Preparation And Evaluation Of Clinopodii Herba Hemostatic Gel

Objective:As one of the ten genuine medicinal materials in Anhui,Clinopodii Herba has excellent hemostatic effect.At present,Clinopodii Herba preparations are mainly oral preparations,and there are few external products on the market.In order to broaden the clinical application of Clinopodii Herba,this paper prepared it into external hemostatic preparations to make up for the market vacancy of external hemostatic products of Clinopodii Herba,expand its application range and improve its utilization rate.Methods:(1)We established a method for the content determination of Clinopodiside A by high performance liquid chromatography.And with the content of Clinopodiside A as the index,the extraction process conditions were optimized by single factor and orthogonal test,including soaking time,water volume,decoction times and decoction time.(2)The appearance,uniformity,fluidity,spreadability and centrifugal stability were used as the indexes of the hemostatic gel.The gel matrix,the content of carbomer-940,carboxymethyl chitosan,glycerol and Clinopodii Herba extract were screened by single factor and orthogonal test.(3)The quality of the prepared hemostatic gel was evaluated,including appearance,p H value,rheological properties,drying weight loss rate,water swelling rate,content determination of Clinopodiside A in the gel,in vitro release and stability.(4)Hemolysis test was performed on the prepared hemostatic gel,and the hemostatic properties of the gel were evaluated by in vitro and in vivo methods(blood coagulation index,rat femoral vein hemostasis,rabbit ear artery hemostasis test).Results:(1)The calibration curve of Clinopodiside A was linear between 1μg/m L and80μg/m L(R~2=0.9996),and the results of each index met the requirements of determination.Through single factor investigation and orthogonal test optimization,the extraction process conditions of Clinopodii Herba were as follows:the medicinal materials were pre-soaked for 1 h,add 14 times the water volume,and boil for 4 times,2 hours each time.(2)Through single factor experiment and orthogonal experiment to optimize the prescription,the optimal prescription was determined:the content of carbomer-940was 1.4%,the content of carboxymethyl chitosan was 2%,the content of glycerol was20%,and the content of broken blood extract was 10%.(3)The prepared gel is a brownish yellow translucent semi-solid state and the p H is between 6 and 7.It is a shear-thinning non-Newtonian fluid with good thixotropy.The results of drying weight loss rate showed that the gel lost water quickly within 8 h,evaporated about 61.00%±2.65%of the water at 24 h,and then tended to be stable at48 h.The results of water swelling rate showed that the swelling rate of the gel increased rapidly in the first 2 h,and the swelling rate could reach 194.67±7.02%at12 h,which had the ability to absorb liquid.In addition,the content of Clinopodiside A in the gel was determined to be 92.3337μg/g by high performance liquid chromatography,and the RSD was 0.78%.In the process of in vitro release,it was found that the gel was first released and then released slowly.In the stability study,it was found that the color of the gel stored in high temperature and the content of Clinopodiside A would change,but it would not change when stored at room temperature.(4)There was no hemolysis in this product.The Blood coagulation index of Clinopodii Herba hemostatic gel was 48.25±6.32%,which was significantly lower than that of blank control group,Clinopodii Herba extract group and blank gel group(P<0.05).In the rat femoral vein and rabbit ear artery bleeding test,the hemostatic time of Clinopodii Herba hemostatic gel was 43±5 s and 106±15 s,respectively,which significantly shortened the hemostatic time(P<0.05),and the amount of bleeding was0.01 g and 0.36±0.04 g,respectively,which significantly reduced the amount of bleeding(P<0.05),indicating that it was an excellent hemostatic material.Conclusion:In this paper,the Clinopodii Herba hemostatic gel was prepared,and a series of quality evaluations were carried out on the prepared gel,which met the requirements of the gel preparation.The gel was stable in nature,could safely act on the wound,and could promote coagulation,shorten the hemostatic time and reduce the amount of bleeding.It is a hemostatic material with excellent hemostatic properties.