Capsules are one of the most common pharmaceutical preparations, capsules with gelatin and gelatin hollow capsules as a special kind of pharmaceutical excipients, Gelatin Hollow Capsules and their quality and safety have been the industry's attention. In recent years, China's capsules gelatin and gelatin hollow capsule quality testing and quality standards system has been continuously improved, the level of quality control continues to improve, but in the control of harmful metal elements, such as security needs to be further strengthened.
The body consists of more than 50 elements, and people's survival and health are closely related. Of course, the elements of human beings are also good or bad, Gelatin Hollow Capsules of which the greatest harm to the human body lead, mercury, arsenic, cadmium, and other harmful to the human body are cobalt, vanadium, antimony, manganese, tin, aluminum and so on. Shaoxing City Food and Drug Testing Center Zhu Linjiao said that the determination of heavy metal elements in the determination of drugs has been used as an important indicator of the quality of drugs to determine one. With the deepening of elemental research, in the field of pharmaceuticals, Gelatin Hollow Capsules from the original heavy metal detection to the present more and more single elements of quality control. Detection of the type of increase in the test method is also progressing. Capsules with gelatin and gelatin hollow capsules as a special medicinal accessories, in which the detection of heavy metal elements have also been more and more attention.
Gelatin hollow capsule is the main raw material capsule gelatin, the current use of plant fiber, hydroxypropyl starch as raw materials, the market share of capsules smaller. Medicinal gelatin as a basic raw material, in the field of medicine is widely used, mainly used for processing and production of hard capsules, soft capsules, on behalf of the blood and pills and so on. China University of Pharmaceutical Professor Liang Yi pointed out that the capsule gelatin is made of animal skin, bone, tendon and ligament in the collagen after appropriate hydrolysis of the preparation, and gelatin hollow capsule is coated with gelatin plus titanium dioxide, dodecyl Sodium sulfate, edible pigments and other accessories made. Some of the harmful elements in gelatin and gelatin hollow capsules can enter the body through drugs. Some of these heavy metal elements such as chromium, copper, Gelatin Hollow Capsules arsenic, cadmium, lead, vanadium, manganese, nickel, strontium and barium not only affect the quality of the drug , But also a direct impact on patients with drug safety and efficacy.
The National Pharmacopoeia Commission has extensively extracted samples from a wide range of references to the United States, Europe, Japan Pharmacopoeia and related standards, and has received the quality of gelatin capsules in the Chinese Pharmacopoeia 2010 edition through methodological validation and extensive sample research standard. Liang Yi said that the "Chinese Pharmacopoeia" 2010 edition of the first supplement of the capsules with gelatin in the harmful elements of chromium (using atomic absorption spectrometry), Gelatin Hollow Capsules heavy metals (using chemical identification method) and arsenic salts (using chemical identification method) Limit the amount of not more than two parts per million, parts per million and parts per million, gelatin hollow capsules in the harmful elements of chromium (using atomic absorption spectrometry) and heavy metals (using chemical identification method) were Not more than two parts per million and parts per million. "Chinese Pharmacopoeia" 2015 edition (hereinafter referred to as the new Pharmacopoeia) on the above indicators of the limit has not changed.
Capsule gelatin and gelatin hollow capsule quality standards to be further improved, heavy metal inspection should be further refined. Zhu Linjiao believes that the European Pharmacopoeia (EMEA) guidelines and the USP (USP) have more requirements and coverage for elements than the Chinese Pharmacopoeia and national standards for the elements of each species. Bureau of the need to control the elements are divided into three major categories of 5 categories, the United States Pharmacopoeia will be divided into two categories of elements, Gelatin Hollow Capsules namely: four kinds of highly toxic elements and 11 must limit the elements of these elements in the oral and parenteral contact drugs And the residues in the accessories are made in detail.