Products made from allogeneic tissue are largely used in clinical treatment due to its wide source compared with autologous tissue, causing less secondary trauma of patients and the good biocompatibility. Various organic solvents and other substances introduced in the production process of allogeneic products will leach down into the human through clinical treatment, thus bringing varying degrees of harm to patients. Therefore, it is very necessary to detect and control the leachables in such products. Based on the classification and summary of leachable substances existing in the allogeneic products, the preparation of extract and the establishment of the detection techniques for known and unknown leachable are briefly introduced in this study, in order to provide research method for the study of leachable substances of allogeneic products.
Humans ; Hematopoietic Stem Cell Transplantation ; Drug Packaging

To analyze the usage and loss of the COVID-19 vaccine in ten districts of Suzhou city from December 18, 2020 to April 30, 2021.The results showed the loss rate was 0.222‰ in Suzhou city. The loss rate of pre-filled packaging COVID-19 vaccine was higher than that of vial packaging. The loss rate of 40 packaging was the lowest in vial packaging. The loss rate of all kinds of COVID-19 vaccine in stable inoculation unit was the lowest. It is recommended to distribute 40 vial packaging COVID-19 vaccine for centralized vaccination to reduce the loss of COVID-19 vaccine.
Humans ; COVID-19 Vaccines ; COVID-19/prevention & control* ; Vaccination ; Cities ; Drug Packaging

Population pharmacokinetic analysis and modeling procedures typically require estimates of both population and individual pharmacokinetic parameters. However, only some of these parameters are contained in models and only parameters in the model can be estimated. In this paper, we introduce a new R package, PKconverter, to calculate pharmacokinetic parameters using the relationships among them. After fitting the model, other parameters can be calculated from the functional relationship among the parameters. PKconverter provides the functions to calculate whole parameters along with a Shiny application for converting the parameters. With this package, it is also possible to calculate the standard errors of the other parameters that are not in the model and estimate individual parameters simultaneously.
Drug Packaging ; Pharmaceutical Preparations ; Models, Biological ; Computer Simulation ; Software

Although intravesical instillation of Mycobacterium bovis bacillus Calmette-Guérin (BCG) is the most successful cancer immunotherapy for superficial bladder cancer, the serious side effects are frequently arisen by using live mycobacteria. To allow less toxic and more potent immunotherapeutic agents following intravesical BCG treatment for superficial bladder cancer, noninfectious immunotherapeutic drug instead of live BCG would be highly desirable. Recently, immune-enhancing adjuvants are considered an effective vaccine immunotherapy for cancer, providing enhanced antitumor effects and boosted immunity. The BCG-cell wall skeleton (BCG-CWS), the main immune active center of BCG, is a potent candidate as a noninfectious immunotherapeutic drug instead of live BCG against bladder cancer. However, the most limited application for anticancer therapy, it is difficult to formulate a water-soluble BCG-CWS due to the aggregation of BCG-CWS in both aqueous and nonaqueous solvents. To overcome the insolubility and improve the internalization of BCG-CWS into bladder cancer cells, it should be developed the lipid nanoparticulation of BCG-CWS, resulting in improved dispensability, stability, and small size. In addition, powerful technology of delivery systems should be applied to enhance the internalization of BCG-CWS, such as encapsulated into lipid nanoparticles using novel packaging methods. Here, we describe the progress in research on effects of BCG-CWS for cancer immunotherapy, development of lipid-based solvent, and packaging method using nanoparticles with drug delivery system.
Administration, Intravesical ; Bacillus ; Cell Wall Skeleton ; Drug Delivery Systems ; Immunotherapy ; Methods ; Mycobacterium bovis ; Nanoparticles ; Product Packaging ; Skeleton ; Solvents ; Urinary Bladder Neoplasms ; Urinary Bladder

Fixed drug eruption is a commonly reported mucocutaneous drug eruption. A 61-year-old male presented to our clinic with a complaint of an itchy round erythematous patch on the left hand dorsum with myalgia. On taking medical history, the patient correlated the episode with the intake of an oral sexual enhancer that he had obtained over the counter. We found the medicine contained tadalafil and sildenafil in combination with herbal ingredients. A short course of oral corticosteroid therapy resulted in the complete resolution of the lesion leaving residual hyperpigmentation of the skin involved. Various sexual enhancers with fancy names and attractive packaging are available without requiring a doctor's prescription. Most contain phosphodiesterase-5 inhibitors in various concentrations, often with herbal additions. These drugs are used erratically by the lay public, and often produce side effects. Herein, we report a case of fixed drug rash related to a sexual enhancer, which we believe to be the first report in Korea.
Cyclic Nucleotide Phosphodiesterases, Type 5 ; Drug Eruptions* ; Exanthema ; Hand ; Humans ; Hyperpigmentation ; Korea ; Male ; Middle Aged ; Myalgia ; Phosphodiesterase 5 Inhibitors ; Prescriptions ; Product Packaging ; Sildenafil Citrate ; Skin ; Tadalafil

As observed in today's health care setting, ampules, which are designed for single-use are still persistently reused when there is a drug left-over, in order to aid the patients lessen the cost of health care. Leaving the ampules exposed, covered with a micropore or cotton plug in the patient's immediate bedside are believed to be beneficial in controlling contamination. This study aimed to compare the practices in safekeeping of opened single-use ampules in a closed plastic container in two environments utilizing a 2 x 3 experimental factorial research design. The specimens were collected from 180 ampules' neck after 6 hours of exposure, which were then cultured; the resultant colony forming units were counted expressed in CFU/mL. The use of various practices in safekeeping, use of a closed plastic container and two environments were not significant in preventing contamination. Results demonstrated that none of the current practices in safekeeping was effective in controlling the number of microbial contaminants. Hence adherence to their nature, "single-use" must be advocated despite circumstance of having a drug left over.

BACKGROUND: Issues concerning with the classification accuracy of Korean Outpatient Groups (KOPGs) have been raised by providers and researchers. The KOPG is an outpatient classification system used to measure casemix of outpatient visits and to adjust provider risk in charges by the Health Insurance Review & Assessment Service in managing insurance payments. The objective of this study were to refine KOPGs to improve the classification accuracy and to evaluate the refinement. METHODS: We refined the rules used to classify visits with multiple procedures, newly defined chemotherapy drug groups, and modified the medical visit indicators through reviews of other classification systems, data analyses, and consultations with experts. We assessed the improvement by measuring % of variation in case charges reduced by KOPGs and the refined system, Enhanced KOPGs (EKOPGs). We used claims data submitted by providers to the HIRA during the year 2012 in both refinement and evaluation. RESULTS: EKOPGs explicitly allowed additional payments for multiple procedures with exceptions of packaging of routine ancillary services and consolidation of related significant procedures, and discounts ranging from 30% to 70% were defined in additional payments. Thirteen chemotherapy drug KOPGs were added and medical visit indicators were streamlined to include codes for consultation fees for outpatient visits. The % of variance reduction achieved by EKOPGs was 48% for all patients whereas the figure was 40% for KOPGs, and the improvement was larger in data from tertiary and general hospitals than in data from clinics. CONCLUSION: A significant improvement in the performance of the KOPG was achieved by refining payments for visits with multiple procedures, defining groups for visits with chemotherapy, and revising medical visit indicators.
Classification ; Drug Therapy* ; Fee-for-Service Plans ; Fees and Charges ; Health Care Costs ; Hospitals, General ; Humans ; Information Systems ; Insurance ; Insurance Claim Review ; Insurance, Health ; Outpatients* ; Product Packaging ; Prospective Payment System ; Referral and Consultation

With the development of society and the improvement of people's living standards, the effect of Chinese medicine in treatment and health care is more and more prominent. The herbal decoction pieces are the important part of Chinese medicine,it can be applied directly to clinical treatment and it's also the raw material of Chinese patent medicine. Therefore, the quality of herbal decoction pieces is quite important. The parts of the production of herbal decoction pieces are numerous, and there are possibilities of adverse effects on the quality of the herbal decoction pieces in every part. In this paper, we based on the production chain of herbal decoction pieces, analyzed the main problem that affect the quality of herbal decoction pieces in the part of selection of Chinese herbal medicines, planting, purchasing, processing, packaging, storage and transport, such as the poor quality of seed and seedlings of plant-based Chinese medicines, some plants left their place of origin and have been introduced in the place that is not suitable for this kind of plant, the insufficient growth time and the excessive harmful substances. The purchasers and the accepters lack of professional knowledge and professional ethics. The mechanism of processing is not clear, the standards can not be uniformed, and lack of qualified person in processing, etc. So we suggest: intensify the basic research of key scientific issues. Improve the quality of persons who work in herbal decoction pieces; Establish an "integration" mode of operation in herbal decoction pieces enterprise; Breeding high quality plant resources, establish the large-scale planting basement; Make the packing of herbal decoction pieces standard; Establish the modernization traditional Chinese medicine logistics enterprise.
Chemistry, Pharmaceutical ; economics ; manpower ; standards ; Drug Packaging ; economics ; manpower ; standards ; Drug Storage ; economics ; standards ; Drugs, Chinese Herbal ; chemistry ; standards ; Humans ; Medicine, Chinese Traditional ; economics ; standards ; Quality Control

OBJECTIVETo elucidate the necessary and research of accelerating basic research of Chinese standard pieces as standard materials.

METHODAccording to over 10 years accumulated experience and be keenly aware of the author, the evaluation method of standardized processing technology and Chinese pieces quality, aimed at consummated the standard material of the quality evaluation of Chinese herbal pieces at the current situation, and inaccordance with the need of improving quality standard system of Chinese herbal pieces, illustrate the necessity of accelerating basic research of Chinese standard pieces as standard materials; from the technical specification for collecting and processing of raw materials, and the technical specification, homogenized sample, packaging, storage and etc., for processing of candidate standard pieces, determine the methods and steps of technical specifications for standard pieces as the standard substance, determine the methods and steps of technical specifications for standard pieces as the standard substance.

RESULT AND CONCLUSIONTo speed up the basic research of standard of Chinese medicine pieces as of standard material is very necessary. The research objective is to specificate the processing technical for a number of standard pieces, to identify technical specifications and to ascertain the guiding principle and technical specification of decoction pieces as standard substance. This research will provide basic scientific data relevant national departments to apply for the accreditation of the standard substance.

To study the effect of different storage conditions and storage time on herb quality of Lonicera macranthoides, different packaging materials including vacuum plastic bags, plastic bags, woven bags, sealed with endometrial bags, paper bags, sack bags were selected for the study under different storage conditions including room temperature, 5 degrees C refrigerator, low temperature of - 20 degrees C refrigerator and desiccator. Twenty-four batches of samples were used for the study, and active ingredients were determined. The experimental results showed that the ingredients in each storage group changed with the storage time, storage conditions (storage environment, packaging). Under the same storage time, the storage environment (temperature, humidity) had effect on the stability of herb quality. Low temperature had less effect on herb quality. The effect of packaging on herb quality was as following: plastic vacuum packaging > woven with endometrial sealed packaging > plastic bag > woven bag > sack bags > paper bags. Under the same storage conditions, with the increase of storage time, caffeic acid content increased slowly, and other five ingredients content decreased gradually. Storage time affected significantly on the intrinsic quality (chemical composition) and appearance of herb. It is suggested that low temperature (5 degrees C), dark and sealed storage are suitable for storage of L. macranthoides herb, the storage time should be not more than 24 months.
Desiccation ; Drug Packaging ; Drug Storage ; methods ; Drugs, Chinese Herbal ; chemistry ; Lonicera ; chemistry ; Organic Chemicals ; analysis ; Quality Control ; Time Factors