Related Professional Knowledge 39-100 Exam Points Explanation
40、The targeting of a drug formulation can be measured by three parameters: relative uptake rate (re), targeting efficiency (te), and peak concentration ratio (Ce).
41、Commonly used stabilizers for protein drugs are (1) buffers (2) surfactants (3) sugars and polyols (4) salts (5) polyethylene glycols (6) macromolecular compounds (7) hydrochlorides of histidine, glycine, glutamic acid, and lysine, etc. (8) metal ions
42, commonly used absorption enhancers can be divided into the following categories: ① surfactants: cationic, anionic, nonionic and lecithin; ② organic solvents: ethanol, propylene glycol, ethyl acetate, dimethyl sulfoxide and dimethylformamide; ③ lauric azide (also known as azone) and its homologues; ④ organic acids, fatty alcohols: oleic acid, linoleic acid and laurin; ⑤ keratin moisturizing and softening agent: urea, Salicylic acid and pyrrolidones; ⑥ terpenes: menthol, camphor, limonene and so on.
43, stability: refers to the drug in the prescribed conditions to maintain its effectiveness and safety of the ability, is an important feature of drugs.
44, the pH of the drug solution not only affects the hydrolysis of the drug, but also affects the oxidation of the drug. Pharmacy circle member collation
45、Pharmaceutical Management Organization of Medical Institutions: The Provisions on Pharmaceutical Management in Medical Institutions make it clear that medical institutions should establish a pharmaceutical management organization, i.e., hospitals above the second level should set up a pharmacy management and pharmacotherapeutics committee; other medical institutions should set up a pharmacy management and pharmacotherapeutics group, and the role, duties and composition of pharmacy management and pharmacotherapeutics committees have been clearly defined.
46, the format of the approval number of the preparation of medical institutions for the X drug pharmaceutical H (Z) + 4 digits of the year + 4 digits of the running number. X is the abbreviation of the province, autonomous region, municipality directly under the Central Government, H is a chemical preparation, Z is a traditional Chinese medicine preparation.
47, the pharmacist’s own requirements: ① love and dedication, excellence. ② conscientious and responsible, quality assurance. ③ honesty and credit, solidarity and cooperation. ③ honesty and credit, solidarity and cooperation. ④ not for fame and fortune, honesty and integrity.
48. Promotion in accordance with the law and honesty is the ethical requirement for the production of medicines, not the pharmacist’s requirement for himself.
49, the composition of the prescription The prescription consists of three parts: the precription, the body of the prescription and the post-prescription.
50, the prescriptions of the custody of the provisions of the daily prescriptions should be categorized and bound into a book with a cover, properly preserved. General, emergency and pediatric prescriptions are kept for 1 year, prescriptions for toxic drugs, essence two drugs and drug addiction drugs are kept for 2 years, and prescriptions for anesthesia essence one are kept for 3 years. After the expiration of the preservation period, it will be registered and destroyed with the approval of the hospital leaders.
51, with the prescription issued: the doctor to the hospitalized patients were issued a prescription, pharmacotherapy nurses with the prescription to the inpatient dispensing room to get drugs, dispensing room based on the prescription piece by piece dispensing. Advantage is that the pharmacist can directly understand the patient’s medication, to facilitate timely correction of clinical medication inappropriate phenomenon, to promote the rational use of drugs. The disadvantage is that it increases the workload of pharmacists and doctors. This way of issuing drugs is now mostly used for narcotic drugs, psychotropic drugs, toxic drugs and a few other clinical drugs.
52, medical institution preparations (hospital preparations), refers to the preparation department of the medical institution holding the “medical institution preparations license” according to the unit’s medical and scientific research needs, with the approval of the preparation, self-use of fixed-prescription preparations. The preparations prepared by a medical institution shall be of a variety that is not available on the market. Preparations prepared by the medical institutions shall not be sold in the market; medical institutions to prepare preparations, subject to the local provincial health administrative department for approval by the provincial drug supervision and management department for approval, issued by the “medical institution preparation license”. No “medical institution preparation license”, shall not be prepared preparations.
53, the preparation of medical institutions, subject to the location of the provincial health administrative department shall be approved by the provincial drug supervision and management department for approval, issued by the “medical institution preparation license. No “medical institution preparation license”, shall not be prepared preparations.
54、The relevant preparation records and quality inspection records of the hospital preparation shall be completely filed and kept for at least 2 years for inspection.
55、Three nil refers to “no approval number, no registered trademark, no label” of the drugs
56, special drugs refers to narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs.
57. Prescriptions for toxic drugs for medical use should be kept for 2 years for inspection.
58, not marked “raw” toxic Chinese medicine, should be paid for the artillery products.
59, at present, China’s drug implementation of government pricing, government-guided prices and market-regulated prices in three forms.
60, hospital drug testing procedures are generally sampling, registration, identification, testing, content determination and the issuance of test reports and other six links.
62, for the rational use of drugs, need to strengthen
62. For the rational use of medication, what needs to be strengthened is the overall business capacity including: doctors, pharmacists, nurses and so on.
63、Clean surgery without contamination of the surgical field, then the prophylactic application of antimicrobial drugs is not required;
64、Adverse drug reactions can be categorized into three types, A, B and C, according to the mechanism of their occurrence.
Type A adverse reactions: closely related to the pharmacological action of the drug, is due to the drug action is too strong due to the dose-related, predictable, stopping or reducing the amount of symptoms soon after the reduction or disappearance of the morbidity rate is high but the mortality rate is low.
Type B adverse reactions: abnormal reactions not related to normal pharmacological effects, not related to dose, difficult to predict, difficult to detect by conventional toxicological screening, low incidence but high mortality.
Type C adverse reactions: high background incidence, appearing after long-term drug use, long latency period, no clear temporal relationship between dosage and reaction, difficult to predict, non-reproducible, and unclear mechanism of occurrence.65、Phase Ⅰ clinical trial is to observe the degree of tolerance and pharmacokinetics of the human body for the new drug, to provide a basis for the development of drug delivery program. 66、The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, topical drugs and non-prescription drugs must bear the prescribed symbols.
67. Drug Administration Law of the People’s Republic of China
Article 27 The pharmacy staff of the institution to dispense prescriptions, must be checked, the drugs listed in the prescription shall not be changed without authorization or substitution. There are contraindications or overdose of the prescription, should be refused to deploy; if necessary, by the prescribing physician to correct or re-signature, can be deployed.68, medical institutions must be qualified to purchase drugs from enterprises with drug production and operation; however, the purchase of Chinese herbal medicines without the implementation of the approval number management except.
69、According to the Regulations for the Implementation of the Drug Administration Law, new drugs refer to drugs that have not been marketed and sold in China.
70. Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China
Article 22 The validity period of the Preparation License for Medical Institutions is five years. The expiration of the validity period, the need to continue to formulate preparations, medical institutions should be in the license expires six months before the expiration date, in accordance with the provisions of the State Council drug supervision and management department to apply for the reissuance of the “preparation license for medical institutions”.73, the prescription is valid on the day of issuance. Special circumstances require an extension of the validity period, the physician who issued the prescription to indicate the validity period, but the maximum validity shall not exceed 3 days.
74, prescriptions by the transfer of prescription drugs to the medical institution for safekeeping.General prescriptions, emergency prescriptions, pediatric prescriptions are kept for a period of 1 year, medical toxic drugs, the second category of psychotropic drugs prescriptions are kept for a period of 2 years, narcotic drugs and the first category of psychotropic drugs prescriptions are kept for a period of 3 years.75. Article 8 of the Measures for the Categorization and Management of Prescription Drugs and Over-the-Counter Drugs (for Trial Implementation) According to the safety of drugs, over-the-counter drugs are divided into two categories: A and B.
76, drug labels using registered trademarks, should be printed in the corners of the drug label, containing text, the font in the area of a single word shall not be greater than one-fourth of the font used in the generic name.
Note here with: Article 26 is different: drug trade names shall not be written with the generic name of the same line, its font and color shall not be more prominent and significant than the generic name, its font to the area of a single word shall not be greater than one-half of the font used in the generic name.
77, Western medicine poison varieties deacetyl trichothecene C atropine digitalis toxin hydrogen bromide postmatropium arsenic trioxide hairy rutabaga alkaloids mercuric salicylic acid lentinanine potassium arsenite scopolamine hydrobromide strychnine
78. Measures for the Administration of Toxic Drugs for Medical Purposes
The correct description of B is: the prescription is valid for one time, and the prescription is kept for two years for examination after taking the medicine.
79、Article 19 shall be judged to be an extraordinary prescription if one of the following circumstances exists:
1. Use of drugs without indications;
2. Prescribing high-priced drugs without justifiable reasons; drug circle members to organize
3. Use of drugs beyond the instructions without justifiable reasons;
4. without justification for the same patient at the same time prescribed more than 2 kinds of drugs with the same pharmacological effect.80, the route of administration: mild infections, can choose oral absorption of antibacterial drugs, severe infections, systemic infections, the initial treatment of patients should be given to the intravenous administration of drugs to ensure the efficacy of the drug. Avoid local application as much as possible.81, Article 21 Drug manufacturers, operators and medical institutions found or were informed of new, serious adverse drug reactions should be reported within 15 days, of which deaths must be reported immediately; other adverse drug reactions should be reported within 30 days. If there is follow-up information, it should be reported in time.82, E’s operation is not a measure that should be taken by the dispensing operation in order to prevent hospital preparations from being contaminated and confused, but rather a drug test82, E’s operation is not a measure that should be taken by the dispensing operation in order to prevent hospital preparations from being contaminated and confused, but rather a drug test
