Studies On Preparation Technology And Quality Standard Of Huoxiang Qingwei Soft Capsule

With the accelerated pace of new lifestyle, functional dyspepsia, a kind of digestive disease with the symptoms of abdominal distention, vomit, bellyache, anepithymia etc, is becoming a frequently-occurring disease no matter at home or abroad. It is time for the public to pay more attentions on it. The pathogenesis of functional dyspepsia are on a heated discussion. Chinese traditional medicine has a long history and promising development on the treatment of functional dyspepsia. In addition to gastric motility disorders, abnormal gastric acid and other reasons, bad habits, increasing pressure and negative emotions may be the other causes of functional dyspepsia. In order to have a better treatment of functional dyspepsia, the preparation is composed with seven traditional Chinese herbs, which included cablin potchouli herb, cape jasmine fruit, divaricate saposhnikovia root, hawthorn fruit, medicated leaven, gypsum and licorice root. This is the first time to make soft capsules with those herbs. Compared with the tablets and capsules which was made of the same herbs, the Huoxiang Qingwei soft capsule has a great advantage of storage. Besides, the preparation has a better retention of volatile components, good quality and efficacy.In this paper, the main purpose is to study the preparation technology, quality standard and stability test. The specific results are as follows:Extraction Process: First, we use the means of steam distillation to distill the essential oil of cablin potchouli herb and divaricate saposhnikovia root. And then discussing the best extraction process boiling water extracted by L9(34) orthogonal experiment, namely, putting the herbs with the 10 times the amount of water, and boiling 2 times, each time for 1 hour.Preparation: Select the soybean oil as the solvent, 2.2% beeswax suspending added under ethyl paraben preservative, made oily suspensions containing volatile oil soft capsules.Quality Standard: According to the soft capsule inspection items of the 2010 edition of "Chinese Pharmacopoeia", this product was investigated with appearance observation, regular inspection, determination of TLC and content test. In TLC, the spots of cablin potchouli herb, hawthorn fruit and licorice root were clear. High performance liquid chromatography index components geniposide determination and methodology showed that the system are suitability, specific, accurate, reproducible, and a good linear relationship was shown range of 0.010176 ~ 0.25440 mg· m L-1.Stability: The sample preparation by leaving at room temperature for 18 months, and accelerated test for 6 months, including character, identification, load difference, disintegration time, determination and assessment of projects such as hygiene inspection and measurement and inspection data 0 monthly data showed no significant change, indicating that the product during storage stability, good stability.Conclusions: The final formulation is cablin potchouli herb 600 g, cape jasmine fruit 600 g, divaricate saposhnikovia root 600 g, hawthorn fruit 600 g, medicated leaven 600 g, gypsum 600 g, licorice root 240 g. Then we extracted volatile oil and put soybean oil, beeswax into the soft capsules. Each capsule contents geniposide should not be less than 4mg, and the valid time of these soft capsules is 18 months.