Common granules mainly include soluble granules and suspended granules. According to the current Chinese Pharmacopoeia 2005 edition and the Chinese Pharmacopoeia 2005 supplement, the granules should be traits and dissolution (dissolution). Inspection of items such as moisture and loss on drying. In practice, due to the fact that the Code has neglected some details, the inspection agencies and regulatory authorities cannot accurately determine the results, which should be taken seriously by the standards setting bodies.
The name is not true but it is not corrected. What is the reason?
In daily supervision, the author noticed that cefradine and cefaclor were slightly soluble and slightly soluble in water, and were mainly used for children after granule preparation. The main drug content per bag was very small (0.125g), at normal dosage. Can be completely dissolved in water. Therefore, the author believes that the description of the traits of these two drugs should be “soluble particlesâ€. Moreover, the bioavailability of soluble particles is higher than that of suspended particles, but the actual implementation of the production enterprises is basically the “suspended particles†standard. . what is the root cause?
The author has communicated with the production company on this matter. Some corporate executives said that they actually know that the product's marked traits are not in line with the actual situation, and that the soluble particles have higher bioavailability than the suspended particles. The reason why it is still marked as “suspended particles†is because the “traits†under the cephalosporin granules and cefaclor granules in the 2005 edition of the Chinese Pharmacopoeia are “this product is suspended particlesâ€. After the promulgation and implementation of the Chinese Pharmacopoeia in 2005, the “traits†were revised to “soluble particles or suspended particlesâ€. The company wanted to change the “traits†expression to “soluble particlesâ€, but worried about the production process. The change must be approved by the registration department of the State Food and Drug Administration. The procedures are troublesome and have to wait for a long time. Zui finally decided to continue the label "traits are suspended particles."
Since the 2005 edition of the Chinese Pharmacopoeia and the 2005 Supplement (including the 2010 edition of the Chinese Pharmacopoeia that has not been implemented yet) have not specifically determined the specific test methods and basis for soluble particles and suspended particles, the inspection agency can only rely on The "characteristics" marked in the product manual and the textual description in the drug standard are used to determine the result to determine whether the drug is subjected to a meltability test. Therefore, the author suggests that when the Codex is revised, it clearly states that the granules are soluble particles or suspended particles, and at the same time increase the test method and judgment basis of the two different particles.
Do not do the dissolution test, the enterprise is guilty
In the 2005 edition of the Chinese Pharmacopoeia and in the supplement, some of the granules are not marked as soluble granules or suspended granules, some are marked as suspended granules, and some are marked as soluble granules or suspended granules. Upon inquiry, the acetaminophen granules and roxithromycin granules in the granules were clearly specified to be tested for dissolution, and the dissolution test items were not listed under other granules.
In this way, whether or not to do the dissolution inspection is really difficult for the company. On the one hand, although the dissolution test item is not listed under the granules, the “other†inspection clearly requires: in addition to the solubility, it should comply with the relevant provisions under the granules (the “General Rules for Preparation†Requirements for suspended granules: Unless otherwise specified, the suspended particles should be tested for dissolution. This indicates that the suspended particles must be tested for dissolution. On the other hand, since the dissolution granules did not list the dissolution test items alone, although there was a dissolution measurement method, the dissolution medium was not clearly defined and the dissolution test could not be performed.
Therefore, the author suggests that the inspection conditions required for the dissolution test of granules should be clearly defined during the revision of the Code to guide the daily supervision.
Is “dry weight loss†a mandatory item?
In the 2005 edition of the Chinese Pharmacopoeia, some granules, such as cephalexin granules, clearly stipulate that moisture should be checked. Some granules, such as bismuth potassium citrate granules, should be clearly defined for dry weight loss inspection, and some granules. Such as calcium phosphate particles, etc., it is stipulated that the above two tests should be carried out.
However, the "General Rules for the Preparation of Granules" in the 2005 edition of the Chinese Pharmacopoeia stipulates that, unless otherwise specified, the granules should be subjected to dry weight loss inspection. The author understands that the dry weight test must be carried out regardless of whether the granule requires moisture inspection. In fact, manufacturers that have clarified granules with moisture inspection have carried out moisture inspection without performing dry weight loss inspection.
The author believes that: moisture measurement is measured by "water", and the weight loss of drying is measured by "water and some substances that will volatilize under certain temperature conditions". If the same drug is simultaneously measured for moisture and loss on drying, the results may be the same or different. In the "General Rules for the Preparation of Granules", both the moisture measurement method and the dry weight loss measurement method, indicating that the moisture check and the dry weight loss test belong to different test items. For example, the cephalosporin for injection contained in the second edition of the Chinese Pharmacopoeia 2005 requires not only the dry weight loss test but also the moisture check. Therefore, the granules for clear moisture check must also check the dry weight loss item.
According to the author's understanding, the reason why the manufacturer only conducts moisture inspection without conducting the weight loss check is the conclusion obtained after consulting the drug inspection agency. This oral reply or the unspoken rules of the industry is obviously unscientific.
Therefore, the author suggests that the Code, as in the General Principles of Granule Preparations, stipulates that “the granules that have been suspended or have been tested for dissolution or release, may not be subjected to the solubility testâ€, indicating that “the granules have been specified to check the moisture, It is not necessary to carry out the dry weight loss check" to determine whether the weight loss of drying must be checked.
Description:
Gentamycin belongs to the group of aminoglycosides and acts bactericidal against mainly Gram-negative bacteria like E. coli, Klebsiella, Pasteurella and Salmonella spp. The bactericidal action is based on inhibition of bacterial protein synthesis.
Indications:
Gastrointestinal and respiratory infections caused by gentamycin sensitive bacteria, like E. coli, Klebsiella, Pasteurella and Salmonella spp. in calves, cattle, goats, sheep and swine.
Gentamicin
Gentamicin Sulfate,Gentamicin Injection,Gentamicin Injection For Cattle,Gentamicin Injection For Animal
Hebei Kexing Pharmaceutical Co., Ltd. , https://www.kexingpharma.com