WANG Zhi-min,LIU Ju-yan,WANG De-qin,et al.Views on Key Technical Problems in Research and Development of Famous Classical Formulas[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(01):212-217.
WANG Zhi-min,LIU Ju-yan,WANG De-qin,et al.Views on Key Technical Problems in Research and Development of Famous Classical Formulas[J].Chinese Journal of Experimental Traditional Medical Formulae,2022,28(01):212-217. DOI: 10.13422/j.cnki.syfjx.20211852.
Views on Key Technical Problems in Research and Development of Famous Classical Formulas
In this paper, the key technical problems in the research and development of famous classical formulas are analyzed. Firstly, the puzzled problem for a long-time, which is conversion relationship from medicinal metrology of Han dynasty (HD) to that of modern (gram,g), is comprehensively expounded that one
Liang
(两) of HD=3 g is more appropriate. Secondly, the model and principles of quality consistency evaluation are given for the transformation from the quality of authoritative basic sample prepared by casserole (ABS-C) to the quality consistency in Laboratory process, pilot-scale process and industrial production. The consistency evaluation model is
ξ
ABS-X
=
K
1
(
Q
1
ABS-X
/
Q
1
ABS-C
)+
K
2
(
Q
2
ABS-X
/
Q
2
ABS-C
)+……+
K
i
(
Q
i
ABS-X
/
Q
i
ABS-C
)=∑
K
i
(
Q
i
ABS-X
/
Q
i
ABS-C
)(
i
=1,2,3……
n
). In the formula, ABS-X means laboratory reference sample ABS-C (ABS-L), pilot-scale ABS-C (ABS-mP) or industrial production ABS-C (ABS-P),
ξ
ABS-X
means the quality consistency rate or similarity degree of ABS-L, ABS-mP and ABS-P processes with ABS-C,
K
i
means the weight of each quality evaluation index (
i
),
Q
i
ABS-X
is the data of
i
in ABS-L, ABS-mP, ABS-P samples, and
Q
i
ABS-C
is the data (or mean) of
i
in ABS-C sample. Thirdly, in order to control the quality of the herbal medicines whose active ingredients were unknown, their chemical constituents should be studied deeply, and if necessary, the bioassay research should be carried out according to the main efficacy or indication of famous classical formulas. Finally, for the special processing of some herbal medicines, it is difficult to formulate the processing method, technology and standard of prepared slices. It is suggested that the scientific connotation and historical evolution of the special processing method should be thoroughly sorted out, and its technological characteristics are summarized, the modern processing technology and production processes are simulated, and then the corresponding processing methods and quality standards are formulated.
ZHA L H , HE L S , LIAN F M , et al . Clinical strategy for optimal traditional Chinese medicine (TCM) herbal dose selection in disease therapeutics:expert consensus on classic TCM herbal formula dose conversion [J]. Am J Chin Med , 2015 , 43 ( 8 ): 1515 - 1524 .