Study On The Preparation And Quality Standards Of Qiangxin Capsules

FoundationHeart Failure caused by several diseases is a kind of critical illness, and remains unsolved in clinic for long time. Western medicine such as cardiotonic, hydragogue, vasodilator, was limited in the disease, because it has unavoidable side effects, such as Hypoxemia, Acid-base Imbalance and Electrolyte Disturbance, etc. A new type of cardiotonic with maximum therapeutic effect, minimal toxic and side effect, continuously improving of heart function and no harm to balance of oxygen supply is needed in clinic application emergently.The Pathogenesis of this disease is the deficiency of vital energy which induces the decline of yang asthenia, and deficiency of both vital energy and yin. Deficiency of vital energy induces stagnation of blood, yang asthenia induces edema, and invasion of Lung by pathogenic water induces obstruction of lung-qi. So, the cause of this disease is deficiency of vital energy and yang asthenia, and the symptom is stagnation of blood and edema. On the principle of tonifying qi to promote blood circulation, warming yang to dispel damp, Radix Ginseng, Radix Astragali, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi and Pepperweed Seed, etc. are chosen to prepare Qiangxin Capsules. By tonifying qi to activate yang to assist source of blood to agitate strength of circulation, the cause can be eliminated. By dredging the meridian passage to deoppilate qi-blood circulation passageway, the symptom can be relieved. Monarch drug and his ministerial drug go together,the cause can be eliminated and symptom relieved together.This prescription was on trial in clinic in Affiliated hospital of Academy of Chinese Traditional Medicine of Henan province (New Drug Clinic Research Base) for long term, and it has a significant effect. Compared with patients under Dixina treatment, patients under Qiangxin Capsules treatment have an obvious increase in cardiac stroke volume, cardiac minute volume, cardiac index, in which patients under Dixina treatment increase a little and have strong side effects. The curative effect of Qiangxin Capsules, a traditional Chinese medicine compounds, is not only higher than Dixina, but also excels in eliminating symptom and strengthening heart function. Qiangxin Capsules has no evident toxic and side effect. This research project aims to develop a high curative effect, but minimal toxic and side effect cardiotonic to provide convenience for patients.Project sourceThis research project was Science and Technology Brainstorm Project of Henan province (NO. 0324420031).Main contentQiangxin Capsules, a traditional Chinese medicine compounds, was prepared by herbs of Radix Ginseng, Radix Astragali, Radix Aconiti Lateralis Preparata, Ramulus Cinnamomi, Radix et Rhizoma Rhei and Pepperweed Seed, etc. Under the prescription principle, mainly around the content of effective compositions, establish scientific and feasible procedure, by applying orthogonal design, uniformity design, etc. Around prescriptions features, the Monarch and his Subjects, Assistant and Envoy, of Qiangxin Capsules, establish scientific and controllable quality standard. And preliminary stability has done for the preparation.Purpose1. Develop a new type of cardiotonic with maximum therapeutic effect, minimal toxic and side effect.2. Select preparing technologies, establish sensitive and reproducible quality standard.3. Study on preliminary stability in this project.Research methods 1. Procedure:β-cyclodextrin inclusion of the essential oil distilled from Ramulus Cinnamomi and Pericarpium Citri Reticulatae Viride, was low-temperature vacuum dried after being captured. Extract Radix Ginseng, etc. under reflux with ethanol. Extract Radix Astragali, etc. under reflux with aqueous, and then flocculate after vacuum concentrating. Combine the concentrated solutions, dry and comminute to extracting powder. Combine theβ-cyclodextrin inclusion with starch, mix thoroughly, make granules, dry and pack.2. Quality standard: The quality standards include: the Thin layer chromatography (TLC) identification of Radix Stephaniae Tetrandrae, etc.; Limited examine of Aconitine; Content determination of Ginsenoside Rb1 in the preparation assayed by High Performance Liquid Chromatography and Ultraviolet Detector (HPLC-UV); Content determination of Astragaloside IV in the preparation assayed by High Performance Liquid Chromatography and Evaporative Light-Scattering Detector (HPLC-ELSD); appearance, moisture, content uniformity, disintegration limited time, and hygiene check.3. Preliminary stability: Explore sample in normal room temperature with 6 month, and study every examining item of the quality standard. The 0, 1,2,3,6 month'results indicate the stability of this medicine.Results and Conclusion1. Procedure:β-Cyclodextrin inclusion of the essential oil distilled from Ramulus Cinnamomi and Pericarpium Citri Reticulatae Viride about 7 hours, was dried after washing under low-temperature vacuum, which captured in super-saturatedβ-Cyclodextrin solution under 50℃(1.0 hour), and essential oil:β-cyclodextrin: aqueous (1ml: 10g: 120ml) as the percentage;Extract Radix Ginseng, etc. for 3 times under reflux with 70% ethanol for 1 hour, filter and combine the filtrates. Combine Radix Aconiti Lateralis Preparata which decocted first, with Radix Astragali, etc.; extract for 3 times under reflux with aqueous for 1.5 hours, filter and combine the filtrates, using 70% ethanol to flocculate after vacuum concentrating.Combine the concentrated solutions to produce a thick extract with a relative density of 1.30～1.35(55～60℃), vacuum dry at 60℃below. Combine theβ-Cyclodextrin inclusion, extracting powder and starch, mix thoroughly, make granules with 90% ethanol and dry, size stabilize and pack to No."0"capsules.2. Quality standard: Established the Thin layer chromatography (TLC) identification of Radix Stephaniae Tetrandrae, etc., and Limited examine of Aconitine; Content determination Ginsenoside Rb1, Astragaloside IV in the preparation assayed by High performance liquid chromatography (HPLC); and Preparing check being up to the General rule of capsules in Chp. The studies indicated that these methods were reproducible, sufficiently simple, sensitive and reproducible.3. Preliminary stability: Study on the preliminary stability of three batches sample showed they were stable and acceleration studies at low temperature stated that these would be available for two years.4. Conclusion : Systematic researches on procedure, quality standard, and preliminary stability have done for this project. The established technology based on the character of capsules is feasible. Moreover, trial productions validate rationality, stability and safety of preparing technology further.New opinion and Creative production1. Original creative design researches have done for Qiangxin Capsules. Serials researches have done, such as extracting Radix Ginseng with ethanol, extracting Radix Astragali with aqueous, decocting Radix Aconiti Lateralis Preparata first, distilling essential oil and capturing toβ-cyclodextrin inclusion and forming process. So, scientific and feasible procedures were established.2. Around the features of Qiangxin Capsules, quantification study of Ginsenoside Rb1, Astragaloside IV, the standard substances of Radix Ginseng and Radix Astragali, qualitative identification of Ramulus Cinnamomi, Radix et Rhizoma Rhei and Herba Leonuri, etc., have done in quality standard research of this preparation.3. The content of Aconitine, high therapeutic effects and strong side effects substance, have been controlled in Qiangxin Capsules, so it was safe and effective in clinic. And preliminary stability can insure stable and controllable quality.