1990年用健骨生丸治疗观察了股骨头坏死、骨髓炎、骨结核、窦道不愈合等二十余位患者，取得了较好的效果，为了进一步的认证健骨生丸的效果，只身来到北京协和医院，找到北京协和医院影像科主任严鸿珍教授，请专家对治疗前后患者的影像片的疗效变化进行评价。开始严鸿珍教授感到疑惑，但在认真的看过患者治疗的片子之后，严谨的写下了患者疗效的意见。

In 1990, more than 20 patients with femoral head necrosis, osteomyelitis, bone tuberculosis, and sinus tract non union were treated and observed with  Bone-strengthening Pills, and good results were achieved. In order to further verify the effectiveness of Bone-strengthening Pills, he went to Beijing Union Medical College Hospital alone and found Professor Yan Hongzhen, the director of the imaging department at Beijing Union Medical College Hospital. Experts were asked to evaluate the changes in the efficacy of the patient's imaging before and after treatment. At first, Professor Yan Hongzhen felt puzzled, but after carefully watching the patient's treatment videos, he rigorously wrote down his opinions on the patient's efficacy

 

医学专家到内蒙古实地患者考察。

Medical experts visiting patients in Inner Mongolia for investigation

 

1991年8月，在健骨生丸成果被专家认可后，为了进一步的认证其治疗效果，由全国知名的北京协和医院教授、影像科主任严鸿珍，骨科教授高清兰等6位专家组成考察团专程赴内蒙古哲里木盟医院（通辽市医院）实地考察。在专家的建议下王璐林与通辽市中医医院（三级甲等）联合成立了坏死性骨病治疗中心，收治骨坏死病患者。

In August 1991, after the achievements of Bone-strengthening Pills were recognized by experts, in order to further verify its therapeutic effect, a team of six experts, including Yan Hongzhen, a nationally renowned professor and director of the imaging department at Peking Union Medical College Hospital, and Gao Qinglan, a orthopedic professor, specially visited the Zhelimu League Hospital in Inner Mongolia (Tongliao City Hospital) for on-site investigation. Under the advice of experts, Wang Lulin and Tongliao Traditional Chinese Medicine Hospital (Grade III Grade A) jointly established a treatment center for osteonecrosis, treating patients with osteonecrosis.

  

 

王璐林医学成果鉴定会在北京召开

Wang Lulin Medical Achievement Appraisal Meeting held in Beijing

 

1993年王璐林医学成果鉴定会在北京召开，由国家科委成果司司长刘美生主持，中国中医科学院骨伤科学教授尚天浴，解放军301总医院教授、全国骨科学会主任委员朱盛修、北京协和医院影像学主任严鸿珍，卫生部药政局局长张世臣等13位专家对健骨生丸的疗效给予充分肯定。鉴定意见为对ⅠⅡ期骨坏死疗效显著，Ш有一定疗效，Ⅳ期可以稳定。骨髓炎、骨结核等骨病有疗效。

In 1993, the Wang Lulin Medical Achievement Appraisal Conference was held in Beijing, presided over by Liu Meisheng, Director of the Achievement Department of the National Science and Technology Commission. Thirteen experts, including Shang Tianyu, Professor of Orthopedics and Traumatology at the Chinese Academy of Traditional Chinese Medicine, Zhu Shengxiu, Professor of the 301 General Hospital of the People's Liberation Army and Chairman of the National Orthopedics Society, Yan Hongzhen, Director of Imaging at Peking Union Medical College Hospital, and Zhang Shichen, Director of the Drug Administration of the Ministry of Health, fully affirmed the therapeutic effect of Bone-strengthening Pills . The appraisal opinion is that the therapeutic effect on stage I and II osteonecrosis is significant, Ш It has a certain therapeutic effect and can be stable in stage IV. Osteomyelitis, bone tuberculosis and other bone diseases have therapeuti

 

1996年1月王璐林专家与中国中医科学院北京望京医院联合成立了坏死性骨病中心

In January 1996, expert Wang Lulin and Beijing Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine jointly established the Center for Necrosis Bone Disease

 

按国家保密处方申报国药准字号新药

Applying for National Drug Approval Number New Drugs According to National Confidential Prescriptions

 

1996年3月，健骨生丸按国家保密品种申请国药准字号新药。1997年10月批准国药准字新药。

In March 1996, Jian Gu Sheng Wan applied for a new drug under the national drug registration number according to the national confidential variety. In October 1997, a new drug with the national drug registration number was approved.

 

临床研究：中国工程院院士李连达教授作为审评组的组长。

Clinical research: Professor Li Lianda, academician of the CAE Member, served as the leader of the review team.

 

审评人员有：王和鸣、李同生、孙树椿、石印玉等十余位专家。

The reviewers include more than ten experts, including Wang Heming, Li Tongsheng, Sun Shuchun, and Shi Yinyu.

临床试验基地：中国中医科学院望京医院，上海中医药大学附属曙光医院，湖北省中医药研究院，福建省中医药研究院。

Clinical trial bases: Wangjing Hospital of the Chinese Academy of Traditional Chinese Medicine, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Hubei Academy of Traditional Chinese Medicine, and Fujian Academy of Traditional Chinese Medicine.

参与试验患者疗程6个月，以患者临床症状和X线片、CT的修复变化作为评价依据。对照药品复方丹参片。

The participants in the trial had a course of 6 months, with clinical symptoms and changes in X-ray and CT repair as evaluation criteria. Reference drug compound Danshen tablets.

健骨生丸与复方丹参片进行临床比较，从疗效以及镇痛、功能和跋行改善等方面看，两者经统计学处理有非常显著性差异．试验组总有效率达82.00% ．对照组总有效率为25.00%. 试验组明显优于对照组。

A clinical comparison was made between Jiangusheng Pill and Compound Danshen Tablets, and significant differences were observed in terms of efficacy, pain relief, function, and postoperative improvement after statistical analysis. The total effective rate of the experimental group was 82.00%, while the total effective rate of the control group was 25.00% The experimental group was significantly better than the control group.

临床实验证明 健骨生无毒副作用，是一种治疗股骨头坏死的好药。

Experiments have shown that Jiangu Sheng has no toxic side effects and is a good medicine for treating femoral head necrosis.

 

动物实验研究结果：

Animal experimental research results:

由中国中医科学院药理研究室对健骨生丸的动物实验进行了研究

Animal experiments on Bone-strengthening Pill were conducted by the Pharmacology Laboratory of the Chinese Academy of Traditional Chinese Medicine

组长为陈燕萍主任教授。进行了急性毒性试验和慢性毒性试验和药效学研究。

The team leader is Professor Chen Yanping. Acute toxicity tests, chronic toxicity tests, and pharmacological studies were conducted.

实验表明，健骨生丸可以(1)丰富股骨头毛细血管分布; (2)减少骨细胞内的脂肪沉积; (3)改善与骨生长相关的生化环境，提高骨矿化沉积速率。并有较好的抗衰老和抗炎作用。由于这些因素的综合作用，健骨生丸具有促进骨生长，增加骨密度，恢复股骨头的血运，抑制和逆转变性、发炎、损伤、坏死的骨细胞和软骨细胞，加速坏死骨的再生和修复。

Experiments have shown that Jian Gu Sheng Wan can (1) enrich the distribution of capillaries in the femoral head; (2) Reduce fat deposition within bone cells; (3) Improve the biochemical environment related to bone growth and increase the rate of bone mineralization deposition. And it has good anti-aging and anti-inflammatory effects. Due to the combined effects of these factors, Bone-strengthening Pill can promote bone growth, increase bone density, restore blood circulation of the femoral head, inhibit and reverse degeneration, inflammation, injury, and necrosis of bone cells and chondrocytes, and accelerate the regeneration and repair of necrotic bone.

图注：组织图片显示骨坏死大鼠服健骨剂后恢复正常

Figure: The bone-strengthening pill (BSP) reduces osteonecrotic changes in osteonecrosis of the femoral head (ONFH) in rats. Histological observations of the femoral head are shown. 

 

图A 正常大鼠股骨头表面光滑，软骨细胞呈柱状排列；图B.模型鼠股骨头表面坏死脱落，塌陷缺损，软骨细胞消失；图C.骨坏死服健骨生股骨头表面光滑，软骨细胞呈柱状排列，未见缺损；图D.模型大鼠可见骨小梁卷曲、紊乱、断裂；

图F.健骨生丸组，骨小梁丰富，形态正常；

图E. 模型大鼠股骨头内髓细胞灶性坏死；

图G. 健骨生丸组髓细胞未见坏死；

图H.正常大鼠软骨细胞表面附着少量脂肪颗粒；图I.模型大鼠股骨头软骨细胞内有大量脂肪颗粒；

图J.健骨生丸组股骨头内见少量脂肪颗粒；

图K.正常大鼠股骨头毛细血管丰富，边缘清晰，交织成网，形成“弓状杯”；

图L.模型大鼠股骨头内毛细细血管稀疏，“弓状杯”消失；

图M.健骨生丸大鼠的股骨头毛细血管明显增加，边缘清晰，“弓状杯”恢复。

 

   (A) The surface of the femoral head is smooth and the cartilage cells show columnar growth pattern. (B) The surface of the femoral head is necrotic and shredded. Collapse and defectsare observed. (C) The surface of the femoral head is smooth and the cartilage cells show columnar growth pattern. (D) Curvature, disturbance, and rupture of bone trabecula are observed. (E) There is abundant distribution of bone trabecula, which has a normal structure. (F) Focal necrosis of marrow cells. (G) No necrosis of marrow cells is observed. (H) A few fat particles adhering to the surface of the cartilage cells were observed. (I) A large amount of fat particles are observed inside the cartilage cells. (J) A few fat particles adhering to the surface of the cartilage cells were observed. (K) Abundant capillaries with clear marginsare observed to form a capillary network and arcuate cup. (L) The capillaries were sparse inside the femoral head and the arcuate cupdisappeared. (M) There was a significant increase in capillaries inside the femoral head with clear margins, with recovery of the arcuate cup.

   Table 1A: BSP reduces osteonecrotic changes in ONFH rats

 

《骨坏死病新药健骨生丸问世暨北京匡达制药厂成立大会》在北京人民大会堂召开

The launch of a new drug for osteonecrosis, Bone-strengthening Pill, and the establishment of Beijing Kuangda Pharmaceutical Factory were held at the Great Hall of the People in Beijing

1998年1月12日，在北京人民大会堂召开了《骨坏死病新药健骨生丸问世暨北京匡达制药厂成立大会》，全国人大副委员长布赫、吴阶平、曹志，卫生部部长张文康、国家中医药管理局房书亭局长，北京协和医院邱贵兴院士，中国中医科学院李连达院士、尚天浴教授，301医院骨科主任朱盛修、张伯勋等骨科界的三百余位专家的到会祝贺。CCTV新闻联播，新华社，人民日报社等百余家新闻媒体进行了报道。

More than 300 experts from the orthopedic community, including Vice Chairman of the National People's Congress Bu He, Wu Jieping, Cao Zhi, Minister of Health Zhang Wenkang, Director of the State Administration of Traditional Chinese Medicine Fang Shuting, Academician Qiu Guixing of Peking Union Medical College Hospital, Academician Li Lianda and Professor Shang Tianyu of the Chinese Academy of Medical Sciences, and Director of the Department of Orthopedics at 301 Hospital Zhu Shengxiu and Zhang Boxun, attended the conference to congratulate the launch of the new drug TCM Bone-strengthening Pills for osteonecrosis and the establishment of Beijing Kuangda Pharmaceutical Factory. CCTV News Network, Xinhua News Agency, People's Daily and other news media reported.

这是会场的一角

This is a corner of the venue

 

王璐林专家（左三）和全国人大副委员长布赫（右二）、吴阶平（左二）、曹志（右一），前卫生部部长钱信忠（左一）合影。

Expert Wang Lulin (third from left) and Vice Chairman of the National People's Congress Buhe (second from right), Wu Jieping (second from left), Cao Zhi (first from right), and former Minister of Health Qian Xinzhong (first from left) take a group photo.

 

北京协和医院邱贵兴院士，中国中医科学院李连达院士、尚天浴教授等参会照片

Photos of Academician Qiu Guixing from Peking Union Medical College Hospital, Academician Li Lianda from the Chinese Academy of Traditional Chinese Medicine, and Professor Shang Tianyu attending the conference

 

在俄罗斯圣彼得堡中医药论坛讨会上与会专家对健骨生丸治疗骨坏死病疗效给予高度的评价。

Experts attending the Orthopedic Symposium in St. Petersburg, Russia gave high praise to the treatment of osteonecrosis with TCM Bone-strengthening Pills .