The 2005 edition of the Chinese Pharmacopoeia stipulates that in addition to the main drug, other substances may be added according to the preparation and medical needs to increase the effectiveness, safety and stability of the injection. These substances are collectively referred to as injection additives.
The selection of the variety and the concentration used are not toxic to the body, and the main non-incompatible contraindications do not affect the main efficacy and content determination. The different uses of the additives should also be indicated in the finished product instructions.
1. Additives that increase the solubility of the main drug
Ways to increase the solubility of the main drug are:
1 Use a mixed solvent or a non-aqueous solvent.
2 Add acid or base to make soluble salts of poorly soluble drugs.
3 Introducing a hydrophilic group on the molecular structure of the main drug.
4 Add solubilizers such as Tween-80, bile, etc. However, when Tween-80 is used, the effects of acidic drugs, benzyl alcohol, chlorobutanol, etc. may be weakened, and care should be taken.
5 Add a co-solvent.
Commonly used are:
1, Tween-80: commonly used solubilizer, commonly used amount of 0.5% -1%. Mainly used for intramuscular injection, there is a slight blood pressure and hemolysis, it should be used with caution.
However, it should be noted that the enamel or phenolic component, the solution is acidic, and the addition of Tween-80 will cause turbidity.
Containing phenolic ingredients, adding Tween-80 reduces the bactericidal effect.
During the Tween-80 sterilization process, turbidity will occur.
Usage: First mix the solubilized drug with Tween-80 and dissolve again.
2, bile: the sodium salt of bile acids, commonly used amount 0.5-1.0%. Commonly used are bovine bile, pig bile, sheep bile, etc., there are impurities, need to be processed.
However, it should be noted that the PH of the drug solution has a pH greater than 6.9 and is stable in nature. PH is less than 6.0, which reduces the solubilization effect and affects the clarity of the preparation.
3. Glycerol: It is a good solvent for enamel and phenolic components. The dosage is generally 15%-20%.
4. Other cosolvents such as organic acids and their sodium salts, amides and amines. Composite solvent system.
2. Additives to help the main drug to be suspended or emulsified
Suspension, emulsifier
(1) Suspending agents and emulsifiers should meet the following quality requirements:
1 no antigenic, non-toxic, pyrogen-free, non-irritating, non-hemolyzed;
2 heat resistant, does not fail under sterilization conditions;
3 has a high degree of dispersion and stability, with a small amount to achieve the purpose;
4 Suspension and emulsifier for intravenous injection must strictly control the particle size, generally less than 1nm, and individual particle size is not more than 5nm.
(2) commonly used suspending agents: Tween-80, Span-85, Pluronic F-68, carboxymethylcellulose, sodium alginate, polyvinylpyrrolidone, gelatin, mannitol, sorbitol, single Aluminum stearate, silicone oil, and the like.
(3) Commonly used emulsifiers: lecithin, soybean phospholipid, Pluronic F-68, oxyethylene propylene polymer, and the like.
Third, an additive to prevent oxidation of the main drug
Purpose: To prevent instability in the injection due to oxidation of the main drug.
In addition to measures such as lowering temperature, avoiding light, driving out oxygen, adjusting to a good pH value and controlling trace metal ions, the addition of antioxidants also plays an important role.
(1) Principles and dosages of commonly used antioxidants:
Principle: Antioxidants are a class of easily oxidizable reducing agents.
Sodium metabisulfite (0.1% to 0.2%), sodium hydrogen sulfite (0.1% to 0.2%), sodium sulfite (0.1% to 0.2%), sodium thiosulfate (0.1%), thiourea (0.05% to 0.1%) ), ascorbic acid (0.05% to 0.2%), and the like.
(2) Principles and dosages of common metal complexing agents:
Principle: Metal ions accelerate the oxidative decomposition of certain chemical components, causing the formulation to deteriorate. Forming a stable complex with the metal complexing agent.
The amount of disodium edetate or calcium edetate is usually 0.01% to 0.05%. In addition, sodium cyclohexanediaminetetraacetate, N-hydroxyethylenediamine triacetate and the like are also usable.
(3) Inert gas to drive off oxygen:
The high-purity inert gas N2 or CO2 is introduced into the injection water for the dosing solution or the prepared chemical solution to saturate it to drive off the dissolved oxygen. Immediately after the liquid is poured into the ampoule, N2 or CO2 is introduced to replace the oxygen in the surface of the liquid, and then sealed.
4. Additives for pH adjustment: including acids, bases and buffers.
Objective: To reduce the local irritation caused by the body, increase the stability of the liquid and accelerate the absorption of the liquid.
From the perspective of adaptability and stability of the body, the drug solution should be adjusted to a suitable pH range. Under the premise of good drug stability, the pH of the liquid is preferably about 7.4 of the normal human body pH, or between pH 7.0 and 7.6. There are only a few varieties that allow a pH between 4 and 9.
Commonly used pH adjustment additives: hydrochloric acid, sulfuric acid, citric acid, sodium hydroxide (potassium), sodium bicarbonate, disodium hydrogen phosphate, sodium dihydrogen phosphate, and the like.
5. Additives that inhibit microbial reproduction
In order to prevent contamination of the microorganisms during the manufacture and use of the injection, particularly by injections prepared by low temperature sterilization, filtration sterilization or aseptic processing, and multi-dose injections, suitable bacteriostatic agents should be added. However, the injection for intravenous or spinal injection should not be added with bacteriostatic agents; the dosage of more than 5mL of injection plus bacteriostatic agents should be particularly careful.
Bacteriostatic agents should meet the following requirements:
(l) Reliable bacteriostatic efficacy;
(2) It is not toxic to the human body;
(3) There is no contraindication to the main drug, and it does not affect the efficacy and quality check;
(4) It is stable in nature and is not susceptible to bacteriostatic effects due to temperature, pH, etc.;
(5) Does not react with the rubber stopper.
Bacteriostatic agents and dosages commonly used in injections: phenol (0.25% to 0.5%), cresol (0.25% to 0.3%), chlorocresol (0.05% to 0.2%), chlorobutanol (0.25% to 0.5%) %), phenylmercuric nitrate (0.001% to 0.002%), benzyl alcohol (1% to 3%), and parabens (about 0.1%).
6. Additives for relieving pain
In order to reduce the pain of the human body when injecting the injection, a local analgesic should be added.
Commonly used analgesics and dosage: benzyl alcohol (about 1%), procaine hydrochloride (0.5% to 2.0%), lidocaine hydrochloride (0.2% to 1.0%), chlorobutanol (0.3%) ~0.5%).
7. Additives for regulating osmotic pressure
Maintaining the osmotic pressure of plasma is not only necessary for cell survival, but also related to maintaining water balance in the body, so the osmotic pressure of the injection should be as equal as possible to plasma. A solution having the same osmotic pressure as plasma or tear is called an isotonic solution, for example, 0.9% sodium chloride solution and 5% glucose injection. Injecting a hypertonic solution, the red blood cells undergo cell atrophy due to water oozing out. However, the body has a certain regulating function on the osmotic pressure, as long as the input amount is not too large, the speed is not too fast, and no adverse effects are caused.
Therefore, intravenous infusion of 10%, 50% glucose and other hypertonic solutions is harmless.
However, a large amount of hypotonic solution is injected, which may lead to hemolysis. It must be avoided. Hemolysis occurs in 0.45% sodium chloride solution, and 0.35% sodium chloride solution can completely hemolyze.
For intraspinal injection, an isotonic solution must be used.
Common osmotic pressure regulators: glucose, sodium chloride, phosphate or citrate.
The most commonly used method for adjusting isotonicity is the freezing point reduction data method and the sodium chloride isotonic equivalent method .
(1) Freezing point reduction data method
The plasma freezing point is -0.52 ° C, and the freezing point of any solution is reduced to -0.52 ° C, which is isotonic with plasma.
For the convenience of calculation, it is expressed by the formula: W=(0.52-a)/b
In the formula, W is the percentage content (W/V) of the isotonic regulator to be added to the isotonic solution; a is the freezing point of the drug solution; b is the freezing point of the 1% solution of the isotonic regulator.
For example, the known plasma freezing point value is -0.52 ° C, the freezing point value of 1% sodium chloride is -0.58 ° C, and the freezing point value of 1% procaine solution is -0.12 ° C, then 2% procaine is pre-formulated. 100 ml of the solution should be added with ( ) sodium chloride to adjust isotonicity.
A, 0.24g B, 0.48g C, 0.68g D, 0.90g
Calculation: The amount of sodium chloride should be added W = (0.52-0.12 * 2) / 0.58 = 0.48% (g / ml), so the answer should be chosen B.
(2) Sodium chloride isotonic equivalent method
The isotonic equivalent of sodium chloride means that the isotonic effect exhibited by 1 g of the drug corresponds to the number of grams of sodium chloride, which is usually expressed by E.
For the convenience of calculation, the formula expression 1: NaCl%=0.9%-Gl*E1-G2*E2
In the formula, G1 and G2 are the percentage concentrations of the drug; and El and E2 are the isotonic equivalents of the sodium chloride of the drug.
For example: 100ml of isotonic eye drops containing horseradin containing 1% bromic acid, sodium chloride () is required (1% bromic acid and the isotonic equivalent of sodium chloride in the solution of the product is 0.17)
A 0.73 B 0.438 C 0.541 D 0.17
Calculation: sodium chloride%=0.9%-1%×0.17=0.73% should be added
0.73% × 100 = 0.73, so A should be chosen.
In the calculation formula 2: its calculation formula is: X=0.009v-EW
Wherein, X is the amount of sodium chloride to be added to the v ml isotonic solution; v is the volume (ml) of the solution; E is the isotonic equivalent of 1 g of the drug; W is the number of grams of the drug.
(3) Isotonic solution and isotonic solution
Isotonic solution: A solution of osmotic pressure equal to plasma osmotic pressure. Some isotonic solutions (boric acid, ephedrine hydrochloride, cocaine hydrochloride, ethylmorphine hydrochloride) do not keep the volume and morphology of red blood cells normal.
Isotonic solution: a solution equal to the tension of the erythrocyte membrane, the red blood cells in the isotonic solution can maintain a normal volume and shape,

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