Baiyunshan No.1 Pharmaceutical Co., Ltd. invested 20 million yuan to carry out multi-dimensional evidence-based verification of Zishenyutai pill

Grasp the favorable factors of the new deal At the end of last year, the decision of the Central Committee of the Communist Party of China on several major issues of comprehensively deepening reform adopted at the Third Plenary Session of the 18th CPC Central Committee was released to the public, in which it was mentioned that "adhere to the basic national policy of family planning, start to implement the policy that couples with one only child can have two children", marking the formal implementation of the policy of "two children only" 2014 is the first year for the state to launch the policy of "two children only", and the number of families applying for two children is increasing Statistics show that there are about 10 million women of suitable age in China who are currently in line with the policy of "having two children by themselves", and about 50% of "single" families intend to have two children This means that a new round of fertility peak may come Medical professionals remind that mothers who have two children need to be more careful when they conceive because of the problems such as old age and cesarean section of the first child, while doctors often take comprehensive consideration of factors such as drug efficacy, ingredients and safety when prescribing Baiyunshan Pharmaceutical Co., Ltd in Guangzhou, which is striving to build a "national gynecology drug production base", has already paid attention to this series of new changes, and invested 20 million yuan to carry out experimental project research on its representative product Zishenyutai pill As a commonly used Chinese patent medicine for the treatment of infertility, Zishenyutai pill has been on the market for more than 30 years In the early 1960s, Professor Luo Yuankai, a famous gynaecologist of traditional Chinese medicine and founder of Lingnan gynaecology academic school, formulated the prescription of Zishen Yutai Pill on the basis of Shoutai Pill (founded by Zhang Xichun, a famous doctor at the end of Qing Dynasty and the beginning of the Republic of China), which is a domestic original research drug recommended in the new version of college teaching materials and diagnosis and treatment guidelines, and a pride of national brand Since then, the basic and clinical research on Zishenyutai pill has been continuously carried out, and evidence-based evidence has been accumulating After many years of clinical practice, it has been proved that the prescription has achieved satisfactory effect in the prevention and treatment of abortion and other gynaecological diseases such as kidney deficiency type Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd., the manufacturer of Zishenyutai pill, is a Chinese time-honored enterprise with a history of more than 350 years, which is subordinate to Guangyao group, the leading state-owned holding large pharmaceutical group in the industry In 2013, the sales volume of Guangyao group reached 54.5 billion yuan In 2014, it is expected to exceed 60 billion yuan By the end of the 13th five year plan, it will exceed 100 billion yuan and become a strategic emerging leading enterprise in China "In the future, more than 20 million yuan will be invested to carry out the research on the basic source, quality standard, technology, efficacy mechanism and clinical application of kidney nourishing and embryo rearing herbs, and strive to build them into a large modern Chinese medicine variety of more than 600 million yuan." Zhang Chunbo, chairman of Baiyunshan No.1 Pharmaceutical Co., Ltd in Guangzhou, said so At present, the product has become the first Chinese medicine for gynecology to carry out evidence-based medicine for assisted reproduction and the first Chinese medicine for gynecology to carry out metabonomics and genomics research Speech by Zou Qi, deputy general manager of Baiyunshan No.1 Pharmaceutical Co., Ltd., Guangzhou Multidimensional evidence-based verification According to Baiyunshan Zhongyi Pharmaceutical Co., Ltd., the research project of Zishenyutai pill is planned to ensure the safety of the drug through the research on safety and toxicology, medicinal material basis, quality standard and technology; confirm the effectiveness of the drug through clinical and mechanism research; reflect the economy of the drug through the research on Pharmacoeconomics, and provide the economic basis for the application of Zishenyutai pill A auxiliary regulation of infertility constitution for female infertility, some researchers pointed out that the standard Chinese medicine treatment is mainly to harmonize qi and blood Yin and Yang, improve the constitution In recent years, studies have confirmed that kidney nourishing and spleen invigorating herbs such as Zishenyutai pill have definite effects in improving the immune regulation of pregnancy, improving the blocking effect, improving the luteal function, increasing the expression of progesterone receptor in decidua, and reducing the excitability of smooth muscle of uterus Xu Haiou et al Studied the application of Zishenyutai pill in ovulation induction of polycystic ovary syndrome As a common gynecological disease, polycystic ovary syndrome (PCOS) can have a variety of clinical manifestations, including irregular menstruation, hirsutism, infertility, etc polycystic ovary leads to infertility due to chronic anovulation, and the risk of endometrial or breast cancer is significantly increased The results show that Zishenyutai pill can effectively promote the development of follicles and induce ovulation, especially with clomiphene, which can improve the ovulation rate, pregnancy rate and reduce the abortion rate It is suggested that Zishenyutai pill can enhance luteal function, improve the internal environment of endometrium and improve the receptivity of endometrium According to one of the most common types of menstrual disorders, luteal dysmenorrhea (LPD) has been studied Due to the lack of progesterone (P) produced by luteal phase of menstruation or the short duration of secretion, luteal premature decline is caused, According to the viewpoint of "treating different diseases with the same treatment" of traditional Chinese medicine, Zhou Zheng et al Made a clinical observation on the treatment of dysmenorrhea of corpus luteum by Zishenyutai pill The results showed that Zishenyutai pill can improve the effect of progesterone P and progesterone / estradiol than that of medroxyprogesterone acetate group It is suggested that Zishenyutai pill can nourish the kidney yin and kidney yang, increase the level of progesterone, adjust the dynamic balance of estrogen and progesterone, promote the development of follicle and ovulation, prolong the corpus luteum, restore the normal menstrual cycle, achieve the purpose of regulating menstruation, and lay a good foundation for pregnancy According to the observation on the pharmacological action of Luo song, the National Committee of Gynecology of traditional Chinese medicine, Zishenyutai pill can also promote the secretion of ovarian hormone and ovulation In this study, the female rabbits were randomly divided into two groups: the administration group and the control group (the whole 26 days) The internal genitals were dissected and taken out, and the changes of uterus and ovary were observed with naked eye and microscope It was found that the blood supply of ovaries and uterus increased significantly, and the ovaries were rich in red body and yellow body, and the endometrial glands increased, and the secretion was obvious B prevention and treatment of habitual / premonitory abortion research on prevention and treatment of habitual abortion and premonitory abortion has also been completed It is disclosed that a study conducted by the first hospital of Peking University, Peking Union Medical College Hospital, Beijing maternity hospital, Peking University People's Hospital, Beijing Xuanwu Hospital, Beijing Haidian maternal and child health care hospital and 301 Hospital of the PLA has observed the efficacy of Zishenyutai pill A total of 231 cases of threatened abortion were observed, including 221 cases in the early stage and 10 cases in the late stage The results showed that the total effective rate of Zishenyutai pill was 91.89% The treatment research conducted by Shuguang Hospital, Longhua Hospital, Ruijin Hospital and Shanghai Hospital of traditional Chinese Medicine Affiliated to Shanghai Second Medical University also reached similar conclusions In this study, 118 cases of early pregnancy threatened abortion were observed, including 88 cases of kidney deficiency type, 24 cases of spleen deficiency type and 6 cases of spleen kidney deficiency type, all of which were within 12 weeks of pregnancy Progesterone and chorionic villi promoting adenohormone were stopped Give 5 grams of Zishenyutai pill three times a day Take it with light salt water or honey water for one month as a course of treatment The results showed that the total effective rate of Zishenyutai pill was 88.98% in the treatment of Early Threatened Abortion of kidney deficiency, spleen deficiency and spleen kidney deficiency At the same time, there are also research reports that Zishenyutai pill can effectively improve the symptoms of vaginal bleeding, low back pain, lower abdominal pain, lower abdominal distention and so on Yuan Hongyu and other researchers carried out a clinical observation on the treatment of Early Threatened Abortion with Zishenyutai pill combined with didroxyprogesterone 80 patients with early threatened abortion were randomly divided into two groups: the treatment group was treated with Zishenyutai pill combined with didroxyprogesterone, and the control group was treated with progesterone injection The cure rate was 95.35% in the treatment group and 81.00% in the control group (P < 0.05) C in the non clinical safety study, considering the attention of doctors and patients on the product safety, Baiyunshan No.1 Pharmaceutical Co., Ltd in Guangzhou, after obtaining the clinical evidence of the effectiveness of the above products, conducted the non clinical safety study on the products It is disclosed that the long-term toxicity test and reproductive toxicity test of Zishenyutai pill have been completed Sun zuyue, a toxicology expert and professor of Fudan University who directed the project, said that the long-term toxicity test was mainly to investigate the possible adverse reactions caused by repeated administration of Zishenyutai pill, as well as the target organs or tissues that produced toxicity According to the long-term toxicity test of dogs for 9 months, there was no significant statistical difference between each dose group and the vehicle control group in general condition, body weight, feeding, ophthalmic examination, body temperature change, urine, ECG, blood pressure, Hematology Index, serum biochemical index, organ weight, pathological section, etc The reproductive toxicity test showed that Zishenyutai pill had no significant effect on body weight, food intake, fertility and reproductive ability, did not cause abnormal development of embryo and fetus, and had no adverse effect on the first / second generation of offspring 。 Since the birth of the world's first in vitro fertilization embryo transfer baby in 1978, human assisted reproductive technology has experienced a rapid development stage The role of drugs in this technology has also attracted the attention of the industry Chinese pharmaceutical industry disclosed that the large sample, multicenter, randomized, double-blind controlled clinical study of Zishenyutai pill in IVF-ET treatment was officially launched in 2013 The research program was completed in accordance with the international standards of evidence-based medicine of Western medicine The purpose of the study was to evaluate the effect of Zishenyutai Pill on ovulation induction and pregnancy outcome of IVF-ET in infertile couples who received IVF / ICSI-ET treatment At present, research and experiment are under way For the research results disclosed at present, some scholars believe that Zishenyutai pill has accumulated rich experience in the treatment of infertility after long-term clinical practice In the clinical application of assisted reproduction, it is suggested that it can improve the implantation rate, improve the quality of egg cells and alleviate the nest hyperstimulation syndrome "However, the clinical application of Zishenyutai pill in assisted reproduction is still in the exploratory stage, and more evidence-based support is still needed It is expected that relevant enterprises can provide more scientific basis for the application of products in assisted reproduction " The future market potential is huge At present, the gynecology market has a very large market capacity and is growing rapidly The infertility market is regarded as the most attractive and development potential in the industry "The incidence rate of infertility in China is 10%~15%, and there are about 20 million couples who have infertility." Analysts pointed out that with the improvement of economic level, the increase of social pressure and the increase of late marriage