Pharmaceutical preparation process, so that the pill smaller curative effect becomes better

What effect does a drug have on a person's body depends on what factors? Ingredients, of course, are important; Formula, very important... But there is another thing that is also crucial in the development and manufacturing of drugs that is not well known, and that is the formulation technology of drugs.

Not long ago, the Key Laboratory of Drug Packaging Materials and drug Compatibility Research of the State Drug Administration officially settled in the National Engineering Research Center for Pharmaceutical Preparations, which has caused widespread concern in the field of biomedicine. With the deepening of the development of biomedicine, the preparation technology in the process of drug research and development is becoming more and more detailed, and more and more people pay attention to it.

In recent years, China's pharmaceutical industry has developed rapidly, becoming the largest country in the production and export of raw materials, and China is also the world's second largest pharmaceutical market. Why are raw materials exported more and drugs exported less? Why are many high-end consumer groups in China still willing to choose imported drugs at the critical moment? The problem lies in the formulation technology.

Pharmaceutical preparations, literally, are pharmaceutical products prepared according to a certain form. Whether the medicine people eat is liquid or solid, tablet or capsule, how the temperature requirements, how to play the effect, all are closely related to the drug preparation technology. It can be said that preparations are the "last kilometer" of drugs from raw materials to consumers. Liu Xiyi, general manager of Qingdao Guohai Biopharmaceutical, has been engaged in pharmaceutical work for many years and has a particularly clear understanding of this. He told the Science and Technology Daily reporter: "The driving force of pharmaceutical technology innovation is the increasing requirements for the application and production of pharmaceutical products, many domestic drugs can not achieve exports, many pharmaceutical companies can not achieve breakthroughs in quality, many are in the preparation technology can not pass."

Pharmaceutical preparations are not only the difference between "capsules" and "pills"

The matter of drug preparation may not be paid much attention by laypeople, but it is one of the key core technologies in drug production, which plays a decisive role in the safety, stability and effectiveness of drugs and is of great significance.

However, the complexity of different categories in the production process of drugs is far more complex than "capsules" and "tablets". Whether it is a common preparation or a new preparation, its research and development and production is a complex system engineering, including the application of a variety of technologies and key technical parameters, which plays a decisive role in the safety, effectiveness and stability of drugs.

In the actual development and production process, how to better play a role in disease prevention and treatment of tens of thousands of preparations is a big issue. For example, some people do not want to take medicine when they are sick, because they hate the bitter taste of medicine. But once the drug is made into sugar-coated tablets, it is different, so that patients can no longer suffer from bitter suffering, which is of course a good thing - reducing the pain for patients is one of the functions of the drug preparation, but how the efficacy changes after making sugar-coated tablets, safety and stability must also be studied clearly.

For another example, insulin is a protein that will be broken down and lose its effect after being eaten by the human body, but insulin is made into an injection and injected into the body of diabetic patients, which will play a therapeutic role for diabetic patients. Different forms of drug preparations can make drugs play different roles and effects, and strong research results must be supported. Also, for example, specific to the treatment of drugs in different parts of the human body, how to work on the slow-release time, accurate calculation, accurate treatment, these are things that researchers must figure out.

Pharmaceutical technology brings new breakthroughs in drugs

In the process of traditional preparation, there are disadvantages of low bioavailability due to large particle size of raw material. "Recently, the bioavailability of our pharmaceutical formulation process prescriptions for many drugs has been recognized by the market while obtaining national invention patents." Zhu Renkuan, founder and chairman of Qingdao Guohai Biopharmaceutical, said.

Megestrol acetate dispersive tablet, is a common drug listed in the medical insurance catalogue, this drug named Yliji is the first approved large dose progesterone anti-tumor drug in China. "The reason why this drug is very popular in the market, the key is to use advanced technology to ultrafine megestrol acetate powder, of which more than 90% of the raw material particles are less than 5 microns, and made into dispersed tablets, overcoming the problem of low bioavailability of this variety and patients taking difficulties, and further ensure the safety and effectiveness of the product." Liu Xiyi said.

Bioavailability refers to the relative amount of a drug absorbed into the systemic blood circulation after being administered through the extravascular route, and represents the extent to which the active drug in the drug preparation is utilized throughout the body.

Researchers try to apply the emerging process technology of ultrafine pulverization to biopharmaceuticals, so that the powder formed after the substance is ultrafined has good surface properties, and the final drug is more dispersible and soluble. "After the improvement of the production process, the absorption of the drug is more rapid, and the dissolution rate is more than 10 percent higher than that of ordinary preparations." Liu Xiyi said.

"What is commendable is that the children's drugs we have developed are also widely praised in the market because of the improvement of preparation technology." Liu Xiyi said his drug, called Yilimei, is a dry suspension of acetaminophen, which is mainly used in children for fever caused by common cold or influenza. In terms of pharmaceutical ingredients, this is a classic drug, but the unique preparation technology makes the "old medicine with a new face."

"Although it is an old formula, we continue to study how to make it better in terms of taste acceptance and drug morphology." On the one hand, the taste is innovative, and the exclusive milk flavor is developed, so that children like this taste, and the medicine is really not bitter. On the other hand, in the form of innovation, we make this drug into a powder or granular substance, and when it is ready to shake with water, it can be dispersed into a suspension for oral administration. In addition to its effectiveness and chemical stability, it has a slow settling, and can be dispersed by gently shaking after settling. The size of suspended particles remains unchanged during long-term storage. Easy toppling and other physical characteristics." Liu Xiyi said.

The innovation and breakthrough in preparation has allowed the relevant technologies of Qingdao Guohai Biopharmaceutical to obtain invention patents, and has also made this drug the most effective and safest child fever reducer recommended by the World Health Organization.

In Zhu Renkuan's view, if China wants to realize the transformation of the raw material drug producing country to the pharmaceutical industry power, it must strengthen the research and development of pharmaceutical preparations, so as to improve the core competitiveness of China's pharmaceutical preparations industry in the international market, so that our people can enjoy cheap and high-quality good drugs.

There are many kinds of pharmaceutical preparations

Medicine preparation as a subject, more and more people pay attention to, because people can not do without it when they are sick. It is generally divided into liquid and solid preparations. Liquid preparations are divided into internal or external liquid preparations, injections and eye drops. Solid preparations are divided into capsules, tablets and coated tablets.

Internal or external liquid preparation refers to the solid or liquid drug dissolved or dispersed in water, alcohol, fat oil or glycerin under certain conditions, and sometimes additives are added to increase the solubility and dispersion of the drug, increase the stability of the product or improve its undesirable odor.

An injection, also known as an injection, is a dosage form designed for injection into the human body. The production method is usually to dissolve the API in water for injection (or oil for injection, or other appropriate solvent) to the required concentration, filter with a filter rod or microporous filter membrane, and fill the ampoule (or infusion bottle) through a pooper sealing machine.

Eye drops are external sterile liquid preparations directly applied to the eyes, mainly aqueous solutions.

Tablet refers to the grinding and screening powder and auxiliary materials (excipients, disintegrators, etc.) of the raw material are mixed evenly in the mixing machine, adding an appropriate amount of wetting agent and adhesive, making particles on the granulator, adding lubricants after drying, stamping and forming on the tablet press.

Coated tablets are sugar-coated tablets, enteric-coated tablets and thin-film coated tablets made by the coating machine after secondary processing.

There are two kinds of capsules: hard capsules and soft capsules. The hard capsule is made by mixing the raw powder and auxiliary material into a hard hollow capsule. Soft capsules are made by sealing oil or liquid drug or suspension that does not dissolve gelatin in a round or oval soft capsule to make a soft preparation for internal consumption.

Aerosol is the drug and the projectile are packed together in a pressure container with a valve, and can be used in a quantitative or non-quantitative spray in the form of a preparation.