Yesterday (November 28), CFDA issued the "Guidelines for the Common Names of Chinese Medicines" (hereinafter referred to as the Guiding Principles), clearly stating that Chinese medicines should be scientifically concise, avoid duplication, standardize naming, avoid exaggeration, and reflect tradition. The principle of cultural identity.
At the same time, the CFDA issued the "Notice on Regulating the Naming of the Common Names of Chinese Medicines Listed on the List" (hereinafter referred to as the Notice). For the listed proprietary Chinese medicines, the "Notice" clarifies three situations that must be renamed, namely: significantly exaggerating the efficacy, misleading doctors and The patient's name is incorrect, unscientific, has a vulgar language and superstitious color; the prescription is the same and the drug name is different, and the drug names are the same or similar and the prescriptions are different.
However, the "Notice" also proposed that there are geographical names, names, surnames, and drug names in the names of medicines, such as "treasure", "fine", "spirit", etc., but the varieties have a certain history of use, and the brand has been formed, which is generally accepted by the public. Can not be renamed, the various traditional Chinese medicine preparations from the ancient classics are not renamed. This means that the well-known Chinese medicine brands such as “Feng Jing Jingâ€, “Quick Saving Heart Pillsâ€, “Yunnan Baiyaoâ€, “Bi Yan Yan Ling†and “Xin Bao Wan†that have been renamed before can be renamed.
For Chinese patent medicines that need to be renamed, the Notice clearly states that the National Pharmacopoeia Committee organizes experts to put forward a list. After the new generic name is approved, a two-year transition period is given, and the new name is used in the transition period to include the old name. And the doctor gradually adapted.
For the use of instructions and labels, the Notice also stipulates that within 30 days from the date of approval of the change of name, the manufacturer shall submit a new specification and label to the local provincial food and drug supervision department for the name change. The original instructions and labels shall not be used for the drugs produced from the date of filing. If the drug produced before the record is valid for a transition period of 2 years, the drug can continue to use the original specification and label until the end of the validity period; if the validity period exceeds 2 years, the drug can continue to use the original manual and label until the end of the transition period.
Guideline for the general name naming technique of Chinese patent medicine
I. Overview
In order to strengthen registration management, standardize the naming of proprietary Chinese medicines, embody the characteristics of traditional Chinese medicine, respect culture, inherit tradition, and formulate these guiding principles.
This guiding principle is based on the technical requirements and principles of the naming of generic names of traditional Chinese medicines, based on the current status of naming of proprietary Chinese medicines, combined with recent research on the naming of proprietary Chinese medicines.
Second, the basic principles
(1) The principle of "scientific conciseness, avoiding duplicate names"
1. The generic name of proprietary Chinese medicine should be scientific, clear, short, not easy to be ambiguous and misleading, and avoid using oysters. The general number of words does not exceed 8 words (except for ethnic medicines, which can be used in Chinese translations).
2. Vulgar, fascinating words should not be used.
3. The dosage form should be clearly defined in the name and the dosage form should be placed at the end of the name.
4. In addition to the dosage form, the name should not be duplicated with the common name of the existing proprietary Chinese medicine, so as to avoid the occurrence of the same name and the same name.
(2) "Standard naming, avoid exaggeration of efficacy" principle
1. Generally, no person's name, place name, company name or endangered protected animal or plant name should be used.
2. The homonym of the noun, the intrinsic specific meaning noun should not be used. Such as: X0X, the homonym of the celebrity name.
3. Names should not be used in modern medical pharmacology, anatomy, physiology, pathology or therapeutics. Such as: cancer, anti-inflammatory, hypoglycemic, blood pressure, lipid-lowering and so on.
4. Exaggerated, self-proclaimed, unrealistic terms should not be used. Such as: strong, quick-acting, imperial system, secret system and spirit, treasure, fine, etc. (except for the name of the medicinal material and the terminology of Chinese medicine).
(3) The principle of "reflecting the characteristics of traditional culture"
The naming of Chinese medicine prescriptions with traditional cultural characteristics is one of the cultural characteristics of traditional Chinese medicine. Therefore, the naming of Chinese patent medicines can draw on the advantages of ancient naming and full integration of aesthetic concepts, so that the names of proprietary Chinese medicines are both scientific and standardized, and reflect the certain traditional Chinese cultural heritage. . However, the culturally appropriate terms used in the name should have a clear literature basis or a recognized cultural origin and avoid exaggerating the efficacy.
Third, the name of the single-flavored preparation
1. Generally, Chinese herbal medicines, traditional Chinese medicine decoction pieces, effective ingredients of traditional Chinese medicines, and effective parts of traditional Chinese medicines should be used. Such as: Huarui Powder, Danshen Oral Liquid, Basil Day Oligosaccharide Capsules, etc.
2. It can be named by the effective ingredients of traditional Chinese medicine, the effective part of traditional Chinese medicine and the functional combination dosage form.
3. The name of the artificial finished product of Chinese herbal medicine should be different from the name of the natural product. Generally, it should not be named after the “artificial XX†dosage form.
Fourth, the name of the compound preparation
The compound preparation of Chinese patent medicine may be named according to the different conditions of the prescription composition by the following methods as appropriate.
1. The abbreviation plus the type of the main medicinal name of the prescription is used, but the abbreviations cannot be combined to violate the meaning of other naming requirements. Such as: Xianglian pill, composed of woody and berberine; Guifu Dihuang pill consists of cinnamon, aconite, rehmannia, yam, hawthorn, alfalfa, paeonol, and diarrhea; pueraria lobata consists of puerarin, astragalus, berberine, licorice composition.
2. The main function (only the TCM terminology function can be used, the same below) is added. In this type of naming, it can be directly named by function, such as: Buzhong Yiqi Mixture, Qufu Zhizhu Pill, Buxin Dan, Dingzhi Pill, etc.; also can use various rhetorical techniques such as metaphor, pun, borrowing, dual, etc. Indicates the functions of prescriptions, such as: Jiaotai Pill, Yufujian, Yuehua Pill, Yupingfeng Powder, etc. An example is as follows:
(1) The use of metaphorical rhetorical naming, that is, according to the similarities of things, using specific, shallow, and well-known things to illustrate the rhetorical methods of abstract, esoteric, and unfamiliar things. Such as: Yuping Fengsan, Yuehua Pills, etc.
Yupingfeng San: The word "screen" is taken from the solid body surface to resist the evil spirits. The name of "Yupingfeng" refers to the barrier of the human body against the outside world by the screen, and has a strong traditional cultural atmosphere, reflecting the characteristics of the image thinking of Chinese medicine.
Yuehua Pill: "Yuehua", the ancients refer to the aura around the moon or moon. This side can nourish yin and moisten the lungs and treat the disease of lung sputum. Because the lungs are yin, it is the cover of the five Tibetans, just like the glory of the moon, hence the name "Yuehua Pills".
(2) The naming of puns is used, that is, in a certain language environment, the use of the polysemy or homonym of the words intentionally makes the statement have a double meaning, and the words are intended to mean this. Such as: arrived as a soup.
As a soup, it consists of leeches, mites, peach kernels and rhubarb. It is used for lower abdomen and full pain caused by lower coke storage, urinating self-interest, yellow as a scorpion, mental madness and other symptoms. There is the power to attack and store blood. "Affirmation" may be the alias of the main medicine, but in more sense, it is "cleansing", which means that this side has the power to cleanse and attack blood.
(3) Using the terminology of the borrowing, that is, borrowing one object instead of another, such as: dressing pills.
Dressing pill, composed of cinnabar and aloe vera, take wine and pills, use yellow wine to blunt, have the effect of diarrhea and laxative, used to treat gastrointestinal dryness, uncomfortable stool, upset and irritated, sleeplessness. "Changer", in ancient times, said the big and urinary words, the name changed clothes. To replace the toilet with the dressing, it is not only elegant, but also clear.
(4) The use of dual rhetoric, that is, a rhetorical way of expressing opposite, similar or related meanings using two phrases or sentences with the same structure, equal number of words, and symmetric meaning. Such as: diarrhea heart redness and so on.
The diarrhea heart is reddened, the function is diarrhea and the spleen is accumulated, and the clinical use is often used to treat the sore tongue of the heart and spleen. "Xie Xin" and "Leading Red" belong to the "positive duality" in the duality. The meanings expressed before or after are similar or similar and complement each other.
3. Named after the drug taste plus dosage form. Such as: Siwu Tang and so on.
Siwutang, consisting of Angelica, Chuanxiong, Baiji and Rehmannia, is the representative of blood supplement.
4. The dosage (injection amount, ratio of drug dose in the prescription, single dose) was used to name the dosage form. Such as: Qi Li San, Liu Yi San and so on.
Seven centimeters scattered, with dilated swelling, swelling and hemostasis. This party has a good service and is in need of a lot of long-term service. Generally, it only takes "seven cents" each time, that is, it is named after each dose.
Liuyisan is composed of talcum powder and licorice. The ratio of the two doses is 6:1, hence the name.
5. Named after the drug color addition type. Most of the prescriptions named by color have certain characteristics due to the color of the finished product, which gives a deep impression. Therefore, it is easy to promote and apply according to the name, such as: peach soup.
Peach Blossom Soup, the prescription of the prescription is a pound of red stone fat, one or two grams of dried ginger, one kilogram of glutinous rice, because the red stone is red and white, alias peach stone, after boiling into soup, its color is reddish, bright as peach blossom, Therefore, it is called peach soup.
6. Named after the time of administration. Such as: chicken sound scattered and so on.
Chicken sounds scattered, the so-called "chicken", refers to the time of cockpit, this party must be served in the early morning on an empty stomach, hence the name "chicken sway".
7. It can be named after the name of the drug or the main drug, plus the function and dosage form. Such as: Longdan Xiegan Pill, Danggui Buxue Tang and so on.
Longdan Xiegan Pill, which has the effect of diarrhea, liver and gallbladder, and the heat of the coke. Fang Zhongjun medicine gentian, there is a diarrhea hepatobiliary effect.
Angelica blood soup, has the effect of qi and blood. The main medicine of the party is angelica, which is beneficial to blood and battalion.
8. The number of medicinal odors and the name of the main medicinal material, or the number of medicinal odors and the function or usage plus dosage form can be used. Such as: Wuyi San, Sansheng drink and so on.
There are two pigs, diarrhea, Atractylodes, Poria, Guizhi, and two "è‹“", hence the name.
Sansheng drink, Fangzhongcaow, Magnolia, and licorice are all used, no need to concoct, licorice is more common, but the herb is used in medicine, which is different from other parties, emphasizing the use of various drugs, is its characteristics .
9. It can be named from the source of the prescription (excluding the dynasty) and the functional or drug name plus dosage form. Such as: refers to the lost pills and so on.
There are a large number of prescriptions containing “茯苓丸†in the name. Refers to the scorpion pill, which refers to the sputum from the "Full Life Fingers", suffixed with "fingers", intended to be distinguished from the source of the prescription.
10. It can be named by the type of disease (Traditional Chinese Medicine) plus the type of function and drug action. Such as: Wendan Tang, Yangyin Qingfei Pills, Qingre Xiexie San, Qingwei Powder, Shaofu Zhuyu Decoction, Huazhi Rougan Capsule and so on.
11. It can be combined with the main medicinal materials and the drug introduction and the dosage form. Such as: Chuanxi tea transfer, with tea to adjust, hence the name.
12. Pediatric medication can be added to the clinical name of the drug, such as: Xiaoerxiaoshi tablets.
13. The use of the drug can be added in the naming, such as: pediatric application of umbilical diarrhea, inclusion of supernatant tablets, topical purple gold ingots and the like.
14. Under the condition of naming principles, the naming can reflect the yin and yang five elements, the ancient academic factions, the names of ancient objects, etc., in order to highlight the traditional Chinese cultural characteristics, such as: Zuojinwan, Yuquan Pill and so on.
Zuojinwan, there is clearing the liver and fire, reducing the power of vomiting. The heart is a fire, the liver is wood, the lung is gold, the liver is on the right and the gas is on the left, and the liver is made of lung gold. Qingxinhuo made the liver to the left with Zuojinjin, so the name "Zuojinwan".
Yuquan Pills are good for qi and nourishing yin. "Yuquan" is the name of spring water, and it also refers to the liquid of the two tongues in the mouth. With the taste of nourishing yin and moistening dryness, Yiqi Shengjin's product group, the service can make Yinjin recharge, the body fluid is self-returning, and the mouth is frequent and moist, just like the water of Yuquan, the source is constant, hence the name "Yuquan Pill".
Attached to the "Guidelines for the General Name Naming Technology of Chinese Patent Medicine"
In order to strengthen the registration management, standardize the naming of Chinese patent medicines and reflect the characteristics of traditional Chinese medicine, the State Food and Drug Administration issued the Guiding Principles for the General Names of Chinese Medicines (hereinafter referred to as the Guiding Principles). The relevant issues are explained as follows:
I. The need for the issuance of guiding principles
The naming of drugs is one of the basic contents of drug standard work. Chinese patent medicines currently do not have a trade name, only a generic name. Because they are not composed of a single chemical component, the generic name is different from the chemical drug. The current technical requirements for the naming of traditional Chinese medicines were formulated and issued by the former Ministry of Health in 1992. The naming of new Chinese medicines was carried out according to the requirements. Although the naming of new Chinese medicines is generally more standardized, it lacks the traditional cultural characteristics of traditional Chinese medicine. The naming methods that can be reviewed and approved are relatively simple. Enterprises generally reflect the difficulty in naming new Chinese medicines.
In addition, most of the currently listed proprietary Chinese medicines are approved for listing in the original place. When the local standards are raised to the national standards, the product names are not cleaned up, so the problems are prominent, mainly in terms of exaggerated efficacy. The exaggerated naming of proprietary Chinese medicines is a concentrated expression of the chaos in the Chinese patent medicine industry. It is obviously contrary to the regulations on the prohibition of advertising and the prohibition of advertising in the Advertising Law of the People's Republic of China. To a large extent, the Chinese medicine industry is in the market economy. Under the conditions, the rule system and the superposition of supervision and management lag. This time, the State Food and Drug Administration has formulated the Guiding Principles for the General Name Naming Technology of Chinese Patent Medicine, which has supplemented the shortcomings of supervision, which is timely and necessary.
2. Traditional naming rules for traditional Chinese medicine prescriptions
The State Food and Drug Administration has organized experts to systematically study the naming characteristics of 531 ancient classics. The results show that the number of named prescriptions related to the drug name in the prescription composition reaches 55.17%, which is a key factor in the naming of prescriptions. The prescriptions named by the efficacy-related factors accounted for 45.52% of the total prescription, and the total proportion of the two reached 98.62%. The third major factor in the naming of prescriptions is undoubtedly a cultural factor, accounting for 26.96%. It can be seen that although the naming of prescriptions is relatively complicated, there are still rules to follow. The name and efficacy of the drug have always been the key factors in the naming of the ancients. At the same time, the role of the power of culture in the naming of ancient prescriptions cannot be ignored. If both culture and efficacy are taken into consideration, it will be more perfect. The results of the study on the traditional naming rules of traditional Chinese medicine prescriptions do not support the view that exaggerated Chinese patent medicines are regarded as the traditional Chinese medicine naming tradition.
3. The embodiment of the naming of Chinese patent medicines to the characteristics of traditional culture
In the naming of newly approved proprietary Chinese medicines after 2007, the names of proprietary Chinese medicines related to cultural factors accounted for only 3.2% of all newly approved proprietary Chinese medicines. The use of rhetorical forms was vacant and far from the ancient classics. . Therefore, in the new revised consultation draft, a variety of rhetorical types such as metaphor, borrowing, and puns have been added to further strengthen the traditional Chinese cultural content in the naming of proprietary Chinese medicines. Under the conditions of naming principles, traditional cultural ideas such as Yin and Yang are allowed to be reflected in the naming of proprietary Chinese medicines.
Fourth, on the issue of avoiding the exaggerated efficacy of Chinese patent medicines
To judge whether the name of a proprietary Chinese medicine exaggerates the effect, you should not only look at the individual words in the name, but should look at the entire name in its entirety. The following situations should not be exaggerated: First, because the name contains the name of the medicinal material or the piece of decoction, "bao", "spirit" and "fine" appear, such as twenty-five flavors of Mabao pills, Ganoderma lucidum granules, Huangjing pills, Huangjing Yangyin syrup, etc. Second, the words containing TCM terms that express the efficacy of traditional Chinese medicine, such as Gujing Bushen Pills.
V. Questions about the naming of proprietary Chinese medicines without using names of people, places, and companies
Regarding the naming of proprietary Chinese medicines, the names of people, places and enterprises are not used. The reasons are mainly: First, from the traditional naming rules of traditional Chinese medicine prescriptions, this is not a traditional naming method; secondly, the names of proprietary Chinese medicines are common names, and they are managed from the generic name of medicines. Look, the generic name is the name shared by similar drugs. If you name it by name, place name, or company name, it will cause confusion in the naming of similar drugs. Take "Liuwei Dihuang" as an example. If Beijing produces "Beijing Liuwei Dihuang Pills", Henan produces "Henan Liuwei Dihuang Pills" and Lanzhou produces "Lanzhou Liuwei Dihuang Pills", which is obviously inappropriate.
6. Specifications for naming the generic names of listed Chinese patent medicines
The newly approved Chinese patent medicines must be named according to the guiding principles. For the generic name of the listed proprietary Chinese medicines, the State Food and Drug Administration will focus on standardizing the situation of exaggerating efficacy or vulgar language, and classifying them in batches. The proprietary Chinese medicines from the ancient classics are named after the name of the classic name prescription and are not included in the scope of the specification. Due to special historical reasons, the names of some listed proprietary Chinese medicines include names of people, places, and names of enterprises. Most of the proprietary Chinese medicines using this naming method are exclusive varieties. The names of these proprietary Chinese medicines have been well-known at home and abroad, and the name itself. There is no exaggeration of efficacy, and such situations are not included in the scope of the specification.
For those listed Chinese medicines that need to be renamed, they will be given a certain transition period. During the transition period, the old name will be allowed to be used in parentheses to allow patients and doctors to gradually adapt. For the specific implementation plan for regulating the generic name of the listed Chinese patent medicine, the State Food and Drug Administration will hold an expert demonstration meeting to listen to the opinions to improve the implementation plan.
Disposable Suction And Irrigation Sets
A Disposable Suction Irrigator Kit is a medical device used during surgery to remove blood, debris, and other fluids from the surgical site. The kit usually includes a straw and rinse tube, both of which are disposable and designed to be used only once. Suction tubing is used to remove fluid from the surgical site, while irrigation tubing is used to introduce sterile saline or other solutions to the surgical site to help clean and irrigate the area. The single-use nature of the kit helps reduce the risk of infection and cross-contamination between patients.
Product features of disposable suction and irrigation equipment:
1. Dual functions of flushing and suction, one machine with multiple functions;
2. The flushing and suction functions are clearly distinguished, and the operation is simple, one-handed operation, convenient and fast;
3.Fully transparent pipeline design provides the best way for suction observation operation;
4.The front and rear ends are detachable, which facilitates the absorption of foreign bodies during the operation.
Disposable Suction And Irrigation Sets,Medical Suction And Irrigation System,Sterile Disposable Suction Sleeve,Medical Tube Suction Tube Set
Changzhou Weipu Medical Devices Co., Ltd. , https://www.cnweipumedical.com