[follow the discussion] only by keeping in mind the original intention can Chinese pharmaceutical preparations develop healthily and comprehensively (2)

2、 Considering the current situation of pharmaceutical industry - teaching, research and development, registration, production, circulation / marketing, use, etc., it is deeply felt that pharmacy can only develop in an all-round way without forgetting its original intention If we don't understand where pharmaceutics comes from and why it goes, how can we be confident and stick to it all the time? If we only follow the same example, the dosage forms and their preparations will be more marginalized in the pharmaceutical industry, maybe it's just alarmism! As far as pharmaceutics is concerned as an applied discipline, where it comes from refers to what pharmaceutics studies, how it should be studied, why it should be studied in this way, and why it goes away refers to how it can be better studied These have been mentioned as properties and tasks in the introduction of pharmaceutics Now it's like a platitude to mention them again When I was a student, I didn't pay attention to the introduction class, and when I was a teacher, I didn't pay much attention to the requirements Now I think there are some problems worth thinking about, and I'll have a brief view for chatting! 1 The positioning of pharmaceutics can be understood from the classification of disciplines and the role in medicine In the national standard "GB / t13745-92" of subject classification, pharmacy is one of five categories and 58 first-class subjects, pharmacy is one of 573 second-class subjects and ten second-class subjects of pharmacy, and there are nearly 6000 third-class subjects below Obviously, in the systematic and specialized pharmaceutical study and research, the technology industry has its own specialty, which not only needs to perform its own duties and responsibilities, but also needs to integrate development and coordination to create an objective reality in line with subjective knowledge It is because of the innovation and development of various disciplines of medicine, the courage to explore that one by one raw material drugs continue to appear Due to the fact that APIs are not suitable or have not been directly used in clinical practice, pharmaceutics has been extended due to the objective and practical needs If a drug that can be directly used in clinical application can be used as a drug, the research of pharmaceutics is the "drug forming" research mentioned today Pharmaceutics research is based on the research results of various disciplines of medicine and pharmacy, and it is directly facing the healthy drug use of patients It is difficult for a woman to cook without rice, and it is difficult for everyone to make a meal The preparation is always at the forefront of clinical drug use, so the preparation workers are proud of the challenging work, and deeply responsible for directly facing the healthy drug use of patients 2 With the development of pharmaceutics, the definition of pharmaceutics has become clearer, that is to say, pharmaceutics is a comprehensive applied subject which studies the preparation theory, production technology, quality evaluation and use method of the preparation of drugs which can be directly used in clinic Obviously, there are two core contents of pharmaceutical research, one is to design dosage forms for APIs, and design the best dosage forms for drug properties, medical needs, etc.; the other is to change the dosage forms of listed drugs to meet the health needs of the whole people Article 12 of the administrative measures for drug registration (version 07) states that "for drugs on the market to change the dosage form, change the way of administration, and.. To apply according to the procedure of new drug application", almost all kinds of drug registration categories contain preparations It can be seen that dosage forms and preparations are necessary forms for drugs to be used in clinical beds, and the diversity of dosage forms promotes the development of pharmaceutical industry and preparation disciplines The importance of R & D and registration has been recognized Recently, the 16 version of the draft of measures for the administration of drug registration has been published, and Article 12 has been deleted There are no new drugs classified according to the application procedure Only in the terms of disapproval, the change of dosage form is mentioned, that is, "Article 90: in case of any of the following circumstances, the examination and approval department shall make the decision of disapproval according to law.. (VI) for the change of dosage form, acid radical, base and For the drug registration application of drug administration route, the applicant can not prove that its technical innovation and clinical value have obvious advantages compared with the original varieties, except for the application of drug registration for children who change the dosage form and specification " In fact, has the change of dosage form been blacklisted, which is in line with the objective reality of the development of Chinese pharmaceutical preparations? Why? Perhaps it can be traced back to 2007, in the rapid development of drug R & D and registration, there has been blind and disordered drug reform for the immediate interests In one year, there will be a peak of approval of tens of thousands of approvals, leading some people to question the national new drug registration Whose fault? Free comment! However, a series of actions were taken to cut the peak of the abnormal phenomenon, and the position of "changing the dosage form" in this revised draft was unimaginable to the pharmacists! Is it "changing the dosage form"? Or executors and regulators forget the original intention of pharmaceutics! Lack of self-confidence, lack of mutual trust, affected by many other factors to go astray! Now we should correct whether we should make objective analysis and take the medicine according to the situation Do not violate the objective law of the development of pharmaceutics, and do not put the stick on changing the dosage form itself It is important to know that the core content of pharmaceutics is to design and change dosage forms Preparations account for most of the pharmaceutical industry, and all the clinical direct drugs are used! How can we stop eating because of choking! Medicine is a very special commodity The understanding of the attribute of medicine as a special commodity will give new meaning: the special attribute of curing disease and saving people; the duality of curing disease and causing disease (life); not the medicine of disease, but the limited time of medicine and other diseases; the medicine is not the priceless of medicine price The predecessors have summed up the attributes of special commodities so comprehensively and accurately If they were given new meanings, wouldn't it become a new concept of drug research and development and management with Chinese characteristics, which also needs to learn from the west? With the fierce competition and progress of human civilization society, the enrichment of material life, the development of medical and health undertakings, organic diseases are restrained, while functional diseases are gradually increasing, people ' Prescription drugs In terms of dosage form selection and design, it is necessary not only to be effective and safe, but also to be easy to use, willing to accept and have good popularity Dosage form diversity is the need of public health How can it be included in the list of disapproval? Think twice! Be careful not to slip into the trap of not being scientific and ignoring innovation while advocating science and encouraging innovation 3 The comprehensive development of pharmaceutics is to study and design dosage forms and change dosage forms In order to facilitate study, research and application, pharmaceutics (drug dosage forms / preparations) are often classified At present, a comprehensive classification method based on morphological classification, combined with dispersion system, route of administration, method of administration, preparation technology and method is often used The statistics of general principles of preparations in Pharmacopoeia are as follows: there are only 17~42 general principles of preparations in Pharmacopoeia, mainly common preparations According to the development of pharmaceutics, the classification of preparation technology is inevitable The special function of a certain preparation is the result of a key preparation technology changing the nature of drug action It is not the form of direct administration The form of administration may still be injection, tablet, etc Therefore, it is classified by the name of preparation technology, such as nifedipine sustained-release tablets, doxorubicin hydrochloride Bixing liposome injection, Tripterygium wilfordii sustained release tablets, etc In recent years, this method has been widely used in the classification of new drug delivery systems (DDS) For example, more than 100 dosage forms (including sub dosage forms) and their preparations are the contents of pharmaceutical research There is no advanced and backward difference between dosage forms and their preparations Each dosage form has the existing value As long as it is properly selected, it can give full play to the efficacy, reduce the toxic and side effects, and the patients are willing to accept it, it is the best dosage form of this drug With the development of medicine, pharmaceutics has gone through five periods and five generations according to the objective law of its own development Based on a comprehensive understanding and careful analysis of the current situation of the pharmaceutical industry, it can be predicted that the five generations of pharmaceutical preparations will coexist for a long time It is not the previous generation of pharmaceutical preparations to replace the next generation of pharmaceutical preparations, but to improve the level of the first and second generation of pharmaceutical preparations Promoting the development of the third, fourth and fifth generation of pharmaceutical preparations is the general trend and the requirement of the whole people for healthy use This is the objective reality of the development of pharmaceutical preparations, which must be developed in an all-round way However, our subjective understanding is not consistent In teaching, there is a very few generation of preparations selected by postgraduates to produce so-called high-level articles; natural fund applications are all cutting-edge topics, in order to win the bid rate; drug research and development and registration are uncertain, in order to avoid risks; drug production is busy with various inspections, for the survival of enterprises; drug use is worried about adverse reactions, in order to avoid liability Such a state of experience, only wish is only a few! Obviously, in this way, can the pharmaceutical industry develop comprehensively and healthily? We need to calm down and think about it carefully Have we forgotten the original intention of pharmaceutics? Is there a lack of awe for science and innovation? 4 Is the drug in the key pharmaceutical definition of pharmaceutical research or the main drug in the formulation design of the drug product the drug in the general "drug" concept? As we all know, substances with health care, medical treatment and diagnosis functions are called drugs, but drugs are not drugs Only those drugs that are legally prescribed by national standards can be called drugs Not all drugs can be directly used in clinical practice Only those drugs that have been registered and approved by the drug registration, are made according to the law, have clear indications, specifications, usage and dosage standards, and are suitable for patients Only in the form of application can the drug dosage form and its preparation be directly used for patients Obviously, the drug in the pharmaceutical definition should be the drug registered and approved, often referred to as API It's just that people usually call drugs as a general term, but the formal regulatory documents are strictly differentiated, such as the drug administration law and the measures for the administration of drug registration In the process of drug registration and evaluation, if a compound preparation, one of which has not been approved by registration, it is necessary to carry out a full set of research on APIs (this is of course mainly the work of drug chemistry), and only after obtaining the registration permission can it form a party It's another piece of evidence However, in the "drug registration management measures (Revised Draft)" in October 2017, the positioning of APIs is questionable, which is related to the objective evaluation of the role and position of pharmaceutical pharmaceutical departments in pharmaceutical creation, such as pharmaceutical chemistry, and the correct understanding of the objective rules of pharmaceutical development, so we must think twice! Since the research object of pharmaceutics is the registered drugs with definite curative effect and comprehensive research, the focus of the research should be on proving whether the preparation reflects the pharmaceutics effect The pharmaceutics effect refers to the function that the API can play in the clinical application after being prepared into the dosage form and preparation by the preparation technology, such as ensuring the effectiveness of the drug, improving the stability of the drug, reducing the toxicity and side effects of the drug, concealing and improving the bad smell of the drug, facilitating the application of the drug, regulating the speed, time and position of the drug's effectiveness, giving full play to the efficacy of the drug, etc 。 Objective facts show that it is precisely because of the dosage forms and their functions that effective APIs with different properties can be safely and smoothly used in clinical practice, and it is possible to give full play to the efficacy It has been proved that pharmaceutical workers can't cook without rice, but they can create a variety of dosage forms and preparations based on the research results of various disciplines of medicine under the condition of limited pharmaceutical raw materials, so as to meet the needs of the whole people's health medication Therefore, no matter which generation of preparations, the focus of pharmaceutical research is: first, pre prescription work, grasp the chemical, physical, biological and medical properties of APIs, analyze the main problems directly used in clinical practice, and screen the problems