Investigation of drug storage

I. Summary:

Objective: To investigate the storage of drugs, including raw materials, powders, tablets, capsules, injections, liquid drugs and drugs for external use.

Methods: The methods and measures of drug storage in pharmacies and drug wholesale enterprises were investigated.

Results: Through investigation, I have mastered the necessary knowledge of drug storage.

Conclusion: Through investigation and analysis, we have a deeper understanding of the storage principle of some special drugs.

Key words: API, powder, tablet, capsule, injection, liquid medicine, external medicine.

Second, the investigation part:

We have completed our study and life in the Medical Device School for nearly four years, and gradually stepped into the social and pharmaceutical industries, facing a new starting point. Just a few months of internship life, let me understand a lot of truth, but also gradually adapt to the society! In practice, I learned some new medical knowledge that books can't. Based on professional theory, combined with the actual situation, deepen the flexible use and understanding of book knowledge. Constantly deepen the impression and understanding.

I investigated the situation of drug storage and nursing during my internship. In order to better apply the knowledge learned in future work. Below I will explain in detail the contents of my investigation and what I know.

Respondents:

The pharmacies we investigated on the spot were Yangxintang Pharmacy, Deweizhi Pharmacy and two Tongrentang pharmacies.

Drugs are special commodities used to prevent, treat and diagnose diseases and help the body to restore normal physiological functions. Therefore, we should pay more attention to its storage.

First of all, we should understand the usual manifestations of factors that lead to qualitative change of drug quality: physical change, chemical change and biological change.

Physical changes are color, hygroscopicity, crystallization, smell, taste, solubility, boiling point, condensation point, refractive index, specific rotation and so on.

Chemical change is the property that drugs react with light, heat, temperature and other factors or with other substances.

Biological changes are influenced by external factors such as temperature, humidity and time, and microorganisms proudly grow and multiply, leading to mildew, corruption or rot.

2. 1 product stability factor; Including internal factors and external factors;

1, the internal factors affecting the change of drug quality are:

Composition, chemical structure and dosage form of drugs.

The components of drugs can be divided into organic components and inorganic components according to chemical components. Organic components are easy to change and difficult to preserve, such as compound acetylsalicylic acid, phenacetin, caffeine, etc. Among them, compound acetylsalicylic acid is the main component, and its stability directly affects the compound preparation. Most inorganic drugs are relatively stable. Chemical structure is the main factor that determines the stability of drugs. For example, barium sulfate is a stable salt, insoluble in water and organic solvents. It is also insoluble in acid and alkali. It has good stability and will not deteriorate after being stored for several years. The stability of drugs is also related to the dosage form. The drug stability of different dosage forms of the same component is different. For example, chloramphenicol is chemically stable and can be stored for several years in dry state, so raw materials, tablets and capsules have no expiration date. However, it is unstable in water solvent, easy to hydrolyze and lose its antibacterial effect, and its color turns yellow to brown, so the validity period of injections and eye drops is stipulated.

2. The external factors affecting the change of drug quality are:

Air, light, temperature, humidity, insects and microorganisms, time, packaging.

(1) Air is a mixture of different gases, and its main components are nitrogen (78.09%), oxygen (20 .09%), carbon dioxide (0.03%), rare gases such as He-Ne-Krypton (0.93%) and water vapor, hydrogen chloride and ammonia. Except nitrogen and inert gas, these gases can make drugs deteriorate, among which oxygen and carbon dioxide have the greatest influence on drugs.

(2) Various drugs have different sensitivities to light, and the effects of light on drugs are mainly manifested in discoloration, decomposition and oxidation.

(3) Temperature has a great influence on drug storage. Too high or too low temperature will promote the deterioration and failure of drugs. Especially biological products, organ preparations, antibiotics, etc. There are stricter temperature requirements.

(4) Humidity The water vapor content in the air is called humidity, which is the most volatile part in the air. It fluctuates with different regions, temperature differences and climate changes. The greater the water vapor in the air, the greater the humidity, the smaller the water vapor, and the smaller the humidity. Humidity also has a great influence on the quality of drugs. Excessive humidity can make drugs absorb moisture, causing deliquescence, dilution, hydrolysis, deformation and mildew. If the humidity is too low, the medicine will be weathered.

(1) deliquescence: Expose water-soluble drugs to humid air, absorb moisture in the air, and make some of them liquid, such as calcium chloride, sodium bromide, chloral hydrate, sodium citrate, etc., which are easy to be wet and deliquescent.

Diluent: Generally, it is liquid medicine with water absorption, such as glycerol, lactic acid, anhydrous ethanol syrup, etc.

③ Hydrolysis: Some drugs can decompose and deteriorate after absorbing water. For example, aspirin absorbs water and hydrolyzes into acetic acid and salicylic acid, which is irritating to the stomach; After low tide, sodium bicarbonate is slowly decomposed into sodium carbonate, which enhances the alkalinity; Penicillin is hydrolyzed by water to produce penicillaldehyde and penicillamine, which is ineffective.

(4) Deformation: the change of physical form caused by drug moisture absorption. Such as: tablets, pills, after being wetted, fragments generated by expansion agent of disintegrant; Sugar-coated tablets absorb moisture and dissolve adhesion. Capsule will stick soft and deform when it is wet; Glycerol suppository becomes opaque when it is wet, and it can soften and deform when it absorbs too much water.

⑤ Weathering: Some drugs are easily weathered. For example, blue crystalline copper sulfate is white powder after weathering; Some are difficult to detect, for example, quinine sulfate contains decahydrate crystal water, which is white powder whether it loses water or not. The weathering of drugs does not affect the efficacy, but the content after dehydration is uncertain, so it is difficult to master the dose, especially for highly toxic drugs, which can easily exceed the safe dose and lead to medical accidents.

(5) Insects and microorganisms

Drugs are exposed to air, microorganisms (bacteria, molds, yeasts), insects, mites, etc. It is easy to be invaded. Their invasive reproduction is an important factor in the quality change of drugs such as corruption and fermentation. Especially water preparations or preparations containing nutritional ingredients (such as starch, sugar, protein, oil and crude drugs), such as water preparations, syrups, tablets, organ preparations and Chinese herbal medicines. It is more prone to mildew, pollution and moth-eaten. The air humidity is too high, the temperature is too high and the temperature is suitable, which is beneficial to the growth and reproduction of microorganisms.

Contaminated drugs and oral liquids include Escherichia coli and live mites. Topical drugs are contaminated by Pseudomonas aeruginosa and Staphylococcus aureus.

(6) Time

Time is also an important external factor affecting the stability of drugs. Due to the changes of drugs themselves and storage environment, various drugs, such as antibiotics, biological products, organ preparations and some chemicals, have a certain period of validity. Even if the storage conditions are suitable, after the expiration, the sales price often decreases or even the toxicity increases.

(7) Packaging also has a certain effect on drug quality.

The packaging of drugs is divided into inner packaging and outer packaging.

Containers with inner packaging for directly containing drugs, such as glass bottles, plastic bottles, cartilage tubes, cartons, kraft paper, tin cans, etc. Also comprises a bottle cap, a bottle stopper, a label and a filler in the bottle.

Outer packaging is packaging other than inner packaging, such as wooden cases, fiberboard boxes, cartons, wooden barrels, metal barrels, linen, cloth bags, etc.

2.2 Investigation methods: According to the nature of different drugs, classified investigation was conducted.

2.2. 1 APIs and powders:

1. Raw materials are mainly used to prepare various preparations.

(1) API can be divided into:

① Inorganic drugs: such as sodium chloride, magnesium oxide, sodium bicarbonate, potassium iodide, ferrous sulfate, potassium permanganate and calcium chloride.

② Organic drugs: such as salicylic acid, aspirin, metamizole, phenobarbital, glucose, sulfadiazine and atropine sulfate.

(3) Crude drugs: such as digitalis leaf powder.

④ biochemical drugs and others: including biochemical drugs, antibiotics, hormones and biological products, such as pepsin, tetracycline, insulin, γ -autumn protein and other drugs.

(2) The quality variation of APIs may occur during storage: moisture absorption, weathering, discoloration, off-flavor, odor, volatilization, mildew, moth-eaten, and titer loss.

2 Storage and maintenance of raw materials:

(1) Drugs requiring strict preservation:

(1) All moisture-absorbing and moldy drugs:

For example, aspirin and sodium bicarbonate are easy to absorb water and hydrolyze; Glucose absorbs moisture and is prone to mildew; Sodium bromide, calcium chloride and easily absorbed water; Glycerol can absorb water molecules and be diluted; The adsorption capacity of medicinal carbon decreased after moisture absorption; Protein and ammonium ferric citrate absorb moisture, adhere and agglomerate. This medicine needs to be sealed and stored in a dry place.

② Weathering drugs:

Such as magnesium sulfate, sodium sulfate, borax, caffeine, etc. It is easily weathered, so it should be sealed and stored in an excessively dry and ventilated place. When the temperature of sodium sulfate is high, it will melt even if it is sealed, so it should be stored in a cool place.

③ Drugs that are easily oxidized and deteriorated by air:

Such as: ferrous sulfate, sodium salicylate, epinephrine, vitamin C and so on. It is easy to oxidize and discolor. Such drugs should be tightly packed to avoid contact with air.

④ Drugs easy to absorb carbon dioxide:

Such as zinc oxide, magnesium oxide, aminophylline, sulfanilamide sodium salt, etc. All of them absorb carbon dioxide, which will deteriorate when exposed to air. When stored, they should be tightly packed to avoid contact with air.

(5) Volatile drugs:

Such as menthol, camphor, iodine, iodoform, volatile oil, etc. Rising temperature can accelerate volatilization and reduce dosage. These drugs should be stored in a closed and cool place.

⑥ Antibiotics: Most of these drugs have an expiration date. The dried products are generally stable at room temperature, but they are easy to decompose and fail after absorbing moisture and heating. This medicine should be stored in a dry, cool and dark place. And pay attention to the deadline, "first production first out, first out in the near future"

⑦ Biochemical products, crude drug preparations and drugs containing nutrients.

Such as: pepsin, thyroid powder, dry yeast, gentian powder, malt powder, starch, etc. , susceptible to temperature, light, moisture and microorganisms. And cause the destruction or smell of mold, insects and effective components. Pay attention to put it in a cool place and avoid light.

(2) Drugs that need to be stored away from light: drugs that are easy to deteriorate when exposed to light, such as sulfonamides, calomel, silver nitrate, aminopyrine, procaine hydrochloride, volatile oil, etc., are easy to change color when exposed to light, and even their toxicity increases. Pay attention to seal in a cool place when storing. Keep away from light.

(3) Drugs stored in isolation:

Drugs that need special storage, such as iodine, iodoform, menthol, peppermint oil, etc., have special smells. Should be stored separately from other drugs, especially adsorption drugs, such as medicinal carbon, starch, glucose, lactose, talcum powder, clay and so on.

2. Powder:

(1) quality change of powder;

Moisture absorption, discoloration, mildew, moth-eaten, odor, volatilization, stratification, microbial pollution.

(2) Temperature, humidity, light, air and microorganisms all have effects on the powder during storage. Pay attention to moisture.

tablet

1, quality difference of tablets:

Slow disintegration, fragmentation, burr, pockmark, lace, shadow, foreign body spots, discoloration, crystallization, mildew, moth-eaten, adhesion and dissolution, bacterial infection.

2. Quality difference of coated tablets:

Fading, mottling or uneven color, cracking and bursting, swelling, shelling, edge grinding, edge leakage, unevenness, dull single side, solution adhesion and mildew, discoloration of tablet core, and difficult disintegration.

Generally speaking, after absorbing water, the tablet may become loose, broken and moldy. Pay attention to seal it and put it in a dry place. The coated tablets are easy to absorb moisture, and the faded coating should be sealed and stored.

2.2.3. Capsule:

Capsules can be divided into hard capsules and soft capsules.

1, quality difference of capsules:

Powder leakage, oil leakage, sticky deformation, mildew, moth-eaten.

2. General capsules should be sealed and placed in a dry place, and pay attention to moisture and heat protection. Not easy to over-dry, and avoid capsule shell brittle fracture. Color capsules can appear uneven color, fading, discoloration and other phenomena after absorbing moisture and heating. Capsules containing crude drugs and organ preparations, such as Ribolone Capsule, Compound Bao Bei Capsule, Royal Jelly Capsule, etc., are prone to mildew and insects after heating. Antibiotic capsules, such as oxacillin sodium capsules, sodium ethoxine capsules, oxytetracycline capsules, etc. The potency decreases after moisture absorption and heating, so this medicine has a "expiration date".

2.2.4 Injection:

1, quality change of injection:

Discoloration, mildew, crystallization or precipitation, peeling, white spots and caking, freezing

2 injections should be stored according to the physical and chemical properties of drugs and the characteristics of solvents and packaging materials.

(1) General injections should be stored away from light and meet the conditions specified in the Pharmacopoeia.

(2) Injections that deteriorate easily when exposed to light, such as epinephrine, chlorpromazine hydrochloride, sodium p-aminosalicylate, and compound quinine vitamins. Pay attention to shading.

(3) Injections that are easily deteriorated by heat.

2.2.5 Liquid medicine:

1, quality change of water-based agent:

Forming, precipitation, discoloration and icing

2. According to its characteristics, the aqueous solution shall be stored in an appropriate way:

(1) Aromatic water agent: It should be sealed in winter to prevent freezing.

(2) Solution: Some special drugs should be stored in isolation.

(3) Mixed liquid: sealed, stored in a cool and dark place, and protected from freezing in winter.

(4) Emulsion: This kind of preparation is unstable, sealed, stored in a cool and dark place, and antifreeze in winter. Keep it below 300 degrees Celsius.

(5) Eye drops: sealed and stored in a cool and dark place to prevent failure.

3. The quality change of syrup:

Moldy, precipitate, discoloration

The general storage method of syrup is to seal it below 300 degrees Celsius.

4. Quality change of ethanol preparation:

Tincture and bleeding ointment will precipitate, change color, and the titer and content will decrease. An elixir, a reagent containing ethanol.

Storage: heat-resistant volatilization, fire prevention, light protection, long-term storage deterioration and antifreeze.

5. Quality change of oil agent:

6, vegetable oil rancidity and drying, volatile oil volatile oxidation.

Storage: oil will deteriorate when exposed to light and heat, and it should be filled with a dense plug when filling. Pay attention to keep warm in cold areas.

2.2.6 Drugs for external use

1, ointment:

Quality change of ointment:

Rancidity, oil flow, hardening, separation, discoloration and deterioration.

Storage: sealed and stored below 300℃ to prevent freezing and heating.

2. Suppositories:

Quality difference of suppositories;

Softening deformation, sweating, dryness, opaque appearance and corruption.

Storage: It should be stored in a dry and cool place below 25℃ to prevent microbial infection. Suppositories that are easy to melt when heated and discolor when exposed to light should be sealed and stored in a cool place.

3. Aerosol:

Storage: Keep away from light and heat, and keep in a cool place. Avoid direct sunlight.

Three. Conclusion:

When drugs are produced from pharmaceutical factories and reach consumers, they have to go through certain circulation channels and fields, that is, drug management links, so drug storage has become an inevitable form of drug circulation. During this period, drugs will be in a corresponding stagnant state, that is, drugs will be stored, so it is a science. As a person who has just entered the society, it is necessary to master the most basic storage knowledge of these drugs, so I will investigate the most basic preservation and maintenance of some drugs.

April 28(th), 2003

Confirm:

My mentor. With his careful help and guidance, I successfully completed this graduation thesis. Thank you!

References: 96th Edition of Drug Inspection and Preservation Editor: Liao Yuemei —— Tianjin Science and Technology Press.