Latest ArticlesTo determine the index weight coefficient, optimize the ultrasonic extraction process of flavonoids in Scutellaria baicalensis Georgi and analyze its anti-inflammatory activity in vitro.
On the basis of single factor test, ethanol concentration (A), ultrasonic time (B), ultrasonic temperature (C) and material-to-liquid ratio (D) were selected as the investigation factors. Taking baicalin, wogonin, baicalein and wogonin as the inspection indicators, the AHP-CRITIC mixed weighting method was used to determine the weight coefficients of each index, multivariate binomial was fitted combined with the response surface method, a three-dimensional graph was drawn, and the best extraction process was chosen. At the same time, the MTT method and Griess method were used to evaluate the in vitro anti-inflammatory activity of the ultrasonic extraction of Scutellaria baicalensis Georgi.
The optimal extraction conditions for flavonoids in Scutellaria baicalensis Georgi were as follows: ethanol concentration of 62.73%, ultrasonic time of 32.23 min, ultrasonic temperature of 51.15 ℃, and material-to-liquid ratio of 1∶16.12. The average AHP-CRITIC comprehensive score of three batches of verification samples was 85.28, and the RSD with the theoretical prediction value was 0.50%. The results of MTT method showed that when the concentration of Scutellaria baicalensis Georgi extraction was greater than 400 μg·mL-1, the cell viability decreased significantly (P<0.05, P<0.01). When the concentration of Scutellaria baicalensis Georgi extraction was 50~350 μg·mL-1, the release of NO in RAW264.7 inflammatory cells was significantly inhibited (P<0.05, P<0.01).
The method is stable and reliable and can be used for the extraction of flavonoids from Scutellaria baicalensis Georgi, and the ultrasonic extract has strong anti-inflammatory activity in vitro.
The aim of the article was to study the difficulties that Chinese drug manufacturing enterprise (hereinafter referred to as drug enterprise) may face after the official implementation of electronic common technical document (eCTD), and to propose countermeasures. The origination, development and global implementation of eCTD were introduced, as well as the relevant guidelines issued by NMPA, so as to analyze the possible problems in the process of eCTD registration application of drug enterprise in China and put forward relative countermeasures. eCTD has been widely used in the world. The eCTD guidelines published in China was established based on V3.2.2 version issued by ICH. eCTD helps to improve the efficiency of drug application but is difficult to develop and has high professional requirements. It is advisable for drug enterprise to make early planning, complete the construction of eCTD registration application system as soon as possible, and prepare the arrival of the eCTD era with a positive attitude.
New drug R&D typically holds the characteristics of high technical barriers of entry, requiring high monetary spending, long cycle of development, multidisciplinary, and carrying high risk and high added value. Formulating and optimizing new drug R&D strategy is of great significance to the survival and development of pharmaceutical enterprises. The problem of absence of new drug strategic management is pervasive in the process of innovation and transformation of Chinese pharmaceutical enterprises. Through analyzing the cases of leading enterprises in the industry and exploring the methods to formulate and optimize the management of R&D strategic planning and its implementation, the author is dedicated to the benefit of domestic enterprises to promote and develop low-cost, high-quality new products with clinical and commercial value, aiming to improve China's influence and competitiveness in the field of innovative drugs.
To explore the elements that influence the behavior choices and the feasibility of delegated manufacturing of traditional Chinese medicine preparations in medical institutions under the marketing authorization holder (MAH) system.
A tripartite evolutionary game model of MAH, trustee, and government was built, the tripartite strategy choices in the process of entrusted manufacturing of preparations were analyzed, and simulation analysis was conducted to investigate the influencing factors of strategy choice.
Considering the interest demand and the risk degree, keeping the appropriate subsidy and penalty intensity can help to improve the enthusiasm of MAH and trustee. The government's initiatives to boost rewards and penalties will help to improve MAH and client engagement in commission allocation, but too many rewards and penalties will conflict with the government's regulatory responsibilities. The social loss caused by the government's non-supervision urges the government to improve the supervision rate.
Entrusted manufacturing of traditional Chinese medicine preparations is feasible. Finding the point of profit balance among stakeholders helps to actualize the beneficial cycle of traditional Chinese medicine preparations in medical facilities.
To scientifically construct the evaluation indicators for human use experience of traditional Chinese medicine (TCM) and provide reference for the formation of "triple combination" registration review evidence system.
Based on the Delphi method, after literature research and expert investigation, two rounds of expert consultation were carried out, and the expert consultation results were evaluated by the mean, variation index, coordination coefficient, etc., and the core indicators for human use experience evaluation of TCM were further screened and optimized.
22 experts in various fields were selected to conduct a questionnaire survey. The participation rates of experts in the 2 rounds of consultation were 100% and 95.46%, and the authority indicators of involved experts were 0.852 and 0.865. According to the mean value and coefficient of variation of the indicators, combined with the revision suggestions of experts, the core indicators of human use experience evaluation including 4 first-level indicators and 22 second-level indicators were finally formed.
The core indicators for human use experience evaluation of TCM could guide the standardized collection and summary of human use experience data, promote the formation of high-quality and evaluable human use experience evidence, and support the research and development of new TCM products.
Since 2015, a series of policies implemented by China's drug review and approval reform have built a good ecological environment for the development of innovative drugs in China. The development of innovative drugs in China has achieved initial results. In recent years, with the increase in the number of pre-approval inspection tasks for innovative drugs, prominent problems such as unclear responsibilities between drug registration applicants and entrusted units, imperfect quality management systems and many GMP observations were found in the pre-approval inspections according to the verification standards such as the "pre-approval inspection procedures" and the "main points and judgment principles on pre-approval inspection". This paper studied the characteristics of the innovative chemical drugs, sorted out the basic situation of the innovative chemical drugs, summarized and analyzed the main problems found in the pre-approval inspection of innovative chemical drugs from 2019 to 2021, and put forward corresponding suggestions, in order to provide reference for the research and development and registration of new drugs in the industry and provide reference for pre-approval inspection of innovative drugs.
Tissue repair is a process that involves coagulation reaction, inflammatory reaction, cell proliferation and remodeling induced by tissue injury. Bletilla striata is a traditional Chinese medicine with astringent and hemostatic effect. Its extract has pharmacological effects such as hemostasis, anti-inflammatory effect, antibacterial and antioxidant effect, so that it can promote tissue repair and reconstruction. This paper reviews the extract and pharmacological mechanism of Bletilla striata in tissue repair and reconstruction, so as to provide reference for its clinical medication and expand the scope of clinical application.
Tumor immunotherapy holds immense potential for tumor treatment because it can utilize the patient's immune system to eradicate tumors and prevent tumor recurrence. Nanoparticles are expected to be the optimal carrier for tumor immunotherapy due to their unique advantages. Ca2+, as the second messenger in cells, plays an important role in regulating the immune response in vivo. Recent studies have shown that calcium nanoparticles, such as calcium peroxide (CaO2) nanoparticles, calcium phosphate (CaP) nanoparticles, calcium hydride (CaH2) nanoparticles and calcium carbonate (CaCO3) nanoparticles, can activate anti-tumor immune responses through a variety of mechanisms. In addition, calcium nanoparticles can also be used in combination with other therapies such as photothermal therapy (PTT), sonodynamic therapy (SDT), chemotherapy and radiotherapy to synergically fight tumors to exert the "immune+" anti-tumor effect. In this article, we reviewed the recent research progress of calcium nanoparticles in tumor immunotherapy, and looked forward to the challenges of this field.
Endocrine therapy is one of the treatment options for estrogen receptor-positive breast cancer. The therapeutic drugs include selective estrogen receptor modulators, selective estrogen receptor down-regulators and aromatase inhibitors. The resistance of tumor cells to endocrine therapy is one of the key factors limiting the clinical application of endocrine therapeutic drugs. Resistance includes intrinsic drug resistance and acquired drug resistance. The generation of acquired drug resistance may be related to the overexpression of ERα coactivators and the abnormal expression of cell cycle regulators mediated by ER, RTKs, PI3K and other pathways. This article mainly reviews the mechanism of breast cancer resistance to endocrine therapy and the treatment strategies.
Tuberculosis infection has always been a major concern for rheumatologists. The treatment of diseases such as spinal arthritis has entered the era of biologics, but the use of biologics will increase the risk of opportunistic infections such as tuberculosis. As a novel biological agent, secukinumab can improve the prognosis and quality of life of patients with ankylosing spondylitis and psoriasis by blocking the effect of IL-17A and playing an immunomodulatory function. This article reviews the safety of secukinumab in terms of tuberculosis infection in order to provide reference for clinical application.
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