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1.
Article in Chinese | WPRIM | ID: wpr-879128

ABSTRACT

In the past few years, continuous manufacturing(CM) has been put forward by the FDA. Pharmaceutical enterprises are encouraged to promote the implementation of CM, which has become a hot research direction of pharmaceutical technology. In February 2019, the FDA issued a draft guideline for the implementation of CM, which greatly promoted the development of CM and provided reference for continuous manufacturing of traditional Chinese medicine(TCM). The production process of TCM is a complex system. With the innovation of production equipment and the promotion of automation and informatization of TCM production, the exis-ting policies, regulations and traditional production control capacity are difficult to meet the market demand for high-quality TCM pro-ducts. In this paper, we reviewed the new technologies and methods of quality control in accordance with the characteristics of TCM production by referring to modern manufacturing technology, information technology and quality control technology. Based on the "QbD" theory and "PAT" technology, process knowledge system(PKS), an advanced control strategy, was proposed to provide a reference for the implementation of CM in TCM production.


Subject(s)
Commerce , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Technology, Pharmaceutical
2.
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
3.
Article in Chinese | WPRIM | ID: wpr-879197

ABSTRACT

In this paper, we first introduced the concept of digital twin(DT) based key technologies for intelligent manufacturing of traditional Chinese medicine(TCM) and applied DT in two case studies of novel extraction equipment for traditional Chinese medicine and drying equipment for Chinese medicine pills to illustrate the advantages of DT in development of new pharmaceutical technology and optimization of pharmaceutical equipment structure. Furthermore, we discussed the feasibility to adopt DT in the production process of TCM for formation of data-driven real-time optimization of production process and dynamic prediction `of operation and maintenance service. The "ruled" production mode based on data and driven by algorithm was constructed to realize the technical scheme of quality perception, evaluation, prediction, intelligent control and intelligent decision-making in product life cycle.


Subject(s)
Commerce , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Technology, Pharmaceutical
4.
Article in Chinese | WPRIM | ID: wpr-828047

ABSTRACT

The present study was aimed to investigate the effect of lime and licorice processing of Pinelliae Rhizoma on its toxic lectin protein and clarify the scientific detoxification connotation of lime and licorice processing of Pinelliae Rhizoma. Western blot was used to semi-quantitatively analyze the contents of lectin in Pinelliae Rhizoma and Pinelliae Rhizoma Praeparatum. Raw products and lectin were treated by soaking in licorice juice, lime solution or mixture solution of these two to investigate the different processing time on the content of toxic lectin protein. SDS-PAGE gel electrophoresis was used to analyze the changes of lectin protein bands in the solution and precipitates before and after processing. MALDI-TOF technology was used to qualitatively analyze and compare the protein molecular weight before and after processing. The results showed that the contents of lectin in Pinelliae Rhizoma and Pinelliae Rhizoma Praeparatum were 5.01% and 0.04% respectively, indicating that processing could significantly reduce the content of active lectin in raw products. The results also showed that the content of lectin in raw drugs decreased significantly after soaking in lime solution for one day or in licorice juice for three day, and the effect was greatest in mixture solution. Qualitative analysis showed that after being treated by soaking in lime solution, the lectin protein was decomposed into small peptide segments, while after being treated by soaking in licorice juice, the lectin protein was denatured and precipitated. The structure of lectin protein in Pinelliae Rhizoma was broken after being processed with licorice juice and lime solution, which significantly reduced the content of toxic lectinprotein. This is one of the detoxification mechanisms of Pinelliae Rhizoma processing.


Subject(s)
Calcium Compounds , Drugs, Chinese Herbal , Glycyrrhiza , Lectins , Oxides , Pinellia , Technology, Pharmaceutical
5.
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
6.
Article in Chinese | WPRIM | ID: wpr-775350

ABSTRACT

In the thermal analysis, the pyrolysis characteristics of crude Kansui Radix, alcohol extract of Kansui Radix, petroleum ether extract, chloroform extract, ethyl acetate extract, n-butanol extract, and licorice vinegar were analyzed with simulated air (N₂-O₂ 4:1) as the carrier gas, at a temperature increase rate of 10 °C·min⁻¹ and a volume flow rate of 60 mL·min⁻¹, respectively. The results showed that due to the different polarity of the extraction solvent, the type and quantity of the chemical components contained in each polar part were different, and with the increase in the amount of solid powder of licorice, the peak of the maximum heat loss rate occurred in advance. For petroleum ether, chloroform, and ethyl acetate fractions, (157.40±1.06), 3.50, (25.83±1.66) °C in advance respectively, but the weight loss rate of the chloroform fraction was increased by (2.62±5.19) °C, while decreased by (33.90±1.72), (19.28±1.11) °C for the petroleum ether and ethyl acetate fractions. So we can conclude that with the addition of licorice, the pyrolysis rate of the petroleum ether and chloroform fractions in the toxic part of Kansui Radix was increased; the temperature point at the peak of the maximum weight loss rate was decreased, and the ethyl acetate fraction (effective part) showed a decrease in temperature rising process, but its overall ratio of weight loss and weight loss rate were relatively small, retaining the effect of medicinal ingredients. This proved the mechanism of licorice system Kansui Radix on attenuating toxicity after processing and the scientificity and rationality of licorice system Kansui Radix. At the same time, as the proportion of glycyrrhizin was increased, the peak of the maximum heat loss rate of petroleum ether, chloroform and ethyl acetate fractions occurred in advance; the peak temperature was decreased, with easy pyrolysis. Among them, the thermogravimetric rate of the mixture of petroleum ether and chloroform fractions (10:1) was relatively large, with a low peak temperature, while ethyl acetate fraction showed opposite results. This conclusion has certain guiding significance for the ratio of gansui to licorice.


Subject(s)
Drugs, Chinese Herbal , Chemistry , Euphorbia , Chemistry , Glycyrrhiza , Chemistry , Plant Extracts , Chemistry , Plant Roots , Chemistry , Technology, Pharmaceutical , Temperature
7.
Article in Chinese | WPRIM | ID: wpr-775336

ABSTRACT

With the publishment of the application guideline for the key project of "Research on Modernization of Traditional Chinese Medicine" by the Ministry of Science and Technology in 2018, the problem of "intelligentization" in the production of decoction pieces of Chinese crude drugs has attracted more and more attention from the industry. Some suggestions on the intelligentization of the production of decoction pieces of Chinese crude drugs in the course of transformation of production mode and innovation of production technology of decoction pieces of Chinese crude drugs" were proposed in this paper, which in order to help the implementation of the project and the development of decoction pieces industry.


Subject(s)
Drugs, Chinese Herbal , Feasibility Studies , Medicine, Chinese Traditional , Technology, Pharmaceutical
8.
Article in English | WPRIM | ID: wpr-812357

ABSTRACT

Astragali Radix, the root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., is widely used as a tonic decoction pieces in the clinic of traditional Chinese medicine (TCM). Astragali Radix has various processed products with varying pharmacological actions. There is no modern scientific evidence to explain the differences in pharmacological activities and related mechanisms. In the present study, we explore the changes in chemical components in Astragali Radix after processing, by ultra-high performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) combined with novel informatics UNIFI platform and multivariate statistical analysis. Our results showed that the crude and various processed products could be clearly separated in PCA scores plot and 15 significant markers could be used to distinguish crude and various processed products by OPLS-DA in UNIFI platform. In conclusion, the present study provided a basis of chemical components for revealing connotation of different processing techniques on Astragali Radix.


Subject(s)
Astragalus propinquus , Chemistry , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Chemistry , Mass Spectrometry , Metabolomics , Plant Roots , Chemistry , Technology, Pharmaceutical
9.
Article in English | WPRIM | ID: wpr-773568

ABSTRACT

Astragali Radix, the root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge., is widely used as a tonic decoction pieces in the clinic of traditional Chinese medicine (TCM). Astragali Radix has various processed products with varying pharmacological actions. There is no modern scientific evidence to explain the differences in pharmacological activities and related mechanisms. In the present study, we explore the changes in chemical components in Astragali Radix after processing, by ultra-high performance liquid chromatography quadrupole time-of-flight mass spectrometry (UPLC-QTOF-MS) combined with novel informatics UNIFI platform and multivariate statistical analysis. Our results showed that the crude and various processed products could be clearly separated in PCA scores plot and 15 significant markers could be used to distinguish crude and various processed products by OPLS-DA in UNIFI platform. In conclusion, the present study provided a basis of chemical components for revealing connotation of different processing techniques on Astragali Radix.


Subject(s)
Astragalus propinquus , Chemistry , Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Chemistry , Mass Spectrometry , Metabolomics , Plant Roots , Chemistry , Technology, Pharmaceutical
10.
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
11.
Braz. J. Pharm. Sci. (Online) ; 54(2): e17183, 2018. tab, graf, ilus
Article in English | LILACS | ID: biblio-951934

ABSTRACT

ABSTRACT Interpolyelectrolyte complexes, which constitute a type of polymeric material obtained through the self-assembly of oppositely charged polymers, exhibit interesting properties for use in the design of smart matrices for drug delivery. In the present study, a stoichiometric interpolyelectrolyte complex (SIPEC) composed of Eudragit E® and Eudragit® L100 was obtained at pH 6.0 and characterized and evaluated as a hydrophilic matrix for dexibuprofen. The formation of a SIPEC was monitored by ζ-potential measurements and characterized using infrared spectroscopy, thermal analysis, and scanning electron microscopy. The results indicated that a SIPEC obtained under these conditions can be used as a matrix for controlling the release of dexibuprofen and exhibit a pH-triggered release


Subject(s)
Drug Liberation , Hydrogen-Ion Concentration , Technology, Pharmaceutical/instrumentation , Anti-Inflammatory Agents/analysis
12.
Einstein (Säo Paulo) ; 16(3): eRW4175, 2018. tab
Article in English | LILACS | ID: biblio-953180

ABSTRACT

ABSTRACT The manufacturing process for biological products is complex, expensive and critical to the final product, with an impact on their efficacy and safety. They have been increasingly used to treat several diseases, and account for approximately 50% of the yearly budget for the Brazilian public health system. As the patents of biological products expire, several biosimilars are developed. However, there are concerns regarding their efficacy and safety; therefore, the regulatory agencies establish rules to approve and monitor these products. In Brazil, partnership programs between national government-owned companies and private technology holders have been implemented, aiming at knowledge sharing, capacity-building and technological transfer. Such partnerships locally promote manufacturing of these strategic drugs at reduced costs to the public health system. These agreements offer mutual advantages to both the government and patent holders: for the former, a biotechnological development flow is established and enables potential cost reduction and self-sufficient production; whereas for the latter, exclusive sales of the product are ensured during technological transfer, for a fixed period.


RESUMO O processo de manufatura de produtos biológicos é complexo, oneroso e crítico para o produto final, com impacto em sua eficácia e segurança. Seu uso está sendo cada vez mais ampliado no tratamento de diversas doenças, e cerca de 50% do orçamento anual do sistema de saúde público brasileiro é consumido por tais produtos. Com o término da proteção de patentes de produtos biológicos diversos, estão sendo desenvolvidos os biossimilares. Porém, há preocupações relacionadas com sua eficácia e segurança, fazendo com que os órgãos reguladores criem regulamentações para sua aprovação e monitoramento. No Brasil, estão sendo implantados programas de parceria entre laboratórios públicos nacionais e laboratórios detentores de tecnologia, objetivando a obtenção de conhecimento, capacitação profissional e transferência desta tecnologia. Tais parcerias visam à produção local destes medicamentos estratégicos a um custo reduzido para o Sistema Único de Saúde. Os acordos oferecem vantagens mútuas para o governo e o laboratório detentor da patente do produto biológico: ao primeiro, estabelece-se um fluxo de desenvolvimento biotecnológico, que possibilita potencial redução de custos e autossuficiência na produção, enquanto ao segundo garante-se a exclusividade da venda do produto durante a transferência da tecnologia por um prazo estabelecido.


Subject(s)
Humans , Public-Private Sector Partnerships/trends , Biosimilar Pharmaceuticals/standards , Patents as Topic , Brazil , Technology, Pharmaceutical/trends , Technology, Pharmaceutical/statistics & numerical data , Drug Approval/legislation & jurisprudence , Biosimilar Pharmaceuticals/economics
14.
Article in English | WPRIM | ID: wpr-812548

ABSTRACT

Aconite is a valuable drug and also a toxic material, which can be used only after detoxification processing. Although traditional processing methods can achieve detoxification effect as desired, there are some obvious drawbacks, including a significant loss of alkaloids and poor quality consistency. It is thus necessary to develop a new detoxification approach. In the present study, we designed a novel one-step detoxification approach by quickly drying fresh-cut aconite particles. In order to evaluate the technical advantages, the contents of mesaconitine, aconitine, hypaconitine, benzoylmesaconine, benzoylaconine, benzoylhypaconine, neoline, fuziline, songorine, and talatisamine were determined using HPLC and UHPLC/Q-TOF-MS. Multivariate analysis methods, such as Clustering analysis and Principle component analysis, were applied to determine the quality differences between samples. Our results showed that traditional processes could reduce toxicity as desired, but also led to more than 85.2% alkaloids loss. However, our novel one-step method was capable of achieving virtually the same detoxification effect, with only an approximately 30% alkaloids loss. Cluster analysis and Principal component analysis analyses suggested that Shengfupian and the novel products were significantly different from various traditional products. Acute toxicity testing showed that the novel products achieved a good detoxification effect, with its maximum tolerated dose being equivalent to 20 times of adult dosage. And cardiac effect testing also showed that the activity of the novel products was stronger than that of traditional products. Moreover, particles specification greatly improved the quality consistency of the novel products, which was immensely superior to the traditional products. These results would help guide the rational optimization of aconite processing technologies, providing better drugs for clinical treatment.


Subject(s)
Aconitum , Chemistry , Toxicity , Alkaloids , Toxicity , Animals , Cardiovascular Agents , Chemistry , Reference Standards , Toxicity , Desiccation , Methods , Drugs, Chinese Herbal , Chemistry , Reference Standards , Toxicity , Male , Maximum Tolerated Dose , Plant Roots , Chemistry , Rats, Sprague-Dawley , Technology, Pharmaceutical , Methods
15.
Article in English | WPRIM | ID: wpr-812547

ABSTRACT

Boiling processing is commonly used in post-harvest handling of White Paeony Root (WPR), in order to whiten the herbal materials and preserve the bright color, since such WPR is empirically considered to possess a higher quality. The present study was designed to investigate whether and how the boiling processing affects overall quality of WPR. First, an ultra-high performance liquid chromatography quadrupole/time-of-flight mass spectrometry-based metabolomics approach coupled with multivariate statistical analysis was developed to compare the holistic quality of boiled and un-boiled WPR samples. Second, ten major components in WPR samples boiled for different durations were quantitatively determined using high performance liquid chromatography to further explore the effects of boiling time on the holistic quality of WPR, meanwhile the appearance of the processed herbal materials was observed. The results suggested that the boiling processing conspicuously affected the holistic quality of WPR by simultaneously and inconsistently altering the chemical compositions and that short-time boiling processing between 2 and 10 min could both make the WPR bright-colored and improve the contents of major bioactive components, which were not achieved either without boiling or with prolonged boiling. In conclusion, short-term boiling (2-10 min) is recommended for post-harvest handling of WPR.


Subject(s)
Chromatography, High Pressure Liquid , Methods , Drugs, Chinese Herbal , Chemistry , Reference Standards , Hot Temperature , Mass Spectrometry , Methods , Paeonia , Chemistry , Plant Roots , Chemistry , Technology, Pharmaceutical , Water
16.
São Paulo; s.n; s.n; 2017. 105 p. tab, ilus, graf.
Thesis in Portuguese | LILACS | ID: biblio-881629

ABSTRACT

O tratamento farmacológico de patologias bucais é conduzido, geralmente, por via de administração local. No entanto, devido ao pouco tempo de permanência do fármaco no local de ação, esse tratamento pode ser bastante comprometido. Assim, este trabalho teve por objetivo o desenvolvimento de formas farmacêuticas que proporcionem a liberação local de triancinolona na cavidade oral. Foram produzidos filmes e comprimidos mucoadesivos a partir de polímeros naturais como gelana e pectina. Os filmes bucais foram preparados por meio de evaporação do solvente (solvent casting) utilizando diferentes quantidades de polímeros. As matérias-primas e os filmes foram caracterizados fisico quimicamente utilizando espectroscopia vibracional (in-infravermelho com transformada de Fourier e Raman) e difração de raios X. As propriedades físicas e mecânicas dos filmes também foram avaliadas. Além disso, realizou-se os ensaios de mucoadesividade e de dissolução do fármaco. Os comprimidos foram preparados por com-pressão direta usando como base os polímeros naturais. Diferentes parâmetros em relação as misturas e as formulações foram avaliados tais como as propriedades de fluxo dos pós constituintes, peso médio, dureza, friabilidade e desintegração. Em relação aos filmes bucais, estes foram obtidos com sucesso através de um método simples, sem a utilização de agentes reticulantes, ácidos ou solventes orgânicos. Todos apresentaram bons resultados nas propriedades avaliadas, no entanto as formulações com quantidades intermediarias de polímeros foram as melhores. Dentre as formulações de comprimidos preparadas, apenas 4 apresentaram boas características, no entanto, os resultados dos ensaios de dissolução mostraram que estas formulações têm capacidade de agir como sistema de liberação controlada de fármacos


Pharmacological treatment of oral pathologies is usually conducted by local administration. However, due to the short time the drug stays in the site of action, this treatment can be quite compromised. Thus, the objective of this work was to develop pharmaceutical forms that pro-vide the local release of triamcinolone in the oral cavity. Mucoadhesive films and tablets were made from natural polymers such as gellan and pectin. The buccal films were prepared by sol-vent casting using different amounts of polymers. The raw materials and films were characte-rized physically chemically using vibrational spectroscopy (FTIR and Raman) and X-ray diffraction. The physical and mechanical properties of the films were also evaluated. In addi-tion, the mucoadhesive and drug dissolution tests were performed. The tablets were prepared by direct pressing with the natural polymers. Different parameters in relation to mixtures and formulations were evaluated such as the flow properties of the constituent powders, average weight, hardness, friability and disintegration. In relation to oral films, these were successfully obtained by a simple method, without the use of crosslinking agents, acids or organic solvents. All presented good results in the evaluated properties, however the formulations with interme-diate amounts of polymers were the best. Among the tablet formulations prepared, only 4 sho-wed good characteristics, however, the dissolution test results showed that these formulations have the ability to act as a controlled drug delivery system


Subject(s)
Pectins/analysis , Triamcinolone/pharmacology , Microscopy, Polarization/methods , Mouth/immunology , Spectroscopy, Fourier Transform Infrared/methods , Tablets/pharmacokinetics , Technology, Pharmaceutical/instrumentation
17.
Pakistan Journal of Pharmaceutical Sciences. 2017; 30 (1): 187-194
in English | IMEMR | ID: emr-185757

ABSTRACT

The human digestive tract contains some 100 trillion cells and thousands of species of micro-organisms may be present as normal flora of this tract as well as other mucocutaneous junctions of the body. Candida specie is the most common organism residing in these areas and can easily invade the internal tissues in cases of loss of host defenses. Modifications of previously existing antifungal agents may provide new options to fight against these species. Inorganic compounds of different antifungals are under investigations. Present study report six complexes of fluconazole with Cu [II]], Fe[II], Cd[II], Co[II], Ni[II] and Mn[II] have been synthesized and characterized by elemental analysis, IR, UV and H-NMR. The elemental analysis and spectroscopic data were found in agreement with the expected values as the metal to ligand value was 1:2 ratios with two chlorides in coordination sphere. The morphology of each complex was studied using scanning electron microscope and compared with fluconazole molecule the flaky-slab rock like particles of pure fluconazole was also observed as reported earlier. However, the complexes of fluconazole were showed different morphology in their micrograph. Fluconazole and its complex derivatives have also been screened in vitro for their antifungal activity against Candida albican and Aspergillus niger by MIC method. The complexes showed varied activity ranging from 2-20%


Subject(s)
Metals, Heavy , Microbial Sensitivity Tests , Aspergillus niger/drug effects , Candida albicans/drug effects , Antifungal Agents/pharmacology , Technology, Pharmaceutical/methods
18.
Pakistan Journal of Pharmaceutical Sciences. 2017; 30 (3 [Special]): 1151-1155
in English | IMEMR | ID: emr-189328

ABSTRACT

This paper was aimed to analyze whether the U.S. strict export control to China affects the technological innovation of Chinese pharmaceutical industry. This paper selected the data of technological innovation and the expenditure of high and new technology adoption in China's pharmaceutical industry from 1995 to 2014, created panel regression model to study the impact of export controls on technology spillovers and the impact of technology spillovers on innovation capacity. The results show that US export control has a significant impact on technology spillovers, but foreign technology spillovers have no significant impact on the innovation of Chinese pharmaceutical industry. Although the US export control prevented foreign technology spillovers to China, but indirectly stimulated the domestic technology spillovers to pharmaceutical manufacturing industry in China. Statistical analysis show that the correlation coefficient between innovation capacity and expenditure for high technology adoption is not significant, but the expenditure of purchasing domestic technical is essential to pharmaceutical innovation. This study shows that US export control indirectly, not directly, affected the technological innovation of China's pharmaceutical industry, affected the allocation of innovative resources, but failed to prevent the technological progress and competitiveness improvement of Chinese pharmaceutical industry


Subject(s)
Technology, Pharmaceutical , Inventions
19.
RECIIS (Online) ; 10(1): 1-10, jan.-mar.2016. tab, graf
Article in Portuguese | LILACS | ID: lil-784671

ABSTRACT

Com o aumento de diagnósticos da doença de Chagas, surge a necessidade de desenvolvimento de fármacos que tenham maior efeito contra os parasitas. O presente artigo objetiva apresentar um mapeamento tecnológico dos documentos de patentes relacionadas a tecnologias que empregam fármacos antiparasitários para tratamento da doença Chagas, por intermédio do banco de patentes do United States Patent andTrademark Office – USPTO. A primeira patente das 117 analisadas foi depositada nessa base em 1976. Os resultados demonstram que os estudos sobre o tratamento da doença de Chagas por meio de fármacos antiparasitários estão em desenvolvimento, focados na prevenção da doença, e são subsidiados em sua maioria por iniciativas particulares. Há pouco interesse da indústria farmacêutica no desenvolvimento de novos fármacos para tratamento e as universidades não têm incentivo para desenvolvimento de pesquisas sobre esse tema...


Con el aumento del diagnóstico de la enfermedad de Chagas, hay una necesidad de desarrollar fármacos quetengan un mayor efecto contra parásitos. Este artículo tiene como objetivo presentar un mapeo tecnológico dedocumentos de patentes relacionadas con las tecnologías que emplean fármacos antiparasitarios para tratarla enfermedad de Chagas, a través del United States Patent and Trademark Office – USPTO. Se analizaron117 patentes; la primera patente había sido presentada en esa base en 1976. Los resultados muestran que losestudios sobre el tratamiento de la enfermedad de Chagas a través de medicamentos antiparasitarios estánen desarrollo, centrados en la prevención de la enfermedad, y la mayoría es subvencionada por iniciativasprivadas. Hay poco interés por parte de la industria farmacéutica para desarrollar nuevos fármacos para eltratamiento y las universidades no tienen incentivos para desarrollar la investigación en esta área...


With increasing diagnostic Chagas disease, it is necessary to develop drugs that have a greater effect againstparasites. This article aims to present a technological mapping of patent documents related to technologiesemploying antiparasitic drugs to treat Chagas disease, through the patent database United States Patentand Trademark Office - USPTO. 117 patents were analyzed, and the first patent was filed on that basis in1976. The results show that studies of the treatment of Chagas disease through antiparasitic drugs are in development,focused on preventing the disease, and most of them are subsidized by private initiatives. Thereis little interest from the pharmaceutical industry to develop new drugs for treatment and universities haveno incentive to develop research in this area...


Subject(s)
Humans , Antiparasitic Agents/therapeutic use , Chagas Disease/drug therapy , Intellectual Property , Patents as Topic/statistics & numerical data , Technology, Pharmaceutical , Brazil/epidemiology , Drug Industry , Governmental Research Institutes , Inventors/statistics & numerical data , Pharmaceutical Preparations
20.
Rev. saúde pública ; 50(supl.2): 3s, 2016. graf
Article in English | LILACS | ID: biblio-830785

ABSTRACT

ABSTRACT This paper describes the development process of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines) based on an integrated approach to pharmaceutical services, science, technology and innovation. It starts by contextualizing health and development in Brazil and features elements of the National Policy for Science, Technology and Innovation in Health in Brazil and the National Policy for Pharmaceutical Services. On presenting pharmaceutical policy guidelines, it stresses the lack of nationwide data. This survey, commissioned by the Brazilian Ministry of Health, has two components: household survey and evaluation of pharmaceutical services in primary care. The findings point to perspectives that represent, besides the enhancement of public policy for pharmaceutical services and public health, results of government action aimed at developing the economic and industrial health care complex to improve the health conditions of the Brazilian population.


RESUMO O artigo apresenta o processo de construção da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamento a partir de uma concepção integradora da Assistência Farmacêutica, Ciência, Tecnologia e Inovação. Inicia-se contextualizando a saúde e o desenvolvimento no País e apresenta elementos da Política Nacional de Ciência Tecnologia e Inovação em Saúde no Brasil e da Política Nacional de Assistência Farmacêutica. Ao apresentar as diretrizes das Políticas Farmacêuticas, destaca-se a carência de dados de abrangência nacional. A presente pesquisa, encomendada pelo Ministério da Saúde, foi estruturada em dois componentes: inquérito domiciliar e avaliação dos serviços de assistência farmacêutica na atenção básica. As perspectivas dos resultados representam, além do incremento das políticas públicas farmacêuticas e de saúde pública, resultados de ações governamentais voltadas ao desenvolvimento do complexo econômico-industrial da saúde, visando a melhoria das condições de saúde da população brasileira.


Subject(s)
Humans , Health Policy , Health Promotion , Health Surveys , Pharmaceutical Services/organization & administration , Science , Technology , Biomedical Technology , Brazil , Diffusion of Innovation , Drug and Narcotic Control , Federal Government , National Health Programs , Primary Health Care , Technology, Pharmaceutical
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