Compound calcium carbonate granule human body biology Using test report 转 中文
Abstract
This experiment uses the inductance coupling plasma launch The spectrographic methods (ICP-AES) separately
determined 18 masculine health to take orally the trying stochastic alternately single dosage a compound prescription
calcium carbonate granule ( to try preparation, Xinjiang Tefeng medicine stock industry limited liability company) and
the Gaierqi D (the senate compared to preparation, Huishi - Baigong manufacture limited company product) the ifferent
time compartment urine calcium density, the plan accumulation urine calcium excretion quantity - time curve, and after
gave the medicine to accumulate the urine calcium excretion quantity to be opposite to the blank comparison accumulation
urine calcium excretion quantity increase, asked to calculate is tried the preparation the relative biological use.
18 health are taken orally trying are tried the preparation and the senate (are equal calcium 600mg), in 0-24 h, blank
comparison average accumulation urine calcium excretion quantity for 78.87±26.94mg; After takes orally is tried the
preparation, average urine calcium accumulation excretion quantity for 113.89±32.35 mg; After takes orally the senate
to compare the preparation, average urine calcium accumulation excretion quantity for 114.16±31.14mg. After takes
orally is tried the preparation the biggest excretion rate for 16.18±11.13mg/h, reaches the peak time for2.3±0.9h ; After
takes orally the senate the to be bigger than the preparation excretion rate for 15.45±8.58mg/h, reaches the peak time
for 2.7±1.2h. To receives tries the preparation the urine calcium accumulation excretion quantity increase Compared
to the senate compared to the preparation urine calcium accumulation excretion quantity increase computation,
obtain tried the preparation the relative biological use is 100.86±16.22%.
After separately is taken 18 trying is tried the preparation and the senate compares the preparation the 24h urine
calcium excretion speed and the blank comparison group ' s 24h urine calcium excretion speed carries on pairs the
t examination, the result its urine calcium excretion speed non- statistics significance. After the explanation takes the
calcium medicinal preparation 24h basically to complete the calcium absorption.
After 18 are taken orally trying is tried the preparation and the senate compared to the preparation, in 0 ~ 24h the
urine calcium accumulation excretion quantity increase and the maximum excretion speed carries on the variance analysis after the logarithm transformation , and uses the two pair unilateral t examines and (1-2 α) the confidence
interval law carries on the biological equivalent appraisal. The result showed that, urinates the calcium accumulation
excretion quantity increase 90% confidence interval compared to the preparation to be corresponding parameter for the
senate 94.7 ~ 110.4%; The biggest excretion speed 90% confidence interval compared to the preparation are
corresponding parameter for the senate 80.4 ~ 136.1%. Is tried the preparation and the senate compared to the
preparation in vivo biology function equivalent.
| 18 healths are taken orally trying a 600mg compound prescription calcium carbonate granule the
relative biological use |
|
| Trying |
urine calcium excretion total quantity only rises in value (mg) |
Relative biological use |
| No. |
Is tried the preparation |
senate compares the preparation |
(%) |
|
| Average value |
35.33 |
35.36 |
100.86
|
| standard is bad |
12.51 |
12.99 |
16.22 |
|
Result analysis
18 healths are taken orally trying are tried the preparation and the senate (are equal calcium 600mg), in 0-24h, blank comparison average accumulation urine calcium excretion quantity for 78.87±26.94mg; After takes orally is tried
the preparation, average urine calcium accumulation excretion quantity for 113.89±32.35mg; After takes orally the
senate to compare the preparation, average urine calcium accumulation excretion quantity for 114.16±31.14mg.After
takes orally is tried the preparation the biggest excretion rate for 16.18±11.13mg/h, reaches the peak time for 2.3±0.9h;
After takes orally the senate the to be bigger than the preparation excretion rate for 15.45± 8.58mg/h, reaches the peak
time for 2.7±1.2h. To receives tries the preparation the urine calcium accumulation excretion quantity increase Compared
to the senate compared to the preparation urine calcium excretion quantity increase computation, obtains is tried the
preparation the relative biological use is 100.86±16.22%.
Put the main medicine generation of dynamics parameter after the logarithm to area difference analysis result reveal
that, does not assume the remarkable difference in two kind of preparations between (P> 0.05); Further uses the two pair
unilateral t examines and (1-2 α) sets to the confidence interval analysis, finally see Table 22, the table 23.
After separately is taken 18 trying is tried the preparation and the senate the 24h urine calcium excretion speed and the
blank comparison group ' s 24h urine calcium excretion speed carries on compared to the preparation pairs the t examination,
the result its urine calcium excretion speed is not remarkable The natural difference (see Table 24). After the
explanation takes the calcium medicinal preparation 24h basically to complete the calcium absorption.
| Table 22 18 are taken orally trying two kind of calcium medicinal preparations the main
medicine kinematics parameter |
Variance analysis |
|
| Parameter |
F value |
|
Between preparation |
Cycle |
Individual |
|
| LnX0-t |
0.06 |
1.57 |
16.85* |
| LnXmax |
0.01 |
0.03 |
1.88 |
Tmax |
2.18 |
1.43 |
2.53* |
|
F0.05(1,16)=4.49 F0.05(16,16)=2.33 *P<0.05 |
| Table 23 18 are taken orally trying two kind of calcium medicinal preparations main
medicine kinematics parameter pair Single side examination and （1-2α） |
Confidence interval law examination |
|
Parameter |
|
|
|
|
LnX0-t |
|
|
|
LnXmax |
|
|
|
|
F0.05(16)=1.76 *P<0.05 |
Table 24 After 18 are taken orally trying is tried the preparation and the senate compares
the preparation and the blank comparison group ' s 24 h urine calcium excretion |
|
| speed pairs the t examination |
| |
s tried the preparation - blank comparison |
senate compares the preparation - blank comparison
|
|
T |
|
|
|
F（1-0.05）(17)=2.11 *P>0.05 |
Not good responded
Is taken orally after trying is tried the preparation and the senate compared to the preparation, in
experimental period has not appeared not good responded.
Reference
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biological equivalent experiment guiding principle, Chinese pharmacopoeia in 2000 version
two - every Example and appendix
[2] Howard JH, Laura GG, Sharon DH, et al. Pharmacokinetic and pharmacodynamic comparison
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[3] Michael JN, Charles YC. Calcium bioavailability from calcium carbonate and calcium
citrate. J. Clin. Endocrinol Metab, 1985,61(2): 391-393
[4] Howard JH, Alan BS, Sharon HR, et al. Pharmacokinetics of calcium absorption from two
commercial calcium supplements.J Clin Pharmacol., 2000, 39: 1151-1154
[5] Sah VP. et al. Analytical methods validation: bioavailability bioequivalence, and pharmacokinetic
studies. J Pharm. Sci., 1992,81(3):309 |
