أقراص هي أشكال جرعات صلبة يتم تصنيعها عن طريق خلط الأدوية بشكل موحد مع سواغات مناسبة وضغطها في مستحضرات صلبة مسطحة أو غير منتظمة الشكل. وهي تشير عمومًا إلى أقراص مستديرة أو ذات أشكال أخرى بدون طلاء سكر, ويمكن أيضًا تحويلها إلى أنواع مختلفة من الأجهزة اللوحية, مثل الأقراص القابلة للتشتت, أقراص الإصدار المستدام, أقراص الإفراج الخاضعة للرقابة, أقراص متعددة الطبقات, أقراص مغلفة معوية, أقراص قابلة للمضغ, وأقراص الشدق. كبسولات, على الجانب الآخر, هي أشكال جرعات صلبة مملوءة بالأدوية أو السواغات في كبسولة مجوفة أو محكمة الغلق في غلاف ناعم, مع شكل بيضاوي في كلا الطرفين, والتي يمكن أن تحتوي على سائل, هلام, أو مسحوق المخدرات في الداخل.
عادة ما تكون الأقراص مستديرة, بينما تكون الكبسولات في الغالب بيضاوية الشكل عند كلا الطرفين, وقد تختلف أيضًا في الحجم, اعتمادا على جرعة الدواء ومتطلبات الصياغة. من حيث الهيكل الداخلي, يتم تصنيع الأقراص بالضغط المباشر على مسحوق أو حبيبات الدواء, بينما تضع الكبسولات الدواء داخل غلاف صالح للأكل. بالإضافة إلى ذلك, في حين أن كلاهما يمكن أن يحقق إطلاقًا بطيئًا للدواء, تتمتع الكبسولات بميزة نسبية في إطلاق الدواء في الوقت المناسب والمستهدف. على سبيل المثال, يمكن أن تضمن الكبسولات المغلفة معويًا إطلاق الدواء في الأمعاء, تقليل تحفيز الدواء على المعدة; بعض الأقراص الخاصة, مثل الأقراص المعوية, لها وظائف مماثلة, لكن الهيكل العام للكبسولات يوفر حماية أفضل لمثل هذا الإطلاق المستهدف.
تتضمن العملية الرئيسية للأقراص خلط الأدوية مع السواغات ثم ضغطها مباشرة, مع الأخذ في الاعتبار عوامل مثل قابلية انضغاط الدواء وتدفقه لضمان جودة الأقراص. على سبيل المثال, يؤثر الضغط أثناء عملية الضغط على صلابة الأقراص وزمن التفكك. يتضمن تحضير الكبسولات تعبئة الكبسولات الصلبة (خلط الأدوية مع السواغات بشكل موحد, تحويلها إلى مساحيق, حبيبات, أقراص صغيرة, أو حبوب صغيرة, وتعبئتها في كبسولات مجوفة) أو تحضير كبسولات ناعمة (ختم كمية معينة من الأدوية السائلة مباشرة, أو إذابة أو تشتيت الأدوية الصلبة في سواغات مناسبة لتحضير المحاليل, تعليق, أو المستحلبات, ومن ثم ختمها في قذائف ناعمة). جودة القشرة عالية, مثل الجيلاتين باعتباره المادة الخام الرئيسية للكبسولات الفارغة, ومن الضروري أيضًا التفكير في استخدام الملدنات, حاصرات الضوء, تلوينات, المواد الحافظة, وغيرها من الإضافات, والتحكم في مواصفات الكبسولات الفارغة (هناك 8 أنواع, 000, 00, 0, 1, 2, 3, 4, 5, شائعة الاستخدام 0-5), طول, سماكة, محتوى الماء, الحد الزمني للحل, بقايا بعد التكليس, الفحص الميكروبي, وغيرها من مؤشرات الجودة.
إخفاء روائح المخدرات الكريهة وتعزيز الاستقرار
يمكن لقشرة الكبسولة تغليف الدواء بشكل فعال, توفير حماية جيدة للأدوية ذات الروائح الكريهة أو تلك التي تتأثر بسهولة بالبيئة الخارجية (مثل الهواء, ضوء, رُطُوبَة, إلخ.) وتتدهور. على سبيل المثال, بعض كبسولات زيت السمك لها رائحة مريبة خاصة. إذا تم تحويلها إلى أقراص, قد تؤثر الرائحة على امتثال المريض بسبب انتشار الرائحة, بينما يمكن لقشرة الكبسولة أن تغطي هذه الرائحة بشكل فعال. في نفس الوقت, يمكن لقذيفة الكبسولة أن تمنع دخول الرطوبة الخارجية والأكسجين, protecting the stability of the drug components. Some drugs that are sensitive to oxygen can be better preserved under the protection of the capsule.
Improving Drug Bioavailability and Rapid Efficacy
Drugs in capsules, especially those that are more easily absorbed in liquid or soft states, may have higher bioavailability compared to some tablets. When the capsule enters the body, the shell dissolves quickly, and the drug inside can disperse and dissolve rapidly, thus being absorbed by the human body. على سبيل المثال, some drugs that are insoluble in water can be made into capsules by dissolving the drug in an appropriate oil and filling it into a soft capsule, which can improve the solubility and absorption rate of the drug, and may work faster than tablets.
Timed and Targeted Drug Release
Capsules can achieve timed and targeted drug release. على سبيل المثال, enteric-coated capsules have a specially designed shell that can resist the erosion of gastric acid and will only dissolve and release the drug when it enters the alkaline environment of the intestines. This is very important for drugs that can only better exert their efficacy in the intestines or are irritating to the stomach, such as some antibiotics or enzyme drugs. Making them into enteric-coated capsules can ensure that the drug works in the intestines, avoid damage to the gastric mucosa, and improve the therapeutic effect of the drug.
Solidification of Liquid Drugs
For some drugs that are liquid in nature, capsules can transform them into solid form, which is convenient for storage, transportation, and administration. على سبيل المثال, some drugs containing fats or essential oils of traditional Chinese medicine, when made into soft capsules, not only facilitate patient administration but also ensure accurate drug dosing and improve drug stability.
Accurate Dosing and Stable Quality
During the production process of tablets, precise molds can ensure uniform drug content in each tablet, with accurate dosing. علاوة على ذلك, since tablets are solid and have a relatively dense structure, they are less affected by external air, ضوء, رُطُوبَة, إلخ., especially those with coatings, such as sugar-coated tablets and film-coated tablets. The coating layer can further protect the drug from external environmental interference, making the drug quality more stable and less likely to deteriorate during storage and transportation.
High Production Efficiency and Low Cost
عملية إنتاج الأجهزة اللوحية ناضجة نسبيًا ومناسبة للإنتاج الصناعي على نطاق واسع. من خلال معدات الضغط الآلية والآلية, يمكن إنتاج عدد كبير من الأجهزة اللوحية بسرعة وكفاءة. علاوة على ذلك, نظرًا لأن عملية الإنتاج لا تتطلب مواد الصدفة الخاصة مثل الكبسولات, تكاليف المواد الخام واستثمار معدات الإنتاج منخفضة نسبيًا. هذا أيضًا يجعل سعر الأجهزة اللوحية أرخص في كثير من الأحيان من الكبسولات, التي يمكن أن تلبي احتياجات الأدوية الواسعة النطاق ولديها مزايا معينة في تخصيص الموارد الطبية.
يمكن تحويلها إلى أنواع مختلفة لتلبية الاحتياجات المختلفة
يمكن تحويل الأجهزة اللوحية إلى أنواع مختلفة وفقًا لاحتياجات علاجية مختلفة. على سبيل المثال, يمكن أن تذوب أقراص مشتتة بسرعة في الماء, suitable for patients with difficulty swallowing or those who need rapid effects; sustained-release tablets and controlled-release tablets can slowly release drugs, maintaining a stable blood drug concentration in the body, reducing the number of doses, and improving patient compliance; chewable tablets are suitable for children or the elderly with poor swallowing function, which can be chewed in the mouth before administration, and the taste is relatively good; buccal tablets are mainly used for local treatment in the oral cavity, such as relieving throat pain.
Limited Range of Applicable Drugs
Not all drugs are suitable for making into capsules. على سبيل المثال, soluble drugs (such as iodides, bromides, إلخ.), deliquescent drugs, and hygroscopic drugs are not suitable for making into capsules. If soluble drugs are made into capsules, they may dissolve a lot in the shell before the capsule shell is completely dissolved, affecting the normal release and efficacy of the drug; deliquescent drugs lose crystalline water during storage, which may change the properties of the drug and also affect the stability of the capsule shell; hygroscopic drugs easily absorb moisture from the air, which may soften, deform, or even damage the capsule shell, thus affecting the quality and stability of the drug.
High Storage Requirements
The shell of the capsule is prone to mold and softening in high temperature and humidity environments. If the storage environment is improper, such as in places with high humidity or high temperature, the capsule shell may be affected, which in turn affects the quality of the drug. على سبيل المثال, during the plum rain season in the south, if the capsules are not properly stored, they are easy to mold, and such capsules, once taken, may pose a risk to health. لذلك, capsules need to be stored in a dry, cool environment, and attention should be paid to moisture-proof and mildew-proof.
May Be Slower in Efficacy
Compared to capsules, the drug release speed of some tablets may be slower. Especially for ordinary tablets without special designs (such as not being dispersible tablets, rapid-release tablets, إلخ.), the drug needs to undergo disintegration and dissolution in the body before it can be absorbed, which may take longer than the dissolution and absorption process of capsules. لذلك, in situations where rapid efficacy is needed, tablets may not be as suitable as capsules. على سبيل المثال, in the treatment of acute pain, if ordinary tablets are used, it may take a longer time to feel the effect of the drug, while drugs in capsule form may work faster.
May Irritate the Gastrointestinal Tract
Some tablets, after disintegrating in the stomach, directly contact the gastric mucosa with the drug. For drugs that are irritating to the gastric mucosa, they may cause gastrointestinal discomfort, such as nausea, vomiting, stomach pain, and other symptoms. Although there are special types of tablets like enteric-coated tablets that can reduce gastric irritation, not all tablets have this protective measure. In comparison, كبسولات (especially enteric-coated capsules) can avoid gastric irritation by releasing the drug in the intestines.
Shape Characteristics
Tablets are generally round or other regular shapes (such as oval, triangular, إلخ.), and their shapes are relatively regular and flat. Capsules are usually oval-shaped at both ends, looking more like a small ellipsoid, with a certain sense of three-dimensionality. This difference in shape makes them easy to distinguish in appearance. على سبيل المثال, common aspirin tablets are round white tablets, while some fish oil capsules are typical oval capsules.
Size and Weight
In terms of size and weight, there is no fixed rule that capsules are definitely larger or smaller, heavier or lighter than tablets. This depends on specific factors such as drug dosage, the use of excipients, and formulation design requirements. على سبيل المثال, some high-dose drugs may be made into larger tablets or capsules; similarly, to facilitate patient administration, some low-dose drugs may also be made into relatively small tablets or capsules. لكن, generally speaking, since the capsule shell itself has a certain thickness, the same dose of drug, if made into a capsule, may be slightly larger than a tablet.
State of Drug Components
Tablets mainly press the drug into powder or granule form, and the drug components inside the tablet are relatively dense solid states. The drugs inside the capsule can be powders, حبيبات, أو السوائل, gels, إلخ. على سبيل المثال, soft capsules often contain liquid drugs, such as some vitamin E soft capsules, which are liquid vitamin E inside; while hard capsules may contain powdered or small granule drugs, such as some cold capsules, which are a mixture of various powdered drug components inside.
Drug Release Mechanism
The drug release of tablets mainly depends on the disintegration and dissolution process in the body. When the tablet enters the gastrointestinal tract, under the action of digestive juices, the tablet gradually disintegrates into small particles, and then the drug components dissolve from these small particles and are absorbed by the gastrointestinal tract. Different types of tablets will have different disintegration and dissolution speeds, such as dispersible tablets that can dissolve quickly in water, while ordinary tablets require a certain amount of time. The drug release of capsules is first dissolved by the shell, and then the drug (whether it is powder, حبيبات, سائل, or gel) inside quickly disperses and dissolves. For enteric-coated capsules, لن يذوب القشرة في المعدة حتى تدخل بيئة محددة للأمعاء ثم يذوب الدواء ويطلقه. يمكن أن تحقق آلية الإفراج الخاصة هذه الإفراج عن المخدرات المستهدفة.
تعقيد عملية الإنتاج
عملية إنتاج الأجهزة اللوحية هي أساسا خلط وضغط الأدوية والسواغات. هذه العملية مباشرة نسبيا, مع التركيز على السيطرة على توحيد خلط الأدوية والسواغ, ضغط الضغط, سمك الجهاز اللوحي, وغيرها من المعلمات. عملية إنتاج الكبسولات أكثر تعقيدًا نسبيًا. للكبسولات الصلبة, كبسولات فارغة تحتاج إلى الاستعداد أولاً (بما في ذلك خطوات مثل تحضير SOL, غمس, تجفيف, شل السحب, قطع, والفرز), ثم يتم ملء المسحوق أو الحبيبات المصنوعة عن طريق خلط الأدوية والسواغات في كبسولات فارغة; للكبسولات الناعمة, الدواء مصنوع في حل, تعليق, أو مستحلب ثم مغلق في قذيفة ناعمة, الذي يتضمن المزيد من العمليات والمتطلبات الفنية. على سبيل المثال, تتطلب عملية صنع الإسقاط أو الضغط على الكبسولات الناعمة تحكمًا دقيقًا.
الاختلافات في تكاليف الإنتاج
نظرًا لأن عملية إنتاج الأجهزة اللوحية بسيطة نسبيًا ولا تتطلب مواد قذيفة خاصة مثل الكبسولات, غالبًا ما تكون تكلفة الإنتاج أقل. معدات الإنتاج للأجهزة اللوحية شائعة نسبيًا, ويمكن إنتاج عدد كبير من الأجهزة اللوحية بسرعة من خلال معدات الضغط الفعالة أثناء الإنتاج على نطاق واسع, كما أن تكلفة السواغات للأجهزة اللوحية منخفضة نسبيًا. The production cost of capsules is relatively high, mainly because the production of empty capsules requires certain raw materials (such as gelatin, إلخ.) and process costs, and the filling or soft capsule production process of capsules also requires specific equipment and technology, which will increase the production cost of capsules.
Ease of Swallowing
For some patients, capsules may be easier to swallow than tablets. The shape of capsules is relatively round and smooth, and they may pass through the throat more smoothly during swallowing. Some larger tablets or irregularly shaped tablets may cause discomfort during swallowing and may even get stuck in the throat. لكن, some patients may find tablets easier to swallow, which may be related to individual swallowing habits. على سبيل المثال, some elderly or children may find capsules too large to swallow, while adults who are used to swallowing drugs whole may have a higher acceptance of tablets.
Differences in Taste
Tablets usually do not have a special taste, and some tablets may have a bitter or strange taste due to the taste of the drug itself or the taste of the excipients. If there is no coating protection, this taste may be more pronounced. كبسولات, due to the wrapping of the shell, basically do not feel the taste of the drug in the mouth until the capsule dissolves in the gastrointestinal tract and releases the taste of the drug, so in terms of taste, they may be better than some uncoated tablets.
For drugs with high stability requirements
If drugs are easily affected by the external environment (مثل الهواء, ضوء, رُطُوبَة, إلخ.) وتتدهور, capsules often have an advantage. على سبيل المثال, some drugs that are sensitive to oxygen or easily absorb moisture, the shell of the capsule can provide better protection, preventing the drug from contacting the external environment, thus maintaining the stability of the drug. Although tablets can also improve stability through coating and other methods, for drugs with extremely high stability requirements, the protective effect of capsules may be better.
For drugs with poor solubility
For drugs that are difficult to dissolve in water or have poor solubility in specific solvents, capsules may be a better choice. If these drugs are made into capsules, their solubility and bioavailability can be improved by dissolving the drugs in appropriate oils and filling them into soft capsules. For tablets with poor solubility drugs, without special formulation designs (such as making into dispersible tablets, إلخ.), it may affect the absorption and efficacy of the drug.
When rapid efficacy is needed
When rapid drug efficacy is needed, such as in the treatment of acute pain, acute infections, and other diseases, capsules may be more suitable. Because the drugs in capsules may dissolve and absorb faster in the body, especially those liquid or soft-state drugs in capsules, once the shell dissolves, the drug can quickly disperse and be absorbed. Ordinary tablets may require a longer disintegration and dissolution time, resulting in slower efficacy.
When stable blood drug concentration is needed
In the treatment of some chronic diseases, it is necessary to maintain a stable blood drug concentration. At this time, special types of tablets such as sustained-release tablets or controlled-release tablets have advantages. These tablets can slowly and continuously release drugs, keeping the blood drug concentration in the body at a relatively stable level, reducing the number of doses, and improving patient compliance. Although capsules can also achieve sustained and controlled release through special formulation designs, tablets have more mature and diverse technologies in this regard.
Mass production needs
If there is a need for mass production of drugs, the production process of tablets is more suitable. The production equipment for tablets is relatively simple and efficient, and a large number of products can be produced quickly. علاوة على ذلك, the cost of tablets is lower, which can meet the needs of mass medication and have certain advantages in the allocation of medical resources. The production process of capsules is relatively complex, and the cost is higher. Mass production may face some challenges in cost control and production efficiency.
Cost-effectiveness considerations
From the perspective of cost-effectiveness, for some common, price-sensitive drugs, tablets are usually a more economical choice. Due to their lower production costs, drug prices can be more affordable, allowing more patients to afford them. كبسولات, due to their higher production costs, often have higher prices, which may be limited to some extent for patients with limited budgets or in large-scale public health projects.
Ease of swallowing
For patients with difficulty swallowing (such as the elderly, children, or patients with certain throat diseases), the ease of swallowing capsules and tablets needs to be judged according to specific situations. Although the shape of capsules is relatively round and may be easier to swallow, if the capsules are large or patients have psychological barriers to swallowing capsules, they may find it difficult. For some smaller tablets or specially designed tablets (such as scored for easy breaking), patients may find it easier to swallow. فضلاً عن ذلك, some patients may be accustomed to chewing or dissolving tablets before administration, which also affects their acceptance of the two dosage forms to a certain extent.
Acceptance of taste and odor
If patients are sensitive to the taste and odor of drugs, capsules may be more popular. Because capsules basically do not release the taste of drugs in the mouth until they dissolve in the gastrointestinal tract. Tablets without coating or incomplete coating may have a bitter or strange taste, affecting the patient’s medication experience. لكن, for some patients who like to swallow drugs whole and do not mind the taste and odor of drugs, tablets are also acceptable.
Capsules and tablets represent two distinct pharmaceutical dosage forms, ولكل منها مزايا وقيود فريدة. Capsules excel in masking unpleasant odors, providing targeted release, and handling liquid medications, while tablets offer precise dosing, cost-effectiveness, and manufacturing versatility. The choice between capsules and tablets depends on specific drug properties, therapeutic requirements, production considerations, and patient preferences, تسليط الضوء على أهمية استراتيجيات صياغة الأدوية المصممة.
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روابط ودية: التعبئة الغنية | شركات تصنيع آلة تعبئة الكبسولة
