care products. This review aims to provide some references for improving the stability of essential oils and their applications by using NLCs.


Subject(s)
Drug Carriers , Emulsions , Lipids , Liposomes , Nanostructures , Oils, Volatile , Particle Size
15.
Article in Chinese | WPRIM | ID: wpr-773733

ABSTRACT

Dry granulation technology is a great innovation in granulation technology,which saves many intermediate links and reduces many intermediate costs. It is closely related to the characteristics of materials,dry granulation equipment and process. Dry granulation technology is a systematic engineering science covering many technical fields. The process of dry granulation involves complex mathematical model mechanisms of temperature field,pressure field and velocity field,closely related to the characteristics of materials and drying equipment. However,due to the late start of research on dry granulation technology of traditional Chinese medicine,basic research is still weak. The research on dry granulation technology has achieved great results in the fields of food,chemical industry,agriculture and forestry,showing great reference significance. The advantage of dry granulation of traditional Chinese medicine is that it can be directly granulated by adding an appropriate amount of auxiliary materials in the extract powder of traditional Chinese medicine,without the need of wetting,mixing,drying and other processes. The process is simple and can effectively guarantee the quality of traditional Chinese medicine. The granules obtained by the dry granulation technique are important intermediates for preparing the solid preparations of traditional Chinese medicines,which would directly affect the subsequent molding process and the quality of the preparation products. Therefore,based on the characteristics of dry granulation method in traditional Chinese medicine and by referring to the advanced research results of dry granulation technology in other fields,we would discuss the research ideas of dry granulation in traditional Chinese medicine in terms of the mechanism of dry granulation equipment,technology,on-line detection technology and mathematical model of dry granulation process,hoping to provide reference for the research of dry granulation method in traditional Chinese medicine.


Subject(s)
Desiccation , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Models, Theoretical , Powders , Quality Control , Technology, Pharmaceutical
16.
Article in Chinese | WPRIM | ID: wpr-802245

ABSTRACT

Objective: Taking single Liuwei Dihuangwan(LDW) as the research object,the moisture content change and volumetric shrinkage characteristics in its drying process were investigated,which provided the theoretical basis for improving the drying efficiency of the pills and reducing the quality problems of the pattern pills,crusts and crack pills. Method: The drying characteristics of LDW at drying temperature of 50,75,100,125℃ were studied by constant temperature hot air drying and vacuum drying.Based on sphere model of Fick's second law and Arrhenius equation,the effective diffusion coefficient and activation energy of the drying process were obtained.The volumetric shrinkage characteristics of the pills during the drying process were studied by the projected area method.The Weibull function was used to fit the drying dynamics curve of single LDW. Result: Hot air drying and vacuum drying of LDW both belonged to the decreasing drying processes,and the time required to achieve the same moisture content in vacuum drying was shorter than that in hot air drying.The moisture ratio in the drying process of single LDW obeyed the Weibull function distribution(R2=0.994 5-0.999 7),the scale parameter(α) decreased with the increase of temperature,and drying temperature had significant influence on the shape parameter (β).The effective diffusion coefficients of hot air drying and vacuum drying were 2.626×10-3-7.823×10-2,3.782×10-3-9.042×10-2 m2·s-1, their activation energy were 47.18,42.69 kJ·mol-1,respectively.The volume ratio of hot air drying and vacuum drying of LDW ranged from 0.638 to 0.741 and 0.607 to 0.689,respectively. Conclusion: Weibull function can be adopted to predict the drying and dehydration law of LDW.Under the condition of low temperature drying,slow-down of shrinkage rate of the pills is helpful to prevent the formation of splitting pills,this study provides theoretical and technical basis for dying of LDW.

17.
Article in Chinese | WPRIM | ID: wpr-802153

ABSTRACT

Volatile oil is widely distributed in Chinese medicinal materials,which contains rich chemical compositions and has a variety of pharmacological activities such as anti-bacterial,anti-inflammatory,anti-oxidant,anti-tumor,transdermal absorption and antalgic activities,etc.In recent years,the research on the Chinese medicines containing volatile oil is increasing,showing a wide prospect of application in clinical medicine,health care,daily products development,etc.Volatile oil of traditional Chinese medicine has poor solubility,volatility and unstable properties.Factors such as species,harvesting seasons,extraction methods,processing technologies and storage conditions would affect the compositions and contents of volatile oil,thus directly affecting its efficacy,safety and quality stability.Hence,it is especially necessary to control the volatile oil content.The current 2015 edition of the Chinese Pharmacopoeia has made a lot of regulations on the quality control of Chinese medicines containing volatile oil,but generally does not provide the lowest and highest concentrations of volatile oil.As the volatile oil of traditional Chinese medicines has good biological activity and the quality standards are not yet perfect,this study would take the Fist Part of Chinese Pharmacopoeia 2015 Edition as the data source to determine the species of Chinese medicines containing volatile oils through literature research and pharmacopoeia description;the functions,indications,and sources of 196 kinds of traditional Chinese medicines containing volatile oil would be classified and the confusable species would be discriminated by using the Chinese pharmacy knowledge.In this study,the quality-influencing factors would be comprehensively analyzed and the content determination methods of volatile oil would be summarized to offer a reference for the development and application of Chinese medicinal materials containing volatile oil,as well as to lay the foundation for further reinforcing and improving their quality standards.

18.
Article in Chinese | WPRIM | ID: wpr-1008229

ABSTRACT

At present,the production equipment and process of Chinese patent medicines still have many problems including high energy consumption,low efficiency,high pollution,and low intelligence,which seriously hinder the transformation,upgrading and modernized development of traditional Chinese medicine industry. With the emergence of various new pharmaceutical technologies and the application of technologies of other fields in traditional Chinese medicine industry,the development of Chinese patent medicine has ushered in new opportunities. The processes such as pulverization,mixing,extraction,separation,concentration,drying and sterilization are unique for the production of Chinese patent medicine. These main features can be distinguished from the manufacturing process of chemical drugs,determining the characteristics of the production process and equipment of Chinese patent medicine. In this paper,each operation unit was mentioned to summarize and analyze the new equipment and new technologies with advantages and characteristics in recent years from the perspectives of definition,principle,classification and application. Among them,the automatic spray device of the mixer,the extraction and separation equipment of volatile oil,and the crane basket-type circulation extraction technology,composite multi-layer spiral vibration countercurrent drying,and vibration sterilization equipment all have rapid development in recent years,with great prospects in the production of Chinese patent medicines. In this paper,we also analyzed some problems existing in the production equipment and technology of Chinese patent medicine and the key factors restricting the development of Chinese patent medicine,discussed the transformation of Chinese patent medicine production from traditional to modern and from semi-automatic to intelligent,and put forward three suggestions to help Chinese patent medicine achieve the goal of improving quality,efficiency and green manufacturing in production.


Subject(s)
Drugs, Chinese Herbal , Medicine, Chinese Traditional , Nonprescription Drugs , Quality Control , Technology, Pharmaceutical
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-776403

ABSTRACT

"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.


Subject(s)
China , Drugs, Chinese Herbal , Reference Standards , Medicine, Chinese Traditional , Reference Standards , Quality Control , Technology, Pharmaceutical
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