Dosing of the fluid particles of insoluble
Author: Xu Xue-Jun Xu Deqin Wang Ying Zou Ruofei
【Key Words】 infusion;,, small volume injection;,, insoluble particles,,,,,
Abstract: Objective: To investigate the small volume
injection of agents and dosing environment on the impact of transfusion of insoluble particles. Methods: Injection cefradine other five kinds of sterile powder injection and dexamethasone sodium phosphate injection and other five kinds of small volume injection, respectively, and purification treatment rooms in the ward clean room, routine operation, the sterile powder injection, respectively, adding 0.9% sodium chloride injection, the injection of small volume, respectively in 5% glucose injection in order to photoresist
Determination of insoluble particles in the sample. Results: Compared with no pre-infusion dosing compared to adding a
small volume injection, the ward treatment room and purification of the samples prepared clean room, ? 10μm
insoluble particles were increased significantly (P <0.05), ?
25μm particles are insoluble no significant increase (P> 0.05); ward treatment room sample preparation and purification of the samples prepared by relatively clean room, ? 10μm
insoluble particles increased very significant (P <0.01), ?
25μm no significant increase of insoluble particles (P> 0.05 ). Conclusion: Add small volume injection of non-cleaning
agents and dosing in ward treatment rooms will enable the transfusion of ? 10μm insoluble particles increased
Keywords: infusion; small volume injection; insoluble particles
Infusion, and other injection of insoluble particles into
the blood, may cause vascular thrombosis, allergic reactions, heat as is the reaction of . 1985 edition of "The People's
Republic of China Pharmacopoeia", starting a large volume injection of insoluble particulate limits there are specific provisions in 2005 edition of "The People's Republic of China Pharmacopoeia" (hereinafter referred to as a new version of
the Chinese Pharmacopoeia), began small volume intravenous injection of insoluble particulate limits are also specified . Although the new version of the Chinese Pharmacopoeia for large and small volume injections of insoluble particulate
limits have been specified, but clinical infusion therapy due to insoluble particles caused by the heat as is reaction occur. To this end, we join the small volume injection of agents and dosing environment for infusion of insoluble particles to explore the impact of the situation in order to propose practical preventive measures.
1 Materials and methods
11 Instrument SHJ Clean Bench (Shanghai Purification Equipment Factory); GWJ4 smart particle analyzer (Tianjin Genius fat Technology Co., Ltd.); Disposable Sterile Syringe
(20ml, Lot 060,821, Changzhou City, Cape Shou Medical Equipment Factory).
12 reagent 5% glucose injection (250ml, batch number 20,060,822), 0.9% sodium chloride injection (250ml, batch number 20,060,825), hospital preparation room were prepared.
Cefradine for injection (0.5g, batch number 05,068,931, Shijiazhuang Sino Pharmaceutical Co., Ltd.), injection of cefazolin sodium (0.5g, Lot 051,115, Shanghai Pioneer Pharmaceutical Co., Ltd.), piperacillin sodium for injection
( 0.5g, batch number 05,011,001, Shijiazhuang Pharmaceutical Co., Ltd. of promise), injection of sodium benzene sit Xilin (0.5g, batch number 06,011,003, Shijiazhuang Pharmaceutical Co., Ltd. of promise), injectable penicillin sodium (800,000 U, Lot Y0506112, North China Pharmaceutical Co., Ltd.), dexamethasone sodium phosphate injection (1ml: 5mg, Lot 060,304, Jinling Pharmaceutical Co., Ltd. Nanjing Jinling Pharmaceutical Factory), vitamin B6 Injection (2ml: 0.1 g, lot number 060,417, Wuhu Koncz Pharmaceutical Co., Ltd.),
ribavirin injection (1ml: 0.1g, lot number 0606168, Jiangsu Lianshui Pharmaceutical Co., Ltd.), vitamin C injection (10ml: 1g, batch No. 060,307, Shanghai Fuda Pharmaceutical Co.,
Ltd.), lincomycin hydrochloride injection (2ml: 0.6g, Lot
060,508, Shanghai Xudong Heipp Pharmaceutical Co., Ltd.).
13 Test Method
Preparation of two sets of 131 samples of sample preparation. The operation of transfusion medicine in Canada were in the ward treatment room and local clean indoor 100.
Each group to take injection cefradine 4, 0.9% sodium chloride injection 2 bottles (one bottle as a solvent), to the plastic cover to alcohol, cotton balls glue covered the surface of exposed sterilized using disposable sterile syringe, extract solvent into the injection cefradine, fully Zhenyao dissolved immediately after the injection of another bottle out of 0.9% sodium chloride injection, shake, or get samples. Taken in each group were injected with cefazolin sodium 4, 4 piperacillin sodium for injection, injection of sodium benzene sit Xilin 4 and 3 sodium penicillin injection, according to the above dosing method, were added to 0.9% a bottle of sodium chloride injection, or get samples. Each group taking Dexamethasone Sodium Phosphate Injection 2, open the ampoules,
disposable sterile syringe immediately extracted liquid, injecting the same way as with the above-mentioned processing
handled infusion of 5% glucose injection a bottle, shake , that was the sample. In each group were taking vitamin B6
injection 3, ribavirin injection 3, vitamin C, and an injection lincomycin hydrochloride injection 1, according to the above dosing methods, respectively, in 5% glucose injection liquid a bottle, shake, or get samples. Reposted elsewhere in the paper for free download http://
132 Determination of insoluble particles in accordance with the provisions of a new version of the Chinese Pharmacopoeia two determined by the method .
Were shown in Table 1, Table 2.
Table 1 Preparation of samples ward treatment room insoluble particulate determination results slightly
Table 2 Preparation of the sample clean room clean insoluble particulate determination results slightly
3 by adding drugs on the impact of infusion of insoluble particles from Table 1, Table 2 shows that by adding a small volume injection, the infusion of ? 10μm in a significant
increase in insoluble particles could easily cause a thermal reaction as is. Are reported in the literature, 383 cases of transfusion reaction, transfusion residue insoluble particulate failure rate of 45.17% . A new version of the
Chinese Pharmacopoeia two pairs of veins with a small volume injection, using the photoresist method detection for the test items for each container containing ? 10μm, ? 25μm
insoluble particles, respectively, shall not be over 6000, 600
, but some pharmaceutical manufacturers of small volume injections to control the number of insoluble particles, although in line with a new version of the Chinese Pharmacopoeia requirements, but close to the ceiling set. Infusion therapy, infusion of drugs is usually as input
vectors, due to the need for clinical treatment, infusion often by adding a large number of small-volume injection, and
sometimes adding more than two small-volume injection, dosing
after the infusion, the insoluble particles are severely than
a new version of Chinese Pharmacopoeia two pairs of large volume injection requirement. Drug production units should be units of containers of small volume injections of insoluble particles in the number of strictly controlled at close to a new version of the Chinese Pharmacopoeia under the lower limit within the framework of, and recommended that the departments concerned, when reprinted in the Chinese Pharmacopoeia, the unit containers of small volume injections of insoluble particles in the number of limit further reduced.
32 Dosing environment on the impact of transfusion insoluble particles prepared by ward treatment room clean room clean preparation of sample and comparison samples, ? 10μm
insoluble particles increased very obvious, indicating the
sample preparation, the ward treatment room air in dust particles contaminated fluids . China's Ministry of Health and the State Chinese Medicine Administration, in 2002 promulgated the "Provisional Regulations on medical institutions Pharmacy," 28th stipulates: "Medical institutions should
gradually establish the basis of clinical need for total parenteral nutrition and cancer chemotherapy drugs such as intravenous fluid Configuration Center (Room), centralized configuration and supplies. " Across an increasing number of
medical institutions have been established or are establishing PIVAS. Intravenous drug configurations, from the open or semi-
open to non-clean environment, clean environment for the conduct, regulate the operation to prevent transfusion was
particulate pollution . Primary health care sector due to lack of funds, establish PIVAS have certain difficulties, the proposed primary health care sector of the intravenous admixture in clearing the table for.
33-insoluble particulate pollution infusion dosing, when other factors, such as dissolved for injection sterile powder, two needle puncture plastic cover and the need to strong Zhen Yao, rubber isolation pads are not covered with film, plastic lid easy to fall off into the liquid; some drugs such as
governance bacteria Erbitux, Ford, glutathione, and sodium benzene sit Xilin, one-time puncture butyl rubber cap, you can see the gray plastic dust off . The trial, sat Xilin sodium benzene prepared samples, the largest increase in the number
of insoluble particles. Ampoule loaded injection, break apart and that the absorption, due to negative pressure inside the ampoule, a large amount of glass debris inhalation liquid. Ampoule with liquid before cutting to make disinfection
treatment, proper operation, to prevent a large number of glass debris sucked liquid; puncture stopper or plastic cap to add drugs, the action should be light, to reduce the rubber crumbs fall off into the liquid.
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