58 results about "Terminal Sterilization" patented technology

The invention discloses a stable vitamin B6 composition and a preparation method thereof. The pH value of the vitamin B6 injection is controlled to be 2.5-2.8, and the impurity content in the product is remarkably reduced by controlling the heating and cooling rate in the terminal sterilization process, so that the product stability and the clinical use safety are improved.

The invention provides a formula of a temperature-sensitive recombinant human epidermal growth factor hydrogel composition, temperature-sensitive gel takes poloxamer as a drug carrier, and a terminal sterilization mode is filtration sterilization. The temperature-sensitive recombinant human epidermal growth factor hydrogel composition provided by the invention has unique advantages in the aspects of degerming process, temperature sensitivity, stability and practical applicability.

The invention discloses a high-strength self-lubricating three-layer nested medicine-carrying hollow cervical cerclage band with an auxiliary miscarriage prevention function and a preparation method of the cerclage band, and belongs to the technical field of medical instruments. Degradable polyester monofilaments are woven into a hollow round rope, and the hollow round rope and a medical curved needle are integrated; then carrying out polydopamine-polyethylene glycol double-layer modification on a copper-based metal organic framework (Cu-MOF), and loading active molecules; then mixing the drug-loaded Cu-MOF with collagen natural polymer sol, and uniformly filling the gel into the inner cavity of the round rope and forming a three-dimensional bracket through synchronous drawing type micro-perfusion and light-enzyme synergistic cross-linking; then constructing a transient hydrated lubricating layer on the surface; and finally carrying out ethylene oxide final sterilization to obtain a finished product. The cervical cerclage band device provided by the invention simultaneously provides degradable mechanical support, collagen scaffold induction and long-acting slow release regulation, has a low-friction implantation characteristic, and can be well used for preventing or treating middle and late abortion and premature delivery caused by cervical insufficiency.

The invention relates to the technical field of terminal sterilization and filtration in a radiopharmaceutical preparation process, in particular to a filter membrane sterilization and filtration device and system. Comprising the steps that a state sensing module collects liquid medicine radioactive activity data and filter membrane structure strain data and generates real-time data flow; the twinborn modeling module constructs a filter membrane digital twinborn body, and outputs an accumulated radiation damage prediction result through data assimilation; the prediction decision module generates a filtering parameter optimization sequence by using a deep reinforcement learning agent; the control execution module adjusts the flow velocity of the liquid medicine through fuzzy self-adaptive PID control and feed-forward compensation; and the verification feedback module performs an integrity test and transmits data back to the twin modeling module to realize model parameter correction. All the modules form a closed-loop control system through a high-speed data bus, so that the damage of radiation to a filter membrane material is effectively inhibited, and the integrity and the sterile guarantee level of a membrane structure in the filtering process are maintained.

The invention discloses a cysteine impurity as well as a quality control method and application thereof, and belongs to the technical field of drug detection. The technical problem to be solved is to provide a cysteine quality control method for impurities generated after terminal sterilization of cysteine. The key point of the technical scheme is that the structural formula of the cysteine impurity 1 is shown in the specification.

This invention belongs to the technical field of traditional Chinese medicine extraction equipment, specifically relating to an automated sterilization process for the entire pipeline of traditional Chinese veterinary medicine extraction. This application modifies the entire pipeline of traditional Chinese veterinary medicine extraction to meet the requirements of high-temperature and high-pressure steam sterilization. Before the extraction of traditional Chinese veterinary medicine, high-temperature and high-pressure steam is used to sterilize the entire pipeline. Then, the extraction temperature in the extraction tank is controlled to ensure the sterilization of the extract, thereby ensuring that the final oral liquid meets the sterilization requirements. This saves on the terminal sterilization process and allows for direct filling with non-high-temperature resistant packaging, greatly saving manufacturing costs.

This invention belongs to the pharmaceutical field, specifically relating to a sodium nitroprusside injection and its preparation method. The sodium nitroprusside injection comprises the following raw materials in parts by weight: 1.5–3.5 parts sodium nitroprusside and 100 parts water for injection. This invention solves the problem of poor stability of sodium nitroprusside aqueous solutions by optimizing the formulation and preparation process without introducing other excipients. The sodium nitroprusside injection prepared by this invention is a sterile injectable preparation manufactured using modern aseptic filling technology combined with non-terminal sterilization. It not only has the advantages of direct and rapid action and high sterility assurance, but also has few adverse reactions and can be transported and stored at room temperature, thus improving the stability and safety of the product. This invention also provides its preparation method, which is simple, safe to use, and has stable quality.

Embodiments of the present disclosure relate to systems and methods for the application of vaporized chemicals in the sterilization of medical products. For example, embodiments of the present disclosure may relate to systems and methods for the terminal sterilization of medical products using vaporized hydrogen peroxide (VHP). Embodiments of the present disclosure may relate to, e.g., systems and methods for the terminal sterilization of medical products, such as pre-filled syringes (PFS).

The invention discloses a nano drug-loaded nasal spray composition for treating nasosinusitis. The nano drug-loaded nasal spray composition is prepared from the following raw materials: nano silver, PVP (Polyvinyl Pyrrolidone), baicalin, flos magnoliae volatile oil, chitosan, PLGA (Poly (Lactic-co-Glycolic Acid), sodium hyaluronate, a citrate buffer solution and the balance of sterile normal saline. The invention also discloses a preparation method of the nano drug-loaded nasal spray composition for treating nasosinusitis, the preparation method comprises the following steps: firstly preparing PVP modified nano silver suspension, then preparing baicalin nanoparticles and magnolia flower volatile oil nanoparticles by adopting an emulsification-solvent evaporation method, and PVP is used as a stabilizer of nano silver to ensure the long-term dispersion stability of nano silver, so that the stability of the nano silver is ensured, and the stability of the nano silver is ensured. Finally, all the components are mixed in a sterile operation table, the pH is adjusted, filtration sterilization is conducted through a 0.22-micron sterile filter membrane, terminal sterilization is conducted through gamma-ray irradiation after split charging is conducted, and the final product can be prepared into quantitative spray or sterile nose drops to meet different clinical requirements.

The invention relates to the technical field of fermented drinks, in particular to antioxidant orange soda water and a preparation method thereof. According to the orange soda water, orange juice is used as a main raw material, a multi-strain stepped fermentation process is adopted, bacillus coagulans, saccharomyces boulardii and lactobacillus plantarum are sequentially inoculated, and matrix degradation, functional precursor release, aroma framework and oxygen-expelling environment creation, flavor roundness and biological preservation are achieved respectively. A fermentation product is compounded with functional ingredients such as vitamin C, sodium D-isoascorbate, a citrus essential oil nano-emulsion and microencapsulated citrus polyphenol, and then high-pressure treatment terminal sterilization and high-power carbon dioxide carbonation filling are performed. The process effectively improves the oxidation resistance, flavor complexity and storage stability of the orange soda water, and is suitable for development of functional carbonated beverages.

The invention relates to the technical field of biomedical materials, in particular to polynucleotide / macromolecular protein composite gel capable of tolerating terminal moist heat sterilization as well as a preparation method and application of the polynucleotide / macromolecular protein composite gel. The product provided by the invention is a composite gel of polynucleotide PN and a specific type of high-molecular protein, and under the conditions of a specific ratio and molecular weight, the high-thermal denaturation temperature is higher, and the high-molecular protein with a specific structure has a better protection effect on the polynucleotide PN; the stability and biological activity of polynucleotide PN molecules can be kept under the condition of high-temperature terminal sterilization, the safety of a sterilized product can achieve the effect of thoroughly inactivating viruses, and the filling and supporting properties of the product serving as a stent material are completely reserved; the compound can be directly used in drugs, medical instruments or cosmetics in the field of tissue engineering, and has high safety and lasting effect.

The application discloses a terminal sterilization mivacurium chloride injection, which comprises mixed solute mivacurium chloride and solvent injection water, and the concentration is 2.14 mg / ml, and the pH value of the mivacurium chloride injection is 3.2-3.8. Under the condition of the specific pH value, the degradation speed of the mivacurium chloride is slowed down, and the mivacurium chloride injection preparation can be subjected to high-temperature terminal sterilization. After sterilization, the impurity level of the preparation is still in a low state, so that no additional stabilizer excipient needs to be added, the stability of the mivacurium chloride injection is improved, the high-temperature sterilization operation can be tolerated, the preparation microorganism and endotoxin level are effectively controlled, and the safety of clinical medication is improved.

The invention discloses an alfentanil micro-dose injection based on clinical precise administration and a preparation method thereof, and relates to the technical field of pharmaceutical preparations, the injection is packaged by adopting a single-use small-capacity polypropylene (PP) material ampoule or a pre-filled syringe, the single package capacity is 0.5-2mL, the alfentanil micro-dose injection contains 0.1-50mu g / mL of alfentanil, and the injection is prepared by adopting a one-time injection method. The PP material has good high-temperature sterilization resistance and low drug adsorbability, so that the terminal sterilization requirement can be met, the drug stability can be ensured, and meanwhile, the risk of disengagement possibly caused by glass packaging is avoided; and finally, through an optimized packaging design and a preparation process, a simplified formula without preservatives and solubilizers is realized, and potential safety hazards possibly brought by auxiliary materials are reduced. According to the scheme, a safer and more economical accurate administration solution of the alfentanil is provided for clinic.

The application relates to a detachable flow type terminal sterilization device which comprises a shell and a sterilization assembly, the shell is provided with a water inlet and a water outlet, the shell is internally formed with a water inlet cavity, a mounting cavity and a water outlet cavity which are sequentially arranged along the water inlet to the water outlet, the sterilization assembly comprises a reflecting sleeve and a sterilization light source, the reflecting sleeve is arranged in the mounting cavity and detachably connected with the shell, the reflecting sleeve is communicated with the water inlet cavity and the water outlet cavity, sterilization light emitted by the sterilization light source penetrates into the reflecting sleeve, and the sterilization light forms a sterilization area penetrating through the reflecting sleeve after multiple reflections in the reflecting sleeve; the mode of prolonging the length of a water pipe to increase sterilization time can cause the problems of large equipment volume, increased energy consumption and poor water flow.

The invention provides a stable acetylcysteine solution and a preparation method thereof. According to the method, the hydrogen sulfide generation inhibitor is added, and the beta-elimination reaction of acetylcysteine is competitively inhibited in the sterilization process, so that the hydrogen sulfide content in the injection after terminal sterilization is obviously reduced from the source, and the problem of high hydrogen sulfide content of the product caused by terminal sterilization in the prior art is solved.

The invention discloses an automatic animal viscera processing production system and method, and relates to the technical field of food processing, and the system comprises a cleaning module which is used for obtaining animal viscera to be processed and obtaining cleaned animal viscera through rolling soaking, branch cleaning, high-pressure spraying and multi-stage cleaning in sequence; the sterilization module is used for performing multi-stage sterilization treatment and ultraviolet sterilization on the cleaned animal viscera to obtain final sterilized animal viscera; the packaging module is used for sequentially carrying out weighing, vacuum packaging and quick freezing on the finally sterilized animal viscera to obtain packaged animal viscera; the storage module is used for sequentially performing outer package code spraying and stacking storage on the packaged animal viscera to complete processing of the animal viscera to be processed; and the sewage treatment module is used for collecting and treating wastewater generated by the cleaning module and the sterilization module to obtain treated water reaching the standard. Automatic operation of the whole process from animal viscera cleaning to finished product warehousing is achieved, the production efficiency is improved, and the product quality, sanitation and safety are guaranteed.

Methods are disclosed for enhanced terminal sterilization of packaged, pre-filled syringes containing drug solutions. The methods utilize a sequence of autoclave steps - including vacuum application, dynamic steam pulsing, and controlled counterpressure - to sterilize both the syringe and its enclosing semipermeable pouch without compromising structural integrity or drug quality. The vacuum removes air from the secondary7 space within the pouch, while steam pulsing ensures thorough penetration. Counterpressure is applied to prevent plunger movement caused by internal expansion. The process concludes with drying and cooling phases. The methods maintain sterility to a sterilization assurance level (SAL) of 10 6 and are suitable for use with a range of syringe and packaging materials. The resulting product is sterile field ready, single-use compliant, and structurally intact. These techniques are adaptable to various sterilization times and temperatures, ensuring flexibility across drug formulations and syringe configurations.

The invention discloses a hotel air closed-loop sterilization system based on multi-stage physical field cooperation and a control method, the system comprises a sealed negative pressure channel, a primary filter layer, an electrostatic sterilization module, a UVC array and a pulse xenon lamp sterilization layer are sequentially arranged in the channel in the airflow direction, a centrifugal fan is matched to maintain a negative pressure environment, and a closed-loop airflow path is formed. The electrostatic module oxidizes and inactivates microorganisms through ROS free radicals, the UVC array breaks DNA / RNA chains of the microorganisms, the pulse xenon lamp achieves end sterilization through photo-thermal synergy, and an action chain of'oxidation-gene disruption-thorough inactivation 'is formed through three-stage synergy. The system further comprises an internet-of-things control module which is linked with a hotel PMS system to automatically trigger disinfection and killing. According to the control method, intelligent operation is achieved through room state detection, negative pressure establishment, sealing detection, graded activation, dynamic duration control and real-time monitoring. The system solves the problems of insufficient safety and efficiency and high manual dependence degree of traditional sterilization, has the characteristics of high inactivation rate, no leakage risk and intelligence, and meets the requirements of hotel scenes.

The invention discloses a preparation method of a terminal sterilized collagen implant product, which is characterized in that a phosphoric acid buffer solution system and a collagen stock solution are mixed according to a mass ratio of 1: (1-9) at 2-20 DEG C and then freeze-dried, the stability of a collagen structure is maintained while the implant is physically and chemically close to a physiological environment, and functional additives are reasonably compatible, so that the terminal sterilized collagen implant product is prepared. Wherein the additive comprises 0.3% of lidocaine hydrochloride and 1.0%-5.0% of glycerol, the stability and histocompatibility of the product are improved, the clinical applicability of the product is enhanced, the phosphate buffer solution and the collagen stock solution are mixed and then freeze-dried, and it can be ensured that the final freeze-dried sponge is in an ideal neutral state after being dissolved without any chemical modification step. Therefore, the residual risk caused by introduction of chemical reagents is thoroughly avoided, the biological safety and the clinical application reliability of the product are remarkably improved, meanwhile, the key functional characteristics of collagen are guaranteed, and the collagen has a wide application prospect in the aspects of tissue engineering, drug delivery systems, cell culture and cosmetics.

Method for producing a sterile oxybutynin-containing composition in a preferably ready-to-use piston syringe, in particular a disposable piston syringe, and / or for producing a preferably ready-to-use, sterile piston syringe filled with an oxybutynin-containing composition, in particular a disposable piston syringe, wherein the piston syringe has a syringe body on one side and a syringe piston with a piston stopper on the other, wherein the syringe body is made of polypropylene, and wherein the final oxybutynin-containing composition obtained after completion of the process, in particular after process step b), is formed as a sterile aqueous composition, in particular a terminally sterilized composition, and has the following specification requirements (i) and (ii) and / or (iii), preferably (i), (ii) and (iii): (i) specified concentration of oxybutynin, preferably in the form of the hydrochloride, with a specified deviation of not more than ± 5%, based on the concentration of oxybutynin, (ii) specified specification pH value with a specified deviation of not more than ± 0.5 pH units, (iii) specified maximum quantity of oxybutynin degradation product(s), in particular reactively generated oxybutynin degradation product(s), preferably hydrolytically and / or oxidatively generated oxybutynin degradation product(s), preferably phenylcyclohexylhydroxyacetic acid; the procedure includes the following steps: a) Providing an oxybutynin-containing starting composition in the piston syringe and / or filling the piston syringe with an oxybutynin-containing starting composition and subsequently b) Heat sterilization, in particular steam sterilization, preferably steam sterilization, preferably terminal sterilization, of the oxybutynin-containing starting composition in the syringe and / or the syringe filled with the oxybutynin-containing starting composition to obtain the sterile oxybutynin-containing final composition in the preferably ready-to-use syringe and / or to obtain the preferably ready-to-use, sterile syringe filled with the oxybutynin-containing composition, wherein the migration and / or incorporation of the oxybutynin into the syringe body and / or the plunger stopper occurring in the process, in particular in process step b), and / or the degradation of the oxybutynin occurring in the process, in particular in process step b), in particular the reactive degradation of the oxybutynin, preferably the hydrolytically and / or oxidatively induced degradation, preferably the degradation to phenylcyclohexylhydroxyacetic acid, is controlled and / or compensated in such a manner and with the proviso that that the sterile oxybutynin-containing final composition obtained after carrying out process step b) meets the previously mentioned specification requirements (i) and (ii) and / or (iii), preferably (i), (ii) and (iii), and that the sterile oxybutynin-containing final composition is obtained in the preferably ready-to-use piston syringe or the preferably ready-to-use, sterile piston syringe filled with the oxybutynin-containing final composition, wherein the migration and / or incorporation of the oxybutynin into the syringe body and / or the plunger stopper occurring in the process, in particular in process step b), and / or the degradation occurring in the process, in particular in process step b), in particular the reactive degradation of the oxybutynin, preferably the hydrolytically and / or oxidatively caused degradation of the oxybutynin, preferably the degradation to phenylcyclohexylhydroxyacetic acid, is controlled and / or monitored, in particular prevented and / or minimized and / or compensated for, by at least one of the following measures and / or steps (1), (2), (3) and / or (4): (1) Adjustment and / or use of an increased concentration and / or amount of oxybutynin, preferably in the form of the hydrochloride, in the initial composition compared to the specified concentration and / or amount of oxybutynin, preferably in the form of the hydrochloride; (2) Adjustment of the pH value of the initial composition to a value that differs from the specified pH value, in particular an increased pH value; (3) Setting and / or selecting the sterilization conditions, in particular selected from the group consisting of sterilization type, sterilization duration, sterilization temperature, sterilization pressure, sterilization atmosphere and combinations thereof, preferably setting and / or selecting the F0 value of the sterilization; (4) Equipment and / or treatment, in particular coating, of the syringe body, preferably the inner wall of the syringe body, and / or the plunger stopper with at least one migration- and / or degradation-reducing agent.

The invention discloses a submicron precision integrated filter material and a filter element with the same, the submicron precision integrated filter material is prepared by carrying out in-mold one-time pressure sintering molding on thermal bonding composite short fibers, and a three-dimensional labyrinth type net structure with high pore tortuosity is formed. According to the invention, the stable filtering precision of the fiber filter material is improved to a submicron level of 0.1-0.5 [mu] m from greater than or equal to 1 [mu] m in the traditional process, so that the intergenerational crossing of technical performance is realized; a unique short fiber random sintering structure is adopted, so that high filtration precision is realized, high porosity and relatively low pressure drop are maintained, and the tradeoff relation that precision and flux are difficult to obtain at the same time in a traditional filtration material is broken; according to the present invention, the traditional multi-process and intermittent production is changed into the one-shearing and one-burning two-step continuous or batch production, such that the expensive carding equipment, the expensive lapping equipment and the expensive other equipment are omitted, the production efficiency is high, the comprehensive cost is low, no chemical binder is introduced, the biological and chemical compatibility is good, and the method is suitable for various harsh scenes from terminal sterilization to high-purity chemical filtration.

An aseptically prepared pharmaceutically acceptable azithromycin premix formulation has a pH value of 5.5 to 7.5, preferably 6.0 to 7.0, more preferably 6.3 to 7.0, even more preferably 6.3 to 6.7, for example about 6.5. Preferred embodiments of the aseptically prepared pharmaceutically acceptable azithromycin premix formulation contain azithromycin, a buffering agent, water and optionally a tonicity adjusting agent and are stable for one month, three months, six months, nine months, twelve months, fifteen months, eighteen months or even twenty-four months, during storage at refrigerated temperatures, such as about 5° C., even without any additional components beyond the azithromycin, the buffering agent, and the optional tonicity adjusting agent in the premix formulation. The pharmaceutically acceptable azithromycin premix formulation may be aseptically filled into a container, preferably a glass or flexible container, to form a sterile pharmaceutical azithromycin premix product which does not undergo terminal sterilization. The azithromycin premix product can be a single use premix which is a sterile, stable and ready-to-use aqueous solution for parenteral administration, for example intravenous (IV) administration such as IV infusion, and requires no dilution prior to parenteral administration.

The invention discloses a composition and a preparation method of deoxycholic acid injection, the formula comprises deoxycholic acid, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, vitamin C ethyl ether and water for injection, and the dosage of vitamin C ethyl ether is 0.25%-2.0%. The deoxycholic acid injection disclosed by the invention is simple in composition, stable in quality, simple, convenient and efficient in preparation process and free of special equipment and inert gas filling, and a finished product prepared after terminal sterilization (F0 is greater than or equal to 12) is low in impurity level and good in safety.

The invention relates to the technical field of traditional Chinese medicine preparations and health-care foods, and discloses a sheep liver compound oral liquid composition with liver repairing and liver protecting effects, and a method comprises the following steps: selecting fresh sheep liver, cleaning, cutting, homogenizing, and carrying out composite enzymatic hydrolysis and enzyme deactivation to obtain sheep liver enzymatic hydrolysate; respectively preparing a water extract of each auxiliary raw material, performing primary purification, and mixing with the enzymatic hydrolysate to form a primary mixed solution; refining and purifying the primary mixed solution by adopting a multi-stage membrane separation technology to obtain purified filtrate; adding other auxiliary materials and additives into the filtrate, stirring and dissolving, fixing the volume, adjusting the pH value, and homogenizing to obtain a homogenized oral liquid; finally, sterile filling and terminal sterilization are conducted, and the final oral liquid composition is obtained.By means of the directional enzymolysis and membrane purification technology, dissolution and bioavailability of active ingredients in the raw materials are effectively improved, and the oral liquid composition has the advantages of being definite in liver protection effect, good in stability and easy to absorb.

The invention discloses a preparation process of enoxaparin sodium, and relates to the technical field of biological medicine, the process comprises the following steps: constructing a non-oxidizing and chromatography-free reaction-separation synergistic system, and sequentially completing quaternary ammonium salinization, benzyl esterification, alkaline beta-elimination degradation, activated carbon decoloration under neutral pH, gradient ultrafiltration classification, nanofiltration concentration and buffer replacement. And finally, carrying out terminal degerming filtration and freeze drying to accurately enrich a target active fragment of 2000-8000 Daltons. According to the present invention, the obtained product has characteristics of high anti-Xa / anti-IIa activity ratio, complete 1, 6-anhydrosugar chain end structure and narrow molecular weight distribution, the product yield achieves 82-86%, the batch-to-batch consistency and the green manufacturing level of the process are significantly improved, and the reliable and efficient technical path is provided for the large-scale production of the high-quality enoxaparin sodium.

This invention relates to a method for removing residual BDDE, a crosslinking agent, from crosslinked hyaluronic acid hydrogels, belonging to the field of gel formulation technology. The invention employs a two-step strategy of "composite solution treatment combined with stabilizer sterilization," with its core feature being the phased, multi-mechanism synergistic removal of BDDE residues. First, the composite solution treatment, through the synergistic action of inorganic salts and / or quaternary ammonium salts with organic solvents, degrades the free epoxy groups of ineffective crosslinked BDDE; simultaneously, the crosslinked hyaluronic acid gel is precipitated, separating the free-state crosslinking agent BDDE. Second, the obtained crosslinked hyaluronic acid gel precipitate is co-sterilized with a stabilizer. The active groups in the stabilizer, such as amino and hydroxyl groups, react with the free epoxy groups of the residual BDDE, achieving in-situ and simultaneous residue removal in the final sterilization step, simplifying the process.

The application discloses a preparation process of enoxaparin sodium, and relates to the technical field of biological medicines.The process comprises the following steps: constructing a non-oxidative and non-chromatographic reaction-separation cooperative system, sequentially completing quaternary ammonium saltization, benzyl esterification, alkaline beta-elimination degradation, active carbon decolorization under neutral pH, gradient ultrafiltration fractionation, nanofiltration concentration and buffer replacement, finally performing terminal sterilization filtration and freeze-drying, and precisely enriching target active fragments with 2000-8000 daltons.The product obtained by the application has a high anti-Xa / anti-IIa activity ratio, complete 1,6-dehydration sugar chain end structure and narrow molecular weight distribution, the product yield reaches 82%-86%, and the batch consistency and green manufacturing level of the process are significantly improved, so that a reliable and efficient technical path is provided for large-scale production of high-quality enoxaparin sodium.

Provided herein are nanoalum particles comprising an aluminum salt and a sizing agent, wherein the size of the particle ranges from about 1 nm to 450 nm. Such a nanoalum particles are stable and are amenable to a terminal sterilization step prior to vialing. Compositions comprising the nanoalum particles, and the making and using of the nanoalum particles are also provided.

The present invention describes a process for preparing an injectable formulation comprising a polyelectrolyte complex gel of hyaluronic acid and cationic hyaluronic acid, mannitol, and optionally an anesthetic and / or hyaluronic acid. This process comprises the concomitant reactions of hyaluronic acid cationization and the formation of a polyelectrolyte complex gel of hyaluronic acid and cationic hyaluronic acid. The injectable formulation obtained by the process of the present invention exhibits rheological properties comparable to injectable formulations of covalently cross-linked hyaluronic acid and is capable of terminal sterilization, such characteristics being important for its application as an intradermal or intra-articular filler.

The invention belongs to the field of pharmaceutical preparations, and particularly relates to a diphenhydramine hydrochloride composition and a preparation method thereof. According to the diphenhydramine hydrochloride injection disclosed by the invention, the pH of the diphenhydramine hydrochloride solution is adjusted by adopting carbon dioxide, and terminal sterilization is performed on the diphenhydramine hydrochloride solution, so that the sterile guarantee level of the diphenhydramine hydrochloride injection is improved, and the clinical use safety is greatly improved.