Thirty-second provincial departments in charge of traditional Chinese medicine shall, jointly with the pharmaceutical supervisory and administrative departments, formulate service standards for Chinese herbal pieces and strengthen the supervision and management of service quality of Chinese herbal pieces. ?
Article 33? Medical institutions shall obtain the Pharmaceutical Preparation License for Medical Institutions according to law, or entrust pharmaceutical production enterprises that have obtained the Pharmaceutical Production License or other medical institutions that have obtained the Pharmaceutical Preparation License for Medical Institutions to prepare traditional Chinese medicine preparations. Medical institutions in the province shall entrust the preparation of traditional Chinese medicine preparations, which shall be filed with the provincial drug supervision and administration department.
Medical institutions shall be responsible for the quality of the traditional Chinese medicine preparations prepared by them, and monitor the clinical adverse reactions of traditional Chinese medicine preparations in accordance with regulations.
Attached to the national requirements for traditional Chinese medicine decoction: management norms for traditional Chinese medicine decocting rooms in medical institutions.
Management standard of Chinese medicine decocting room in medical institutions
Chapter one? Total? rule
Rule number one In order to strengthen the standardization and institutionalization of Chinese medicine decocting rooms in medical institutions and ensure the quality of Chinese medicine decocting, this specification is formulated in accordance with the provisions of relevant laws and administrative regulations.
Rule number two This specification is applicable to all kinds of medical institutions at all levels to carry out Chinese medicine decocting services.
Chapter two? Facilities and equipment requirements
Rule three. Chinese medicine decocting room (hereinafter referred to as decocting room) should be far away from all kinds of pollution sources, and the surrounding ground, road surface and vegetation should avoid polluting the decocting.
Article 4? The housing and area of the decocting room should be reasonably configured according to the scale and quantity of decocting in this medical institution. The working area should be separated from the living area, and the working area should be provided with functional areas such as storage (medicine), preparation, decoction and cleaning.
Article 5? The decocting room should be spacious and bright, and the floor, walls and roof should be flat, clean, pollution-free and easy to clean. There should be effective ventilation, dust removal, waterproof and fire fighting facilities, and all kinds of pipes, lamps, tuyeres and other facilities should avoid the parts that are not easy to clean.
Article 6? The decocting room should be equipped with complete decocting equipment and facilities, and according to the actual needs, it should be equipped with medicine storage facilities, cold storage facilities, measuring cups (cylinders), filtering devices, timers, medicine storage containers, medicine bottle racks, etc.
Article 7? The decocting table should be flat and clean.
Decocting containers should be made of ceramics, stainless steel, copper and other materials, and corrosive containers such as iron are prohibited.
Drug storage containers should be dust-proof, mildew-proof, insect-proof, rat-proof and pollution-proof. It should be strictly disinfected before use and cleaned in time after use.
Chapter three? Personnel requirements
Article 8? Chinese pharmacists with certain theoretical level and practical experience are responsible for the business guidance, quality supervision and organization management of the decocting room.
Article 9? Decocting personnel shall be trained in the knowledge and skills related to decocting traditional Chinese medicine, and only after passing the examination can they engage in the work of decocting traditional Chinese medicine.
Decocting personnel should receive on-the-job training on relevant professional knowledge and operational skills in a planned way.
Article 10? Decocting personnel shall have a physical examination at least once a year. Patients with infectious diseases, skin diseases, hepatitis B virus carriers and unhealed wounds on the body surface are not allowed to engage in decoction.
Article 11? Decocting personnel should pay attention to personal hygiene. Wash your hands before decocting, wear special work clothes at work and keep them clean.
Chapter four? Decocting operation method
Article 12? Decocting drugs should use drinking water that meets the national hygiene standards. The drugs to be decocted should be soaked first, and the soaking time is generally not less than 30 minutes.
The water consumption for initial decoction is generally 2-5 cm after soaking the powder, and water should be added appropriately for flowers and plants or long-term decoction.
Article 13 Each dose of medicine is generally decocted twice, and the decoctions are mixed and packaged.
The decocting time should be determined according to the functional indications of the prescription and the curative effect of the medicine. Generally, the medicine is boiled and then decocted for 20-30 minutes; Drugs for relieving exterior syndrome, clearing heat and aromatic drugs should not be decocted for a long time, and then decocted after boiling for 15-20 minutes; The tonic is first boiled with strong fire, and then slowly decocted with slow fire for about 40-60 minutes. The second decocting time is slightly shorter than the first decocting time.
Stir for 2-3 times during the boiling process. Tools for mixing medicinal materials should be rods made of ceramics, stainless steel, copper and other materials. After mixing one medicinal material, it should be cleaned before mixing the next medicinal material.
Article 14 The amount of decoction should be determined according to children and adults respectively. Children generally fry until each dose is 100-300ml, and adults generally fry until each dose is 400-600ml, and each dose is generally divided into two equal parts, or as directed by the doctor.
Fifteenth Chinese herbal pieces with special requirements, such as initial frying, re-frying, re-frying, melting, package frying, decocting in water, etc., should be operated according to the requirements or according to the doctor's advice.
(a) the first decoction should be boiled for 10- 15 minutes, and then decocted with other herbs (soaked first).
(2) When the first decocted medicinal materials are about to be decocted to a predetermined amount, they should be decocted together for 5- 10 minutes.
(3) cutting the rest decoction into small pieces, and decocting for about 2 hours to obtain juice; Another kind of stew should be sliced, put into a covered container, add cold water (generally about 10 times the amount), stew for 2-3 hours, and take juice. If the original prescription of this kind of medicine is compound, the decoction (stew) should be mixed with the decoction of other ingredients in the prescription and then packaged. Some special drugs can be decocted (stewed) according to their medicinal properties (appropriate amount of water).
(4) Dissolved drugs (dissolved) should be put into the liquid medicine after other drugs are boiled to a predetermined amount and dregs are removed, and decocted with low fire while constantly stirring until the drugs to be dissolved are dissolved.
(5) Put the decocted medicine into a decoction bag, and then decoct it with other medicines. The material of the bag should meet the medical requirements (harmless to human body) and have filtering function.
(6) Instead of decocting drugs in water, decoct them for15-25min, then remove the residue, filter to get juice, and then decoct them together with other ingredients in the prescription.
(7) Drugs with other special decocting requirements, such as long-term decoction, oral administration and soaking administration, shall be operated according to the corresponding specifications.
Decocting the medicine first, then taking the medicine, decocting or stewing the medicine alone, and packaging the decoction. The decoction should be soaked in water first, and the soaking time should generally be not less than 30 minutes.
Sixteenth ingredients should be fried thoroughly, so that there is no paste, no white heart and no hard heart.
When decocting medicine, it should prevent the liquid from overflowing, frying dry or boiling. Dry frying or charring is prohibited for medicinal use.
Article 17? Internal medicine and surgery should be distinguished by different markers.
Article 18? Boiled liquid medicine should be put into a container that has been cleaned and disinfected and meets the edible requirements to prevent pollution.
Article 19 Chinese medicines are decocted by a decocting machine, and the decocting function of the decocting machine shall meet the relevant requirements of this specification. Drugs should be decocted under normal pressure, and the decocting temperature should generally not exceed 65438 000℃. The amount of decocted liquid medicine should be consistent with the prescription dosage, and the repackaging dosage should be uniform.
Article 20? The packaging materials of liquid drugs shall conform to the national standards for pharmaceutical packaging materials.
Chapter five? Management of decocting room
Article 21? The decocting room is managed by the pharmacy department. The pharmacy department should have a special person responsible for the organization, coordination and management of the decocting room.
Article 22? According to the actual situation of the unit, the pharmacy department should formulate the corresponding working system of the decocting room and the standardized operating procedures (SOP) of related equipment. The working system and operating procedures should be bound into volumes, hung in the appropriate position of the decocting room, and strictly implemented.
Article 23? Decocting personnel should carefully check the relevant contents of the prescription (or decoction certificate) when receiving, decocting, charging and distributing the medicine, and establish the receiving and sending records with true contents and complete records.
Each party (agent) should have an operation record reflecting all aspects of decoction. Records should be kept clean, true and complete.
Article 24? The quick decoction of drugs should be completed within 2 hours, and the system of quick decoction of traditional Chinese medicine should be established to standardize the records of quick decoction.
Article 25? Decocting equipment, facilities and containers should be kept clean before use, and there should be cleaning procedures and daily cleaning records. Equipment and instruments used for cleaning, cleaning and disinfection should be placed in special places for safekeeping.
The decocting room should be disinfected regularly. The varieties of detergents and disinfectants should be changed regularly, which conforms to the hygienic standard for cleaning food tools and equipment (GB 14930. 1), hygienic standard for cleaning disinfectants for food tools and equipment (GB 14930.2) and other relevant hygienic standards and requirements, and shall not corrode and pollute equipment and drugs.
Article 26? In principle, drug containers for patients with infectious diseases should be disposable, and should be managed and disposed of according to medical waste after use. If the above conditions are not met, the management of reusable drug containers should be strengthened, fixed personnel should use them, and strict disinfection should be carried out to prevent cross-contamination.
Article 27? Strengthen the quality control and monitoring of decoction. The person in charge of pharmacy department should evaluate and inspect the quality of decoctions regularly (at least once every quarter), solicit the opinions of medical staff and inpatients, and establish quality control and monitoring files.
Chapter six? Attached? rule
Article 28? This specification shall come into force as of the date of promulgation, and the Management Specification for Chinese Medicine Decocting Room issued by state administration of traditional chinese medicine 1997 shall be abolished at the same time.
Article 29? State administration of traditional chinese medicine is responsible for the interpretation of this specification.
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