Inspection Method of Chinese Medicine Pills (1)

The quality requirements of the pills: the appearance should be round, the size and color should be uniform, and there should be no adhesion

(1) Moisture check

1.

(1) Pills are mostly made of fine powder of decoction pieces and a binder such as honey, and contain a certain amount of water

(2) Moisture inspection refers to the determination of the moisture content (%) in the test product by an appropriate method under specified conditions

(3) The wax pellets do not check the moisture

2.

(1) Operate according to the method under each corresponding item of the Chinese herbal medicine moisture determination method (General Rule 0832)

(2) Honey pill (big mi pill and small mi pill), water pill cut or chopped; water pill, paste pill, concentrated pill (concentrated water pill, concentrated honey pill and concentrated water pill) crushed or ground

(3) Take an appropriate amount of the test product, accurately weigh it, and take 2～5g by drying method; take about 1～4ml water content by toluene method; take 0.

3.

4.

Table 15-12 Inspection limits of pill moisture

5.

(2) Weight difference check

1.

2.

(1) Unless otherwise specified, take 10 pills as 1 part (1 pill as 1 part if the weight is 1.

Table 15-13 Pill weight difference weighing table

(2) Take 10 samples of the test product, weigh them separately, and compare them with the labeled weight of each (labeled amount per pill × number of pill weighed) (for pills without labeled weight, compare with the average weight)
.

3.
Matters needing attention

(1) Dragees should check the weight difference of the core and meet the regulations
.
The weight difference is no longer checked after sugar coating
.

(2) Other coated pills (referring to film-coated pills, enteric-coated pills, and coated pills with talc, Indigo Naturalis, cinnabar, ocher, etc.
) as coating materials should be checked for weight differences after coating and meet the requirements
.

(3) For single-dose packaged pills that have been checked for difference in filling quantity, no weight difference check will be carried out (for example, the marked filling quantity is 6g per bag, and the dosage is 6g at a time.
The filling quantity difference is checked, and the weight difference is not checked)
.

(4) Do not touch the test product directly with your fingers during the weighing process
.

4.
Results and Judgment

(1) Check 10 parts, compare with the labeled weight of each (labeled quantity per pill × number of weighed pills) (for pills without label weight, compare with the average weight), according to the provisions of Table 15-14, none of them exceed the weight Difference limit; or not more than 2 parts exceeding the weight difference limit, and none of them exceed the weight difference limit by 1 time; all are judged to be in compliance with the regulations
.

Table 15-14 Limits of Pill Weight Difference

(2) If the weight difference limit is exceeded by more than 2 parts, or the weight difference limit is not more than 2 parts, but 1 part exceeds the weight difference limit by 1 time, it will be judged as non-compliance
.

5.
Records and calculations

(1) Record the model of the analytical balance
.

(2) data is recorded for each weighing and the like
.

(3) Calculate the weight of each pill or each test product, and find the average weight if necessary
.

(4) Calculate the label weight (labeled quantity per pill × number of weighed pill)
.

(5) Calculate the allowable range of pill weight based on the weight difference limit specified by the weight of each part or the average weight
.

Attached drop pill weight difference check

1.
Brief description

(1) This law is applicable to the weight difference inspection of dropping pills.
The purpose of this inspection is to control the consistency of the weight of each pill
.
To ensure the accuracy of the dosage
.

(2) For single-dose packaged drops that are checked for difference in filling quantity, no difference in weight will be checked
.

2.
Method of operation

(1) Take 20 pellets of the test product, accurately weigh the total weight, and obtain the average pellet weight
.

(2) Then take out 1 pill from the 20 test samples whose total weight has been weighed, and then use tweezers to take out 1 pill in turn, and accurately weigh the weight of each pill
.

(3) The weight of each pill is compared with the labeled pill weight (for the unlabeled pill weight, it is compared with the average pill weight).

3.
Matters needing attention

(1) Avoid touching the test product directly with your hands during the weighing process
.
The dropped pills that have been taken out shall not be put back into the original packaging container of the test product
.

(2) Film-coated dripping pills should be checked for weight difference after coating and meet the requirements
.

(3) For sugar-coated dripping pills, check the weight difference of the core and meet the regulations
.
The weight difference is no longer checked after sugar coating
.
4.
Results and judgment

(1) The weight of each pill is compared with the labeled pill weight (for the unlabeled pill weight, compared with the average pill weight), according to the provisions of Table 15-15, the weight difference limit is not exceeded; or the weight difference limit is not more than 2 pills, and none of them exceed the weight difference limit by 1 times, all are judged to meet the regulations
.

Table 15-15 Differences in the weight of drop pills

(2) The weight of each pill is compared with the labeled pill weight (the weight of the unlabeled pill is compared with the average pill weight), and the weight difference limit is more than 2 pellets; or the weight difference limit is not more than 2 pellets, but If one pill exceeds the weight difference limit by 1 time, it will be judged as non-compliant
.

5.
Records and calculations

(1) Record the model of the analytical balance
.

(2) Record the data of each weighing
.

(3) Calculate the allowable weight range based on the labeled pill weight or average pill weight
.