41results about How to "Improving Sterility Assurance Levels" patented technology

The invention discloses an ambroxol hydrochloride liquid preparation and a preparation method thereof. The method comprises the steps: dissolving ambroxol hydrochloride, stabilizing agent and osmotic pressure regulator into water used for injection, and evenly mixing together to obtain solution I; then, filtering the solution I, and obtaining the ambroxol hydrochloride liquid preparation. The preparation method does not introduce active carbon, so as to avoid the danger of hurting human body since active carbon particle is introduced into the preparation; meanwhile, the active ingredients in the preparation is ensured to be stable, and the safety (namely, the chemical stability of the ambroxol hydrochloride can be effectively improved, the particle content in the preparation is reduced, and the purity of the preparation is improved) of the finished product can be guaranteed.

The invention discloses a method for preparing a sodium-potassium-magnesium-calcium glucose injection. The method comprises the following steps: adding water for injection into a preparation tank; sequentially adding calcium gluconate, sodium chloride, potassium chloride, magnesium chloride, glucosum anhydricum, sodium acetate and sodium citrate; dissolving, regulating the pH value to 4.5-5.5 with hydrochloric acid, filtering and filling; sterilizing for 12 minutes at 121 DEG C, inspecting with a lamp, and packaging. According to the method, after the pH value is regulated to 4.5-5.5, a durable overkilling method is carried out at 121 DEG C for 12 minutes (F0 is more than or equal to 12) for sterilizing, the content of glucose is not remarkably reduced, 5-hydroxymethylfurfural and other glucose degrading impurities are in a relatively low level, and the sterility assurance level of the sodium-potassium-magnesium-calcium glucose injection is improved.

The present invention provides a muscular amino acids and peptides and nucleosides injection, which is extracted from the muscle and the cardiac muscle of healthy rabbit and is a freeze-drying agent which is prepared by the sterilized water solution containing the compositions of polypeptide, amino acids, nucleosides, nucleotides, etc. The muscular amino acids and peptides and nucleosides is used for the adjuvant therapy of brain hypofunction and peripheral nerve disease caused by cerebral apoplexy and cerehral circulation insufficiency. The present invention belongs to the technical field of medicine. The invention introduces a preparing method which comprises the steps of cleaning, cutting into blocks, homogenizing, deep freezing, heating to boiled, separating the supernatant, depositing with acid and the base, depositing with the base, hot pressing, deep freezing, ultra-filtering, detecting, adjusting the proportion between the polypeptide and the hypoxanthine, and ultra-filtering. The muscular amino acids and peptides and nucleosides injection is prepared through the steps of sterilizing filtering, filling into containers, and sterilizing. An appropriate amount of accessory is added and the steps of sterilizing filtering, filling into containers, and freeze drying are executed for preparing the muscular amino acids and peptides and nucleosides for injection. The muscular amino acids and peptides and nucleosides and the preparing method of the invention have the advantages of excellent convenience, excellent wholeness, ensured product which satisfies the national standard, guaranteed virus blanching, injection sterilization F0 larger than 8, and high level of sterilizing guaranteeing.

The invention relates to the technical field of antitumor drugs, and discloses a composition containing paclitaxel and a preparation method thereof. The composition containing paclitaxel comprises 1 part by weight of paclitaxel and 1.2-15 parts by weight of egg yolk lecithin; the pH value range of the composition is 4.0-6.0. According to the composition containing paclitaxel of the invention, egg yolk lecithin is adopted as an emulsifier; the pH value of the composition is adjusted to be within a proper range; no polyoxyethylated castor oil with large toxicity is adopted; no ethanol is contained; the medication risk of the composition containing paclitaxel is reduced; and the patient compliance is improved.

The invention discloses an aseptic packaging method of a large volume injection. The aseptic packaging method comprises the following steps: (1) weighing raw materials and auxiliary materials of an injection according to a process proportion under a negative-pressure weighing hood, sequentially adding the materials into a pre-sterilized batching pot, adding water for injection to dilute, and mixing uniformly; (2) supplementing the water for injection to achieve the preparation total amount according to the process proportion in combination with a weighing system of a batching pot, adjusting the pH value of the liquor, and filtering and sterilizing the liquor through double 0.22 microns sterilizing grade filters of a redundancy filtering system; and (3) injecting the filtered aseptic liquor to a plastic bottle-blowing, filling and sealing integrated machine through an aseptic pipeline system, finishing the bottle blowing, filling and sealing under the protection of a grade-A laminar flow hood, and finally sterilizing at high temperature to obtain a finished product. According to the aseptic packaging method of the large volume injection, double 0.22 microns sterilizing grade filters are added before filling, and the high-temperature sterilization is performed after filling, so that the aseptic assurance level of the large volume injection is greatly improved in comparison with the traditional terminal sterilization process, the content of a heat source is controlled effectively, and the security of clinical use is strongly guaranteed.

The invention discloses a dry-cleaning sterilizer. The dry-cleaning sterilizer comprises an arranging mechanism, a conveying belt, a dry-cleaning device and a sterilization device, wherein a jet nozzle is arranged at the top end of the dry-cleaning device; the conveying belt is used for conveying a material to a material use point through the dry-cleaning device and the sterilization device from the collection opening end of the conveying belt; the sterilization device comprises an inert gas lamp, a pulse laser generator and reflectors on two sides of the sterilization device; the conveying belt positioned in the sterilization device passes through the space between the reflectors on two sides of the sterilization device; and high-intensity pulse laser generated by the pulse laser generator is used for completely illuminating all light energy to a to-be-processed material on the conveying belt by virtue of the reflectors. According to the dry-cleaning sterilizer, pre-treatment and cleaning operation before foreign material cleaning and sterilization of a material surface can be completed by adopting a mode of cleaning, boosting, high-temperature air local dry-cleaning and integral wiping; the material surface is sterilized by adopting a harmless pulse laser irradiation mode; and the material is continuously conveyed by adopting the transmission mechanism, and the effective effect of cleaning and sterilizing can be guaranteed.

The invention discloses an isosorbide mononitrate liquid preparation and a preparing method thereof. The method comprises the steps: dissolving isosorbide mononitrate, stabilizing agent and osmotic pressure regulator into water used for injection, and evenly mixing together to obtain solution I; then, filtering the solution I, and obtaining isosorbide mononitrate injection. As active carbon is notintroduced into the preparing method, the active carbon particles are prevented from being introduced into the preparation to be harmful to the human body, and the stability of the active ingredientsin the preparation as well as the safety of the finished product can be ensued (namely, the chemical stability of the isosorbide mononitrate is effectively improved, the particulate content in the preparation is reduced, and the purity of the preparation is increased).

The invention belongs to the field of bio-medicine, and discloses a tafluprost eye drop agent and a preparation method thereof. The eye drop agent take tafluprost as an active ingredient, a hydrophilic gel skeleton material is used as a skeleton and a solubilizer, the tafluprost eye drop agent further includes an antioxidant and a stabilizer, and the antioxidant and the stabilizer are macromolecular compounds. A process of the tafluprost eye drop agent improves the asepsis level of a product, the characteristics of simple preparation composition, easy, convenient and quick operation, high compatibility for medicinal packaging materials, low cost, stable properties of liquid medicine and high quality standard are achieved, and the tafluprost eye drop agent is suitable for industrial production.

The invention discloses a preparation method of a local anesthetic liposome, and belongs to the technical field of preparations. The preparation method of the local anesthetic liposome includes the steps of preparing a blank liposome; carrying out ultrafiltration concentration on the blank liposome; co-incubating drug to be encapsulated and the blank liposome, and performing sterilizing and filtering to obtain a drug-loaded liposome; and mixing the drug-loaded liposome with a poloxamer aqueous solution, performing subpackaging, performing freezing after subpackaging, and performing freeze-drying after subpackaging to prepare a liquid preparation, a frozen preparation or a freeze-dried preparation. According to the preparation method of the local anesthetic liposome, a local anesthetic liposome product with lower particle size, higher uniformity and higher entrapment rate can be prepared, the operation is simple, and industrial production is easy to realize.

The invention provides an ibuprofen sodium chloride injection preparation with pH of 6.0-6.5, and a preparation method thereof. The injection contains 1-10 mg/ml of ibuprofen, and injection water, wherein the pH is adjusted to 6.0-6.5 by an acid-base modifier; the dosage of the required acid-base modifier accounts for about 2-6% by weight/volume of the injection; the sodium chloride content of an isoosmotic adjusting agent is 0.70-0.90% by weight/volume. The preparation technology comprises the following steps: firstly, dissolving the acid-base modifier and the ibuprofen; adding the injection water to 20% of total mass; adding sodium chloride to stir and dissolve; adding activated carbon, filtering and decarburizing; adding water to 90% of total mass, adjusting the pH to 6.0-6.5, and adding water to total mass; filtering by 0.45 microns and 0.22 microns of microfiltration membranes; and filling and sealing and sterilizing at 121 DEG C for 8-20 minutes.

The invention discloses a preparation method of a pharmaceutical composition containing deslanoside. The invention provides a preparation method of a deslanoside injection. The preparation method is characterized by comprising the following step: sterilizing a mixture containing the deslanoside, ethanol, glycerol and water for injection by adopting a terminal sterilization mode of sterilizing at 121 DEG C for 15 minutes. The deslanoside injection prepared by a prescription and process disclosed by the invention is stable in quality and low in impurity content, and can be placed for 5 days and10 days at a high temperature (60 DEG C) and for 1 day and 3 days at a high temperature (80 DEG C), and results show that the deslanoside injection is stable in product quality and relatively small inimpurity increase.

The invention relates to the pharmaceutical field, especially to production of bulk drugs by a solvent crystallization method and to a sterile logistics method, particularly a vertical logistics based method for sterile preparation of N-(2)-L-alanyl-L-glutamine. According to the traditional solvent crystallization method, a N-(2)-L-alanyl-L-glutamine reaction solution is concentrated and is adjusted to a pH value of 5-6.5, desalination treatment is performed, then solid-liquid separation is conducted, and the separated solid is transferred by action of gravity. Environmental exposure caused pollution problems are avoided during material transfer. The prepared bulk drug has a high sterile level. In addition, the logistics system with gravity as the main driving force has the characteristics of high transport efficiency and low cost.