Suppository Inspection Laboratory

Summary

Suppositories (Chinese Pharmacopoeia, 2010 Edition, Part II, Appendix I D) refer to solid preparations made of drugs and suitable matrices for cavernous administration. Suppositories are divided into rectal suppositories, vaginal suppositories and urethral suppositories due to the difference in the lumen of application. Rectal suppositories are torpedo-shaped, conical or cylindrical; vaginal suppositories are duckbill, spherical or ovoid; urethral suppositories are generally rod-shaped.

Operation method

"Weight discrepancy" checking method

Principle

This method is suitable for checking the weight difference of suppositories. There are many factors affecting the size difference of suppositories, such as the amount of soft material injected, temperature and speed during the production process, as well as the steps of cooling, curing, cutting, etc. The purpose of this check is to control the consistency of the weight of each suppository to ensure that the dosage is accurate. The purpose of this check is to control the consistency of the weight of each capsule to ensure that the dosage is accurate. For suppositories for which the checking of content uniformity is specified, the checking of weight difference is generally not carried out.

Materials and Instruments

Suppositories
Analytical balance Flat weighing flask Surgical forceps

Move

I. Operational steps

Refer to the tablets weight difference checking experiment except for taking 10 grains of the test material.

II. Record and Calculation

1. Record the data of each weighing.
2. Determine the average grain weight (m _flat ) to three significant figures.
3. Find the permissible range of grain weights (m _flat ± m _flat weight variation limits) by applying the weight variation limits specified in the table below.Mean Grain Weight Weight Variation Limit Below 1.0 g to 1.0 g 士 10% Above 1.0 g to 3.0 g 士 7.5% Above 3.0 g 士 5%
4. If the permissible weight range is exceeded and is marginal, it shall be compared with the average weight of the grains and the percentage difference in weight of the grains shall be calculated and used as a basis for the decision based on the limits of the weight difference specified in the table above (to avoid the influence of numerical modifications in the calculation of the permissible weight range).
III. Results and determinations
1. Compliance is determined when the weight of each capsule does not exceed the allowable capsule weight range (5 ± 5 x the weight variation limit); or when compared to the average capsule weight, the weight variation limit is not exceeded; or when the weight variation limit is exceeded by no more than one capsule and not more than one times the limit.
2. If the weight of each capsule, when compared with the average capsule weight, exceeds the weight difference limit by more than one capsule; or if the weight difference limit is not exceeded by more than one capsule but exceeds the limit by a factor of one, it is judged to be a non-compliance.

Caveat

1. The number of tablets should be carefully checked before and after weighing. Avoid direct hand contact with the test article during weighing. The removed tablets should not be put back into the original packaging container of the test material.

2. Tablets detected beyond the weight difference limit should be kept in a separate container for review when necessary.

3. sugar-coated tablets should be checked for weight difference of the core before coating, and the tablets should be coated only after complying with the requirements. After coating, the weight difference should not be checked.

4. Film-coated tablets should also be checked for weight difference after coating.

5. If the room temperature of the testing place is higher than 30°C, it should be cooled down in an appropriate way so that the suppositories will not be melted or softened due to the high room temperature, which makes it difficult to operate.

Common Problems

Suppositories (Chinese Pharmacopoeia, 2010 Edition, Part II, Appendix I D) refer to solid preparations made of drugs and suitable matrices for cavernous administration. Suppositories are divided into rectal suppositories, vaginal suppositories and urethral suppositories due to the difference in the lumen of application. Rectal suppositories are torpedo-shaped, conical or cylindrical; vaginal suppositories are duckbill, spherical or ovoid; urethral suppositories are generally rod-shaped.

Suppositories are divided into ordinary suppositories and sustained-release suppositories. Commonly used bases for suppositories can be divided into greasy bases (such as semi-synthetic glyceryl fatty acid ester, cocoa butter, polyoxyethylene stearate, polyoxyethylene sorbitan fatty acid ester, hydrogenated vegetable oil, etc.) and water-soluble or water-miscible bases (such as glycerol gelatin, Porosam, polyethylene glycol, etc.). Whether the choice of substrate is appropriate or not has a great influence on the quality and efficacy of suppositories; because of the oil-based substrate (such as cocoa bean wax) can not be absorbed in the vagina and form residue, not as a substrate for vaginal suppositories; commonly used in water-soluble or water miscible substrates for the preparation of vaginal suppositories.

Quality requirements for suppositories, in addition to the shape should be intact and smooth, suitable hardness, non-irritation and pharmacopoeia varieties of the test items specified under the species, should also check the "weight difference", "time limit for melting" (slow-release suppositories should be checked for the degree of release, and no longer melt) and "time limit for melting" (the time limit for melting). time limit check) and "microbial limit".

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