药剂学I试卷（A卷，2007年7月）
适用对象：2003级药学(英语)专业
专业 级 班 姓名 学号
题 号 满 分 得 分 评阅人
一 10
二 20
三 10
四 10
五 10
六 10
七 12
八 18
总 分 100
一、名词解释（每题1分，共计10分）
1. Consolvency: The solubility of weak electrolytes and nonpolar molecules can be increased by the addition of water-misible solvents. This process is known as Consolvency.
2. Tincture: are alcoholic or hydroalcoholic solutions prepared from vegetable materials or from chemical substances.
3. Flocculation: particles experience attraction at significant interparticle distance and form the fluffy aggregates. 4． Isotonic solution: solutions that have the same osmotic pressure as the body
fluid.
5. Critical relative humidity: is defined as the relative humidity of the surrounding atmosphere at which the material begins to absorb moisture from the moisture, below which it will not absorb atmospheric moisture.
6. Displacement value: weight ratio of the drug substance and the base having the same volume as the drug substance.
7. Extracts (浸膏剂): traditional Chinese medicine is extracted with solvents, and the solvent is completely evaporated, getting the semisolid state or powder state substance is called extracts.
8. Pyrogen:are products of metabolism of microorganisms， endotoxins the most prevalent
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9. Sedimentation volume: is expressed by the ratio of the equivalent volume of the sediment to the total volume of the suspension. The higher, the better stability.
10. Wet gum method: also referred to as the 4:2:1 method, used to prepare emulsion. Every 4 parts by volume of oil, 2 parts of water and 1 part of gum are added in preparing the initial emulsion. Mucilage of the gum is prepared by triturating the emulsifier with water, the oil is then added slowly in portion, and the mixture is triturated to emulsify the oil. 二、填空（每空0.5分，共计20分）
1. If two surfactants with HLB values 9.0 and 12.0 respectively are blended in a 2:1 ratio, then the HLB value of the system will be (10 ).
2. Emulsion is mainly composed of (oil phase ) (aqueous phase ) and ( emulsifier ). 3. Pyrogens have the following properties, (thermostable), (filterable), (water soluble ) and (non-volatile).
4. ( Lecithin ) and ( Poloxamer 188 ) can be used emulsifiers for fat emulsions for intravenous injection.
5. When a small amount of a potent substance is to be mixed with a large amount of diluent, we should use (geometric) method.
6. Aerosol is composed of the following four parts, (product concentrate), (propellant), (valve assembly) and (Pressurized package).
7. Empty capsules are manufactured in eight various sizes, they are (000,00,0,1,2,3,4,5 ).
8. Sugar coating includes the following process, (waterproofing and sealing) if needed, (subcoating), (smooth and final rounding), (finishing and coloring) if desired and (polishing ).
9. Pyrogens can be tested with (Rabbit test) and (limulus amoebocyte lysate) method.
10. Write down the full name of the following abbreviation
HPMC(Hydropropelmethylcelluclose) GMP (Good manufacture practice ) MC(methylcelluclose ) CMC-Na(Sodium carboxymethylcelluclose ) CMS-Na(carboxymethyl starch sodium) CAP (celluclose acetate phthalate ) 11. Describe the function of the following excipients in Pharmaceutics Glycero-gelatin base (base of suppository )
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Carbopol (base for gels, suspending agent)
PVP ( binders, pore-forming agent, suspending agent, viscometer ) glycerin (solvent, wetting agent, cosolvent )
PEG (solvent, bases for ointment and suppository, water-soluble lubricant,pore-forming agent, plasticizer ) PVA (film-forming material ) Chlorobutanol ( antibacterials ) Corn oil (solvent ) MCC ( fillers, binder, disintegrant ) HPMC ( binder, suspending agent ) Sodium chloride (osmotic pressure adjustment ) 三、判断题（每题1分，共计10分）
1. Antibacterials should be added into multi-dosing injections and intravenous
injections. ( × ).
2. Normal serum osmolarity values are in the vicinity of 298 mOsm. ( √ ) 3. Phosphate buffer and boric acid buffer are commonly used to prepare ophthalmic preparations. (√ )
4. For the general tablet, it should disintegrate in 15 min, for film coated tablet, it should disintegrate in 30 min. (× )
5. For the pH adjustment of injection, it is a combination of compatibility, chemical stability and solubility. (√ )
6. After mixing two water soluble drugs, their critical relative humidity will be the
sum of their individual critical relative humidity. ( × ). 7. Suppository and ointment belong to semisolid preparation. ( × ) 8. Hard gelatin capsules are suitable for hygroscopic drugs. (× )
9. By changing the dosage form, the pharmacological response can be changed. (√ ).
10. Suspension can be used for drugs with sharp therapeutic window. ( × ) 四、单项选择题（共计10分）
1. The first Chinese Pharmacopoeia was issued in ( D )
A. 1949 B. 1950 C. 1952 D. 1953 E. 1957 2. Dosage form can’t be classified according to ( B )
A．Administration route B．Formulation C．Dispersing system
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D．Preparation method
3．The function of tragacanth(西黄蓍胶) in suspension is ( A ）
A. Suspending agent B. Diluent C. Wetting agent D. Flocculating agent E. deflocculating agent
4.According to Chinese Pharmacopoeia, water for injection should be（D ） A.pure water B.distilled water C.deionized water D.Redistilled water E.Ultrapure water 5. pH of injection should be in the range of ( B） A.4～11 B.4～9 C.2～9 D.3～8 E.5～8
6. In the quality requirement of ophthalmic drops, which one is different from that of injection?（ D ）
A. pH B. Osmotic pressure C. Sterility D. Pyrogen E. clarity 7．Which of the following tablet can bypass the hepatic metabolism?（C ） A．Effervescent tablet B．Dispersing tablet C．Sublingual tablet D．Solution tablet E．Chewable tablet
8．In vitro parameter reflecting the in vivo absorption of water-insoluble drugs is（B）
A．Disintegration time B．Dissolution rate C．Friability D．Weight variation E．Hardness
9．Which of the following belongs to two-phase aerosol（ A ）
A．Solution aerosol B．O／W emulsion aerosol C．W／O emulsion aerosol D．Suspending aerosol E．W／O/ W emulsion aerosol
10．The biggest difference between general ointment and ophthalmic ointment is（ A ）
A. Type of base B. Sterility C. Preparation method D. Appearance 五、多选题（每题两分，共计10分）
1．Which of the following belongs to water-soluble bases of ointment：（ B D ） A.Stearly alcohol B.PEG C. Starch D.CMC-Na
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2．Which of the following excipients can be used for direct compression（BCDE ）
A．EC B．Spray dried lactose C．MCC D．Modified starch E．Dicalcium phosphate 3．Which of the following can be used as binders of tablets (CD ）
A．Dry starch B．Talc C． Syrup D．Starch mucilage E．Aerosol 4. Physicochemical properties measurement of sterile powder injections include
（BDE ）
A.Thermal stability B.CRH C.Rheology
D.Powder crystalline E.Bulk density of the powder 5．Sources of pyrogen contamination include（ ABCDE ） A．Solvent B.Medicament C. Containers and equipment D．In the preparation process E.Infusion device
六、计算题（共计10分）
1. To prepare 100 ml 2% Morphine hydrochloride solution, how much sodium chloride is required to make the solution isotonic ( for Morphine hydrochloride, the freezing point of 1% solution 0.086; b=0.58 for NaCl). ( 5分)
w=(0.52-2*0.086)/0.58=0.6g
2．The weight of a blank base suppository is 3.0g，the weight of suppository containing 70％ active drug is 5.3g. Now we need to preparing suppositories containing 500 mg active drug in each suppository, please write out the formulation for 1000 suppository.
DV＝5.3×70%/(3.0-5.3×30%)=2.63
drug：500×1000=500g
base：（3.0-0.5/2.63）×1000=2809.89 g
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七、处方题（共计12分）
Analyze the following preparation, indicating which dosage form it belongs to and the function of each ingredient in the formation. In addition, describe the preparation process.
1．Vitamin C 104 g active drug substance EDTA 0.05 g chelator NaHCO3 49 g pH adjuster NaHSO3 2 g antioxidant Water for injection to make 1000 ml solvent
EDTA
Vc dissolved in water + add NaHCO3 slowly NaHSO3
adjust the pH to the accurate volume solution filtered transferred to the final container and sealed sterilization Quality control
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2． Loratadine(氯雷他定) 1 g
Corn starch 30 g filler Lactose 25 g filler 10% starch mucilage q.s. binder L-HPC 3 g disintegrant Talc 2 g glidant Magnesium stearate 0.5g lubricant Preparation process:
Loratadine + corn starch + lactose homogeneously mixed add 10% starch mucilage preparing damp mass screening the damp mass into granules drying the granules sizing the granules by dry screening Adding L-HPC, Talc and magnesium stearate and blending forming tablets by compression.
八、简答题（共计18分）
1. Describe factors influencing drug absorption from rectal suppositories. (4分)
Physicological factors:
¾ Colonic content ¾ Circulation route: 2cm
¾ pH and lack of buffering capacity of the rectal fluids Physicochemcial factors of the drug and suppository base
¾ Lipid-water solubility ¾ Particle size ¾ Nature of the base
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2. Which liquid contents can’t be filled in soft gelatin capsules.( 4分) ¾ Water cannot exceed 5% ¾ pH must be between 2.5 and 7.5
¾ low molecular weight water soluble and volatile compounds must be excluded ¾ aldehydes must be excluded
¾ strong acids, strong based, salts of strong acid or bases may hydrolyze gelatin ¾ Emulsions
¾ Contents must flow under gravity at <35 degrees
3. Describe the advantages of tablet film coating （ In English） ( 5分)
¾ Place a thin, skin-tight coating of a plasticlike material over the compressed
tablet
¾ Having essentially the same weight, shape and size as the originally compressed tablet
¾ The coating is thin enough to reveal any identifying compression by the tablet
punches
¾ Far more resistant to destruction by abrasion than are sugarcoated tablets.
4. Describe the factors influencing the mixing process.( In English) (5 分)
¾ Components ratio ¾ Density
¾ Cohesion and charge
¾ Containing liquid or hygroscopic components
Adsorbents
Hygroscopic components
Containing crystal water: use anhydrous substitute Highly hygroscopic: operate under CRH
Hydroscopic after mixing: Packed individually
¾ Containing eutectic mixtures
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