On the other hand, traditional Chinese medicine decoction pieces are in full swing to carry out the whole industry chain rectification; on the other hand, medical equipment has also ushered in a thorough investigation from clinical trials to circulation channels. Our reporter was informed that the State Food and Drug Administration recently issued two heavyweight notices, requiring local drug regulatory systems to carry out centralized rectification of illegal business operations in the field of medical device circulation; in the field of clinical trials, imported medical devices are “finalistsâ€. Be the focus of spot checks.
Circulation field
Investigate the eight major illegal acts
Recently, the General Administration of Food and Drug Administration issued the "Notice on Regulating the Operational Behavior of Medical Device Circulation Fields" and the "Notice on Carrying out the Supervision and Spot Checking of Medical Device Clinical Trials", not only to check the illegal business operations in the circulation field, but also to conduct clinical trials of medical devices. Work has been incorporated into the regulatory system. “As medical devices become more and more important in clinical and civilian fields, and become a 'up-and-coming star' beyond the traditional medicine big brother, the regulatory authorities are paying more and more attention, and the new field is from clinical trials to circulation. There are also many problems, so the rectification is very practical." An industry observer thinks so.
It is understood that the Food and Drug Administration has stipulated that medical device operating enterprises should conduct self-examination of medical device management behaviors since June 1, 2014, and describe the existing problems in detail, by means of medical procedures and personnel. Carefully formulate rectification measures and plans, form self-examination and rectification reports, and promptly report to local food and drug supervision departments.
The reporter found out that the focus of this monitoring is mainly on the following three points: First, enterprises with low daily management level, chaotic purchase and sales channels, and frequent cases, and self-inspection found that the problems are few and the rectification measures are weak; The second is to engage in the operation of low-temperature, refrigerated medical device business enterprises; the third is to focus on the inspection of imported medical device domestic agents, and to select a number of varieties for each key inspection enterprise, to carry out upstream and downstream extension inspection of flow and bill authenticity . Cases across administrative areas should be thoroughly investigated in a combination of case investigation and field investigation.
Imported medical devices are "finalists"
The industry said it is not "different treatment"
In the field of clinical trials, the Food and Drug Administration requires that the clinical trial data in the application for medical device registration should be supervised and examined, and the clinical trials and violations, especially fraudulent acts, should be investigated. It is understood that the spot check will include all domestic third-class and imported medical devices in China through clinical trials to obtain clinical trial data registration applications, taking into account the degree of risk, the proportion of imported domestic applications, applicants, clinical trial institutions Factors such as the size and number of projects undertaken are drawn at a certain percentage.
It is understood that one of the following circumstances will be judged to be true: the clinical trial data submitted by the registration application is inconsistent with the corresponding clinical trial data kept by the clinical trial institution; the clinical trial data cannot be traceable; the test product/test In vitro diagnostic reagents or test samples are not true. In addition, even if no authenticity problem is found, if the clinical trial process does not meet the requirements of medical device regulations, it will be determined that there is a compliance problem.
"This move cannot be regarded as a 'differential treatment' of imported medical devices, because the clinical trial data including drugs have been thoroughly investigated since last year, and many domestic listed drug companies are involved, and the medical device sector is already There are many imported equipment, so the focus of the 'finalists' spot check can be regarded as equal treatment." The observer analyzed.
Plant extraction process
1. Select plants/medicinal materials. It is nothing more than ancient prescriptions, proven prescriptions, and folk medicinal herbs. At present, common and uncommon medicinal materials have been studied. Most of the time, the amount of medicinal materials has been increased to extract low-isolated components, or medicinal plants have not been studied from Miao medicine, Tibetan medicine, Mongolian medicine, Africa, Latin America and other places.
2. Extract. Solvent petroleum ether, n-hexane, cyclohexane, benzene, chloroform, ethyl acetate, n-butanol, acetone, ethanol, methanol, water (small polarity → large polarity). Daily decoction of medicines is effective, use water and ethanol and other solvents with high polarity. Artemisinin and other boiling methods are not effective, use petroleum ether and other solvents with low polarity. The common medicinal materials, water/alcohol/ether, are presented again, and more compounds can be separated and identified.
3. Separation. This is the most important task. There are dozens of compounds in the solution extracted in the second step. Generally, column chromatography is used, which is what we often call column flushing. The workload is large, boring, and low-tech. A master's degree may do this every day for 2 years of experimentation. As shown in the figure below, the column for separating compounds is as large as 2 meters high and as small as 10 cm. Change the solvent conditions of the mobile phase, change the material of the column, and repeatedly wash the column under different conditions and separation principles to separate the monomer compound.
High Content Monomer,Kudzu Root Powder,Magnolia Bark Extract Powder,Golden Turtle Lotus Extract
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